SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
OF THE SECURITIES EXCHANGE ACT OF 1934
[X] | ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
OR
[ ] | TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
Commission file number 0-28272
Delaware | 13-3647113 | |||||
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(State or other jurisdiction of incorporation or organization) | (I.R.S. Employer Identification No.) |
Alameda, California 94502
including area code)
Common Stock, $.001 par value
Page | ||||||||||
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PART I | ||||||||||
Item 1. | Business | 2 | ||||||||
Item 1A. | Risk Factors | 11 | ||||||||
Item 1B. | Unresolved Staff Comments | 19 | ||||||||
Item 2. | Properties | 19 | ||||||||
Item 3. | Legal Proceedings | 19 | ||||||||
Item 4. | Submission of Matters to a Vote of Security Holders | 19 | ||||||||
PART II | ||||||||||
Item 5. | Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities | 21 | ||||||||
Item 6. | Selected Financial Data | 22 | ||||||||
Item 7. | Management’s Discussion and Analysis of Financial Condition and Results of Operations | 23 | ||||||||
Item 7A. | Quantitative and Qualitative Disclosures About Market Risk | 34 | ||||||||
Item 8. | Financial Statements and Supplementary Data | 35 | ||||||||
Item 9. | Changes in and Disagreements with Accountants on Accounting and Financial Disclosure | 63 | ||||||||
Item 9A. | Controls and Procedures | 63 | ||||||||
Item 9B. | Other Information | 65 | ||||||||
PART III | ||||||||||
Item 10. | Directors and Executive Officers of the Registrant | 65 | ||||||||
Item 11. | Executive Compensation | 65 | ||||||||
Item 12. | Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters | 65 | ||||||||
Item 13. | Certain Relationships and Related Transactions | 66 | ||||||||
Item 14. | Principal Accountant Fees and Services | 66 | ||||||||
PART IV | ||||||||||
Item 15. | Exhibits and Financial Statement Schedules | 66 | ||||||||
SIGNATURES | . | 70 |
• | the potential of our product development programs, including AV650 for neuromuscular spasm and spasticity, AV411 for neuropathic pain, and AV513 for the treatment of multiple bleeding disorders, including hemophilia; |
• | our expectations with respect to the clinical development of our product candidates, our clinical trials and the regulatory approval process, including the potential acceleration of clinical development in the U.S. of our two lead product development programs that are based on compounds with prior experience in human clinical trials outside the U.S.; |
• | our intention to submit Investigational New Drug filings (INDs) to the FDA regarding AV650 and AV411; |
• | our expectations relating to our selection of additional disease targets for compounds we are developing; |
• | our expectations with regard to our ability to expand our drug development portfolio through a combination of internal research, acquisitions, and in-licensing opportunities from third parties; |
• | our expectations regarding our receipt of future revenues based on the development success by Genzyme Corporation in developing and commercializing gene therapy products based on rights included in our assignment agreement; |
• | our expectations regarding expense savings and cash burn rate resulting from the reduction in our staff level, consolidation of operations, and the sublease of portions of our facilities; and |
• | our expectations regarding our capital requirements, how long our current financial resources will last, and our needs for additional financing. |
Item 1. | Business |
• | Entered into an agreement with Genzyme Corporation in December 2005, conveying patent rights and other assets related to our previously developed gene therapy technologies in exchange for an initial payment of $12.0 million, potential future development-based milestones, sublicensing fees and royalty payments, and certain diligence commitments from Genzyme; |
• | Completed an in-license agreement in January 2006 for North American rights to AV650 for neuromuscular spasm and spasticity with a division of Sanochemia, an Austrian-based pharmaceutical company; |
• | Reduced operating expenses associated with prior gene therapy activities by reducing staff and subleasing portions of our facilities, and |
• | Published data from AV513, our drug candidate for hemophilia, which was highlighted by an editorial in the January 2006 edition of “Thrombosis and Haemostasis.” |
the University of Colorado at Boulder, we believe that certain specialized cells in the nervous system known as “glial cells” or “glia”, rather than other nervous system cells known as “neurons” or “nerve cells”, are important mediators of neurological pain states. Neurons have long been considered the sole cell types responsible for the development and maintenance of neuropathic pain. Glia traditionally have been disregarded as being little more than supporting cells for neurons. However, recent research has demonstrated that glia enhance the release of neurotransmitters that relay pain information to the spinal cord, and, as is even more strikingly, release substances that increase the excitability of pain-responsive neurons in the spinal cord. These substances, called pro-inflammatory cytokines, create and maintain exaggerated or pathological pain responses. Blocking the activation of glia has been shown in preclinical models to reduce pro-inflammatory cytokines and reverse pathological pain.
financial and other resources and larger research and development and clinical and regulatory affairs staffs. We expect our products, if approved, will face competition from both branded pharmaceuticals and generic compounds. In addition, colleges, universities, governmental agencies and other public and private research organizations continue to conduct research and are becoming more active in seeking patent protection and licensing arrangements to collect royalties for use of technologies that they have developed. We also must compete with these institutions in recruiting highly qualified scientific personnel. Some of our competitors’ products and technologies are in direct competition with ours. In addition, we are aware that physicians may utilize other products in an off-label manner for the treatment of disorders we attempt to target.
• | continued scientific progress in research and development programs; |
• | the scope and results of preclinical studies and clinical trials; |
• | the time and costs involved in obtaining regulatory approvals; |
• | the costs involved in filing, prosecuting and enforcing patent claims and other intellectual property rights; |
• | the costs involved in obtaining licenses to patented technologies from third parties that may be needed to commercialize our products; |
• | how successful, if at all, we are at expanding our drug development portfolio through a combination of internal research, acquisitions, and in-licensing compounds, and the nature of the consideration we pay for acquiring or in-licensing compounds; |
• | competing technological developments; |
• | the cost of manufacturing for clinical trials and commercialization; |
• | the cost of commercialization activities; and |
• | other factors which may not be within our control. |
additional funds by issuing equity securities there may be further dilution to existing stockholders. We cannot assure our investors that we will be able to enter into such financing arrangements on acceptable terms or at all. Without such additional funding, we may be required to delay, reduce the scope of, or eliminate one or more of our research or development programs.
whether any legislative or regulatory proposals will be adopted or the effect that such potential proposals or managed care efforts may have on our business.
know-how or other proprietary information. In addition, the laws of certain foreign countries do not protect our intellectual property rights to the same extent as do the laws of the United States. We cannot assure you that we will be able to protect our intellectual property successfully.
to us. Termination of any of our license agreements could harm our business and force us to cease our activities with the affected product candidate or technology.
• | technological innovations or regulatory approvals; |
• | results of clinical trials; |
• | new products by us or our competitors; |
• | developments or disputes concerning patents or proprietary rights; |
• | achievement or failure to achieve certain developmental milestones; |
• | public concern as to the safety of pharmaceutical products; |
• | health care or reimbursement policy changes by governments or insurance companies; |
• | developments of significant acquisitions or in relationships with corporate partners; |
• | announcements by us regarding financing transactions and/or future sales of equity securities; or |
• | changes in financial estimates or securities analysts’ recommendations. |
Name | Age | Position | ||||||||
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Kenneth G. Chahine, J.D., Ph.D. | 41 | President, Chief Executive Officer and Director | ||||||||
Michael D. Coffee | 60 | Chief Business Officer | ||||||||
Dawn McGuire, M.D. | 52 | Chief Medical Officer | ||||||||
Kirk Johnson, Ph.D. | 46 | Vice President, Preclinical Research | ||||||||
M. Christina Thomson, J.D. | 35 | Vice President, Corporate Counsel and Secretary | ||||||||
Andrew A. Sauter | 39 | Vice President, Finance |
scientist post at the University of Utah Department of Human Genetics from 1994 to 1996. Dr. Chahine served as western regional news and legal correspondent forNature Biotechnology from 1996 to 2002. Dr. Chahine holds a J.D. from the University of Utah and a Ph.D. in biochemistry and molecular biology from the University of Michigan.
Item 5. | Market for Registrants Common Equity, Related Stockholder Matters, and Issuer Purchases of Equity Securities |
Year ended December 31, 2004 | High | Low | ||||||||
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Quarter End 3/31/04 | $ | 7.93 | $ | 5.29 | ||||||
Quarter End 6/30/04 | $ | 5.40 | $ | 3.00 | ||||||
Quarter End 9/30/04 | $ | 3.79 | $ | 3.12 | ||||||
Quarter End 12/31/04 | $ | 3.77 | $ | 3.15 |
Year ended December 31, 2005 | High | Low | ||||||||
---|---|---|---|---|---|---|---|---|---|---|
Quarter End 3/31/05 | $ | 3.25 | $ | 2.78 | ||||||
Quarter End 6/30/05 | $ | 3.54 | $ | 2.78 | ||||||
Quarter End 9/30/05 | $ | 3.70 | $ | 2.63 | ||||||
Quarter End 12/31/05 | $ | 3.27 | $ | 2.70 |
Year Ended December 31, | ||||||||||||||||||||||||||||||||
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Statement of Operations Data: (in thousands, except share and per share amounts) | 2005 | 2004 | 2003 | 2002 | 2001 | (1) Six Months Ended December 31, 2001 | Fiscal Year Ended June 30, 2001 | Period from October 22, 1992 (inception) through December 31, 2005 | ||||||||||||||||||||||||
(unaudited) | ||||||||||||||||||||||||||||||||
Revenue | $ | 12,026 | $ | 2,195 | $ | 463 | $ | 57 | $ | 94 | $ | 8 | $ | 116 | $ | 15,471 | ||||||||||||||||
Operating expenses: | ||||||||||||||||||||||||||||||||
Research and development | 13,775 | 19,344 | 21,805 | 24,809 | 22,333 | 11,465 | 17,041 | 141,280 | ||||||||||||||||||||||||
General and administrative | 8,264 | 8,367 | 7,399 | 8,146 | 7,559 | 3,957 | 6,761 | 60,454 | ||||||||||||||||||||||||
Impairment loss related to long-lived assets | 6,130 | — | — | — | — | — | — | 6,130 | ||||||||||||||||||||||||
In-license fees | — | — | — | — | — | — | — | 5,034 | ||||||||||||||||||||||||
Total operating expenses | 28,169 | 27,711 | 29,204 | 32,955 | 29,892 | 15,422 | 23,802 | 212,898 | ||||||||||||||||||||||||
Loss from operations | (16,143 | ) | (25,516 | ) | (28,741 | ) | (32,898 | ) | (29,798 | ) | (15,414 | ) | (23,686 | ) | (197,427 | ) | ||||||||||||||||
Interest expense | (323 | ) | (209 | ) | (250 | ) | (278 | ) | (347 | ) | (204 | ) | (180 | ) | (2,703 | ) | ||||||||||||||||
Interest income | 1,682 | 1,905 | 3,282 | 5,569 | 9,364 | 4,316 | 7,907 | 28,992 | ||||||||||||||||||||||||
Other income (expense), net | 88 | (103 | ) | (65 | ) | (132 | ) | (68 | ) | (17 | ) | (55 | ) | (137 | ) | |||||||||||||||||
Net loss | $ | (14,696 | ) | $ | (23,923 | ) | $ | (25,774 | ) | $ | (27,739 | ) | $ | (20,849 | ) | $ | (11,319 | ) | $ | (16,014 | ) | $ | (171,275 | ) | ||||||||
Basic and diluted net loss per common share | $ | (0.71 | ) | $ | (1.17 | ) | $ | (1.28 | ) | $ | (1.38 | ) | $ | (1.05 | ) | $ | (0.57 | ) | $ | (0.85 | ) | |||||||||||
Shares used in basic and diluted net loss per common share calculation | 20,624,229 | 20,362,155 | 20,149,214 | 20,080,998 | 19,845,640 | 19,959,941 | 18,730,437 |
December 31, | June 30, | ||||||||||||||||||||||||||
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Balance Sheet Data: (in thousands) | 2005 | 2004 | 2003 | 2002 | 2001 (1) | 2001 | |||||||||||||||||||||
Cash, cash equivalents, available-for-sale securities and restricted investments | $ | 70,388 | $ | 76,218 | $ | 98,878 | $ | 119,224 | $ | 148,254 | $ | 157,737 | |||||||||||||||
Working capital | 59,649 | 63,873 | 86,051 | 107,398 | 137,486 | 151,341 | |||||||||||||||||||||
Total assets | 76,264 | 90,507 | 116,595 | 140,686 | 168,409 | 174,946 | |||||||||||||||||||||
Long-term obligations | 9,282 | 9,064 | 10,592 | 8,852 | 8,558 | 5,391 | |||||||||||||||||||||
Deficit accumulated during development stage | (171,275 | ) | (156,579 | ) | (132,656 | ) | (106,882 | ) | (79,143 | ) | (67,823 | ) | |||||||||||||||
Stockholders’ equity | 65,464 | 79,875 | 103,886 | 130,057 | 157,350 | 167,182 |
(1) | We changed our fiscal year end from June 30 to December 31, effective December 31, 2001. |
Item 7. | Management’s Discussion and Analysis of Financial Condition and Results of Operations |
of the development-phase time period changes, the amount of revenue we recognize related to up-front payments for a given period will accelerate or decrease accordingly. For example, in March 2003, we received a $2.5 million payment from Bayer under the terms of a collaboration agreement for Coagulin-B, a gene therapy product candidate for hemophilia. The revenue associated with the payment was being recognized ratably over the development phase, which was initially estimated to be five years. In May 2004, we suspended subject enrollment in the phase I clinical trial for this product candidate and, as a result, ended the development phase for this product candidate and recognized as revenue $2.0 million, constituting the portion of the $2.5 million payment not previously recognized as revenue, during the quarter ended June 30, 2004.
