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SECURITIES AND EXCHANGE COMMISSION
Washington, DC 20549
Form 10-K
     
þ
  ANNUAL REPORT UNDER SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
 
    For the fiscal year ended December 31, 2004
 
or
 
o
  TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
 
    For the transition period from           to
Commission file number 0-29993
IntraBiotics Pharmaceuticals, Inc.
(Exact name of Registrant as specified in its charter)
     
Delaware
  94-3200380
(State or Other Jurisdiction of
Incorporation or Organization)
  (IRS Employer
Identification No.)
 
2483 East Bayshore Road,
Suite 100, Palo Alto, CA
(Address of principal executive offices)
  94303
(Zip code)
Registrant’s telephone number, including area code:
(650) 526-6800
Securities registered under Section 12(b) of the Exchange Act:
None.
Securities registered under Section 12(g) of the Exchange Act:
Common Stock, par value $.001 per share
(Title of Class)
     Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days.     Yes þ          No o
      Indicate by check mark if disclosure of delinquent filers pursuant to Item 405 of Regulation S-K is not contained herein, and will not be contained, to the best of registrant’s knowledge, in definitive proxy or information statements incorporated by reference in PART III of this Form 10-K or any amendment to this Form 10-K.     þ
      Indicate by check mark whether the registrant is an accelerated filer (as defined in Rule 12b-2 of the Securities Exchange Act of 1934).     Yes o          No þ
      The aggregate market value of the Common Stock, held by non-affiliates of the registrant, based on the closing price on June 30, 2004 as reported by the NASDAQ National Market was approximately $24,571,000. The determination of affiliate status for the purposes of this calculation is not necessarily a conclusive determination for other purposes. The calculation excludes approximately 2,527,000 shares held by directors, officers and stockholders whose ownership exceeds five percent of the Registrant’s outstanding common stock as of June 30, 2004. Exclusion of these shares should not be construed to indicate that such person controls, is controlled by or is under common control with the Registrant. The number of shares outstanding of the registrant’s Common Stock, par value $0.001 per share, as of February 28, 2005 was 9,067,645 shares.
 
 


TABLE OF CONTENTS
                 
        Page
         
 PART I
 Item 1.    Business     1  
 Item 2.    Properties     3  
 Item 3.    Legal Proceedings     3  
 Item 4.    Submission of Matters to a Vote of Security Holders     3  
 
 PART II
 Item 5.    Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities     3  
 Item 6.    Selected Financial Data     5  
 Item 7.    Management’s Discussion and Analysis of Financial Condition and Results of Operations     6  
 Item 7A.    Quantitative and Qualitative Disclosure About Market Risk     16  
 Item 8.    Financial Statements and Supplementary Data     18  
 Item 9.    Changes in and Disagreements with Accountants on Accounting and Financial Disclosure     42  
 Item 9A.    Controls and Procedures     42  
 Item 9B.    Other Information     44  
 
 PART III
 Item 10.    Directors and Executive Officers of the Registrant     44  
 Item 11.    Executive Compensation     48  
 Item 12.    Security Ownership of Certain Beneficial Owners and Management     53  
 Item 13.    Certain Relationships and Related Transactions     57  
 Item 14.    Principal Accountant Fees and Services     57  
 
 PART IV
 Item 15.    Exhibits and Financial Statement Schedules     58  
 EXHIBIT 10.34
 EXHIBIT 23.1
 EXHIBIT 23.2
 EXHIBIT 31.1
 EXHIBIT 31.2
 EXHIBIT 32.1


