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UNITED STATES FORM 10-Q|X| QUARTERLY
REPORT UNDER SECTION 13 OR 15(d) OF THE For the quarterly period ended September 30, 2002OR |_| TRANSITION REPORT
PURSUANT TO SECTION 13 0R 15(d) OF THE For the transition period from _______________ to _______________ .Commission File Number 000-23186 BIOCRYST
PHARMACEUTICALS, INC. |
| DELAWARE (State or other jurisdiction of incorporation or organization) |
62-1413174 (I.R.S. employer identification no.) |
|
2190 Parkway Lake
Drive; Birmingham, Alabama 35244 (205) 444-4600
NONE
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 |_| Indicate the number of shares outstanding of each of the issuers classes of common stock, as of the latest practicable date: 17,657,097 shares of the Companys Common Stock, $.01 par value, were outstanding as of October 31, 2002. |
BIOCRYST PHARMACEUTICALS, INC.INDEX |
| Part
I. Financial Information
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Page
No.
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| Item 1. | Financial Statements: | ||||
| Condensed Balance Sheets September 30, 2002 and December 31, 2001 | 2 | ||||
| Condensed Statements of Operations Three and Nine Months Ended | |||||
| September 30, 2002 and 2001 | 3 | ||||
| Condensed Statements of Cash Flows Nine Months Ended September 30, | |||||
| 2002 and 2001 | 4 | ||||
| Notes to Condensed Financial Statements | 5 | ||||
| Item 2. | Managements
Discussion and Analysis of Financial Condition and Results of Operations |
6 | |||
| Item 3. | Quantitative and Qualitative Disclosures About Market Risk | 17 | |||
| Item 4. | Controls and Procedures | 18 | |||
| Part II. Other Information | |||||
| Item 1. | Legal Proceedings | 18 | |||
| Item 2. | Changes in Securities and Use of Proceeds | 18 | |||
| Item 3. | Defaults Upon Senior Securities | 18 | |||
| Item 4. | Submission of Matters to a Vote of Security Holders | 18 | |||
| Item 5. | Other Information | 18 | |||
| Item 6. | Exhibits and Reports on Form 8-K | 18 | |||
| Signatures | 20 | ||||
| Certifications | 21 | ||||
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2 |
PART I. FINANCIAL INFORMATIONItem 1. Financial StatementsBIOCRYST
PHARMACEUTICALS, INC.
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| 2002 (Unaudited) |
2001 (Note 1) |
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|---|---|---|---|---|---|
| Assets | |||||
| Cash and cash equivalents | $ 13,537 | $ 18,865 | |||
| Securities heldtomaturity | 13,628 | 13,122 | |||
| Prepaid expenses and other current assets | 717 | 416 | |||
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| Total current assets | 27,882 | 32,403 | |||
| Securities heldtomaturity | 11,254 | 20,954 | |||
| Furniture and equipment, net | 4,867 | 5,396 | |||
| Patents | 89 | 343 | |||
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| Total assets | $ 44,092 | $ 59,096 | |||
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| Liabilities and Stockholders Equity | |||||
| Accounts payable | $ 460 | $ 617 | |||
| Accrued expenses | 474 | 1,365 | |||
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| Total current liabilities | 934 | 1,982 | |||
| Deferred revenue | 300 | 300 | |||
| Stockholders equity: | |||||
| Preferred stock: shares authorized 5,000 | |||||
| Series A Convertible Preferred stock, $.01 par value, shares | |||||
| authorized 1,800; shares issued and outstanding none | |||||
| Series B Junior Participating Preferred Stock, $.001 par value, shares | |||||
| authorized 21.5; shares issued and outstanding none | |||||
| Common
stock, $.01par value, shares authorized 45,000; shares issued and outstanding 17,657 in 2002 and 17,607 in 2001 |
177 | 176 | |||
| Additional paidin capital | 131,905 | 131,669 | |||
| Accumulated deficit | (89,224 | ) | (75,031 | ) | |
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| Total stockholders equity | 42,858 | 56,814 | |||
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| Total liabilities and stockholders equity | $ 44,092 | $ 59,096 | |||
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See accompanying notes to condensed financial statements. 3 |
BIOCRYST
PHARMACEUTICALS, INC.