• | the length of time and the extent to which the market value of the security has been less than cost; |
• | the financial condition and near-term prospects of the issuer; and |
• | our intention and ability to retain our investment in the issuer for a period of time sufficient to allow for any anticipated recovery in market value, which could be until maturity. |
• | failure of manufacturing facilities and equipment to comply with government mandated policies and procedures; |
• | failure of the product candidates for which the manufacturing facilities have been constructed to receive regulatory approval; and |
• | the extent that facilities could be idled or abandoned due to a decrease in the scope of our research and development activities for an other-than-temporary period, resulting in excess capacity. |
Year Ended December 31, | |||||||||||||||
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(In thousands, except percentages) | 2005 | 2004 | 2003 | ||||||||||||
Revenue | $ | 12,026 | $ | 2,195 | $ | 463 | |||||||||
Percentage increase over prior period | 448 | % | 374 | % |
technologies in products for commercial sale. Royalty revenue totaled $3,200, $5,800 and $9,000 during 2005, 2004, and 2003, respectively, and was attributed to a single royalty license that was entered into in July 2000, which allowed for the development, manufacture, use and commercial sale of research products using our patented AAV technologies.
Year Ended December 31, | ||||||||||||||||||||||
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(In thousands, except percentages) | 2005 | 2004 | Percentage decrease 2005 over 2004 | Year Ended December 31, 2003 | Percentage decrease 2004 over 2003 | |||||||||||||||||
Research and preclinical development | $ | 9,350 | $ | 12,612 | (26 | )% | $ | 13,450 | (6 | )% | ||||||||||||
Clinical development | 4,425 | 6,732 | (34 | )% | 8,355 | (19 | )% | |||||||||||||||
Total research and development expenses | $ | 13,775 | $ | 19,344 | (29 | )% | $ | 21,805 | (11 | )% |
Year Ended December 31, | |||||||||||||||
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(In thousands) | 2005 | 2004 | 2003 | ||||||||||||
Personnel-related | $ | 2,938 | $ | 4,880 | $ | 5,015 | |||||||||
External research and development | 582 | 1,544 | 2,113 | ||||||||||||
Other expenses including facilities overhead and depreciation | 5,830 | 6,188 | 6,322 | ||||||||||||
Total research and preclinical development expenses | $ | 9,350 | $ | 12,612 | $ | 13,450 |
• | lower personnel-related expenses of $1.9 million, reflecting the impact of a significantly lower average staff level as a result of staff reductions in July 2004 and August 2005, partially offset by higher average salaries and higher severance expense in 2005, |
• | lower expenditures for external research and development services from third-party collaborators associated with our preclinical animal studies of $1.0 million, primarily related to our completion of significant preclinical work with Parkinson’s disease in 2004 as it transitioned into a clinical development phase, and |
• | lower other expenses of $358,000, primarily reflecting a decrease in depreciation charges as a result of the write-down of the cost basis of our long-lived assets during the year due to impairment. |
• | lower expenditures for external research and development services from third-party collaborators associated with our preclinical animal studies of $569,000, primarily related to our completion of a significant portion of our preclinical work with Parkinson’s disease in 2003 and a reduction in preclinical work associated with other gene therapy projects, primarily due to our lower staff levels in 2004, |
• | lower personnel-related expenses of $135,000, primarily reflecting a lower average staff count as a result of the staff reduction in July 2004 and lower recruiting and relocation expenses reflecting a decline in hiring and the use of relocation payment incentives in 2004 compared to 2003, partially offset by higher severance expenses paid to employees affected by the staff reduction in 2004 and higher bonus expenses in 2004, and |
• | lower other expenses of $134,000, primarily reflecting lower materials expenses due to a decrease in our consumption of materials to produce AAV vectors and support our other on-going research activities as a result of the transfer of our Parkinson’s program into a clinical development phase, and the general impact of our lower staff levels in 2004. |
Year Ended December 31, | |||||||||||||||
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(In thousands) | 2005 | 2004 | 2003 | ||||||||||||
Personnel-related | $ | 1,343 | $ | 2,189 | $ | 2,709 | |||||||||
External research and development | 543 | 660 | 435 | ||||||||||||
Other expenses including facilities overhead and depreciation | 2,539 | 3,883 | 5,211 | ||||||||||||
Total clinical development expenses | $ | 4,425 | $ | 6,732 | $ | 8,355 |
• | lower personnel-related expenses of $846,000, reflecting a significantly lower average staff level as a result of staff reductions in July 2004 and August 2005 and lower severance-related costs, partially offset by higher average salaries in 2005, and |
• | lower other expenses of $1.3 million, primarily due to a decrease in depreciation charges as a result of the write-down of the cost basis of our long-lived assets during the year due to impairment, a decrease in the amounts of materials consumed in 2005 compared to the prior year in connection with the production of clinical-grade AAV vectors to support the needs of our clinical trials, and a decrease in other costs associated with our transition out of gene-therapy related activities. |
• | lower other expenses of $1.3 million, primarily reflecting lower license origination fees, including $97,000 of non-cash charges in connection with the issuance of warrants in 2003, and lower materials expenses reflecting lower levels of material consumed in 2004 for the production of clinical grade AAV vectors due to the delayed needs of our development programs at the clinical development stage, and |
• | lower personnel-related expenses of $520,000, reflecting a lower average staff level, partially offset by higher severance expenses paid to employees affected by the staff reduction in 2004, |
• | higher expenditures for external clinical development services from third-party collaborators associated with recruiting and treating subjects in our clinical trials of $225,000, primarily related to regulatory costs associated with the filing for FDA approval and recruiting of our first subject in our phase I/II clinical trial for AV201, our gene-therapy-based product candidate for the treatment of Parkinson’s disease. |
Year Ended December 31, | |||||||||||||||
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(In thousands, except percentages) | 2005 | 2004 | 2003 | ||||||||||||
Personnel-related | $ | 3,434 | $ | 3,162 | $ | 3,244 | |||||||||
Legal and professional fees | 2,219 | 1,450 | 1,497 | ||||||||||||
Non-recurring severance | 22 | 1,022 | — | ||||||||||||
Other expenses including facilities overhead and depreciation | 2,589 | 2,733 | 2,658 | ||||||||||||
Total general and administrative expenses | $ | 8,264 | $ | 8,367 | $ | 7,399 | |||||||||
Percentage (decrease) increase over prior period | (1 | %) | 13 | % |
• | lower severance expenses of $1.0 million, primarily related to severance expense accrued in March 2004 in connection with the resignation of our former CEO, and |
• | lower other expenses of $144,000, including savings from lower corporate insurance premiums, |
• | higher legal and professional fees of $769,000, primarily related to an increase in costs associated with being a public company and increased use of third-party business consultants, and |
• | higher personnel-related expenses of $272,000, reflecting higher average salaries and bonuses, partially offset by a slightly lower staff level in 2005. |
Year Ended December 31, | |||||||||||||||
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(In thousands) | 2005 | 2004 | 2003 | ||||||||||||
Impairment loss related to long-lived assets | $ | 6,130 | $ | — | $ | — |
Year Ended December 31, | |||||||||||||||
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(In thousands, except percentages) | 2005 | 2004 | 2003 | ||||||||||||
Interest income | $ | 1,682 | $ | 1,905 | $ | 3,282 | |||||||||
Percentage decrease over prior period | (12 | %) | (42 | %) |
decrease in our outstanding interest-bearing cash and securities balances, due to the use of such resources to fund our on-going operations during the year, partially offset by a rising average yield earned on our portfolio of investments. The decline in interest income between 2004 and 2003 was due to the decrease in our outstanding interest-bearing cash and securities balance combined with a declining average yield earned on our portfolio of investments during the period.
$1.5 million in restricted investments at December 31, 2005, was directly associated with the reduction in our pledge to collateralize certain equipment operating leases. At December 31, 2005 and 2004, the portion of our investment portfolio pledged as collateral, which we refer to as restricted investments, includes $10.0 million for our line of credit and approximately $428,000 for letters of credit which serve as security deposits on a building lease. Our restricted investments would not be considered a current source of additional liquidity.