Table of Contents

PART I
      This report contains forward-looking statements. These forward-looking statements are based on our current expectations, estimates, projections and assumptions about our business and industry. In some cases, these statements may be identified by terminology such as “may”, “will”, “should”, “expects”, “plans”, “anticipates”, “believes”, “estimates”, “predicts”, “potential” or “continue”, or the negative of such terms and other comparable terminology. These statements involve known and unknown risks and uncertainties that may cause our or our industry’s results, levels of activity, performance or achievements to be materially different from those expressed or implied by the forward-looking statements. Factors that may cause or contribute to such differences include, among others, those discussed under the captions “Business”, “Factors That Could Affect Future Results” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations”. Except as required by law, we undertake no obligation to update any forward-looking statement to reflect events after the date of this report.
Item 1. Business
Overview
      Since inception in 1994, we have devoted substantially all of our efforts to research and development of anti-microbial drugs and have generated no product revenues. From the fourth quarter of 2002 until June 2004, we focused our efforts on developing iseganan for the prevention of ventilator-associated pneumonia (“VAP”). In June 2004, we discontinued our clinical trial of iseganan for the prevention of VAP following a recommendation of the independent data monitoring committee. We have since terminated our iseganan development program, reduced employee headcount by 60% to six employees and are now evaluating our strategic options, including mergers, acquisitions, in-licensing opportunities, and liquidation of the Company. We have retained the investment banking firm, Lazard, to advise the Company in evaluating its strategic options. Our future operations and financial condition will depend on the strategic alternative we elect to pursue. To date, our efforts have been focused on strategic options in the biotechnology and pharmaceutical industries. See Note 7 of the notes to the financial statements included in Item 8 of this Form 10-K for additional information concerning our restructuring efforts in 2004.
      On December 31, 2004, the Company had a total of $50.7 million in cash, cash equivalents, and short-term investments, and recorded liabilities of $0.7 million.
Clinical Supplies and Manufacturing
      We have no manufacturing capabilities. We relied on third-party manufacturers to produce our products in clinical and commercial quantities to support our iseganan development programs.
Clinical Pipeline
      Prior to the termination of our iseganan development program our clinical pipeline had included development of an iseganan oral solution for the prevention of ventilator-associated pneumonia and for the treatment of respiratory infections in cystic fibrosis patients. We currently have no clinical pipeline. Our research and development expenditures will depend upon the strategic alternative we elect to pursue.
      Research and development expense for the three years ended December 31, 2004, 2003 and 2002 was $11.5 million, $7.7 million and $23.1 million, respectively.
Marketing and Sales
      Currently, we have no marketing and sales capability, and have no current plans to develop any. Our strategy for marketing and sales will depend upon the strategic alternative we elect to pursue.

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Competition
      The biotechnology and pharmaceutical industries are extremely competitive. Many companies have substantially greater financial and other resources than we do. In addition, they may have substantially more experience in effecting strategic combinations, in-licensing technology, developing drugs, obtaining regulatory approvals, and manufacturing and marketing products. We cannot give any assurances that we can effectively compete with these other pharmaceutical and biotechnology companies.
Intellectual Property
      In April 1994, we entered into a license agreement (the “License Agreement”) with the Regents of the University of California, (the “Regents”) under which we obtained exclusive rights to develop and commercialize Protegrin-based products, such as iseganan. We terminated this License Agreement in December 2004 and re-assigned to the Regents its previously owned undivided ownership interest in certain joint patent rights. As owner of an interest in these patent rights, the Regents would be free to license such rights to any third party and would not be required to compensate us. A number of provisions in the License Agreement survive including confidentiality, restrictions on using either party’s names or trademarks, attorneys fees in the event of a dispute, maintenance of books and records and certain indemnification obligations.
Government Regulation
      Governmental authorities in the U.S. and other countries extensively regulate, among other things, the research, development, testing, manufacture, labeling, promotion, advertising, distribution, and marketing, of products produced by the biotechnology and pharmaceutical industry. In the United States the Food and Drug Administration (the “FDA”) regulates drugs under the Federal Food, Drug, and Cosmetic Act and its implementing regulations. Outside the U.S., the requirements governing conduct of clinical trials and marketing authorization vary widely from country to country, but involve a similar degree of oversight and rigor as in the U.S.
Employees
      As of February 28, 2005, we had six full-time employees. Our employees are not represented by a collective bargaining agreement. We believe that we have good relations with our employees.
Available Information
      Our website address is www.intrabiotics.com. We make available free of charge through our website, our annual report on Form 10-K, quarterly reports on Form 10-Q, current reports on Form 8-K, and all amendments to these reports as soon as reasonably practicable after filing.

