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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

Form 10-Q

     
x   Quarterly report pursuant to Section 13 or 15 (d) of the Securities Exchange Act of 1934

For the quarterly period ended September 30, 2003
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   (I.R.S. Employer Identification Number)
incorporation or organization)    

2483 East Bayshore Road, Suite 100
Palo Alto, CA 94303

(Address of principal executive offices)

(650) 526-6800

(Registrant’s telephone number including area code)

Indicate by check mark whether the Registrant: (1) has filed all reports required to be filed by Section 13 or 15 (d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the Registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days.
Yes x No o

Indicate by checkmark whether registrant is an accelerated filer (as defined in Rule 12b-2 of Securities Exchange Act of 1934).
Yes o No x

There were 5,253,983 shares of the Company’s Common Stock, par value $.001, outstanding as of October 31, 2003.

 


TABLE OF CONTENTS

PART I. FINANCIAL INFORMATION
ITEM I. FINANCIAL STATEMENTS
CONDENSED BALANCE SHEETS
CONDENSED STATEMENTS OF OPERATIONS
CONDENSED STATEMENTS OF CASH FLOWS
NOTES TO CONDENSED FINANCIAL STATEMENTS
ITEM 2. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
ITEM 3. QUANTITATIVE AND QUALITATIVE DISCLOSURE ABOUT MARKET RISK
ITEM 4. CONTROLS AND PROCEDURES
PART II. OTHER INFORMATION
ITEM 6. EXHIBITS AND REPORTS ON FORM 8-K
SIGNATURES
EXHIBIT INDEX
EXHIBIT 3.3
EXHIBIT 3.4
EXHIBIT 31.1
EXHIBIT 31.2
EXHIBIT 32.1


Table of Contents

INTRABIOTICS PHARMACEUTICALS, INC.
FORM 10-Q
QUARTER ENDED September 30, 2003
TABLE OF CONTENTS

         
        Page
       
PART I.   FINANCIAL INFORMATION    
Item 1.   Financial Statements (unaudited)    
    Condensed Balance Sheets as of September 30, 2003 and December 31, 2002   3
    Condensed Statements of Operations for the Three- and Nine-Month Periods Ended September 30, 2003 and 2002   4
    Condensed Statements of Cash Flows for the Nine-Month Periods Ended September 30, 2003 and 2002   5
    Notes to Condensed Financial Statements   6
Item 2.   Management’s Discussion and Analysis of Financial Condition and Results of Operations   10
Item 3.   Quantitative and Qualitative Disclosure About Market Risk   22
Item 4.   Controls and Procedures   22
PART II.   OTHER INFORMATION    
Item 6.   Exhibits and Reports on Form 8-K   23
SIGNATURES       24

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PART I. FINANCIAL INFORMATION

ITEM I. FINANCIAL STATEMENTS

INTRABIOTICS PHARMACEUTICALS, INC.
CONDENSED BALANCE SHEETS
(IN THOUSANDS)

                     
        SEPTEMBER 30,   DECEMBER 31,
        2003   2002
       
 
        (Unaudited)   (Note 1)
Assets
               
Current assets:
               
 
Cash and cash equivalents
  $ 10,061     $ 10,170  
 
Restricted cash
    250       250  
 
Short-term investments
          2,895  
 
Prepaid drug substance
          2,375  
 
Prepaid expenses
    467       247  
 
   
     
 
   
Total current assets
    10,778       15,937  
Property and equipment, net
    31       112  
Other assets
    184       177  
 
   
     
 
   
Total assets
  $ 10,993     $ 16,226  
 
   
     
 
Liabilities and stockholders’ equity
               
Current liabilities:
               
 
Accounts payable
  $ 376     $ 345  
 
Accrued clinical liabilities
    128        
 
Accrued employee liabilities
    91       135  
 
Accrued restructuring charges
          64  
 
Other accrued liabilities
    244       202  
 
   
     
 
   
Total current liabilities
    839       746  
Stockholders’ equity:
               
Preferred stock
    1,886        
Common stock
    3       3  
Additional paid-in capital
    219,244       216,466  
Deferred stock compensation
    (180 )     (720 )
Accumulated deficit
    (210,799 )     (200,269 )
 
   
     
 
   
Total stockholders’ equity
    10,154       15,480  
 
   
     
 
   
Total liabilities and stockholders’equity
  $ 10,993     $ 16,226  
 
   
     
 

See accompanying notes.

