For the quarterly period ended March 31, 2006
Table of Contents

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 


FORM 10-Q

 


(Mark One)

x QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the quarterly period ended March 31, 2006

or

 

¨ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15 (d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the transition period from              to             

Commission File Number: 0-12104

 


Immunomedics, Inc.

(Exact name of Registrant as specified in its charter)

 


 

Delaware   61-1009366

(State or other jurisdiction of

incorporation or organization)

 

(I.R.S. Employer

Identification No.)

300 American Road, Morris Plains, New Jersey 07950

(Address of principal executive offices) (Zip Code)

(973) 605-8200

(Registrant’s Telephone Number, Including Area Code)

Former Name, Former Address and Former Fiscal Year, If Changed Since Last Report: Not Applicable

 


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 by check mark whether the registrant is a large accelerated filer, an accelerated filer, or a non-accelerated filer. See definition of “accelerated filer and large accelerated filer” in Rule 12b-2 of the Exchange Act. (Check one):

Large Accelerated Filer  ¨    Accelerated Filer  x    Non-Accelerated Filer  ¨

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act).    Yes  ¨    No  x

The number of shares of the registrant’s common stock outstanding as of May 9, 2006 was 57,415,066.

 



Table of Contents

IMMUNOMEDICS, INC.

TABLE OF CONTENTS

 

         Page No.
PART I:   FINANCIAL INFORMATION   
ITEM 1.   FINANCIAL STATEMENTS:   
  Consolidated Balance Sheets as of March 31, 2006 (unaudited) and June 30, 2005    3
  Consolidated Statements of Operations and Comprehensive Loss for the Three Months and Nine Months Ended March 31, 2006 (unaudited) and 2005 (unaudited)    4
  Condensed Consolidated Statements of Cash Flows for the Nine Months Ended March 31, 2006 (unaudited) and 2005 (unaudited)    5
  Notes to Unaudited Consolidated Financial Statements    6
ITEM 2.   MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS    19
ITEM 3.   QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK    29
ITEM 4.   CONTROLS AND PROCEDURES    30
PART II:   OTHER INFORMATION   
ITEM 1.   LEGAL PROCEEDINGS    31
ITEM 1A.   RISK FACTORS    32
ITEM 6.   EXHIBITS    44
SIGNATURES    45

 

2


Table of Contents

ITEM 1. FINANCIAL STATEMENTS

IMMUNOMEDICS, INC. AND SUBSIDIARIES

CONSOLIDATED BALANCE SHEETS

 

    

March 31,

2006

   

June 30,

2005

 
     (unaudited)        
ASSETS     

Current Assets:

    

Cash and cash equivalents

   $ 8,947,085     $ 11,937,483  

Marketable securities

     1,373,601       3,547,507  

Accounts receivable, net of allowance for doubtful accounts of $125,000 and $150,000, at March 31, 2006 and June 30, 2005, respectively

     778,747       409,458  

Inventory, net of reserve for obsolescence of $66,000 and $150,000 at March 31, 2006 and June 30, 2005, respectively

     620,506       493,603  

Other current assets

     799,633       785,677  

Restricted securities- current portion

     1,275,200       15,575,200  
                

Total current assets

     13,794,772       32,748,928  

Property and equipment, net of accumulated depreciation of $16,381,719 and $15,058,604, at March 31, 2006 and June 30, 2005, respectively

     8,949,786       10,152,115  

Restricted securities

     1,594,000       2,550,400  

Other long-term assets

     1,571,672       2,471,706  
                
   $ 25,910,230     $ 47,923,149  
                
LIABILITIES AND STOCKHOLDERS’ DEFICIT     

Current Liabilities:

    

Current portion of long-term debt

   $ 1,275,200     $ 1,275,200  

Accounts payable and accrued expenses

     7,466,865       8,147,723  

Derivative interest liability

     1,329,198       —    
                

Total current liabilities

     10,071,263       9,422,923  
                

Long-term debt

     30,527,534       36,743,233  

Other liabilities – warrants

     —         2,748,240  

Minority interest

     198,944       272,160  

Commitments and Contingencies

    

Stockholders’ deficit:

    

Preferred stock, $0.01 par value; authorized 10,000,000 shares at March 31, 2006 and 70,000,000 shares at June 30, 2005; no shares issued and outstanding at March 31, 2006 and June 30, 2005

     —         —    

Common stock, $0.01 par value; authorized 110,000,000 shares; issued and outstanding, 56,827,736 shares at March 31, 2006 and 54,073,059 shares at June 30, 2005

     568,277       540,730  

Capital contributed in excess of par

     182,837,290       173,417,147  

Treasury stock, at cost, 34,725 shares

     (458,370 )     (458,370 )

Accumulated deficit

     (198,122,734 )     (175,015,679 )

Accumulated other comprehensive income

     288,026       252,765  
                

Total stockholders’ deficit

     (14,887,511 )     (1,263,407 )
                
   $ 25,910,230     $ 47,923,149  
                

See accompanying notes to unaudited consolidated financial statements.