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Item 2. Properties
      We currently lease one facility at 2483 East Bayshore Road, Suite 100, in Palo Alto, California. The facility provides approximately 3,600 square feet of office space. The lease expires on June 30, 2005 and includes an option to extend until December 31, 2005. This facility is adequate for our current needs.
Item 3. Legal Proceedings
      (a) Beginning on July 2, 2004, three purported class action shareholder complaints were filed in the United States District Court for the Northern of California against IntraBiotics and several of its officers. The actions were consolidated and a consolidated amended complaint has been filed, purportedly brought on behalf of purchasers of IntraBiotics common stock between September 5, 2003 and June 22, 2004. The amended complaint generally alleges that IntraBiotics and several of its officers and directors made false or misleading statements concerning the clinical trial of iseganan. The plaintiffs seek unspecified monetary damages. On February 28, 2005, the Company and the individual defendants filed a motion to dismiss the amended complaint. The Company believes the suit to be without merit and intends to defend itself vigorously. Due to the uncertainties surrounding the final outcome of this matter, no amounts have been accrued at December 31, 2004.
      (b) No legal proceedings were terminated in the fourth quarter.
Item 4. Submission of Matters to a Vote of Security Holders
      No matters were submitted to a vote of stockholders through the solicitation of proxies or otherwise during the three-month period ended December 31, 2004.
PART II
Item 5.     Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities
Market for Common Equity
      Our common stock began trading on the NASDAQ National Market on March 28, 2000, under the symbol “IBPI.” Prior to that time, there had been no public market for our common stock. We effected a 1:12 reverse stock split on April  10, 2003. All amounts herein have been retroactively adjusted to reflect this stock split. The table below sets forth the high and low bid prices for our common stock for the periods indicated:
                 
    High   Low
         
1st Quarter ended March 31, 2003
  $ 4.08     $ 1.56  
2nd Quarter ended June 30, 2003
  $ 6.48     $ 1.54  
3rd Quarter ended September 30, 2003
  $ 15.60     $ 3.08  
4th Quarter ended December 31, 2003
  $ 17.50     $ 10.50  
1st Quarter ended March 31, 2004
  $ 19.25     $ 13.25  
2nd Quarter ended June 30, 2004
  $ 18.00     $ 3.70  
3rd Quarter ended September 30, 2004
  $ 4.38     $ 3.35  
4th Quarter ended December 31, 2004
  $ 4.20     $ 3.46  
      As of February 28, 2005, there were 123 holders of record of common stock. We estimate that, included within the holders of record, there are approximately 3,000 beneficial owners of common stock. As of February 28, 2005, the closing price for our common stock was $3.79.

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Dividend Policy
      We have never paid dividends on our common stock. We currently intend to retain any future earnings to support the development of our business. The holders of our Series A preferred stock are entitled to receive cumulative dividends at the rate of 8% per annum of the original purchase price of $10,000 per share of Series A preferred stock, prior to and in preference to any declaration or payment of a dividend to the holders of common stock. The dividends are payable quarterly in shares of common stock. The number of shares payable is determined based on the average closing sale price of the common stock on the NASDAQ National Market, or other market on which our common stock is traded, for each of the five trading days immediately preceding the applicable dividend payment date. Until accrued and unpaid dividends on the Series A preferred stock are paid and set apart, no dividends or other distributions in respect of any other shares of our capital stock shall be declared. We do not currently anticipate paying any cash dividends in the foreseeable future.