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| Three Months | Nine Months | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| 2002
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2001
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2002
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2001
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| Revenues: | |||||||||
| Collaborative and other research and development | $ 0 | $ 3,400 | $ 0 | $ 7,737 | |||||
| Interest and other | 412 | 731 | 1,412 | 2,817 | |||||
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| Total revenues | 412 | 4,131 | 1,412 | 10,554 | |||||
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| Expenses: | |||||||||
| Research and development | 3,172 | 2,830 | 12,935 | 8,073 | |||||
| General and administrative | 655 | 689 | 2,296 | 2,045 | |||||
| Impairment of patents and licenses | 0 | 0 | 374 | 0 | |||||
| Royalty expense | 0 | 195 | 0 | 444 | |||||
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| Total expenses | 3,827 | 3,714 | 15,605 | 10,562 | |||||
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| Net income (loss) | $(3,415 | ) | $ 417 | $(14,193 | ) | $ (8 | ) | ||
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| Amounts per common share: | |||||||||
| Net income (loss) (Note 2) | |||||||||
| -Basic | $ (.19 | ) | $ .02 | $ (.80 | ) | $ .00 | |||
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| -Diluted | (.19 | ) | $ .02 | $ (.80 | ) | $ .00 | |||
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| Weighted average shares outstanding (Note 2) | |||||||||
| -Basic | 17,650 | 17,565 | 17,638 | 17,548 | |||||
| -Diluted | 17,650 | 17,602 | 17,638 | 17,548 | |||||
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See accompanying notes to condensed financial statements. 4 |
BIOCRYST
PHARMACEUTICALS, INC.
|
| 2002
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2001
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|---|---|---|---|---|---|
| Operating activities: | |||||
| Net loss | $(14,193 | ) | $ (8 | ) | |
| Depreciation and amortization | 937 | 750 | |||
| Amortization of patents and licenses | 3 | 0 | |||
| Impairment of patents and licenses | 374 | 0 | |||
| Deferred expense | 0 | 444 | |||
| Deferred revenue | 0 | (7,737 | ) | ||
| Non-monetary compensation | 114 | 108 | |||
| Changes in operating assets and liabilities, net | (1,349 | ) | (435 | ) | |
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| Net cash used in operating activities | (14,114 | ) | (6,878 | ) | |
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| Investing activities: | |||||
| Purchases of furniture and equipment | (408 | ) | (1,829 | ) | |
| Purchases of patents and licenses | (123 | ) | (31 | ) | |
| Purchases of marketable securities | (4,085 | ) | (24,450 | ) | |
| Maturities of marketable securities | 13,279 | 43,979 | |||
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| Net cash provided by investing activities | 8,663 | 17,669 | |||
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| Financing activities: | |||||
| Principal payments of debt and capital lease obligations | 0 | (10 | ) | ||
| Proceeds from sale of common stock | 123 | 166 | |||
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| Net cash provided by financing activities | 123 | 156 | |||
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| Increase (decrease) in cash and cash equivalents | (5,328 | ) | 10,947 | ||
| Cash and cash equivalents at beginning of period | 18,865 | 8,456 | |||
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| Cash and cash equivalents at end of period | $ 13,537 | $ 19,403 | |||
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See accompanying notes to condensed financial statements. 5 |
BIOCRYST
PHARMACEUTICALS, INC.