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INTRABIOTICS PHARMACEUTICALS, INC.
CONDENSED STATEMENTS OF OPERATIONS
(IN THOUSANDS, EXCEPT PER SHARE AMOUNTS)

(UNAUDITED)

                                     
        THREE MONTHS ENDED   NINE MONTHS ENDED
        SEPTEMBER 30,   SEPTEMBER 30,
       
 
        2003   2002   2003   2002
       
 
 
 
Operating expenses:
                               
 
Research and development
  $ 3,641     $ 3,955     $ 5,261     $ 17,407  
 
General and administrative
    1,125       2,388       3,833       6,295  
 
Arbitration settlement
                      (3,600 )
 
Restructuring and other charges
          5,140             5,231  
 
 
   
     
     
     
 
   
Total operating expenses
    4,766       11,483       9,094       25,333  
 
 
   
     
     
     
 
 
Operating loss
    (4,766 )     (11,483 )     (9,094 )     (25,333 )
 
Interest income
    28       143       99       623  
 
Interest expense
          (131 )           (397 )
 
Other income
          200             984  
 
 
   
     
     
     
 
Net loss
    (4,738 )     (11,271 )     (8,995 )     (24,123 )
Non-cash deemed dividend related to beneficial conversion feature of Series A preferred stock
                (1,418 )      
Dividends on Series A preferred stock
    (70 )           (117 )      
 
 
   
     
     
     
 
Net loss applicable to common stockholders
  $ (4,808 )   $ (11,271 )   $ (10,530 )   $ (24,123 )
 
 
   
     
     
     
 
Basic and diluted net loss per share applicable to common stockholders
  $ (1.46 )   $ (3.59 )   $ (3.22 )   $ (7.99 )
 
 
   
     
     
     
 
Shares used to compute basic and diluted net loss per share applicable to common stockholders
    3,283       3,143       3,274       3,018  
 
 
   
     
     
     
 

See accompanying notes.

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INTRABIOTICS PHARMACEUTICALS, INC.
CONDENSED STATEMENTS OF CASH FLOWS
(IN THOUSANDS)

(UNAUDITED)

                     
        NINE MONTHS ENDED SEPTEMBER 30,
       
        2003   2002
       
 
Operating activities
               
Net loss
  $ (8,995 )   $ (24,123 )
Adjustments to reconcile net loss to net cash used in operating activities:
               
 
Amortization of deferred stock compensation
    110       848  
 
Depreciation and amortization
    81       575  
 
Acquired workforce amortization
          234  
 
Stock compensation expense
    411       619  
 
Gain on sale of pre-clinical programs
          (975 )
 
Change in assets and liabilities:
               
   
Prepaid expenses
    2,155       2,025  
   
Other assets
    (7 )      
   
Accounts payable
    31       (33 )
   
Accrued clinical liabilities
    128       (222 )
   
Accrued employee liabilities
    (44 )     (300 )
   
Accrued restructuring charges
    (64 )     2,859  
   
Deferred rent
          203  
   
Other accrued liabilities
    (28 )     (396 )
 
   
     
 
Net cash used in operating activities
    (6,222 )     (18,686 )
Investing activities
               
 
Capital expenditures
          (17 )
 
Proceeds from sale of pre-clinical programs
          400  
 
Maturities of short-term investments
    2,895        
 
Cash received in acquisition of subsidiary
          58  
 
   
     
 
Net cash provided by investing activities
    2,895       441  
Financing activities
               
 
Proceeds from issuance of common stock, net
    6       19,472  
 
Proceeds from issuance of Series A preferred stock and warrants, net
    3,212        
 
Payments on financing obligations
          (1,406 )
 
   
     
 
Net cash provided by financing activities
    3,218       18,066  
 
   
     
 
Net decrease in cash and cash equivalents
    (109 )     (179 )
Cash and cash equivalents at beginning of period
    10,170       27,982  
 
   
     
 
Cash and cash equivalents at end of period
  $ 10,061     $ 27,803  
 
   
     