 

3


Table of Contents

IMMUNOMEDICS, INC. AND SUBSIDIARIES

CONSOLIDATED STATEMENTS OF OPERATIONS AND

COMPREHENSIVE LOSS

 

    

Three Months Ended

March 31,

   

Nine Months Ended

March 31,

 
     2006     2005     2006     2005  
     (unaudited)  

Revenues:

  

Product sales

   $ 1,142,461     $ 947,386     $ 1,685,186     $ 2,806,171  

License fee and other revenues

     83,250       74,457       246,931       263,386  

Research and development

     89,523       67,143       268,570       134,286  
                                

Total revenues

     1,315,234       1,088,986       2,200,687       3,203,843  
                                

Costs and Expenses:

        

Costs of goods sold

     186,984       218,337       387,639       543,836  

Research and development

     4,654,183       5,764,833       17,432,526       17,284,809  

Sales and marketing

     151,417       277,859       490,797       702,534  

General and administrative

     1,015,830       853,151       3,026,780       2,865,274  
                                

Total costs and expenses

     6,008,414       7,114,180       21,337,742       21,396,453  
                                

Operating loss

     (4,693,180 )     (6,025,194 )     (19,137,055 )     (18,192,610 )

Loss on change in fair value of warrants

     —         —         (269,988 )     —    

Litigation settlement

     —         —         —         1,111,750  

Interest and other income

     101,949       81,140       417,037       260,170  

Interest expense

     (1,174,887 )     (110,164 )     (4,705,593 )     (318,893 )

Minority interest

     22,360       23,416       73,216       84,116  

Foreign currency transaction gain (loss)

     737       75,571       978       43,798  
                                

Loss before income tax benefit

     (5,743,021 )     (5,955,231 )     (23,621,405 )     (17,011,669 )

Income tax (provision) benefit

     —         (103,792 )     514,350       347,565  
                                

Net loss

   $ (5,743,021 )     (6,059,023 )   $ (23,107,055 )   $ (16,664,104 )
                                

Per share data (basic and diluted):

        

Net loss

   $ (0.10 )   $ (0.11 )   $ (0.42 )   $ (0.31 )
                                

Weighted average number of common shares outstanding

     55,670,994       54,073,059       54,606,327       53,554,566  
                                

Comprehensive income (loss):

        

Net loss

   $ (5,743,021 )   $ (6,059,023 )   $ (23,107,055 )   $ (16,664,104 )

Other comprehensive income (loss), net of tax:

        

Foreign currency translation adjustments

     29,330       (87,107 )     16,466       91,220  

Unrealized gain (loss) on securities available for sale – net

     12,919       (70,772 )     18,795       (18,869 )
                                

Other comprehensive income (loss)

     42,249       (157,879 )     35,261       72,351  
                                

Comprehensive loss

   $ (5,700,772 )   $ (6,216,902 )   $ (23,071,794 )   $ (16,591,753 )
                                

See accompanying notes to unaudited consolidated financial statements.

 

4


Table of Contents

IMMUNOMEDICS, INC. AND SUBSIDIARIES

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS

 

    

Nine Months Ended

March 31,

 
     2006     2005  
     (unaudited)  

Cash flows from operating activities:

  

Net loss

   $ (23,107,055 )   $ (16,664,104 )

Adjustments to reconcile net loss to net cash provided by (used in) operating activities:

    

Depreciation

     1,323,115       1,402,231  

Non-cash interest charges related to 5% senior convertible notes

     2,509,594       —    

Minority interest

     (73,216 )     (84,116 )

Credit for allowance for doubtful accounts

     (24,557 )     (67,649 )