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Item 6. Selected Financial Data
      The following selected financial data should be read in conjunction with our financial statements and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” included in Items 7 and 8 of this report. The financial data for periods prior to the financial statements presented in Item 8 of this Form 10-K are derived from audited financial statements not included in this Form 10-K.
                                           
    Year Ended December 31,
     
    2004   2003   2002   2001   2000
                     
    (In thousands, except per share amounts)
Statement of Operations Data:
                                       
Operating expenses:
                                       
 
Research and development
  $ 11,519     $ 7,727     $ 23,053     $ 38,034     $ 39,152  
 
General and administrative
    4,819       5,782       8,617       9,202       11,560  
 
Restructuring and other charges
    858             6,118       21,956        
 
Arbitration settlement
                (3,600 )            
 
Impairment of acquired workforce
                1,365              
                               
Total operating expenses
    17,196       13,509       35,553       69,192       50,712  
                               
Operating loss
    (17,196 )     (13,509 )     (35,553 )     (69,192 )     (50,712 )
 
Interest income
    700       166       703       2,843       5,699  
 
Interest expense
                (459 )     (1,110 )     (563 )
 
Other income/(expense), net
    (204 )     31       856       93        
                               
Net loss
    (16,700 )     (13,312 )     (34,453 )     (67,366 )     (45,576 )
Non-cash deemed dividend related to beneficial conversion feature of Series A preferred stock
          (1,436 )                  
Non-cash dividends on Series A preferred stock
    (260 )     (182 )                  
                               
Net loss applicable to common stockholders
  $ (16,960 )   $ (14,930 )   $ (34,453 )   $ (67,366 )   $ (45,576 )
                               
Basic and diluted net loss per share applicable to common stockholders
  $ (2.24 )   $ (4.01 )   $ (11.25 )   $ (27.47 )   $ (24.29 )
                               
Shares used to compute basic and diluted net loss per share applicable to common stockholders
    7,559       3,720       3,064       2,453       1,876  
                               
Balance Sheet Data:
                                       
Cash, cash equivalents, restricted cash and short-term investments
  $ 50,743     $ 26,644     $ 13,315     $ 35,470     $ 86,065  
Working capital
    50,462       25,424       15,191       29,629       86,142  
Total assets
    51,185       27,326       16,226       42,465       108,288  
Long term obligations, less current portion
                      5,000       8,309  
Accumulated deficit
    (232,159 )     (215,199 )     (200,269 )     (165,816 )     (98,450 )
Total stockholders’ equity
    50,508       25,628       15,480       26,212       89,955  

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Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations
      The following discussion and analysis of our financial condition and results of operations should be read together with our financial statements and related notes appearing elsewhere in this Form 10-K. This discussion and analysis contains forward-looking statements that involve risks, uncertainties and assumptions. The actual results may differ materially from those anticipated in these forward-looking statements as a result of many factors, including but not limited to those set forth under “Factors That Could Affect Future Results”. All forward-looking statements included in this document are based on information available to us on the date of this document and we assume no obligation to update any forward-looking statements contained in this Form  10-K.
Overview
      Since inception in 1994, we have devoted substantially all of our efforts to research and development of anti-microbial drugs, and have generated no product revenues. From the fourth quarter of 2002 until June 2004, we focused our efforts on developing iseganan for the prevention of ventilator-associated pneumonia (“VAP”). In June 2004, we discontinued our clinical trial of iseganan for the prevention of VAP following a recommendation of the independent data monitoring committee. We have since terminated our iseganan development program and in August 2004, the Company implemented a restructuring plan, which included the termination of nine employees and various operating lease commitments. We have six employees and occupy one office facility in Palo Alto, California.
      We are evaluating our strategic options, including mergers, acquisitions, in-licensing opportunities, and liquidation of the Company. We have retained the investment banking firm, Lazard, to advise the Company in evaluating its strategic options. Our future operations and financial condition will depend on the strategic alternative that we elect to pursue. On December 31, 2004, the Company had a total of $50.7 million in cash, cash equivalents, and short-term investments, and recorded liabilities of $0.7 million. Based on current projections, the Company expects cash outflows of between $2.5 million and $3.5 million during 2005. This estimate does not include any costs that may be associated with completing a merger, acquisition, in-license opportunity, liquidation of the Company or the disposition of the securities litigation referred to in Item 3 (a) of this Form 10-K. There can be no assurance that such a range will be achieved, as actual expenditures and interest income may differ significantly from projected levels.
      In February 2003, the Board of Directors approved a cancellation and re-grant of 308,835 unexercised stock options held by existing employees and directors of the Company in a one-for-one exchange and 12,500 options that were re-granted in connection with the cancellation of 54,166 unexercised stock options held by a director of the Company. The re-granted options have an exercise price equal to the closing price of the Company’s common stock on the NASDAQ National Market on February 5, 2003, or $2.76 per share. The options generally vest over a four-year period and will expire in February 2008 if not previously exercised. Variable accounting is being applied to the re-granted options throughout their term. The related compensation expense depends on both the cumulative vesting of outstanding options and the price of the Company’s common stock at each quarter end, and therefore may have a significant impact on the Company’s future results of operations. In 2004, we recorded a non-cash stock compensation recovery of $638,000 as compared to a non-cash stock compensation expense of $1.0 million during 2003 in connection with variable accounting for re-granted stock options. In addition, we recorded non-cash stock compensation expense related to the amortization of deferred stock compensation of $61,000, $126,000 and $1.3 million during the years ended December 31, 2004, 2003 and 2002, respectively, primarily in connection with the grant of certain stock options to employees and officers on, or prior to, the Company’s initial public offering on March 20, 2000. In addition, we have granted stock options to consultants, which resulted in non-cash stock compensation expense of $472,000, $254,000 and $512,000 during the years ended December 31, 2004, 2003 and 2002, respectively. In addition, in connection with the issuance of shares of common stock the Company recorded compensation expense of $545,000 based on the fair market value of the common stock on the date of issuance during the year ended December 31, 2002. This expense was recorded primarily in connection with stock issued to a former landlord of the Company in connection with a restructuring. For additional details and a