 
Supplemental disclosure of cash flow information:
               
 
Interest paid
  $     $ 397  
 
   
     
 
Supplemental disclosure of non-cash information:
               
 
Net deferred stock compensation (cancellations due to employee termination)
  $ (430 )   $ (1,076 )
 
   
     
 
 
Other assets received from sale of pre-clinical programs
  $     $ 575  
 
   
     
 
 
Beneficial conversion feature on Series A preferred stock
  $ (1,418 )   $  
 
   
     
 
 
Issuance of common stock dividend on Series A preferred stock
  $ (117 )   $  
 
   
     
 
Cash flow for acquisition of subsidiary:
               
 
Acquired workforce
  $     $ 1,694  
 
Other current assets acquired
          297  
 
Property and equipment acquired
          56  
 
Liabilities assumed
          (75 )
 
Acquisition costs incurred
          (106 )
 
Common stock issued
          (1,924 )
 
   
     
 
 
Cash received in acquisition
  $     $ (58 )
 
   
     
 

See accompanying notes.

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INTRABIOTICS PHARMACEUTICALS, INC.
NOTES TO CONDENSED FINANCIAL STATEMENTS
(Unaudited)

Note 1. Basis of Presentation and Summary of Significant Accounting Policies

     The accompanying condensed financial statements are unaudited and have been prepared by IntraBiotics Pharmaceuticals, Inc. (the “Company”) in accordance with the rules and regulations of the Securities and Exchange Commission for interim financial information, and in accordance with the instructions to Form 10-Q and Article 10 of Regulation S-X.

     Certain information and footnote disclosures normally included in the Company’s annual audited financial statements (as required by accounting principles generally accepted in the United States) have been condensed or omitted. The interim condensed financial statements, in the opinion of management, reflect all adjustments (consisting entirely of normal recurring adjustments) necessary for a fair presentation of the Company’s financial position as of September 30, 2003, the results of its operations for the three- and nine-month periods ended September 30, 2003 and 2002 and cash flows for the nine-month periods ended September 30, 2003 and 2002.

     The results of operations of the interim periods are not necessarily indicative of the results of operations to be expected for the entire fiscal year. These interim condensed financial statements should be read in conjunction with the audited financial statements for the year ended December 31, 2002, which are contained in the Company’s Annual Report on Form 10-K/A, and filed with the Securities and Exchange Commission on June 25, 2003. The condensed balance sheet as of December 31, 2002 is derived from such audited financial statements.

     Use of estimates

     The preparation of financial statements in conformity with generally accepted accounting principles in the United States requires management to make estimates and assumptions that affect the amounts reported in the financial statements and accompanying notes. Actual results could differ from those estimates.

     Recent Accounting Pronouncements

     In August 2002, the Financial Accounting Standards Board issued Statement No. 146 (“SFAS No. 146”), “Accounting for Costs Associated with Exit or Disposal Activities.” SFAS No. 146 supersedes Emerging Issues Task Force Issue No. 94-3, “Liability Recognition for Certain Employee Termination Benefits and Other Costs To Exit an Activity (Including Certain Costs Associated with a Restructuring)” and requires that a liability for a cost associated with an exit or disposal activity be recognized when the liability is incurred, as opposed to when management is committed to an exit plan. SFAS No. 146 also establishes that the liability should initially be measured and recorded at fair value. This statement is effective for exit or disposal activities initiated after December 31, 2002. The provisions of SFAS No. 146 are required to be applied prospectively after the adoption date to newly initiated exit activities, and may affect the timing of recognizing future restructuring costs, as well as the amounts recognized. The adoption of the statement on January 1, 2003 did not have a material impact on the Company’s financial position, results of operations or disclosure.

     In November 2002, the FASB issued Interpretation No. 45 (“FIN 45”), “Guarantor’s Accounting and Disclosure Requirements for Guarantees, Including Indirect Guarantees of Indebtedness of Others.” FIN 45 requires that a liability be recorded in the guarantor’s balance sheet upon issuance of a guarantee. In addition, FIN 45 requires disclosures about the guarantees that an entity has issued. FIN 45 is effective on a prospective basis to guarantees issued or modified after December 31, 2002. The disclosure requirements of FIN 45 are effective for financial statements for interim and annual periods ending after December 31, 2002. The adoption of FIN 45 did not have any impact on the Company’s financial position, results of operations or disclosure.