Inventory reserve increase

     4,900       47,000  

Amortization of premiums of marketable securities

     85,432       116,590  

Loss on change in fair value of warrants

     269,988       —    

Non-cash expense relating to issuance of stock options

     21,871       —    

Payment of interest expense with common stock

     791,628       —    

Changes in operating assets and liabilities

     (1,190,299 )     16,132  

Other

     16,466       91,220  
                

Net cash used in operating activities

     (19,372,133 )     (15,142,696 )
                

Cash flows from investing activities:

    

Purchases of marketable and restricted securities

     (1,150,000 )     (7,356,984 )

Proceeds from sales and maturities of marketable securities

     4,213,671       9,210,342  

Purchases of property and equipment

     (120,786 )     (325,502 )
                

Net cash provided by investing activities

     2,942,885       1,527,856  
                

Cash flows from financing activities:

    

Proceeds from issuance of common stock, net of transaction costs

     —         13,961,019  

Release of restricted funds from escrow relating to the 5% senior convertible notes

     14,300,000    

Exercise of stock options

     95,250       4,062  

Payments of debt

     (956,400 )     (956,400 )
                

Net cash provided by financing activities

     13,438,850       13,008,681  
                

Net decrease in cash and cash equivalents

     (2,990,398 )     (606,159 )

Cash and cash equivalents, beginning of period

     11,937,483       9,133,297  
                

Cash and cash equivalents, end of period

   $ 8,947,085     $ 8,527,138  
                

See accompanying notes to unaudited consolidated financial statements.

 

5


Table of Contents

IMMUNOMEDICS, INC. AND SUBSIDIARIES

NOTES TO UNAUDITED CONSOLIDATED

FINANCIAL STATEMENTS

Reference is made to the Annual Report on Form 10-K of Immunomedics, Inc., a Delaware corporation (“Immunomedics,” the “Company,” “we,” “our” or “us”) for the fiscal year ended June 30, 2005, which contains our audited consolidated financial statements and the notes thereto.

1. Business Overview and Basis of Presentation

The accompanying unaudited consolidated financial statements of Immunomedics, which incorporate our majority-owned subsidiaries, have been prepared in accordance with U.S. generally accepted accounting principles (“GAAP”) for interim financial information and the instructions to the Quarterly Report on Form 10-Q and Rule 10-01 of Regulation S-X. Accordingly, the statements do not include all of the information and footnotes required by GAAP for complete annual financial statements. With respect to the financial information for the interim periods included in this Quarterly Report on Form 10-Q, which is unaudited, management believes that all adjustments necessary for a fair presentation of the results for such interim periods have been included. The balance sheet at June 30, 2005 has been derived from the Company’s audited 2005 consolidated financial statements. Operating results for the three and nine-month periods ended March 31, 2006 are not necessarily indicative of the results that may be expected for the full fiscal year ending June 30, 2006, or any other period.

Immunomedics is subject to significant risks and uncertainties, including, without limitation, our inability to further identify, develop and achieve commercial success for new products and technologies; the possibility of delays in the research and development necessary to select drug development candidates and delays in clinical trials; the risk that clinical trials may not result in marketable products; the risk that we may be unable to successfully finance and secure regulatory approval of and market our drug candidates; our dependence upon pharmaceutical and biotechnology collaborations; the levels and timing of payments under our collaborative agreements, (if any); uncertainties about our ability to obtain new corporate collaborations and acquire new technologies on satisfactory terms, if at all; the development of competing products; our ability to protect our proprietary technologies; patent-infringement claims; and risks of new, changing and competitive technologies and regulations in the United States and internationally. For more details regarding such risks and uncertainties please refer to the section entitled Item 1A “Risk Factors” included in this Quarterly Report on Form 10-Q.

By entering into the Agreement with UCB (see Note 11) and the anticipated receipt of the initial payments related thereto, the Company will have sufficient funds to continue its research and development programs for at least the next twelve months. UCB will assume the financial responsibilities of completing the clinical and regulatory submissions of epratuzumab for SLE. The Company will continue to conduct its’ other antibody-based research and development programs for other compounds in its development pipeline in line with its corporate strategy. While epratuzumab continues to progress through the clinical trials and regulatory approval process before it is available for commercialization, the Company’s losses will continue as it continues to conduct its other research and development activities. These activities are budgeted to expand over time and will require further resources if the Company is to be successful. As a result, the Company’s operating losses are likely to be substantial over the next several years.