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Note 4. Impairment of long-lived assets The Company periodically reviews its patents and licenses for impairment in accordance with Statement of Financial Accounting Standards No. 144, Accounting for the Impairment or Disposal of Long-Lived Assets (Statement No. 144) to determine any impairment that needs to be recognized. During the quarter ended June 30, 2002, the Company abandoned the development of peramivir, its influenza neuraminidase inhibitor. As a result, the Company recognized an expense of $374,000 during the quarter ended June 30, 2002 related to the patents for our neuraminidase inhibitors, as they no longer have any readily determinable value to the Company. Note 5. Recent Accounting Pronouncements In June 2002, the FASB issued Statement of Financial Accounting Standards No. 146, Accounting for Costs Associated with Exit or Disposal Activities (SFAS 146), which is effective for exit or disposal activities that are initiated after December 31, 2002. The Company adopted this statement on July 1, 2002. On July 10, 2002, the Company streamlined its operations, reducing its workforce from 75 employees to 45 employees in order to conserve its resources and provide a longer timeframe in which to advance its other programs. As a result of early implementation of SFAS 146, the Company recognized all expenses related to this reduction in staff during the third quarter of 2002. As of September 30, 2002 total compensation paid, plus benefits, related to this staff reduction was $259,742. Note 6. Commitments and Contingencies On August 5, 2002, at the request of the compensation committee, our board of directors approved a reduction in salary by 25% for both Dr. Charles E. Bugg, our Chairman and Chief Executive Officer and Dr. J. Claude Bennett, our President, Chief Operating Officer and Medical Director, effective August 1, 2002. In the event of any change of control of the Company, any cumulative salary reductions up to the date of the change of control would become due and payable to them. This arrangement has not been documented in any formal written agreement. Item 2. Managements Discussion and Analysis of Financial Condition and Results of OperationsThis Quarterly Report on Form 10-Q contains certain statements of a forward-looking nature relating to future events or the future financial performance of the Company. Such statements are only predictions and the actual events or results may differ materially from the results discussed in the forward-looking statements. Factors that could cause or contribute to such differences include those discussed below as well as those discussed in other filings made by the Company with the Securities and Exchange Commission, including the Companys Annual Report on Form 10-K. OverviewSince our inception in 1986, we have been engaged in research and development activities and organizational efforts, including: |
| | identification and licensing of enzyme targets; |
| | drug discovery; |
| | structure-based design of drug candidates; |
| | small-scale synthesis of compounds; |
| | conducting preclinical studies and clinical trials; |
|
7 |
| | recruiting our scientific and management personnel; |
| | establishing laboratory facilities; and |
| | raising capital. |
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Our revenues have generally been limited to license fees, milestone payments, interest income, collaboration research and development fees. The Company recognizes revenue in accordance with SEC Staff Accounting Bulletin No. 101, Revenue Recognition in Financial Statements (SAB 101). Research and development revenue on cost-reimbursement agreements is recognized as expenses are incurred, up to contractual limits. Research and development fees, license fees and milestone payments are recognized as revenue when the earnings process is complete, the Company has no further continuing performance obligations and has completed its performance under the terms of the agreement, in accordance with SAB 101. License fees and milestone payments received under licensing agreements that are related to future performance are deferred and taken into income as earned over the estimated drug development period. The Company has not received any royalties from the sale of licensed pharmaceutical products. It could be several years, if ever, before we will recognize significant revenue from royalties received pursuant to our license agreements, and we are not likely to ever generate revenue directly from product sales. Future revenues, if any, are likely to fluctuate substantially from quarter to quarter. We have incurred operating losses since our inception. Our accumulated deficit at September 30, 2002 was $89.2 million. We will require substantial expenditures relating to the development of our current and future drug candidates. During the three years ended December 31, 2001, we spent 26.9% of our research and development expenses on contract research and development, including: |
| | payments to consultants; |
| | funding of research at academic institutions; |
| | large scale synthesis of compounds; |
| | preclinical studies; |
| | engaging investigators to conduct clinical trials; |
| | hiring contract research organizations to monitor and gather data on clinical trials; and |