     In January 2003, the FASB issued FASB Interpretation No. 46 (“FIN 46”), “Consolidation of Variable Interest Entities, an Interpretation of ARB No. 51.” FIN 46 requires certain variable interest entities to be consolidated by the primary beneficiary of the entity if the equity investors in the entity do not have the characteristics of a controlling financial interest or do not have sufficient equity at risk for the entity to finance its activities without additional subordinated financial support from other parties. FIN 46 is effective for all new variable interest entities created or acquired after January 31, 2003. For variable interest entities created or acquired prior to February 1, 2003, the provisions of FIN 46, as amended, must be applied for the first interim or annual period ending after December 15, 2003. The adoption of FIN 46 did not have any impact on the Company’s financial position, results of operations or disclosure.

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     In May 2003, the FASB issued SFAS No. 150, “Accounting for Certain Financial Instruments with Characteristics of both Liabilities and Equity.” SFAS No. 150 requires that certain financial instruments, which under previous guidance were accounted for as equity, must now be accounted for as liabilities. The financial instruments affected include stock with mandatory redemption, certain financial instruments that require or may require the issuer to buy back some of its shares in exchange for cash or other assets and certain obligations that can be settled with shares of stock. SFAS No. 150 is effective for all financial instruments entered into or modified after May 31, 2003 and must be applied to the Company’s existing financial instruments effective July 1, 2003, the beginning of the first fiscal period after June 15, 2003. The adoption of SFAS No. 150 did not have a material impact on the Company’s financial position, results of operations or disclosure.

Note 2. Stock-Based Compensation

     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 value of the underlying stock on the date of grant, no compensation expense is recognized. If the exercise price of the employee or director stock option is set at less than the fair value of the underlying stock on the grant date, the Company records deferred compensation for the difference. Deferred compensation is amortized on a straight-line basis over the vesting period of the original award, ranging from four to six years.

     Options or stock awards issued to non-employees are recorded at their fair value as determined in accordance with SFAS 123, and are recognized over the related service period and are periodically re-measured as the underlying options vest.

     The following table illustrates the effect on net loss and net loss per share applicable to common stockholders if the Company had applied the fair value recognition provisions of SFAS 123 to stock-based employee compensation (in thousands, except per share amounts):

                                   
      Three Months Ended   Nine Months Ended
      September 30,   September 30,
     
 
      2003   2002   2003   2002
     
 
 
 
Net loss applicable to common stockholders, as reported
  $ (4,808 )   $ (11,271 )   $ (10,530 )   $ (24,123 )
Add: Stock-based employee compensation expense included in reported net loss
    300       161       419       848  
Deduct: Total stock-based employee compensation expense determined under fair value based method for all awards
    (384 )     (720 )     (1,194 )     (1,799 )
 
   
     
     
     
 
Pro forma net loss applicable to common stockholders
  $ (4,892 )   $ (11,830 )   $ (11,305 )   $ (25,074 )
 
   
     
     
     
 
Net loss per share applicable to common stockholders:
                               
 
Basic and diluted — as reported
  $ (1.46 )   $ (3.59 )   $ (3.22 )   $ (7.99 )
 
   
     
     
     
 
 
Basic and diluted — pro forma
  $ (1.49 )   $ (3.76 )   $ (3.45 )   $ (8.20 )
 
   
     
     
     
 

The fair value for the Company’s options was estimated at the date of grant using the Black-Scholes option pricing model for the three- and nine-month periods ended September 30, 2003 and 2002 with the following weighted-average assumptions:

                                 
    Three Months Ended   Nine Months Ended
    September 30,   September 30,
   
 
    2003   2002   2003   2002
   
 
 
 
Risk-free interest rate
    3.20 %     3.35 %     2.81 %     4.08 %
Volatility
    1.00       1.00       1.00       1.00  
Dividend yield
                       
Expected life of option
  5 years   5 years   5 years   5 years

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Note 3. Comprehensive Loss

     Comprehensive loss is solely comprised of the net loss in each period presented.