As of March 31, 2006, the Company had unrestricted cash, cash equivalents and marketable securities totaling $10,321,000. By entering into the Agreement with UCB and the anticipated receipt of approximately $38 million (before fees), the Company will have sufficient funds to continue operations at least through the next fiscal year. Management anticipates that with the transfer of the SLE clinical trials to UCB the average monthly cash outflow will be reduced.

 

6


Table of Contents

The Company continues to review and evaluate opportunities for the future funding of the organization, of which there is no assurance will be obtained. These opportunities include entering into partnership arrangements for products that are at various stages of product development and financing alternatives for additional debt or equity financings. At the present time, the Company is unable to determine whether any of these future activities will be successful and, if so, the terms and timing of any definitive agreements.

2. Summary of Significant Accounting Policies

Principles of Consolidation and Presentation

The consolidated financial statements include the accounts of Immunomedics and its majority-owned subsidiaries. All significant intercompany balances and transactions have been eliminated in consolidation. Minority interest is recorded for a majority-owned subsidiary.

Use of Estimates

The preparation of financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the reported period. Actual results could differ from those estimates.

Foreign Currencies

For subsidiaries outside of the United States that operate in a local currency environment, income and expense items are translated to United States dollars at the monthly average rates of exchange prevailing during the year, assets and liabilities are translated at the period-end exchange rates, and equity accounts are translated at historical exchange rates. Translation adjustments are accumulated in a separate component of stockholders’ equity in the Consolidated Balance Sheets and are included in the determination of comprehensive loss. Transaction gains and losses are included in the determination of net loss.

Cash Equivalents, Marketable Securities and Restricted Securities

The Company considers all highly liquid investments with original maturities of three months or less, at the time of purchase, to be cash equivalents.

Immunomedics’ investments in cash equivalents, marketable securities and restricted securities are classified as securities that are available for sale. The portfolio at March 31, 2006 primarily consisted of corporate debt securities and municipal bonds.

Concentration of Credit Risk

Cash, cash equivalents, marketable securities, and restricted securities are financial instruments that potentially subject the Company to concentration of credit risk. Immunomedics invests its cash in debt instruments of financial institutions and corporations with strong credit ratings. The Company has established guidelines relative to diversification and maturities that are designed to help ensure safety and liquidity. These guidelines are periodically reviewed to take advantage of trends in yields and interest rates. The Company has the ability to sell these investments before maturity and has therefore classified the investments as available for sale. The Company has never experienced any significant losses on its’ investments.

 

7


Table of Contents

Inventory

Inventory is stated at the lower of average cost (which approximates first-in, first-out) or market, and includes materials, labor and manufacturing overhead. As of March 31, 2006 the inventory balance consisted of finished goods.

Property and Equipment

Property and equipment are stated at cost and are depreciated on a straight-line basis over the estimated useful lives (5-10 years) of the respective assets. Leasehold improvements are capitalized and amortized over the lesser of the life of the initial lease term or the estimated useful life of the asset. The Company reviews long-lived assets for impairment whenever events or changes in business circumstances occur that indicate that the carrying amount of the assets may not be recoverable. The Company assesses the recoverability of long-lived assets held and to be used based on undiscounted cash flows, and measures the impairment, if any, using discounted cash flows.

Revenue Recognition

Revenue from the sale of diagnostic products is recorded when there is persuasive evidence that an arrangement exists, delivery has occurred, the price is fixed and determinable and collectability is reasonably assured. Allowances, if any, are established for uncollectible amounts, estimated product returns and discounts.

Payments received under contracts to fund certain research activities are recognized as revenue in the period in which the research activities are performed. Payments received in advance that are related to future performance are deferred and recognized as revenue when the research projects are performed.

Research and Development Costs

Research and development costs are expensed as incurred.

Income Taxes

Income taxes are accounted for under the asset and liability method. Deferred tax assets and liabilities relate to the expected future tax consequences of events that have been recognized in the Company’s consolidated financial statements and tax returns. A valuation allowance is provided when it is more likely than not that some portion or all of the deferred tax assets will not be realized. Income taxes are provided for profitable foreign jurisdictions at the applicable effective tax rate. During the nine-month period ended March 31, 2005, the Company provided income taxes of $243,000 relating to foreign operations, however no income taxes were provided for in the current year to date due to losses in those jurisdictions for the nine month period ended March 31, 2006.