| | using statisticians to evaluate the results of clinical trials. |
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The above expenditures for contract research and development for our current and future drug candidates will vary from quarter to quarter depending on the status of our research and development projects. For example, on June 25, 2002, we announced preliminary Phase III clinical trial data for peramivir, our investigational oral influenza neuraminidase inhibitor. The trial indicated no statistically significant difference in the primary efficacy endpoint between groups treated with peramivir and groups treated with placebo. Based on these data, we discontinued the development of peramivir. During the first nine months of 2002, our cash expenses related to this trial were approximately $4 million. After terminating the development of peramivir, the Company streamlined its operations, reducing its workforce from 75 employees to 45 employees in order to conserve its resources and provide a longer timeframe in which to advance its other programs. Changes in our existing and future research and development and collaborative relationships will also impact the status of our research and development projects. Although we may, in some cases, be able to control the timing of development expenses, in part by accelerating or decelerating certain of these costs, many of these costs will be incurred irrespective of whether or not we are able to discover drug candidates or obtain collaborative partners for commercialization. As a result, we believe that quarter-to-quarter comparisons of our financial results are not necessarily meaningful and should not be relied upon as an indication of future performance. If we fail to meet the research, clinical and financial expectations of securities analysts and investors, it could have a material adverse effect on the price of our common stock. 8 |
Results of Operations (three months ended September 30, 2002 compared to the three months ended September 30, 2001)Revenues decreased 90.0% to $412,000 in the three months ended September 30, 2002 from $4,131,000 in the three months ended September 30, 2001. The decrease was primarily due to the termination by Ortho-McNeil Pharmaceutical, Inc. (Ortho-McNeil) and The R.W. Johnson Pharmaceutical Research Institute (RWJPRI) of the worldwide license agreement with BioCryst for peramivir, the Companys neuraminidase inhibitor. As a result, we had no collaborative revenue during the third quarter of 2002 as compared to $3,400,000 in the third quarter of 2001. In addition, interest and other income decreased 43.6% to $412,000 in the third quarter of 2002 from $731,000 in the third quarter of 2001, due to a reduction in cash from funding operations and renovation of our facilities completed in February 2002, plus the effect of lower interest rates on some of our investments. Research and development expenses increased 12.1% to $3,172,000 in the three months ended September 30, 2002 from $2,830,000 in the three months ended September 30, 2001. The increase is primarily attributable to the final clinical trial expenses related to the Phase III development of peramivir, a program discontinued earlier this year, as well an increase in animal studies for other programs. General and administrative expenses for the three months ended September 30, 2002 decreased 4.9% to $655,000 as compared to $689,000 for the same period in 2001. Royalty expense decreased 100.00% to $0 in the three months ended September 30, 2002 from $195,000 for the three months ended September 30, 2001, as a result of the termination agreement with Ortho-McNeil and RWJPRI. Results of Operations (nine months ended September 30, 2002 compared to the nine months ended September 30, 2001)Revenues decreased 86.6% to $1,412,000 in the nine months ended September 30, 2002 from $10,554,000 in the nine months ended September 30, 2001. The decrease was primarily due to the termination of Ortho-McNeil and RWJPRIs agreement with BioCryst. As a result of this change, we had no collaborative revenue during the first nine months of 2002 as compared to $7,737,000 in the first nine months of 2001. In addition, interest and other income decreased 49.9% to $1,412,000 in the nine months ended September 30, 2002 from $2,817,000 in the first nine months of 2001, due to a reduction in cash from funding operations and renovation of our facilities completed in February 2002, plus the effect of lower interest rates on some of our investments. Research and development expenses increased 60.2% to $12,935,000 in the nine months ended September 30, 2002 from $8,073,000 in the nine months ended September 30, 2001. The increase is primarily attributable to an increase in clinical trial expenses related to the Phase III development of peramivir, a program discontinued earlier this year. General and administrative expenses for the nine months ended September 30, 2002 increased 12.3% to $2,296,000 as compared to $2,045,000 for the same period in 2001, primarily due to an increase in expenses related to the adoption of a stockholder rights plan and other professional fees. Royalty expense decreased 100.00% to $0 in the nine months ended September 30, 2002 from $444,000 for the nine months ended September 30, 2001, as a result of the termination agreement with Ortho-McNeil and RWJPRI. During the second quarter of 2002, the Company recorded a non-cash impairment loss of $374,000 related to the influenza patents, as this program was terminated effective June 25, 2002. There were no impairment charges in 2001. Liquidity and Capital ResourcesCash expenditures have exceeded revenues since the Companys inception. Our operations have principally been funded through various sources, including the following: |