Payments Due by Period | |||||||||||||||||||
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Contractual Commitment | Total | Less than 1 year | 2-3 years | 4-5 years | |||||||||||||||
Operating leases | $ | 10,153 | $ | 2,437 | $ | 4,550 | $ | 3,166 | |||||||||||
Sublease income | (1,989 | ) | (532 | ) | (966 | ) | (491 | ) | |||||||||||
Net operating leases | 8,164 | 1,905 | 3,584 | 2,675 | |||||||||||||||
Revolving line of credit | 8,000 | — | 8,000 | — | |||||||||||||||
Research funding for third-parties | 510 | 510 | — | — | |||||||||||||||
Total | $ | 16,674 | $ | 2,415 | $ | 11,584 | $ | 2,675 |
• | continued scientific progress in research and development programs; |
• | the scope and results of preclinical studies and clinical trials; |
• | the time and costs involved in obtaining regulatory approvals; |
• | the costs involved in filing, prosecuting and enforcing patents claims and other intellectual property rights; |
• | the costs involved in obtaining licenses to patented technologies from third-parties that may be needed to commercialize our product candidates; |
• | competing technological developments; |
• | the cost of manufacturing our product candidates for clinical trials and sales; |
• | the costs of marketing and commercialization activities; |
• | how successful, if at all, we are at acquiring or in-licensing additional compounds, and the nature of the consideration we pay for acquired or in-licensed compounds; and |
• | other factors which may not be within our control. |
the existing shelf registration agreement is approximately $26.4 million. If we raise additional funds by issuing equity securities, there may be further dilution to existing stockholders. We cannot assure our investors that we will be able to enter into such financing arrangements on acceptable terms or at all. Without such additional funding, we may be required to delay, reduce the scope of, or eliminate one or more of our research or development programs.
Page | ||||||
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Report of Independent Registered Public Accounting Firm | 36 | |||||
Balance Sheets | 37 | |||||
Statements of Operations | 38 | |||||
Statements of Stockholders’ Equity | 39 | |||||
Statements of Cash Flows | 45 | |||||
Notes to Financial Statements | 46 |
March 14, 2006
(a development stage company)
(in thousands, except share and per share information)
December 31, | |||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|
2005 | 2004 | ||||||||||
ASSETS | |||||||||||
Current Assets: | |||||||||||
Cash and cash equivalents | $ | 11,510 | $ | 3,217 | |||||||
Available-for-sale securities | 48,450 | 61,073 | |||||||||
Accrued interest | 470 | 708 | |||||||||
Prepaid expenses and other current assets | 737 | 443 | |||||||||
Total current assets | 61,167 | 65,441 | |||||||||
Restricted investments | 10,428 | 11,928 | |||||||||
Property and equipment, net | 3,929 | 12,497 | |||||||||
Deposits and other assets | 740 | 641 | |||||||||
Total assets | $ | 76,264 | $ | 90,507 | |||||||
LIABILITIES AND STOCKHOLDERS’ EQUITY | |||||||||||
Current Liabilities: | |||||||||||
Accounts payable and other accrued liabilities | $ | 984 | $ | 641 | |||||||
Accrued compensation and related expenses | 534 | 927 | |||||||||
Total current liabilities | 1,518 | 1,568 | |||||||||
Long-term loan payable | 8,000 | 8,000 | |||||||||
Deferred rent and other liabilities | 1,282 | 1,064 | |||||||||
Commitments | |||||||||||
Stockholders’ equity: | |||||||||||
Preferred Stock, $0.001 par value, 5,000,000 shares authorized, none issued and outstanding in 2005 and 2004 | — | — | |||||||||
Common Stock, $0.001 par value, 50,000,000 shares authorized, and 20,907,273 and 20,381,250 shares issued and outstanding at December 31, 2005 and 2004, respectively | 21 | 20 | |||||||||
Additional paid-in capital | 237,258 | 236,959 | |||||||||
Accumulated other comprehensive loss | (540 | ) | (525 | ) | |||||||
Deficit accumulated during development stage | (171,275 | ) | (156,579 | ) | |||||||
Total stockholders’ equity | 65,464 | 79,875 | |||||||||
Total liabilities and stockholders’ equity | $ | 76,264 | $ | 90,507 |
(a development stage company)
(in thousands, except for share and per share information)
Year Ended December 31, | Period from October 22, 1992 (inception) through | ||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
2005 | 2004 | 2003 | December 31, 2005 | ||||||||||||||||
Revenue | $ | 12,026 | $ | 2,195 | $ | 463 | $ | 15,471 | |||||||||||
Operating expenses: | |||||||||||||||||||
Research and development | 13,775 | 19,344 | 21,805 | 141,280 | |||||||||||||||
General and administrative | 8,264 | 8,367 | 7,399 | 60,454 | |||||||||||||||
Impairment loss related to long-lived assets | 6,130 | — | — | 6,130 | |||||||||||||||
In-license fees | — | — | — | 5,034 | |||||||||||||||
Total operating expenses | 28,169 | 27,711 | 29,204 | 212,898 | |||||||||||||||
Loss from operations | (16,143 | ) | (25,516 | ) | (28,741 | ) | (197,427 | ) | |||||||||||
Interest expense | (323 | ) | (209 | ) | (250 | ) | (2,703 | ) | |||||||||||
Interest income | 1,682 | 1,905 | 3,282 | 28,992 | |||||||||||||||
Other income (expense), net | 88 | (103 | ) | (65 | ) | (137 | ) | ||||||||||||
Net loss | $ | (14,696 | ) | $ | (23,923 | ) | $ | (25,774 | ) | $ | (171,275 | ) | |||||||
Basic and diluted net loss per common share | $ | (0.71 | ) | $ | (1.17 | ) | $ | (1.28 | ) | ||||||||||
Shares used in basic and diluted net loss per common share calculation | 20,624,229 | 20,362,155 | 20,149,214 |
(a development stage company)
(in thousands, except for share information)
Preferred Stock | Common Stock | Class B Convertible Common Stock | ||||||||||||||||||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Shares | Amount | Shares | Amount | Shares | Amount | Additional Paid-in Capital | Accumulated Other Comprehensive Gain (Loss) | Deficit Accumulated During the Development Stage | Total Stockholders’ Equity | |||||||||||||||||||||||||||||||
Balance at October 22, 1992 (inception) | — | $ | — | — | $ | — | — | $ | — | $ | — | $ | — | $ | — | $ | — | |||||||||||||||||||||||
Issuance of common stock at $.004 per share in November and December 1992 | — | — | 896,062 | 1 | — | — | 4 | — | — | 5 | ||||||||||||||||||||||||||||||
Issuance of common stock at $.554 per share from January to June 1993 for services rendered | — | — | 20,316 | — | — | — | 11 | — | — | 11 | ||||||||||||||||||||||||||||||
Issuance of common stock at $.004 to $.222 per share from November 1992 to March 1993 for cash | — | — | 1,003,406 | 1 | — | — | 54 | — | — | 55 | ||||||||||||||||||||||||||||||
Issuance of Class B common stock at $.004 per share in December 1992 for cash | — | — | — | — | 90,293 | — | 1 | — | — | 1 | ||||||||||||||||||||||||||||||
Issuance of Series A preferred stock at $4.43 per share from March to June 1993 for cash (net of issuance costs of $410,900) | 678,865 | 1 | — | — | — | — | 2,595 | — | — | 2,596 | ||||||||||||||||||||||||||||||
Issuance of Series A preferred stock at $3.85 per share in March 1993 for cancellation of note payable and accrued interest | 68,991 | — | — | — | — | — | 266 | — | — | 266 | ||||||||||||||||||||||||||||||
Issuance of common stock at $.004 per share in November 1993 pursuant to antidilution rights | — | — | 22,869 | — | — | — | 1 | — | — | 1 | ||||||||||||||||||||||||||||||
Issuance of Series A preferred stock at $4.43 per share from July to November 1993 for cash and receivable (net of issuance costs of $187,205) | 418,284 | — | — | — | — | — | 1,665 | — | — | 1,665 | ||||||||||||||||||||||||||||||
Issuance of Series B preferred stock at $5.54 per share in March 1994 for cash (net of issuance costs of $34,968) | 128,031 | — | — | — | — | — | 674 | — | — | 674 | ||||||||||||||||||||||||||||||
Issuance of Series C preferred stock at $4.87 per share from July 1994 to June 1995 for cash and receivables (net of issuance costs of $259,620) | 739,655 | 1 | — | — | — | — | 3,344 | — | — | 3,345 | ||||||||||||||||||||||||||||||
Issuance of Series C preferred stock at $4.87 per share in June 1995 for cancellation of notes payable | 35,500 | — | — | — | — | — | 173 | — | — | 173 | ||||||||||||||||||||||||||||||
Net loss and comprehensive loss from inception to June 30, 1995 | — | — | — | — | — | — | — | — | (8,608 | ) | (8,608 | ) | ||||||||||||||||||||||||||||
Balance at June 30, 1995 (carried forward) | 2,069,326 | $ | 2 | 1,942,653 | $ | 2 | 90,293 | $ | — | $ | 8,788 | $ | — | $ | (8,608 | ) | $ | 184 |
(a development stage company)
(in thousands, except for share information)
Preferred Stock | Common Stock | Class B Convertible Common Stock | ||||||||||||||||||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Shares | Amount | Shares | Amount | Shares | Amount | Additional Paid-in Capital | Accumulated Other Comprehensive Gain (Loss) | Deficit Accumulated During the Development Stage | Total Stockholders’ Equity | |||||||||||||||||||||||||||||||
Balance at June 30, 1995 (brought forward) | 2,069,326 | $ | 2 | 1,942,653 | $ | 2 | 90,293 | $ | — | $ | 8,788 | $ | — | $ | (8,608 | ) | $ | 184 | ||||||||||||||||||||||
Issuance of Series C preferred stock at $4.87 per share in July 1995 for cash (net of issuance costs of $26,000) | 41,042 | — | — | — | — | — | 174 | — | — | 174 | ||||||||||||||||||||||||||||||
Issuance of Series D preferred stock at $7.09 per share from October 1995 to February 1996 for cash (net of issuance costs of $25,279) | 205,351 | — | — | — | — | — | 1,430 | — | — | 1,430 | ||||||||||||||||||||||||||||||
Issuance of Series D preferred stock at $7.09 per share in March 1996 in settlement of accounts payable | 22,574 | — | — | — | — | — | 160 | — | — | 160 | ||||||||||||||||||||||||||||||
Issuance of common stock at $.004 per share in March 1996 pursuant to antidilution rights | — | — | 17,630 | — | — | — | 1 | — | — | 1 | ||||||||||||||||||||||||||||||
Issuance of stock options in February 1996 in settlement of certain accrued liabilities | — | — | — | — | — | — | 137 | — | — | 137 | ||||||||||||||||||||||||||||||
Conversion of Class B common stock to common stock | — | — | 231,304 | 1 | (90,293 | ) | — | (1 | ) | — | — | — | ||||||||||||||||||||||||||||