Benefits received resulting from the sale of our State of New Jersey net operating losses (“NOL”) are recognized as a tax benefit when the NOL is approved for sale by the State of New Jersey. During the nine month periods ended March 31, 2006 and 2005, the Company sold and received benefits of approximately $514,350 and $591,000, respectively, as a result of the State of New Jersey NOL.

Net Loss Per Share Allocable to Common Stockholders

Net loss per basic and diluted common share allocable to common stockholders is based on the net loss for the relevant period, divided by the weighted-average number of common shares outstanding

 

8


Table of Contents

during the period. For purposes of the diluted net loss per common share calculations, the exercise or conversion of all potential common shares is not included because their effect would have been anti-dilutive, due to the net loss recorded for the nine-month periods ended March 31, 2006 and 2005. The common stock equivalents excluded from the diluted per share calculation are 19,897,900 and 5,231,500 shares at March 31, 2006 and 2005, respectively.

Comprehensive Loss

Comprehensive loss consists of net loss, net unrealized gains (losses) on securities available for sale and foreign exchange translation changes and is presented in the Consolidated Statements of Operations and Comprehensive Loss.

Stock-Based Compensation

Prior to July 1, 2005, the Company’s stock option plan was accounted for under the recognition and measurement provisions of APB Opinion No. 25, Accounting for Stock Issued to Employees and related Interpretations, as permitted by FASB Statement No. 123, Accounting for Stock-Based Compensation. No stock-based employee compensation cost was recognized in the Statement of Operations for the years ended June 30, 2005 or 2004, as all options granted under the plan had an exercise price equal to the market value of the underlying common stock on the date of grant. Effective July 1, 2005, the Company adopted the fair value recognition provisions of FASB Statement No. 123(R), Share-Based Payment, using the modified-prospective-transition method. Under that transition method, compensation cost recognized in 2006 includes: (a) compensation cost for all share-based payments granted prior to, but not yet vested as of July 1, 2005, based on the grant date fair value estimated in accordance with the original provisions of Statement 123, and (b) compensation cost for all share-based payments granted subsequent to July 1, 2005, based on the grant-date fair value estimated in accordance with the provisions of Statement 123(R). As of June 30, 2005, all outstanding stock options have been fully vested. Results for prior periods have not been restated.

As a result of adopting Statement 123(R) on July 1, 2005, the Company’s net loss for the three and nine-month periods ended March 31, 2006, were $8,000 and $22,000 higher than if the Company had continued to account for share-based compensation under Opinion No. 25.

The following table illustrates the effect on net loss and loss per share if the Company had applied the fair value recognition provisions of Statement 123 to options granted under the Company’s stock option plan in 2005. For purposes of this pro forma disclosure, the value of the options is estimated using a Black-Scholes-Merton option-pricing formula and amortized to expense over the options’ vesting periods.

 

     Three Months Ended
March 31, 2005
    Nine Months Ended
March 31, 2005
 

Net income (loss), as reported

   $ (6,059,023 )   $ (16,664,104 )

Add: Total stock–based employee compensation expense determined under fair value based method for all awards

     (9,835,330 )     (12,937,687 )
                

Pro forma net loss

   $ (15,894,353 )   $ (29,601,791 )
                

Loss per share:

    

-as reported

   $ (0.11 )   $ (0.31 )

-pro forma

   $ (0.29 )   $ (0.55 )

 

9


Table of Contents

Share Option Plan

The Company’s Employee Share Option Plan (the “Plan”) permits the grant of share options and shares to its employees for up to 8 million shares of common stock. A summary of these plans is provided in Note 7 in our audited financial statements. The Company believes that such awards better align the interests of its employees with those of its shareholders. Option awards are generally granted with an exercise price equal to the market price of the Company’s stock at the date of grant; those option awards generally vest based on four years of continuous service and have 10-year contractual terms. Certain options provide for accelerated vesting if there is a change in control (as defined in the Plan).

During the second half of the 2005 fiscal year the Company’s Board of Directors approved the acceleration of vesting of all outstanding stock options (the “Acceleration”). The exercise price of all stock options was above market value at the time of the Acceleration. In accordance with SFAS 123, the Company expensed the remaining unrecognized compensation cost associated with the options with accelerated vesting in the pro forma disclosure in its June 30, 2005 financial statements. These actions were taken in order to avoid expense recognition in future financial statements upon adoption of FAS 123(R). The total additional compensation cost of $8,100,000 was recorded in the pro forma table above.