| | public offerings and private placements of equity and debt securities, |
| | equipment lease financing, |
| | facility leases, |
|
9 |
| | collaborative and other research and development agreements (including licenses and options for licenses), |
| | research grants and |
| | interest income. |
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In addition, we have attempted to contain costs and reduce cash flow requirements by renting scientific equipment and facilities, contracting with other parties to conduct certain research and development and using consultants. We expect to incur additional expenses, potentially resulting in significant losses, as we continue to pursue our research and development activities and undertake additional preclinical studies and clinical trials of compounds, which have been or may be discovered. We also expect to incur substantial expenses related to the filing, prosecution, maintenance, defense and enforcement of patent and other intellectual property claims. On June 25, 2002, the Company announced we were discontinuing the development of peramivir, our investigational oral influenza neuraminidase inhibitor designed to treat and prevent influenza. After terminating the development of peramivir, the Company streamlined its operations in order to conserve its resources and provide a longer timeframe in which to advance its other programs. On August 5, 2002, at the request of the compensation committee, our board of directors approved a reduction in salary by 25% for both Dr. Charles E. Bugg, our Chairman and Chief Executive Officer and Dr. J. Claude Bennett, our President, Chief Operating Officer and Medical Director, effective August 1, 2002. In the event of any change of control of the Company, any cumulative salary reductions up to the date of the change of control would become due and payable to them. This arrangement has not been documented in any formal written agreement. The Company invests its excess cash principally in U.S. marketable securities from a diversified portfolio of institutions with strong credit ratings and in U.S. government and agency bills and notes, and by policy, limits the amount of credit exposure at any one institution. These investments are generally not collateralized and mature within three years. The Company has not realized any losses from such investments. In addition, at September 30, 2002, approximately $7.7 million was invested in the Merrill Lynch Premier Institutional Fund, which invests primarily in commercial paper, U.S. government and agency bills and notes, corporate notes, certificates of deposit and time deposits. The Merrill Lynch Premier Institutional Fund is not insured. At September 30, 2002, our cash, cash equivalents and securities held-to-maturity were $38.4 million, a decrease of $14.5 million from December 31, 2001, principally due to the funding of current operations, which included the Phase III development of peramivir, a program that was terminated in June 2002. We have financed some of our equipment purchases with lease lines of credit. We currently have a $500,000 general line of credit with our bank, secured by a pledge of $600,000 in marketable securities. There was nothing drawn against this line as of September 30, 2002. In July 2000, we renegotiated our lease for our current facilities, which will expire on June 30, 2010. We have an option to renew the lease for an additional five years at current market rates. The lease, as amended effective July 1, 2001 for an additional 7,200 square feet, requires us to pay monthly rent starting at $33,145 per month in July 2001 and escalating annually to a minimum of $47,437 per month in the final year, plus our pro rata share of operating expenses and real estate taxes in excess of base year amounts. As part of the lease, we have pledged a U.S. Treasury security deposited in escrow for the payment of rent and performance of other obligations specified in the lease. This pledged amount is currently $455,000, which will be decreased by $65,000 annually throughout the term of the lease. During 2000, we renovated our facilities to gain additional laboratory space, update our existing laboratories, and add a small good manufacturing practices (GMP) clean room. In addition, we updated our general office facility to provide for growth and efficiencies. The total cost of these changes, including furniture and laboratory equipment, was approximately $2.7 million. This phase of renovation was completed in December 2000. Another phase of renovation was completed in February 2002 for approximately $2.6 million to add two chemistry laboratories and purchase additional equipment. Currently, there are no plans for additional renovations. 10 |