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tabular summary of stock compensation expense see Note 10 of the notes to the financial statements included in Item 8 of this Form 10-K.
      We intend that the following discussion of our results of operations and financial condition will provide information to assist in the understanding of our financial statements, the changes in certain key items in those financial statements from year to year, and the primary factors that accounted for those changes, as well as how certain accounting principles, policies and estimates affect our financial statements.
Critical Accounting Policies and Estimates
      An accounting policy is deemed to be critical if it requires an accounting estimate to be made based on assumptions about matters that are highly uncertain at the time the estimate is made, and if different estimates that reasonably could have been used, or changes in the accounting estimates that are reasonably likely to occur periodically, could materially impact the financial statements. Management believes the following critical accounting policies reflect its more significant estimates and assumptions used in the preparation of the financial statements. We review the accounting policies used in our financial statements on a regular basis. In addition, management has reviewed these critical accounting policies and related disclosures with our Audit Committee.
      Our discussion and analysis of our financial condition and results of operations is based upon our financial statements, which have been prepared in accordance with accounting principles generally accepted in the United States of America. The preparation of these financial statements requires management to make estimates and judgments that affect the reported amounts of assets, liabilities and expenses, and related disclosures. On an ongoing basis, we evaluate these estimates, including those related to clinical trial accruals, income taxes (including the valuation allowance for deferred tax assets), restructuring costs and stock-based compensation. Estimates are based on historical experience, information received from third parties and on various other assumptions that are believed to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources. Actual results could therefore differ materially from those estimates under different assumptions or conditions.
Stock-Based Compensation
      In February 2003, the Board of Directors approved a cancellation and re-grant of 308,835 unexercised stock options held by existing employees and directors of the Company in a one-for-one exchange and 12,500 options that were re-granted in connection with the cancellation of 54,166 unexercised stock options held by a director of the Company. The re-granted options have an exercise price equal to the closing price of the Company’s common stock on the NASDAQ National Market on February 5, 2003, or $2.76 per share. The options generally vest over a four-year period and will expire in February 2008 if not previously exercised. Variable accounting is being applied to the re-granted options throughout their term. The related compensation expense depends on both the cumulative vesting of outstanding options and the price of the Company’s common stock at each quarter end, and therefore may have a significant impact on the Company’s future results of operations. No adjustments for material changes in estimates have been recognized in any period presented.
      As permitted by Statement of Financial Accounting Standards No. 123 (“SFAS 123”), “Accounting for Stock-Based Compensation”, as amended by Statement of Financial Standards No. 148, “Accounting for Stock-Based Compensation — Transition and Disclosure,” the Company has elected to follow APB 25 and related interpretations in accounting for stock-based employee compensation. Under APB 25, if the exercise price of an employee or director stock option is set equal or in excess of the fair market value of the underlying stock on the date of grant, no compensation expense is recognized. In February 2003, certain employee and director stock options for which the exercise prices had originally been set at less than the fair market value of the underlying stock on the grant date, were cancelled and re-granted in a one-for-one exchange. The Company had recorded deferred compensation for the difference between the original exercise price and the fair market value of the underlying stock on the grant date as a component of stockholders’ equity, and the