The fair value of each option granted during the nine-month periods ended March 31, 2006 and 2005 is estimated on the date of grant using the Black-Scholes option-pricing model with the following weighted-average assumptions: (i) dividend yield of 0%, (ii) expected term of 6.25 years and 7.0 years for March 31, 2006 and 2005, respectively, (iii) expected volatility of 113% at March 31, 2006 and 117% at March 31, 2005 and (iv) a risk-free interest rate of 4.33% - 4.85% for the nine-month period ended March 31, 2006 and 4.24% - 4.50%, for the nine-month period ended March 31, 2005. The weighted average fair value at the date of grant for options granted during the nine month periods ended March 31, 2006 and 2005 was $1.74 and $3.20 per share, respectively. The Company uses historical data to estimate employee forfeitures for employees (28%), executive officers (22%) and outside directors (25%) within the valuation model. The expected term of options granted represents the period of time that options granted are expected to be outstanding. The risk-free rate for periods within the contractual life of the option is based on the U.S. Treasury yield curve in effect at the time of grant.

Information concerning options for the nine-month period ended March 31, 2006 is summarized as follows:

 

     Shares     Option Price Range

Outstanding, July 1, 2005

   5,486,650     $1.44 - $24.56

Granted

   81,000       1.76 -     2.98

Exercised

   (54,000 )     1.75 -     2.25

Terminated

   (709,200 )     1.75 -   24.06
        

Outstanding, March 31, 2006

   4,804,450     $1.44 - $24.56
        

Exercisable, March 31, 2006

   4,723,450     $1.44 - $24.56
        

The Company has 81,000 non-vested options outstanding. As of March 31, 2006, there was $119,000 of total unrecognized compensation cost related to non-vested share-based compensation arrangements granted under the Plan. That cost is being recognized over a weighted-average period of four years.

 

10


Table of Contents

3. Marketable Securities and Restricted Securities

Immunomedics utilizes SFAS No. 115, Accounting for Certain Investments in Debt and Equity Securities, to account for investments in marketable securities. Under this accounting standard, securities for which there is not the positive intent and ability to hold to maturity are classified as available-for-sale and are carried at fair value. Unrealized holding gains and losses, which are deemed to be temporary, on securities classified as available-for-sale are classified as separate component of accumulated other comprehensive loss. Immunomedics considers all of its current investments to be available-for-sale. Marketable securities and restricted securities at March 31, 2006 and June 30, 2005 consist of the following ($ in thousands):

 

     Amortized
Cost
   Gross
Unrealized
Gain
   Gross
Unrealized
Loss
    Estimated
Fair Value

March 31, 2006

          

Municipal Bonds/Agency

   $ 3,537    $ —      $ (28 )   $ 3,509

Corporate Debt Securities

     734      —        —         734
                            
   $ 4,271    $ —      $ (28 )   $ 4,243
                            

June 30, 2005

          

Money Market Funds

   $ 14,300    $ —      $ —       $ 14,300

Municipal Bonds/Agency

     6,307      —        (54 )     6,253

Corporate Debt Securities

     1,113      8      (1 )     1,120
                            
   $ 21,720    $ 8    $ (55 )   $ 21,673
                            

Restricted securities at March 31, 2006 and June 30, 2005 of approximately $2,869,000 and $18,125,000, respectively, are included in the table above.

4. Property and Equipment

Property and equipment consists of the following ($ in thousands):

 

     March 31, 2006     June 30, 2005  

Machinery and equipment

   $ 5,748     $ 5,683  

Leasehold improvements

     17,418       17,398  

Furniture and fixtures

     800       786  

Computer equipment

     1,365       1,343  
                
     25,331       25,210  

Accumulated depreciation and amortization

     (16,381 )     (15,058 )
                
   $ 8,950     $ 10,152  
                

5. Geographic Segments

Immunomedics manages its operations as one line of business of researching, developing, manufacturing and marketing biopharmaceutical products, particularly antibody-based products for cancer, autoimmune and other serious diseases, and it currently reports as a single industry segment. Immunomedics markets and sells its products in the United States and throughout Europe.