Issuance of warrants to purchase common stock in connection with 1996 bridge financing in March 1996 | — | — | — | — | — | — | 300 | — | — | 300 | ||||||||||||||||||||||||||||||
Conversion of preferred stock to common stock in May 1996 | (2,338,293 | ) | (2 | ) | 2,355,753 | 2 | — | — | (1 | ) | — | — | (1 | ) | ||||||||||||||||||||||||||
Issuance of common stock at $8.00 per share in connection with the May 1996 initial public offering (net of issuance costs of $798,414 and underwriting discount of $1,500,000) | — | — | 2,500,000 | 2 | — | — | 17,699 | — | — | 17,701 | ||||||||||||||||||||||||||||||
Proceeds from exercise of options at $0.44 per share in June 1996 | — | — | 6,178 | — | — | — | 3 | — | — | 3 | ||||||||||||||||||||||||||||||
Repurchase of common stock | — | — | (18,325 | ) | — | — | — | (1 | ) | — | — | (1 | ) | |||||||||||||||||||||||||||
Deferred compensation | — | — | — | — | — | — | 164 | — | — | 164 | ||||||||||||||||||||||||||||||
Amortization of deferred compensation | — | — | — | — | — | — | (128 | ) | — | — | (128 | ) | ||||||||||||||||||||||||||||
Net loss and comprehensive loss | — | — | — | — | — | — | — | — | (4,097 | ) | (4,097 | ) | ||||||||||||||||||||||||||||
Balance at June 30, 1996 (carried forward) | — | $ | — | 7,035,193 | $ | 7 | — | $ | — | $ | 28,725 | $ | — | $ | (12,705 | ) | $ | 16,027 |
(a development stage company)
(in thousands, except for share information)
Preferred Stock | Common Stock | Class B Convertible Common Stock | ||||||||||||||||||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Shares | Amount | Shares | Amount | Shares | Amount | Additional Paid-in Capital | Accumulated Other Comprehensive Gain (Loss) | Deficit Accumulated During the Development Stage | Total Stockholders’ Equity | |||||||||||||||||||||||||||||||
Balance at June 30, 1996 (brought forward) | — | $ | — | 7,035,193 | $ | 7 | — | $ | — | $ | 28,725 | $ | — | $ | (12,705 | ) | $ | 16,027 | ||||||||||||||||||||||
Issuance of common stock at $8.00 per share in July 1996 in connection with the exercise of underwriters’ over-allotment option (net of underwriting discount of $150,000) | — | — | 250,000 | — | — | — | 1,850 | — | — | 1,850 | ||||||||||||||||||||||||||||||
Proceeds from exercise of options at $0.44 to $0.71 per share | — | — | 3,387 | — | — | — | 1 | — | — | 1 | ||||||||||||||||||||||||||||||
Amortization of deferred compensation | — | — | — | — | — | — | 41 | — | — | 41 | ||||||||||||||||||||||||||||||
Net loss and comprehensive loss | — | — | — | — | — | — | — | — | (5,578 | ) | (5,578 | ) | ||||||||||||||||||||||||||||
Balance at June 30, 1997 | — | — | 7,288,580 | 7 | — | — | 30,617 | — | (18,283 | ) | 12,341 | |||||||||||||||||||||||||||||
Proceeds from exercise of options at $0.44 to $0.71 per share | — | — | 17,278 | — | — | — | 10 | — | — | 10 | ||||||||||||||||||||||||||||||
Amortization of deferred compensation | — | — | — | — | — | — | 41 | — | — | 41 | ||||||||||||||||||||||||||||||
Compensation expense related to options granted for services | — | — | — | — | — | — | 68 | — | — | 68 | ||||||||||||||||||||||||||||||
Net loss and comprehensive loss | — | — | — | — | — | — | — | — | (8,877 | ) | (8,877 | ) | ||||||||||||||||||||||||||||
Balance at June 30, 1998 | — | — | 7,305,858 | 7 | — | — | 30,736 | — | (27,160 | ) | 3,583 | |||||||||||||||||||||||||||||
Proceeds from exercise of options at $0.44 to $4.31 per share | — | — | 181,045 | — | — | — | 222 | — | — | 222 | ||||||||||||||||||||||||||||||
Amortization of deferred compensation | — | — | — | — | — | — | 41 | — | — | 41 | ||||||||||||||||||||||||||||||
Issuance of common stock at $2.25–$2.94 per share and warrants in August to September 1998 in connection with a Private Placement (net of issuance cost of $233,584) | — | — | 1,306,505 | 1 | — | — | 2,734 | — | — | 2,735 | ||||||||||||||||||||||||||||||
Issuance of common stock at $3.81–$4.88 per share and warrants in December 1998 in connection with a Private Placement (net of issuance cost of $438,183) | — | — | 1,367,280 | 2 | — | — | 5,195 | — | — | 5,197 | ||||||||||||||||||||||||||||||
Issuance of common stock at $5.50–$6.00 per share and warrants in February to April 1999 in connection with a Private Placement (net of issuance cost of $1,033,225) | — | — | 2,198,210 | 2 | — | — | 12,154 | — | — | 12,156 | ||||||||||||||||||||||||||||||
Net loss and comprehensive loss | — | — | — | — | — | — | — | — | (9,611 | ) | (9,611 | ) | ||||||||||||||||||||||||||||
Balance at June 30, 1999 (carried forward) | — | $ | — | 12,358,898 | $ | 12 | — | $ | — | $ | 51,082 | $ | — | $ | (36,771 | ) | $ | 14,323 |
(a development stage company)
(in thousands, except for share information)
Preferred Stock | Common Stock | Class B Convertible Common Stock | ||||||||||||||||||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Shares | Amount | Shares | Amount | Shares | Amount | Additional Paid-in Capital | Accumulated Other Comprehensive Gain (Loss) | Deficit Accumulated During the Development Stage | Total Stockholders’ Equity | |||||||||||||||||||||||||||||||
Balance at June 30, 1999 (brought forward) | — | $ | — | 12,358,898 | $ | 12 | — | $ | — | $ | 51,082 | $ | — | $ | (36,771 | ) | $ | 14,323 | ||||||||||||||||||||||
Proceeds from exercise of options at $0.44 to $15.50 | — | — | 440,259 | 1 | — | — | 1,533 | — | — | 1,534 | ||||||||||||||||||||||||||||||
Proceeds from exercise of warrants at $2.81 to $31.95 | — | — | 1,017,215 | 1 | — | — | 8,427 | — | — | 8,428 | ||||||||||||||||||||||||||||||
Amortization of deferred compensation | — | — | — | — | — | — | 5 | — | — | 5 | ||||||||||||||||||||||||||||||
Compensation expense related to options granted for services | — | — | — | — | — | — | 89 | — | — | 89 | ||||||||||||||||||||||||||||||
Warrants granted for patent licenses | — | — | — | — | — | — | 3,182 | — | — | 3,182 | ||||||||||||||||||||||||||||||
Warrants granted for building lease | — | — | — | — | — | — | 1,738 | — | — | 1,738 | ||||||||||||||||||||||||||||||
Issuance of common stock at $16.19 to $25.56 per share and warrants in October and November 1999 in connection with a Private Placement (net of issuance cost of $2,804,255) | — | — | 2,033,895 | 2 | — | — | 37,220 | — | — | 37,222 | ||||||||||||||||||||||||||||||
Issuance of common stock at $26 per share in April and May 2000 in connection with a Public Offering (net of issuance cost of $2,288,966) | — | — | 1,150,000 | 1 | — | — | 27,610 | — | — | 27,611 | ||||||||||||||||||||||||||||||
Comprehensive loss: | ||||||||||||||||||||||||||||||||||||||||
Net loss | — | — | — | — | — | — | — | — | (15,039 | ) | (15,039 | ) | ||||||||||||||||||||||||||||
Net unrealized loss on available-for-sale securities | — | — | — | — | — | — | — | (80 | ) | — | (80 | ) | ||||||||||||||||||||||||||||
Comprehensive loss | (15,119 | ) | ||||||||||||||||||||||||||||||||||||||
Balance at June 30, 2000 (carried forward) | — | $ | — | 17,000,267 | $ | 17 | — | $ | — | $ | 130,886 | $ | (80 | ) | $ | (51,810 | ) | $ | 79,013 |
(a development stage company)
(in thousands, except for share information)
Preferred Stock | Common Stock | Class B Convertible Common Stock | ||||||||||||||||||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Shares | Amount | Shares | Amount | Shares | Amount | Additional Paid-in Capital | Accumulated Other Comprehensive Gain (Loss) | Deficit Accumulated During the Development Stage | Total Stockholders’ Equity | |||||||||||||||||||||||||||||||
Balance at June 30, 2000 (brought forward) | — | $ | — | 17,000,267 | $ | 17 | — | $ | — | $ | 130,886 | $ | (80 | ) | $ | (51,810 | ) | $ | 79,013 | |||||||||||||||||||||
Proceeds from exercise of options at $0.44 to $34.00 per share | — | — | 165,700 | — | — | — | 869 | — | — | 869 | ||||||||||||||||||||||||||||||
Proceeds from exercise of warrants at $2.18 to $23.43 | — | — | 174,255 | 1 | — | — | 771 | — | — | 772 | ||||||||||||||||||||||||||||||
Compensation expense related to options granted for services | — | — | — | — | — | — | 336 | — | — | 336 | ||||||||||||||||||||||||||||||
Issuance of common stock at $37.50 to $45.06 per share in November 2000 Public Offering (net of issuance cost of $4,622,188) | — | — | 2,291,239 | 2 | — | — | 86,084 | — | — | 86,086 | ||||||||||||||||||||||||||||||
Issuance of common stock at $47.82 per share in February 2001 pursuant to a collaboration agreement | — | — | 313,636 | — | — | — | 15,000 | — | — | 15,000 | ||||||||||||||||||||||||||||||
Comprehensive loss: | ||||||||||||||||||||||||||||||||||||||||
Net loss | — | — | — | — | — | — | — | — | (16,014 | ) | (16,014 | ) | ||||||||||||||||||||||||||||
Net unrealized gain on available-for-sale securities | — | — | — | — | — | — | — | 1,120 | — | 1,120 | ||||||||||||||||||||||||||||||
Comprehensive loss | (14,894 | ) | ||||||||||||||||||||||||||||||||||||||
Balance at June 30, 2001 | — | — | 19,945,097 | 20 | — | — | 233,946 | 1,040 | (67,824 | ) | 167,182 | |||||||||||||||||||||||||||||
Proceeds from exercise of options at $2.13 to $6.75 per share | — | — | 11,282 | — | — | — | 60 | — | — | 60 | ||||||||||||||||||||||||||||||
Proceeds from exercise of warrants $7.50 per share | — | — | 9,955 | — | — | — | 75 | — | — | 75 | ||||||||||||||||||||||||||||||
Compensation expense related to options granted for services | — | — | — | — | — | — | 179 | — | — | 179 | ||||||||||||||||||||||||||||||
Comprehensive loss: | ||||||||||||||||||||||||||||||||||||||||
Net loss | — | — | — | — | — | — | — | — | (11,319 | ) | (11,319 | ) | ||||||||||||||||||||||||||||
Net unrealized gain on available-for-sale securities | — | — | — | — | — | — | — | 1,173 | — | 1,173 | ||||||||||||||||||||||||||||||
Comprehensive loss | (10,146 | ) | ||||||||||||||||||||||||||||||||||||||
Balance at December 31, 2001 | — | — | 19,966,334 | 20 | — | — | 234,260 | 2,213 | (79,143 | ) | 157,350 | |||||||||||||||||||||||||||||
Proceeds from exercise of options at $1.875 to $8.525 per share | — | — | 34,627 | — | — | — | 113 | — | — | 113 | ||||||||||||||||||||||||||||||
Proceeds from exercise of warrants at $7.50 per share | — | — | 99,585 | — | — | — | 747 | — | — | 747 | ||||||||||||||||||||||||||||||