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total was being amortized on a straight-line basis over the vesting period of the original awards, ranging from four to six years. The related re-granted options all vest over a four-year period, and the remaining unamortized deferred compensation as of the re-grant date is now being amortized over the new four-year vesting schedule, commencing at the date of re-grant. The amount of deferred stock compensation expense to be recorded in future periods could decrease if options, for which accrued but unvested compensation has been recognized, are forfeited prior to vesting. No adjustments for material changes in estimates have been recognized in any period presented.
      Options or stock awards issued to non-employees are recorded at their fair value as determined in accordance with SFAS 123 and the FASB’s Emerging Issues Task Force issue No. 96-18, “Accounting for Equity Instruments That Are Issued to Other Than Employees for Acquiring, or in Conjunction with Selling, Goods or Services”, and are recognized over the related service period and are periodically re-measured as the underlying options vest. The fair values are estimated using the Black-Scholes option pricing model, and are periodically re-measured as the underlying options vest. The option pricing model is dependent on a number of inputs, which may change over time. Other option pricing models may produce fair values that are substantially different from the Black-Scholes model. No adjustments for material changes in estimates have been recognized in any period presented.
Clinical Trial Accruals
      The Company’s accrued costs for clinical trial activities are based upon estimates of the services received and related expenses incurred that have yet to be invoiced by the contract research organizations (CROs), investigators, drug processors, laboratories, consultants, or other clinical trial service providers that perform the activities. Related contracts vary significantly in length, and may be for a fixed amount, a variable amount based on actual costs incurred, capped at a certain limit, or for a combination of these elements. Activity levels are monitored through close communication with the service provider, including detailed invoice and task completion review, analysis of expenses against budgeted amounts, and pre-approval of any changes in scope of the services to be performed. Each CRO provides an estimate of costs incurred but not invoiced at the end of each period for each individual trial. The estimates are reviewed and discussed with the CRO as necessary, and included in research and development expenses for the related period. For investigator study grants, which are paid quarterly on a per-patient basis to the institutions performing the clinical study, the Company accrues an estimated amount based on patient enrollment in each quarter. All estimates may differ significantly from the actual amount subsequently invoiced. No adjustments for material changes in estimates have been recognized in any period presented. As of December 31, 2004 amounts accrued related to clinical trials are approximately $161,000, due to the cessation of clinical trial activity.
Results of Operations
Comparison of Years Ended December 31, 2004, 2003 and 2002
Revenues
      IntraBiotics had no product sales or contract revenue for the years ended December 31, 2004, 2003 and 2002. We do not anticipate any product revenues until we obtain FDA approval for, and commence commercialization of, any product candidate.
Expenses
Research and Development
                                         
    2004   Change   2003   Change   2002
                     
    (In thousands)
Research and development
  $ 11,519       49.1 %   $ 7,727       (66.5 )%   $ 23,053  
      Research and development expenses primarily include clinical trial expenses, research and development payroll expense, drug substance expense, allocated facilities costs and non-cash stock compensation charges. Research and development expenses increased in 2004 by $3.8 million from 2003. These expenses increased