 

11


Table of Contents

The following table presents financial information based on the geographic location of the facilities of Immunomedics for the three and nine-month periods ended March 31, 2006 and 2005 ($ in thousands):

 

    

Three-Months Ended

March 31, 2006

 
     United States     Europe     Total  

Total assets

   $ 22,812     $ 3,098     $ 25,910  

Property and equipment, net

     8,948       2       8,950  

Revenues

     218       1,097       1,315  

Income (loss) before tax benefit

     (6,068 )     325       (5,743 )
    

Three-Months Ended

March 31, 2005

 
     United States     Europe     Total  

Total assets

   $ 26,055     $ 2,683     $ 28,738  

Property and equipment, net

     10,452       4       10,456  

Revenues

     210       879       1,089  

Income (loss) before tax benefit

     (6,085 )     130       (5,955 )
    

Nine-Months Ended

March 31, 2006

 
     United States     Europe     Total  

Revenues

   $ 698     $ 1,503     $ 2,201  

Income (loss) before tax benefit

     (23,611 )     (10 )     (23,621 )
    

Nine-Months Ended

March 31, 2005

 
     United States     Europe     Total  

Revenues

   $ 647     $ 2,557     $ 3,204  

Income (loss) before tax benefit

     (17,693 )     681       (17,012 )

6. Related Party Transactions

Certain of the Company’s affiliates, including members of senior management and its Board of Directors, as well as their respective family members and other affiliates, have relationships and agreements among themselves as well as with the Company and its affiliates, that create the potential for both real, as well as perceived, conflicts of interest. These include Dr. David M. Goldenberg, the Chairman of the Board of Directors and Chief Strategic Officer, Ms. Cynthia L. Sullivan, the President and Chief Executive Officer, and certain companies with which the Company does business, including the Center for Molecular Medicine and Immunology (“CMMI”). Dr. Goldenberg and Ms. Sullivan are husband and wife. For a description of these relationships and transactions, see the Company’s Annual Report on Form 10-K for the fiscal year ended June 30, 2005 and the notes to the audited financial statements contained therein.

 

12


Table of Contents

The Company reimbursed CMMI for expenses incurred on behalf of Immunomedics, including amounts incurred pursuant to research contracts, in the amount of approximately $47,000 and $52,000 for the nine-month periods ended March 31, 2006 and 2005, respectively. It also provides to CMMI, at no cost, laboratory materials and supplies. Beginning January 1, 2005, the Company incurred legal expenses on behalf of CMMI for patent related matters. The Company has first rights to license those patents and may decide whether or not to support them. However, any inventions made independently of the Company at CMMI are the property of CMMI. For the nine month period ended March 31, 2006, the Company incurred $127,000 of patent related expenses as compared to $41,000 for the nine-month period ended March 31, 2005.

During the nine-month periods ended March 31, 2006 and 2005, the Board of Directors authorized grants to CMMI of $1,000 and $3,000, respectively, to support research and clinical work being performed at CMMI. Such grants are to be expended in a manner deemed appropriate by the Board of Trustees of CMMI.

For the nine-month periods ended March 31, 2006 and 2005, Dr. Goldenberg received $18,333 and $41,250, respectively, in compensation for his services to IBC Pharmaceuticals, Inc., a Delaware corporation, and a majority-owned subsidiary of the Company (“IBC”). Effective November 1, 2005 Dr. Goldenberg has voluntarily deferred his salary compensation until the financial situation for the Company improves. The Company owns approximately 74% of the capital stock of IBC. Dr. Goldenberg owns approximately 18% of the capital stock of IBC, and the remaining 8% of IBC is held by various third parties, some of whom are adult members of Dr. Goldenberg’s family, as to which shares Dr. Goldenberg disclaims beneficial ownership.

7. License and Distribution Agreements

In June 2002, the Company granted a non-exclusive license to Daiichi Pure Chemicals Co. under Immunomedics’ carcinoembryonic antigen (CEA) patents. The Company recorded a royalty of $218,000 and $185,000 for the nine-month periods ended March 31, 2006, and 2005, respectively, as “License fee and other revenues” under that license.

In September 2004, a patent infringement suit with Cytogen, Inc. and C.R. Bard was settled for an undisclosed amount without any admission of fault or liability. In connection with the settlement, the Company settled legal fees associated with the suit with the attorneys representing it in the case. For the quarter ended September 30, 2004, the Company recorded a litigation settlement gain in the amount of $1,111,750, which includes the reversal of legal fees previously accrued for this patent suit. The specific amount of the settlement, however, is undisclosed in accordance with the terms of the parties’ settlement agreement.