Compensation expense related to options granted for services | — | — | — | — | — | — | 217 | — | — | 217 | ||||||||||||||||||||||||||||||
Comprehensive loss: | ||||||||||||||||||||||||||||||||||||||||
Net loss | — | — | — | — | — | — | — | — | (27,739 | ) | (27,739 | ) | ||||||||||||||||||||||||||||
Net unrealized loss on available-for-sale securities | — | — | — | — | — | — | — | (631 | ) | — | (631 | ) | ||||||||||||||||||||||||||||
Comprehensive loss | (28,370 | ) | ||||||||||||||||||||||||||||||||||||||
Balance at December 31, 2002 (carried forward) | — | $ | — | 20,100,546 | $ | 20 | — | $ | — | $ | 235,337 | $ | 1,582 | $ | (106,882 | ) | $ | 130,057 |
(a development stage company)
(in thousands, except for share information)
Preferred Stock | Common Stock | Class B Convertible Common Stock | ||||||||||||||||||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Shares | Amount | Shares | Amount | Shares | Amount | Additional Paid-in Capital | Accumulated Other Comprehensive Gain (Loss) | Deficit Accumulated During the Development Stage | Total Stockholders’ Equity | |||||||||||||||||||||||||||||||
Balance at December 31, 2002 (brought forward) | — | $ | — | 20,100,546 | $ | 20 | — | $ | — | $ | 235,337 | $ | 1,582 | $ | (106,882 | ) | $ | 130,057 | ||||||||||||||||||||||
Proceeds from exercise of options at $2.12 to $6.50 per share | — | — | 63,746 | — | — | — | 242 | — | — | 242 | ||||||||||||||||||||||||||||||
Proceeds from exercise of warrants at $2.47 to $6.09 per share | — | — | 112,102 | — | — | — | 476 | — | — | 476 | ||||||||||||||||||||||||||||||
Compensation expense related to options granted for services | — | — | — | — | — | — | 65 | — | — | 65 | ||||||||||||||||||||||||||||||
Comprehensive loss: | ||||||||||||||||||||||||||||||||||||||||
Net loss | — | — | — | — | — | — | — | — | (25,774 | ) | (25,774 | ) | ||||||||||||||||||||||||||||
Net unrealized loss on available-for-sale securities | — | — | — | — | — | — | — | (1,180 | ) | — | (1,180 | ) | ||||||||||||||||||||||||||||
Comprehensive loss | (26,954 | ) | ||||||||||||||||||||||||||||||||||||||
Balance at December 31, 2003 | — | — | 20,276,394 | 20 | — | — | 236,120 | 402 | (132,656 | ) | 103,886 | |||||||||||||||||||||||||||||
Proceeds from exercise of options at $0.443 to $6.313 per share | — | — | 86,856 | — | — | — | 403 | — | — | 403 | ||||||||||||||||||||||||||||||
Proceeds from exercise of warrants at $6.05 per share | — | — | 18,000 | — | — | — | 109 | — | — | 109 | ||||||||||||||||||||||||||||||
Compensation expense related to options granted for services | — | — | — | — | — | — | 230 | — | — | 230 | ||||||||||||||||||||||||||||||
Warrants granted for patent licenses | — | — | — | — | — | — | 97 | — | — | 97 | ||||||||||||||||||||||||||||||
Comprehensive loss: | ||||||||||||||||||||||||||||||||||||||||
Net loss | — | — | — | — | — | — | — | — | (23,923 | ) | (23,923 | ) | ||||||||||||||||||||||||||||
Net unrealized loss on available-for-sale securities | — | — | — | — | — | — | — | (927 | ) | — | (927 | ) | ||||||||||||||||||||||||||||
Comprehensive loss | (24,850 | ) | ||||||||||||||||||||||||||||||||||||||
Balance at December 31, 2004 | — | — | 20,381,250 | 20 | — | — | 236,959 | (525 | ) | (156,579 | ) | 79,875 | ||||||||||||||||||||||||||||
Proceeds from exercise of options at $0.487 to $3.53 per share | — | — | 526,023 | 1 | — | — | 286 | — | — | 287 | ||||||||||||||||||||||||||||||
Compensation expense related to options granted for services | — | — | — | — | — | — | 13 | — | — | 13 | ||||||||||||||||||||||||||||||
Comprehensive loss: | ||||||||||||||||||||||||||||||||||||||||
Net loss | — | — | — | — | — | — | — | — | (14,696 | ) | (14,696 | ) | ||||||||||||||||||||||||||||
Net unrealized loss on available-for-sale securities | — | — | — | — | — | — | — | (15 | ) | — | (15 | ) | ||||||||||||||||||||||||||||
Comprehensive loss | (14,711 | ) | ||||||||||||||||||||||||||||||||||||||
Balance at December 31, 2005 | — | $ | — | 20,907,273 | $ | 21 | — | $ | — | $ | 237,258 | $ | (540 | ) | $ | (171,275 | ) | $ | 65,464 |
(a development stage company)
(in thousands)
Year Ended December 31, | ||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
2005 | 2004 | 2003 | Period from October 22, 1992 (inception) through December 31, 2005 | |||||||||||||||
Operating Activities | ||||||||||||||||||
Net loss | $ | (14,696 | ) | $ | (23,923 | ) | $ | (25,774 | ) | $ | (171,275 | ) | ||||||
Adjustments to reconcile net loss to net cash used in operating activities: | ||||||||||||||||||
Depreciation and amortization | 2,549 | 3,610 | 3,640 | 18,526 | ||||||||||||||
Gain on disposal of property and equipment | (65 | ) | — | — | (65 | ) | ||||||||||||
Impairment loss related to long-lived assets | 6,130 | — | — | 6,130 | ||||||||||||||
Amortization of deferred compensation | — | — | — | 164 | ||||||||||||||
Non-cash rent expense for warrants issued in connection with the extension of the building lease | 217 | 217 | 217 | 1,266 | ||||||||||||||
Amortization of deferred rent | 3 | 97 | 115 | 954 | ||||||||||||||
Non-cash compensation expense for common stock, warrants, and stock options issued for services | 13 | 230 | 65 | 1,718 | ||||||||||||||
Warrants issued for patent license | — | — | — | 3,182 | ||||||||||||||
Changes in operating assets and liabilities: | ||||||||||||||||||
Accrued interest | 238 | 66 | 219 | (286 | ) | |||||||||||||
Prepaid expenses and other current assets | �� | (294 | ) | 1 | 14 | (921 | ) | |||||||||||
Deposits and other assets | (316 | ) | — | 210 | (342 | ) | ||||||||||||
Accounts payable, other accrued liabilities and accrued compensation and related expenses | 167 | 49 | (160 | ) | 2,245 | |||||||||||||
Deferred revenue | — | (2,125 | ) | 2,125 | — | |||||||||||||
Net cash used in operating activities | $ | (6,054 | ) | $ | (21,778 | ) | $ | (19,329 | ) | $ | (138,704 | ) | ||||||
Investing Activities | ||||||||||||||||||
Purchases of property and equipment | (277 | ) | (467 | ) | (555 | ) | (28,455 | ) | ||||||||||
Proceeds from disposal of property and equipment | 231 | — | — | 231 | ||||||||||||||
Decrease (increase) in restricted investments | 1,500 | — | (428 | ) | (10,428 | ) | ||||||||||||
Purchases of available-for-sale securities | (66,475 | ) | (79,670 | ) | (84,129 | ) | (771,560 | ) | ||||||||||
Maturities of available-for-sale securities | 79,082 | 102,236 | 98,228 | 722,571 | ||||||||||||||
Net cash provided by (used in) investing activities | 14,061 | 22,099 | 13,116 | (87,641 | ) | |||||||||||||
Financing Activities | ||||||||||||||||||
Proceeds from long-term obligations | — | — | — | 10,133 | ||||||||||||||
Repayment of long-term obligations | — | — | — | (1,710 | ) | |||||||||||||
Proceeds from bridge financing | — | — | — | 1,937 | ||||||||||||||
Repayment of bridge financing | — | — | — | (2,131 | ) | |||||||||||||
Payments on capital lease obligations | — | — | — | (2,154 | ) | |||||||||||||
Proceeds from sale-leaseback of equipment | — | — | — | 1,927 | ||||||||||||||
Proceeds from issuance preferred stock, net of issuance costs | — | — | — | 9,885 | ||||||||||||||
Proceeds from warrants and options exercised | 286 | 512 | 718 | 14,349 | ||||||||||||||
Proceeds from issuance of common stock, net of issuance costs and repurchases | — | — | — | 205,619 | ||||||||||||||
Net cash provided by financing activities | 286 | 512 | 718 | 237,855 | ||||||||||||||
Net increase (decrease) in cash and cash equivalents | 8,293 | 833 | (5,495 | ) | 11,510 | |||||||||||||
Cash and cash equivalents, beginning of period | 3,217 | 2,384 | 7,879 | — | ||||||||||||||
Cash and cash equivalents, end of period | $ | 11,510 | $ | 3,217 | $ | 2,384 | $ | 11,510 | ||||||||||
Supplemental disclosure | ||||||||||||||||||
Issuance of warrants in connection with building lease extension | $ | — | $ | — | $ | — | $ | 1,738 | ||||||||||
Issuance of preferred stock for cancellation of accounts payable, notes payable and accrued interest | — | — | — | 499 | ||||||||||||||
Issuance of stock options for repayment of certain accrued liabilities | — | — | — | 137 | ||||||||||||||
Issuance of warrants in connection with bridge financing | — | — | — | 300 | ||||||||||||||
Issuance of warrants in connection with the extension of the building lease | — | — | — | 1,738 | ||||||||||||||
Deferred compensation related to stock option grants | — | — | — | 164 | ||||||||||||||
Purchase of property and equipment under capital lease financing | — | — | — | 226 | ||||||||||||||
Cash paid for interest | $ | 323 | $ | 209 | $ | 250 | $ | 2,210 |
(a development stage company)
NOTES TO FINANCIAL STATEMENTS
1. | Summary of Significant Accounting Policies |
(a development stage company)
NOTES TO FINANCIAL STATEMENTS — (Continued)
(a development stage company)
NOTES TO FINANCIAL STATEMENTS — (Continued)
(a development stage company)
NOTES TO FINANCIAL STATEMENTS — (Continued)
(a development stage company)
NOTES TO FINANCIAL STATEMENTS — (Continued)
Year Ended December 31, | |||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
2005 | 2004 | 2003 | |||||||||||||
Potential dilutive stock options outstanding | 273,667 | 530,731 | 554,852 | ||||||||||||
Outstanding securities excluded from the potential dilutive common shares calculation (1) | 3,756,850 | 3,970,588 | 4,512,838 |
(1) | For purposes of computing the potential dilutive common shares, we have excluded outstanding stock options and warrants to purchase common stock whose exercise prices exceed the average of the closing sale prices of our common stock as reported on the NASDAQ National Market for the period. |
(a development stage company)
NOTES TO FINANCIAL STATEMENTS — (Continued)
Year Ended December 31, | |||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
2005 | 2004 | 2003 | |||||||||||||
Net loss — as reported | $ | (14,696 | ) | $ | (23,923 | ) | $ | (25,774 | ) | ||||||
Add: Stock-based employee compensation included in reported net loss | — | 220 | 28 | ||||||||||||
Less: Total stock-based employee compensation expense determined under the fair-value-based method for all awards | (2,219 | ) | (6,637 | ) | (9,941 | ) | |||||||||
Net loss — pro forma | $ | (16,915 | ) | $ | (30,340 | ) | $ | (35,687 | ) | ||||||