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by $0.4 million as a result of additional headcount and by $3.4 million from clinical trial expenses associated with the commencement of phase III trials of iseganan for the prevention of VAP. Although these expenses increased during 2004, as compared to 2003, $8.9 million of the total expense was incurred in the first half of 2004, with only $2.1 million and $0.6 million of research and development expense in the third and fourth quarters of 2004, respectively. This significant reduction in the fourth quarter is as a result of the termination of our iseganan development project in June 2004.
      Research and development expenses decreased in 2003 by $15.3 million from 2002, primarily due to a $9.3 million reduction in clinical trial expenses and a $3.2 million reduction in research and development payroll expense, allocated facilities costs and non-cash stock compensation charges as a result of restructuring activities in 2002. The clinical trial expenses of $4.3 million in 2003 relate to the first pivotal trial of iseganan for the prevention of VAP, which commenced in September 2003
      In 2003, research and development expenses include a write-off of $2.4 million for prepaid iseganan drug substance, relating to an order of seven kilograms of iseganan bulk drug substance that was expected to be delivered in 2003. Due to significant uncertainty over the timing and outcome of discussions with the contract manufacturer about whether the drug substance was manufactured in accordance with a validation plan and the adequacy of manufacturing documentation, the entire $2.4 million prepaid amount was written off in September 2003. In 2002, research and development expenses included a $4.8 million charge in relation to the delivery of certain other lots of iseganan bulk drug substance as a result of the termination of a supply agreement with the same contract manufacturer.
      Non-cash stock compensation charges were $26,000, $59,000 and $656,000 for the years ended December 31, 2004, 2003 and 2002, respectively. The decrease from 2003 to 2004 was due to lower amortization of deferred stock compensation expense during 2004 and a recovery related to stock compensation for variable options awards during 2004, as compared to an expense during 2003. These decreases were offset, in part, by an increase in the stock compensation expense for consultant services. The decrease from 2002 to 2003 was primarily due to the cancellation of options for terminated employees and consultants.
General and Administrative
                                         
    2004   Change   2003   Change   2002
                     
    (In thousands)
General and administrative
  $ 4,819       (16.7 )%   $ 5,782       (32.9 )%   $ 8,617  
      General and administrative costs primarily include administrative payroll expense, outside contractors, legal and accounting fees, insurance, non-cash stock compensation charges, facilities, travel and other general administrative expenses. General and administrative expenses decreased by $1.0 million from 2003 to 2004. Expenses associated with increased headcount and facilities increased by $0.4 million, which was offset by a reduction in stock compensation expense of $1.4 million primarily related to variable accounting for stock options. During 2003 stock compensation charges were $1.3 million as compared with a recovery of $0.1 million during 2004.
      General and administrative expenses in 2003 decreased by $2.8 million from 2002, primarily due to reduced headcount and facility-related costs as a result of a restructuring in October 2002.
      Non-cash stock compensation charges were a recovery in the year ended December 31, 2004 of $0.1 million as compared to expenses of $1.3 million and $1.7 million for the years ended December 31, 2003 and 2002, respectively.
Restructuring and Other Charges
                         
    2004   2003   2002
             
    (In thousands)
Restructuring and other charges
    $858       $—       $6,118  
      In June 2004, the Company discontinued its clinical trial of iseganan for the prevention of VAP, following a recommendation of the independent data monitoring committee. The Company has since terminated its