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As a result of the reduction in our staff during July 2002, we now have approximately 14,000 square feet of excess space we are currently attempting to sublease. At December 31, 2001, we had long-term operating lease obligations, which provide for aggregate minimum payments of $567,123 in 2002, $580,803 in 2003 and $594,897 in 2004. These obligations include the future rental of our operating facility. We plan to finance our needs principally from the following: |
| | our existing capital resources and interest earned on that capital; |
| | payments under collaborative and licensing agreements with corporate partners; and |
| | through lease or loan financing and future public or private financing. |
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We believe that our available funds will be sufficient to fund our operations at least through 2004. However, this is a forward-looking statement, and there may be changes that would consume available resources significantly before such time. Our long-term capital requirements and the adequacy of our available funds will depend upon many factors, including: |
| | the progress of our research, drug discovery and development programs; |
| | changes in existing collaborative relationships; |
| | our ability to establish additional collaborative relationships; |
| | the magnitude of our research and development programs; |
| | the scope and results of preclinical studies and clinical trials to identify drug candidates; |
| | competitive and technological advances; |
| | the time and costs involved in obtaining regulatory approvals; |
| | the costs involved in preparing, filing, prosecuting, maintaining and enforcing patent claims; |
| | our dependence on others for development and commercialization of our product candidates, and |
| | successful commercialization of our products consistent with our licensing strategy. |
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Additional funding, whether through additional sales of securities or collaborative or other arrangements with corporate partners or from other sources, may not be available when needed or on terms acceptable to us. The issuance of preferred or common stock or convertible securities, with terms and prices significantly more favorable than those of the currently outstanding common stock, could have the effect of diluting or adversely affecting the holdings or rights of our existing stockholders. In addition, collaborative arrangements may require us to transfer certain material rights to such corporate partners. Insufficient funds may require us to delay, scale-back or eliminate certain of our research and development programs. Critical Accounting PoliciesWe have established various accounting policies that govern the application of accounting principles generally accepted in the United States in the preparation of our financial statements. Our significant accounting policies are described in the footnotes to the financial statements of the Companys most recent Annual Report on Form 10-K. Certain accounting policies involve significant judgments and assumptions by management that have a material impact on the carrying value of certain assets and liabilities; management considers such accounting policies to be critical accounting policies. The judgments and assumptions used by management are based on historical experience and other factors, which are believed to be reasonable under the circumstances. Because of the nature of the judgments and assumptions made by management, actual results could differ from these judgments and estimates, which could have a material impact on the carrying values of assets and liabilities and the results of operations. 11 |
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We believe the following critical accounting policies affect our more significant judgments and estimates used in the preparation of our financial statements. Revenue Recognition The Company recognizes revenue in accordance with SEC Staff Accounting Bulletin No. 101, Revenue Recognition in Financial Statements ("SAB 101"). Research and development revenue on cost-reimbursement agreements is recognized as expenses are incurred, up to contractual limits. Research and development fees, license fees and milestone payments are recognized as revenue when the earnings process is complete, the Company has no further continuing performance obligations and has completed its performance under the terms of the agreement, in accordance with SAB 101. License fees and milestone payments received under licensing agreements that are related to future performance are deferred and taken into income as earned over the estimated drug development period. Recognized revenues and profit are subject to revisions as these contracts or agreements progress to completion. Revisions to revenue or profit estimates are charged to income in the period in which the facts that give rise to the revision became known. Valuation of Financial Instruments We carry our held-to-maturity securities at amortized cost, as adjusted for other-than-temporary declines in market value. In determining if and when a decline in market value below amortized cost is other-than-temporary, we evaluate the market conditions and other key measures for our held-to-maturity investments. Future adverse changes in market conditions could result in losses or an inability |