Net loss per common share basic and diluted — as reported | $ | (0.71 | ) | $ | (1.17 | ) | $ | (1.28 | ) | ||||||
Net loss per common share basic and diluted — pro forma | $ | (0.82 | ) | $ | (1.49 | ) | $ | (1.77 | ) |
(a development stage company)
NOTES TO FINANCIAL STATEMENTS — (Continued)
Year Ended December 31, | |||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
2005 | 2004 | 2003 | |||||||||||||
Expected volatility | 0.6670 | 0.8110 | 0.8343 | ||||||||||||
Risk free interest rate | 4.05 | % | 3.43 | % | 2.97 | % | |||||||||
Expected life of options in years | 4.5 | 5 | 5 | ||||||||||||
Expected dividend yield | — | — | — |
2. | Cash, Available-for-Sale Securities and Restricted Investments |
Cost | Gross Unrealized Gains | Gross Unrealized Losses | Fair Value | |||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Cash | $ | 11,510 | $ | — | $ | — | $ | 11,510 | ||||||||||
Corporate debt securities | 21,415 | — | (197 | ) | 21,218 | |||||||||||||
Federal agency obligations | 26,013 | — | (306 | ) | 25,707 | |||||||||||||
Asset-backed and other securities | 9,882 | 5 | (24 | ) | 9,863 | |||||||||||||
Treasury obligations | 2,108 | — | (18 | ) | 2,090 | |||||||||||||
Total | $ | 70,928 | $ | 5 | $ | (545 | ) | $ | 70,388 | |||||||||
Amounts reported as: | ||||||||||||||||||
Cash and cash equivalents | $ | 11,510 | $ | — | $ | — | $ | 11,510 | ||||||||||
Restricted investments | 10,428 | — | — | 10,428 | ||||||||||||||
Available for sale securities | 48,990 | 5 | (545 | ) | 48,450 | |||||||||||||
Total | $ | 70,928 | $ | 5 | $ | (545 | ) | $ | 70,388 |
(a development stage company)
NOTES TO FINANCIAL STATEMENTS — (Continued)
Cost | Gross Unrealized Gains | Gross Unrealized Losses | Fair Value | |||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Cash | $ | 3,217 | $ | — | $ | — | $ | 3,217 | ||||||||||
Corporate debt securities | 33,438 | 1 | (210 | ) | 33,229 | |||||||||||||
Federal agency obligations | 27,362 | — | (248 | ) | 27,114 | |||||||||||||
Asset-backed and other securities | 3,200 | — | (34 | ) | 3,166 | |||||||||||||
Auction rate certificates | 3,350 | — | — | 3,350 | ||||||||||||||
Treasury obligations | 6,176 | — | (34 | ) | 6,142 | |||||||||||||
Total | $ | 76,743 | $ | 1 | $ | (526 | ) | $ | 76,218 | |||||||||
Amounts reported as: | ||||||||||||||||||
Cash and cash equivalents | $ | 3,217 | $ | — | $ | — | $ | 3,217 | ||||||||||
Restricted investments | 11,928 | — | — | 11,928 | ||||||||||||||
Available-for-sale securities | 61,598 | 1 | (526 | ) | 61,073 | |||||||||||||
Total | $ | 76,743 | $ | 1 | $ | (526 | ) | $ | 76,218 |
Less Than 12 Months | 12 Months or Greater | ||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Gross Unrealized Losses | Estimated Fair Value | Gross Unrealized Losses | Estimated Fair Value | ||||||||||||||||
December 31, 2005 | |||||||||||||||||||
Corporate debt securities | $ | (108 | ) | $ | 11,246 | $ | (88 | ) | $ | 8,883 | |||||||||
Federal agency obligations | (101 | ) | 12,789 | (205 | ) | 12,918 | |||||||||||||
Asset-backed and other securities | (4 | ) | 996 | (20 | ) | 5,385 | |||||||||||||
Treasury obligations | (8 | ) | 1,201 | (11 | ) | 889 | |||||||||||||
Total | $ | (221 | ) | $ | 26,232 | $ | (324 | ) | $ | 28,075 |
Less Than 12 Months | 12 Months or Greater | ||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Gross Unrealized Losses | Estimated Fair Value | Gross Unrealized Losses | Estimated Fair Value | ||||||||||||||||
December 31, 2004 | |||||||||||||||||||
Corporate debt securities | $ | (96 | ) | $ | 18,844 | $ | (114 | ) | $ | 13,532 | |||||||||
Federal agency obligations | (50 | ) | 8,434 | (199 | ) | 18,680 | |||||||||||||
Asset-backed and other securities | (34 | ) | 2,885 | — | — | ||||||||||||||
Treasury obligations | (25 | ) | 4,848 | (8 | ) | 1,294 | |||||||||||||
Total | $ | (205 | ) | $ | 35,011 | $ | (321 | ) | $ | 33,506 |
(a development stage company)
NOTES TO FINANCIAL STATEMENTS — (Continued)
3. | Property and Equipment |
December 31, | |||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|
2005 | 2004 | ||||||||||
Leasehold improvements | $ | 6,742 | $ | 18,439 | |||||||
Laboratory equipment | 1,551 | 6,930 | |||||||||
Office furniture and equipment | 1,702 | 2,301 | |||||||||
9,995 | 27,670 | ||||||||||
Less accumulated depreciation and amortization | (6,066 | ) | (15,173 | ) | |||||||
Property and equipment, net | $ | 3,929 | $ | 12,497 |
4. | Impairment Loss related to Long-Lived Assets |
(a development stage company)
NOTES TO FINANCIAL STATEMENTS — (Continued)
5. | Termination Costs Associated with Exit Activities |
6. | Collaboration Agreement — Bayer Corporation |
7. | AAV Gene Therapy Assignment Agreement — Genzyme Corporation |
8. | Loan Payable |
(a development stage company)
NOTES TO FINANCIAL STATEMENTS — (Continued)
capacity from the line of credit to secure a letter of credit. The letter of credit was established pursuant to the terms required under a ten-year property lease entered into in November 2000, and was issued in favor of the property owner. As a result of the cash borrowings and the establishment of the letter of credit, we did not have any remaining borrowing capacity under the line of credit at December 31, 2005.
9. | Stockholders’ Equity |
(a development stage company)
NOTES TO FINANCIAL STATEMENTS — (Continued)
December 31, 2005 | ||||||
---|---|---|---|---|---|---|
Stock options outstanding | 3,487,254 | |||||
Stock options available for grant | 4,798,546 | |||||
Warrants to purchase common stock | 15,000 | |||||
Shares available for Employee Stock Purchase Plan | 360,000 | |||||
8,660,800 |
10. | Stock Options and Stock Purchase Plan |
(a development stage company)
NOTES TO FINANCIAL STATEMENTS — (Continued)
were 3,500,000 shares authorized for grant under the 1996 Plan. Under the 1996 Plan, incentive stock options may be granted at a price per share not less than the fair market value at the date of grant, and nonqualified stock options may be granted at a price per share not less than 85% of the fair market value at the date of grant. Options granted generally have a maximum term of 10 years from the grant date and become exercisable over four years. At December 31, 2005, there were options to purchase 1,213,161 shares outstanding under the 1996 Plan and 1,537,137 shares available for grant. This Plan is scheduled to expire in March 2006. At that time, the Plan would no longer have any options available for future grant.
(a development stage company)
NOTES TO FINANCIAL STATEMENTS — (Continued)
Outstanding Options | |||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|
Number of Shares | Weighted-Average Exercise Price per Share | ||||||||||
Outstanding at December 31, 2002 | 4,144,488 | 14.31 | |||||||||
Granted | 685,800 | 3.73 | |||||||||
Canceled | (404,100 | ) | 16.21 | ||||||||
Exercised | (63,746 | ) | 3.81 | ||||||||
Outstanding at December 31, 2003 | 4,362,442 | 12.62 | |||||||||
Granted | 1,111,150 | 3.92 | |||||||||
Canceled | (962,008 | ) | 14.63 | ||||||||
Exercised | (86,856 | ) | 4.63 | ||||||||
Outstanding at December 31, 2004 | 4,424,728 | 10.16 | |||||||||
Granted | 658,366 | 3.17 | |||||||||
Canceled | (1,069,817 | ) | 8.25 | ||||||||
Exercised | (526,023 | ) | 0.54 | ||||||||
Outstanding at December 31, 2005 | 3,487,254 | 10.87 |
Options Outstanding | Options Exercisable | ||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Range of Exercise Prices | Number Of Shares | Weighted- Average Remaining Contractual Life | Weighted- Average Exercise Price | Number Of Shares | Weighted- Average Exercise Price | ||||||||||||||||||
$ 0.71 – $ 3.13 | 469,633 | 8.09 | $ | 2.85 | 147,916 | $ | 2.59 | ||||||||||||||||
3.14 – 3.31 | 180,929 | 7.96 | $ | 3.20 | 51,737 | $ | 3.26 | ||||||||||||||||
3.38 – 3.38 | 365,625 | 8.48 | $ | 3.38 | 124,999 | $ | 3.38 | ||||||||||||||||
3.45 – 3.53 | 458,362 | 7.42 | $ | 3.50 | 199,813 | $ | 3.52 | ||||||||||||||||
3.63 – 6.00 | 362,950 | 4.29 | $ | 4.93 | 302,286 | $ | 5.04 | ||||||||||||||||
6.16 – 8.53 | 459,249 | 6.60 | $ | 7.42 | 310,577 | $ | 7.70 | ||||||||||||||||
8.88 – 14.36 | 124,374 | 5.92 | $ | 10.77 | 123,492 | $ | 10.77 | ||||||||||||||||
14.63 – 14.63 | 496,632 | 4.22 | $ | 14.63 | 496,632 | $ | 14.63 | ||||||||||||||||
15.44 – 38.19 | 527,000 | 3.74 | $ | 33.20 | 527,000 | $ | 33.20 | ||||||||||||||||
40.75 – 47.63 | 42,500 | 4.51 | $ | 43.99 | 42,500 | $ | 43.99 | ||||||||||||||||
$ 0.71 – $47.63 | 3,487,254 | 6.12 | $ | 10.87 | 2,326,952 | $ | 14.42 |
(a development stage company)
NOTES TO FINANCIAL STATEMENTS — (Continued)
11. | Employee Profit Sharing/401(k) Plan |
12. | Commitments and Sublease Accounting |
Minimum Lease Commitments | Sublease Income | Net Lease Commitments | ||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Year ending December 31: | ||||||||||||||
2006 | $ | 2,437 | $ | (532 | ) | $ | 1,905 | |||||||
2007 | 2,543 | (574 | ) | 1,969 | ||||||||||
2008 | 2,007 | (392 | ) | 1,615 | ||||||||||
2009 | 1,624 | (252 | ) | 1,372 | ||||||||||
2010 and thereafter | 1,542 | (239 | ) | 1,303 | ||||||||||
Total | $ | 10,153 | $ | (1,989 | ) | $ | 8,164 |
Year Ended December 31, | |||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
2005 | 2004 | 2003 | |||||||||||||
Rent Expense | $ | 2.6 | $ | 2.6 | $ | 2.4 | |||||||||
Sublease income, net | (0.1 | ) | — | — |
(a development stage company)
NOTES TO FINANCIAL STATEMENTS — (Continued)
13. | Income Taxes |
December 31, | |||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|
2005 | 2004 | ||||||||||
Net operating loss carryforward | $ | 56,000 | $ | 52,500 | |||||||
Research and development credits | 7,600 | 7,400 | |||||||||
Capitalized research and development | 7,100 | 6,500 | |||||||||
Depreciation | 3,200 | 2,700 | |||||||||
Capitalized patents | 500 | 800 | |||||||||
Other | 3,300 | 1,000 | |||||||||
Gross deferred tax assets | 77,700 | 70,900 | |||||||||
Valuation allowance | (77,700 | ) | (70,900 | ) | |||||||
Net deferred tax assets | $ | — | $ | — |
(a development stage company)
NOTES TO FINANCIAL STATEMENTS — (Continued)
carryforwards may be subject to the annual limitation provisions of Internal Revenue Code (IRC) Sections 382 and 383 if we incur a “change in ownership.”