Note 4. Contractual Commitments

     In February 2003, the Company entered into an operating lease agreement for a facility in Palo Alto, California, which expires in June 2004. Under the terms of the lease, the Company is committed to pay an aggregate amount of approximately $84,000 in 2003 and $43,000 in 2004.

Note 5. Stock Options Cancellation and Regrant

     In February 2003, the Board of Directors approved a cancellation and re-grant of 321,335 unexercised stock options held by existing employees and directors of the Company. Upon election by the participants, all of the unexercised stock options were cancelled and new stock options were granted in a one-for-one exchange. 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, post-split (see Note 8). The options 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, starting from the date of re-grant, and the related compensation expense may have a significant impact on the Company’s future results of operations. Compensation expense of $285,000 and $309,000 was recorded for these options during the three- and nine-month periods ended September 30, 2003, respectively.

Note 6. Net Loss Per Common Share

     Basic and diluted net loss per share applicable to common stockholders is presented in accordance with Financial Accounting Standards Board Statement No. 128, “Earnings Per Share”, and is calculated using the weighted-average number of shares of common stock outstanding during the period. Diluted net loss per share applicable to common stockholders includes the impact of potentially dilutive securities (stock options, warrants and convertible preferred stock). As the Company’s potentially dilutive securities were anti-dilutive for all periods, they are not included in the calculations of diluted net loss per share applicable to common stockholders. The total number of shares underlying the stock options, warrants and convertible preferred stock excluded from the calculations of net loss per common share were 3,200,874 and 623,410 for the three-month periods ended September 30, 2003 and 2002, respectively, and 2,991,807 and 385,114 for the nine-month periods ended September 30, 2003 and 2002, respectively.

Note 7. Restructuring and Other Charges

     In October 2002, the Company announced a restructuring plan as a result of the failure of its then recently completed phase III clinical trial for the prevention of oral mucositis in cancer patients. This restructuring plan reduced headcount by 26 employees in research and development and general and administration, or 70% of the Company’s workforce. In accordance with provisions of EITF 94-3 and related interpretations, the Company recorded restructuring charges of $848,000 for severance costs of which $784,000 were paid as of December 31, 2002. The remaining severance accrual as of December 31, 2002 of $64,000 was paid in January 2003 to employees who left the Company in December 2002. No other charges were expensed in 2003 as a result of the restructuring plan.

Note 8. Reverse Stock Split

     On April 3, 2003, the Company’s stockholders authorized a 1-for-12 reverse stock split of all outstanding shares of the Company’s common stock, which was effected on April 10, 2003. All share and per share amounts have been retroactively adjusted to reflect the stock split for all periods presented.

Note 9. Stockholders’ Equity

     On May 1, 2003, in a private placement transaction, the Company sold 350 shares of a newly created Series A convertible preferred stock (the “Preferred Stock”), $0.001 par value, and issued warrants to purchase 920,699 shares of common stock, resulting in net cash proceeds of $3.2 million. The primary purpose of completing the private placement was to provide funds for a clinical trial of iseganan HCl for the prevention of ventilator-associated pneumonia (VAP), as well as for other general corporate purposes and working capital.

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     The Preferred Stock is convertible into 1,841,404 shares of common stock at any time, at a conversion price of $1.90 per share, subject to adjustment upon the occurrence of certain events, such as stock splits, payment of dividends to common stockholders, reorganizations, mergers or consolidations. Each share of Preferred Stock automatically converts into shares of common stock on the tenth day after the day that the closing sale price of the Company’s common stock on the Nasdaq National Market has reached at least $8.28 and has remained at such level for 20 consecutive trading days, but only after the earlier to occur of (1) the unblinding and the public announcement of the results of the Company’s first pivotal clinical trial of iseganan HCl for the prevention of VAP, or (2) the second anniversary of the date the Preferred Stock was first issued. The holders of Preferred Stock are also entitled to receive, but only out of funds legally available for dividends, cumulative dividends payable quarterly, at the annual rate of eight percent of the original issue price of $10,000 on each outstanding share of Preferred Stock. The dividend will be paid in common stock based on the average of the closing sales prices of the common stock on the Nasdaq National Market for the five trading days immediatel