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iseganan development program, and is focusing efforts on evaluating various strategic options, which may include mergers, acquisitions, in-licensing opportunities, and liquidation of the Company. As a result, in August 2004, the Company implemented a restructuring plan, which included the termination of nine employees and various operating lease commitments.
      The Company recorded a restructuring charge of $858,000 during the year ended December 31, 2004, of which $748,000 related to involuntary employee termination benefits and $110,000 related to the termination of facility operating leases and the write-off of certain property and equipment. The $748,000 of involuntary employee benefits were comprised of $700,000 of lump sum severance payments, $13,000 of related employer taxes and $35,000 of health and other benefits payable. As of December 31, 2004, approximately $5,000 of the restructuring charge remained unpaid and is included under the caption “Other Accrued Liabilities” on the accompanying balance sheet. The remaining liability should be settled by June 30, 2005.
      There were no restructurings during 2003.
      In 2002, restructuring expense of $6.1 million was comprised of two components. The first component was as a result of the failure of a phase III clinical trial of iseganan for the prevention of oral mucositis in cancer patients, which occurred in October 2002. As a result of this restructuring we reduced our headcount to 11 as of December 31, 2002 from 37 as of December 31, 2001 and recorded an expense of $848,000. The second component of $5.2 million was as a result of an additional expense related to a previous restructuring which occurred during 2001. The additional expense of $5.2 million related to the termination of a lease and related sublease and included cash payments, the issuance of common stock and the write-off of a deferred rent balance.
Arbitration Settlement
      During the year ended December 31, 2002, we received $3.6 million from a contract vendor as a result of an arbitration settlement relating to a drug dispensing error in a phase III trial of iseganan for oral mucositis. We had no comparable item in 2004 or 2003.
Interest Income and Expense
                                         
    2004   Change   2003   Change   2002
                     
    (In thousands)
Interest income
  $ 656       295.2 %   $ 166       (76.4 )%   $ 703  
Interest expense
  $       n/m     $       (100.0 )     (459 )
      Interest income in 2004 increased from 2003 because of substantially higher average interest earning investment balances due to a public stock offering in May 2004, which raised net proceeds of $41.5 million. Interest income decreased in 2003, as compared to 2002, primarily as a result of decreases in average investment balances and lower interest rates in each year. For additional information on the public stock offering in May 2004 please see Liquidity and Capital Resources, below.
      Interest expense decreased to zero in 2003 due to the repayment of our line of credit and bank loan in October 2002.
Other Income/(Expense), net
                                         
    2004   Change   2003   Change   2002
                     
    (In thousands)
Other income/(expense), net
  $ (175 )     (564.5% )   $ 31       (96.4 )%   $ 856  
      In September 2004 the Company recorded an expense, included in other income/(expense), net, of $175,000 related to the write-down of the carrying value of 350,000 shares of Series A redeemable preferred stock of Micrologix Biotech Inc., (“Micrologix”).
      Other income/(expense), net in 2002 includes income of $975,000 from the sale of two pre-clinical anti-infective programs to Micrologix in May 2002, for $400,000 in cash and 750,000 shares of Series A

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redeemable preferred stock of Micrologix. The shares are redeemable at $1 per share or convertible into common stock at the election of Micrologix upon the occurrence of certain time and achievement milestones as follows: (1) shares converted into common stock with a value of $400,000 upon the four month anniversary of the effective date of the agreement; (2) shares will convert into common stock with a value of $100,000 upon commencement of certain toxicology studies; and (3) shares will convert into common stock with a value of $250,000 upon filing for marketing approval for certain drugs in certain countries. Other income of $775,000 was recognized in the second quarter of 2002 upon receipt of the $400,000 in cash and the 750,000 shares, and other income of $200,000 was recognized in the third quarter of 2002 upon redemption of 400,000 of the shares at $1 per share, which was triggered by the first milestone set forth above. Subsequent to this redemption the Company owned 350,000 shares of Series A redeemable preferred stock with a carrying value of $175,000 which were included in “Other Assets”.
Income Taxes
      Since inception, we have incurred operating losses and accordingly have not recorded a provision for income taxes for any of the periods presented. As of December 31, 2004, we had net operating loss carryforwards for federal and state income tax purposes of approximately $211.0 million and $38.0 million, respectively. We also had federal and state research and development tax credits each of approximately $3.3 million. If not utilized, the net operating losses and credits will expire in the years 2004 through 2024. Utilization of net operating losses and credits are subject to a substantial annual limitation due to ownership change limitations provided by the Internal Revenue Code of 1986, as amended. The annual limitation could result in the expiration of our net operating losses and credit carryforwards before they can be used. Please read Note 12 of the notes to the financial statements included in Item 8 of this Form 10-K for further information.
Liquidity and Capital Resources
                                         
    2004   Change   2003   Change   2002