14. | Condensed Quarterly Financial Information (Unaudited) |
Year Ended December 31, 2005 | |||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
(amounts in thousands except per share data) | First Quarter | Second Quarter | Third Quarter | Fourth Quarter | |||||||||||||||
Total revenue | $ | 9 | $ | 11 | $ | 4 | $ | 12,002 | |||||||||||
Net loss | (5,190 | ) | (9,848 | ) | (6,764 | ) | 7,106 | ||||||||||||
Net loss per share, basic and diluted | (0.25 | ) | (0.48 | ) | (0.32 | ) | 0.34 |
Year Ended December 31, 2004 | |||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
(amounts in thousands except per share data) | First Quarter | Second Quarter | Third Quarter | Fourth Quarter | |||||||||||||||
Total revenue | $ | 150 | $ | 2,002 | $ | 8 | $ | 35 | |||||||||||
Net loss | (7,281 | ) | (4,513 | ) | (6,470 | ) | (5,659 | ) | |||||||||||
Net loss per share, basic and diluted | (0.36 | ) | (0.22 | ) | (0.32 | ) | (0.27 | ) |
15. | Subsequent Event — Sanochemia-License Agreement |
16. | Subsequent Event — Severance |
Item 9. | Changes in and Disagreements with Accountants on Accounting and Financial Disclosure |
March 14, 2006
Item 11. | Executive Compensation |
Item 12. | Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters |
Inc. 2006 Equity Incentive Plan — Equity Compensation Plan Information”. Such information is incorporated herein by reference.
Item 13. | Certain Relationships and Related Transactions |
Item 14. | Principal Accountant Fees and Services |
(a) | The following documents are filed as part of this Annual Report on Form 10-K: |
(1) | Financial Statements: |
Balance Sheets
Statements of Operations
Statements of Stockholders’ Equity
Statements of Cash Flows
Notes to Financial Statements
(2) | Financial Statement Schedules |
(3) | Exhibits |
Exhibit Number | Exhibits | |||||
---|---|---|---|---|---|---|
2.1 | See Exhibit 10.58 | |||||
3.1(1) | Amended and Restated Certificate of Incorporation | |||||
3.1.1(13) | Certificate of Amendment to Certificate of Incorporation | |||||
3.2 (1) | Restated Bylaws of the Registrant | |||||
4.1(1) | Specimen Common Stock Certificate | |||||
10.2(1, 2) | 1993 Stock Option Plan | |||||
10.3 (2, 17) | 1996 Equity Incentive Plan, as amended | |||||
10.4(1, 2) | Form of Incentive Stock Option Grant for 1996 Equity Incentive Plan | |||||
10.5(1, 2) | Form of Nonstatutory Stock Option Grant for 1996 Equity Incentive Plan | |||||
10.6(2, 14) | 1996 Non-Employee Directors’ Stock Option Plan, as amended | |||||
10.7(2, 4) | 1997 Employee Stock Purchase Plan | |||||
10.8(1, 2) | Form of Indemnification Agreement between Avigen and its directors and executive officers. | |||||
10.10(2, 5) | 2000 Equity Incentive Plan | |||||
10.11(2, 12) | Form of Nonstatutory Stock Option Grant for 2000 Equity Incentive Plan | |||||
10.14(2, 15) | Form of Incentive Stock Option Grant for 1993 Stock Option Plan | |||||
10.15(2, 15) | Form of Nonstatutory Stock Option Grant for 1993 Stock Option Plan | |||||
10.16(2, 24) | Form of Nonstatutory Stock Option Grant for 1996 Non-Employee Directors’ Stock Option Plan, as amended | |||||
10.17(2, 25) | Compensation Agreements with Named Executive Officers | |||||
10.29(2, 6) | Employment Agreement dated August 14, 1996, between Avigen and Thomas J. Paulson. | |||||
10.32(15) | Revolving line of credit note signed November 2, 2000 with Wells Fargo Bank. | |||||
10.33(15) | Letter Agreement to the revolving line of credit note signed November 2, 2000 with Wells Fargo Bank. | |||||
10.36(2, 8) | Management Transition Plan | |||||
10.41(10) | Property Lease Agreement between ARE-1201 Harbor Bay, LLC and Avigen, dated February 29, 2000 | |||||
10.45(13) | Office Lease Agreement between Lincoln-RECP Empire OPCO, LLC and Avigen, Inc., dated November 2, 2000. | |||||
10.46(13) | First Amendment to Lease Agreement between Lincoln-RECP Empire OPCO, LLC and Avigen, Inc., dated December 1, 2000. | |||||
10.47(13) | Second Amendment to Lease Agreement between Lincoln-RECP Empire OPCO, LLC and Avigen, Inc., dated February 12, 2001. | |||||
10.49(16) | Revolving line of credit note with Wells Fargo Bank, dated June 1, 2002. | |||||
10.50(16) | Letter of Agreement to the revolving line of credit note signed June 1, 2002 with Wells Fargo Bank. | |||||
10.51(11, 23) | License Agreement, dated November 21, 2003, by and between University of Colorado and Avigen |
Exhibit Number | Exhibits | |||||
---|---|---|---|---|---|---|
10.52 (2, 22) | Separation Agreement dated March 8, 2004 between Avigen and John Monahan | |||||
10.53 (20) | Revolving line of credit note with Wells Fargo Bank, dated June 1, 2004 | |||||
10.54 (20) | Amendment to Letter of Agreement to the revolving line of credit note signed June 1, 2004 with Wells Fargo Bank | |||||
10.55 (2, 21) | Arrangement Regarding Non-Employee Director Compensation | |||||
10.56 (26) | Sublease Lease Agreement, dated November 4, 2005, between Pepgen Corporation and Avigen | |||||
10.57 (27) | Sublease Lease Agreement, dated November 29, 2005, between Advanced Cell Technology, Inc. and Avigen | |||||
10.58 (3) | Assignment Agreement, dated December 19, 2005, by and between Genzyme Corporation and Avigen | |||||
10.59 (3) | License Agreement, dated January 12, 2006, by and between SDI Diagnostics International LTD, a division of Sanochemia Pharmazeutika AG, and Avigen | |||||
10.60 (2) | Separation Agreement, dated January 6, 2006, between Avigen and Thomas J. Paulson, together with Amendment No. 1 thereto dated February 3, 2006. | |||||
23.1 | Consent of Independent Registered Public Accounting Firm | |||||
24.1 | Power of Attorney (included on the signature pages hereto) | |||||
31.1 | CEO Certification required by Rule 13a-14(a) or Rule 15d-14(a) | |||||
31.2 | CFO Certification required by Rule 13a-14(a) or Rule 15d-14(a) | |||||
32.1(19) | Certification required by Rule 13a-14(b) or Rule 15d-14(b) and Section 1350 of Chapter 63 of Title 18 of the United States Code (18 U.S.C. §1350) |
(1) | Filed as an exhibit to the Registrant’s Registration Statement on Form S-1 (No. 333-03220) and incorporated herein by reference. |
(2) | Management Contract or Compensation Plan. |
(3) | Confidential treatment has been requested for portions of this exhibit. |
(4) | Incorporated by reference from such document filed with the SEC as an exhibit to Avigen’s Annual Report on Form 10-K for the year ended June 30, 1999, as filed with the SEC (Commission File No. 000-28272). |
(5) | Incorporated by reference from such document filed with the SEC as an exhibit to Avigen’s Registration Statement on Form S-8 (Registration No. 333-42210) filed with the SEC on July 25, 2000. |
(6) | Incorporated by reference from such document filed with the SEC as an exhibit to Avigen’s Annual Report on Form 10-K for the year ended June 30, 1997, as filed with the SEC (Commission File No. 000-28272). |
(8) | Incorporated by reference from such document filed with the SEC as an exhibit to Avigen’s Current Report on Form 8-K filed with the SEC on May 31, 2005 (Commission File No. 000-28272). |
(10) | Incorporated by reference from such document filed with the SEC as an exhibit to Avigen’s Quarterly Report on Form 10-Q for the quarter ended March 31, 2000, as filed with the SEC (Commission File No. 000-28272). |
(11) | Portions of this exhibit have been omitted pursuant to a grant of confidential treatment. |
(12) | Incorporated by reference from such document filed with the SEC as an exhibit to Avigen’s Annual Report on Form 10-K for the year ended June 30, 2000, as filed with the SEC on September 27, 2000 (Commission File No. 000-28272). |
(13) | Incorporated by reference from such document filed with the SEC as an exhibit to Avigen’s Quarterly Report on Form 10-Q for the quarter ended December 31, 2000, as filed with the SEC (Commission File No. 000-28272). |
(14) | Incorporated by reference from such document filed with the SEC as an exhibit to Avigen’s Registration Statement on Form S-8 (Registration No. 333-56274) filed with the SEC on June 22, 2004. |
(15) | Incorporated by reference from such document filed with the SEC as an exhibit to Avigen’s Annual Report on Form 10-K for the year ended June 30, 2001, as filed with the SEC on September 27, 2001 (Commission File No. 000-28272). |
(16) | Incorporated by reference from such document filed with the SEC as an exhibit to Avigen’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2002, as filed with the SEC (Commission File No. 000-28272). |
(17) | Incorporated by reference from such document filed with the SEC as an exhibit to Avigen’s Registration Statement on Form S-8 (Registration No. 333-90504) filed with the SEC on June 14, 2002. |
(19) | This certification accompanies the Form 10-K to which it relates, is not deemed filed with the Securities and Exchange Commission and is not to be incorporated by reference into any filing of Avigen under the Securities Act of 1933, as amended, or the Securities Exchange Act of 1934, as amended (whether made before or after the date of the Form 10-K), irrespective of any general incorporation language contained in such filing. |
(20) | Incorporated by reference from such document filed with the SEC as an exhibit to Avigen’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2004, as filed with the SEC (Commission File No. 000-28272). |
(21) | Incorporated by reference from the disclosure contained in Item 1.01 of Avigen’s Current Report on Form 8-K filed with the SEC on February 21, 2006 discussing such compensation (Commission File No. 000-28272). |
(22) | Incorporated by reference from such document filed with the SEC as an exhibit to Avigen’s Quarterly Report on Form 10-Q for the quarter ended March 31, 2004, as filed with the SEC (Commission File No. 000-28272). |
(23) | Incorporated by reference from such document filed with the SEC as an exhibit to Avigen’s Annual Report on Form 10-K for the year ended December 31, 2003, as filed with the SEC on March 15, 2004 (Commission File No. 000-28272). |
(24) | Incorporated by reference from such document filed with the SEC as an exhibit to Avigen’s Annual Report on Form 10-K for the year ended December 31, 2004, as filed with the SEC on March 15, 2004 (Commission File No. 000-28272). |
(25) | Incorporated by reference from the disclosure contained in Item 1.01 of Avigen’s Current Reports on Form 8-K filed with the SEC on May 31, 2005 and February 28, 2006 (Commission File No. 000-28272). |
(26) | Incorporated by reference from such document filed with the SEC as an exhibit to Avigen’s Current Report on Form 8-K filed with the SEC on November 28, 2005 (Commission File No. 000-28272). |
(27) | Incorporated by reference from such document filed with the SEC as an exhibit to Avigen’s Current Report on Form 8-K filed with the SEC on December 16, 2005 (Commission File No. 000-28272). |
By: | /s/ KENNETH G. CHAHINE Kenneth G. Chahine, J.D., Ph.D. President and Chief Executive Officer |
Signature | Title | Date | ||||||||
---|---|---|---|---|---|---|---|---|---|---|
/s/ KENNETH G. CHAHINE | President, Chief Executive Officer and Director | March 14, 2006 | ||||||||
Kenneth G. Chahine, J.D., Ph.D. | (Principal Executive Officer) | |||||||||
/s/ ANDREW A. SAUTER | Vice President, Finance | March 14, 2006 | ||||||||
Andrew A. Sauter | (Principal Financial and Accounting Officer) | |||||||||
/s/ ZOLA HOROVITZ, | Chairman of the Board | March 14, 2006 | ||||||||
Zola Horovitz, Ph.D. | ||||||||||
/s/ YUICHI IWAKI | Director | March 14, 2006 | ||||||||
Yuichi Iwaki, M.D., Ph.D. | ||||||||||
/s/ JOHN K.A. PRENDERGAST | Director | March 14, 2006 | ||||||||
John K.A. Prendergast, Ph.D. | ||||||||||
/s/ DANIEL VAPNEK | Director | March 14, 2006 | ||||||||
Daniel Vapnek, Ph.D. |
Exhibit Number | Exhibits | |||||
---|---|---|---|---|---|---|
2.1 | See Exhibit 10.58 | |||||
3.1(1) | Amended and Restated Certificate of Incorporation | |||||
3.1.1(13) | Certificate of Amendment to Certificate of Incorporation | |||||
3.2 (1) | Restated Bylaws of the Registrant | |||||
4.1(1) | Specimen Common Stock Certificate | |||||
10.2(1, 2) | 1993 Stock Option Plan | |||||
10.3 (2, 17) | 1996 Equity Incentive Plan, as amended | |||||
10.4(1, 2) | Form of Incentive Stock Option Grant for 1996 Equity Incentive Plan | |||||
10.5(1, 2) | Form of Nonstatutory Stock Option Grant for 1996 Equity Incentive Plan | |||||
10.6(2, 14) | 1996 Non-Employee Directors’ Stock Option Plan, as amended | |||||
10.7(2, 4) | 1997 Employee Stock Purchase Plan | |||||
10.8(1, 2) | Form of Indemnification Agreement between Avigen and its directors and executive officers. | |||||
10.10(2, 5) | 2000 Equity Incentive Plan | |||||
10.11(2, 12) | Form of Nonstatutory Stock Option Grant for 2000 Equity Incentive Plan | |||||
10.14(2, 15) | Form of Incentive Stock Option Grant for 1993 Stock Option Plan | |||||
10.15(2, 15) | Form of Nonstatutory Stock Option Grant for 1993 Stock Option Plan | |||||
10.16(2, 24) | Form of Nonstatutory Stock Option Grant for 1996 Non-Employee Directors’ Stock Option Plan, as amended | |||||
10.17(2, 25) | Compensation Agreements with Named Executive Officers | |||||
10.29(2, 6) | Employment Agreement dated August 14, 1996, between Avigen and Thomas J. Paulson. | |||||
10.32(15) | Revolving line of credit note signed November 2, 2000 with Wells Fargo Bank. | |||||
10.33(15) | Letter Agreement to the revolving line of credit note signed November 2, 2000 with Wells Fargo Bank. | |||||
10.36(2, 8) | Management Transition Plan | |||||
10.41(10) | Property Lease Agreement between ARE-1201 Harbor Bay, LLC and Avigen, dated February 29, 2000 | |||||
10.45(13) | Office Lease Agreement between Lincoln-RECP Empire OPCO, LLC and Avigen, Inc., dated November 2, 2000. | |||||
10.46(13) | First Amendment to Lease Agreement between Lincoln-RECP Empire OPCO, LLC and Avigen, Inc., dated December 1, 2000. | |||||
10.47(13) | Second Amendment to Lease Agreement between Lincoln-RECP Empire OPCO, LLC and Avigen, Inc., dated February 12, 2001. | |||||
10.49(16) | Revolving line of credit note with Wells Fargo Bank, dated June 1, 2002. | |||||
10.50(16) | Letter of Agreement to the revolving line of credit note signed June 1, 2002 with Wells Fargo Bank. | |||||
10.51(11, 23) | License Agreement, dated November 21, 2003, by and between University of Colorado and Avigen |
Exhibit Number | Exhibits | |||||
---|---|---|---|---|---|---|
10.52 (2, 22) | Separation Agreement dated March 8, 2004 between Avigen and John Monahan | |||||
10.53 (20) | Revolving line of credit note with Wells Fargo Bank, dated June 1, 2004 | |||||
10.54 (20) | Amendment to Letter of Agreement to the revolving line of credit note signed June 1, 2004 with Wells Fargo Bank | |||||
10.55 (2, 21) | Arrangement Regarding Non-Employee Director Compensation | |||||
10.56 (26) | Sublease Lease Agreement, dated November 4, 2005, between Pepgen Corporation and Avigen | |||||
10.57 (27) | Sublease Lease Agreement, dated November 29, 2005, between Advanced Cell Technology, Inc. and Avigen | |||||
10.58 (3) | Assignment Agreement, dated December 19, 2005, by and between Genzyme Corporation and Avigen | |||||
10.59 (3) | License Agreement, dated January 12, 2006, by and between SDI Diagnostics International LTD, a division of Sanochemia Pharmazeutika AG, and Avigen | |||||
10.60 (2) | Separation Agreement, dated January 6, 2006, between Avigen and Thomas J. Paulson, together with Amendment No. 1 thereto dated February 3, 2006. | |||||
23.1 | Consent of Independent Registered Public Accounting Firm | |||||
24.1 | Power of Attorney (included on the signature pages hereto) | |||||
31.1 | CEO Certification required by Rule 13a-14(a) or Rule 15d-14(a) | |||||
31.2 | CFO Certification required by Rule 13a-14(a) or Rule 15d-14(a) | |||||
32.1(19) | Certification required by Rule 13a-14(b) or Rule 15d-14(b) and Section 1350 of Chapter 63 of Title 18 of the United States Code (18 U.S.C. §1350) |
(1) | Filed as an exhibit to the Registrant’s Registration Statement on Form S-1 (No. 333-03220) and incorporated herein by reference. |
(2) | Management Contract or Compensation Plan. |
(3) | Confidential treatment has been requested for portions of this exhibit. |
(4) | Incorporated by reference from such document filed with the SEC as an exhibit to Avigen’s Annual Report on Form 10-K for the year ended June 30, 1999, as filed with the SEC (Commission File No. 000-28272). |
(5) | Incorporated by reference from such document filed with the SEC as an exhibit to Avigen’s Registration Statement on Form S-8 (Registration No. 333-42210) filed with the SEC on July 25, 2000. |
(6) | Incorporated by reference from such document filed with the SEC as an exhibit to Avigen’s Annual Report on Form 10-K for the year ended June 30, 1997, as filed with the SEC (Commission File No. 000-28272). |
(8) | Incorporated by reference from such document filed with the SEC as an exhibit to Avigen’s Current Report on Form 8-K filed with the SEC on May 31, 2005 (Commission File No. 000-28272). |
(10) | Incorporated by reference from such document filed with the SEC as an exhibit to Avigen’s Quarterly Report on Form 10-Q for the quarter ended March 31, 2000, as filed with the SEC (Commission File No. 000-28272). |
(11) | Portions of this exhibit have been omitted pursuant to a grant of confidential treatment. |
(12) | Incorporated by reference from such document filed with the SEC as an exhibit to Avigen’s Annual Report on Form 10-K for the year ended June 30, 2000, as filed with the SEC on September 27, 2000 (Commission File No. 000-28272). |
(13) | Incorporated by reference from such document filed with the SEC as an exhibit to Avigen’s Quarterly Report on Form 10-Q for the quarter ended December 31, 2000, as filed with the SEC (Commission File No. 000-28272). |
(14) | Incorporated by reference from such document filed with the SEC as an exhibit to Avigen’s Registration Statement on Form S-8 (Registration No. 333-56274) filed with the SEC on June 22, 2004. |
(15) | Incorporated by reference from such document filed with the SEC as an exhibit to Avigen’s Annual Report on Form 10-K for the year ended June 30, 2001, as filed with the SEC on September 27, 2001 (Commission File No. 000-28272). |
(16) | Incorporated by reference from such document filed with the SEC as an exhibit to Avigen’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2002, as filed with the SEC (Commission File No. 000-28272). |
(17) | Incorporated by reference from such document filed with the SEC as an exhibit to Avigen’s Registration Statement on Form S-8 (Registration No. 333-90504) filed with the SEC on June 14, 2002. |
(19) | This certification accompanies the Form 10-K to which it relates, is not deemed filed with the Securities and Exchange Commission and is not to be incorporated by reference into any filing of Avigen under the Securities Act of 1933, as amended, or the Securities Exchange Act of 1934, as amended (whether made before or after the date of the Form 10-K), irrespective of any general incorporation language contained in such filing. |
(20) | Incorporated by reference from such document filed with the SEC as an exhibit to Avigen’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2004, as filed with the SEC (Commission File No. 000-28272). |
(21) | Incorporated by reference from the disclosure contained in Item 1.01 of Avigen’s Current Report on Form 8-K filed with the SEC on February 21, 2006 discussing such compensation (Commission File No. 000-28272). |
(22) | Incorporated by reference from such document filed with the SEC as an exhibit to Avigen’s Quarterly Report on Form 10-Q for the quarter ended March 31, 2004, as filed with the SEC (Commission File No. 000-28272). |
(23) | Incorporated by reference from such document filed with the SEC as an exhibit to Avigen’s Annual Report on Form 10-K for the year ended December 31, 2003, as filed with the SEC on March 15, 2004 (Commission File No. 000-28272). |
(24) | Incorporated by reference from such document filed with the SEC as an exhibit to Avigen’s Annual Report on Form 10-K for the year ended December 31, 2004, as filed with the SEC on March 15, 2004 (Commission File No. 000-28272). |
(25) | Incorporated by reference from the disclosure contained in Item 1.01 of Avigen’s Current Reports on Form 8-K filed with the SEC on May 31, 2005 and February 28, 2006 (Commission File No. 000-28272). |
(26) | Incorporated by reference from such document filed with the SEC as an exhibit to Avigen’s Current Report on Form 8-K filed with the SEC on November 28, 2005 (Commission File No. 000-28272). |
(27) | Incorporated by reference from such document filed with the SEC as an exhibit to Avigen’s Current Report on Form 8-K filed with the SEC on December 16, 2005 (Commission File No. 000-28272). |