8. Debt

In April 2005, the Company issued through a private placement $37,675,000 of 5% Senior Convertible Notes, due in May 2008, (the “5% Notes”). The net proceeds of $35,200,000 from the financing have been and will be used to fund clinical development programs for epratuzumab in moderate and severe lupus patients, repay existing indebtedness and fund general working capital requirements. The 5% Notes bear interest at a fixed annual rate of 5%, to be paid semiannually in arrears beginning in November 2005. The 5% Notes are convertible into the Company’s common stock at $2.62 per share subject to adjustment based on the anti-dilution provision.

The holders of the 5% Notes may elect to convert the 5% Notes into shares of common stock at any time. The Company may cause the holders of the 5% Notes to convert their 5% Notes, in whole or in part, into shares of common stock, subject to the “blocker” provision (discussed below), at any time on or

 

13


Table of Contents

prior to the trading day immediately preceding the maturity date of the 5% Notes if the market price of the Company’s common stock for at least 20 trading days in any consecutive 30 trading day period, including on such 30th trading day, exceeds 150% of the conversion price in effect on that 30th trading day.

Conversion of the 5% Notes into common stock is subject to the following “blocker” provision: The Company shall not effect any conversion of a 5% Note held by a holder, and no holder shall have the right to convert any portion of any such 5% Note, to the extent that after giving effect to such conversion, such holder (together with the holder’s affiliates) would beneficially own in excess of 4.99% of the number of shares of common stock of the Company outstanding immediately after giving effect to such conversion. By written notice in accordance with the terms of the 5% Notes Indenture, any holder may increase or decrease the conversion limitation applicable to such holder to any percentage specified in such notice; provided, that any increase will not be effective until the 61st day after such notice is delivered to the Company.

The holders of the 5% Notes who convert their 5% Notes will also receive on the date of conversion a payment equal to the amount of accrued and unpaid interest, less interest actually previously paid or provided for, up to and including the maturity date of the 5% Notes, known as the “make-whole” interest payment.

The make-whole interest payment is considered a bifurcated derivative since the embedded call option can accelerate the settlement of the interest component of the debt host at the holder’s option. Since this instrument is bifurcated, changes in the fair value of the make-whole interest payment will be recorded in current period operations. At March 31, 2006, the fair value of this instrument was approximately $1,329,000 and was recorded in the consolidated balance sheet as derivative interest liability. Changes in the derivative interest liability associated with its fair value and conversions of the 5% Notes into shares of common stock of approximately $387,000 was recorded as a credit to interest expense in the third quarter of fiscal 2006. The initial value of the derivative interest liability associated with the make-whole interest provision of $751,000 is recorded as additional debt discount and is being amortized to interest expense over the remaining life of the 5% Notes, subject to adjustments for conversions of the 5% Notes into shares of common stock.

The Company may pay the interest, including the make-whole interest payment in (1) cash, (2) shares of common stock or (3) a combination thereof; provided that, (A) if the conversion is at the holder’s election, the stock paid in exchange for interest shall be valued at the greater of: (i) the stock price at the 5% Notes closing date (April 29, 2005) and (ii) 95% of the daily volume weighted average price of the Company’s common stock for the three trading-day period beginning on and including the trading day prior to the conversion date, to and including the trading day following the conversion date and (B) if the conversion is at the Company’s election, the stock paid in exchange for interest shall be valued at the greater of (i) 150% of the conversion price and (ii) 95% of the daily volume weighted average price of the common stock for the three trading day period beginning on and including the trading day prior to the conversion date, to and including the trading day following the conversion date.

As part of the transaction, the Company included detachable warrants (the “Warrants”) to purchase additional shares of the Company’s common stock. The Warrants are converted into shares of the Company’s common stock at a rate of 76.394 shares of common stock for each $1,000 amount of principal 5% Notes. The Warrants are exercisable at $2.98 per warrant share. The Warrants expire in April 2008.

The Company accounted for the proceeds received from the 5% Notes under the guidance of APB 14 Accounting for Convertible Debt and Debt Issued with Stock Purchase Warrants. The proceeds received from the issuance of debt and stock warrants were allocated between the two components based on the relative fair values of the two securities at the time of issuance (April 29, 2005). The portion of the

 

14


Table of Contents

proceeds allocated to the Warrants was initially valued at $3,687,000. The resulting debt discount will be amortized to interest expense over the life of the 5% Notes, resulting in an adjustment of the stated interest yield. This amortization to the debt discount is subject to adjustments for conversions of the 5% Notes into shares of common stock.

The Warrants were recorded as a liability in the balance sheets in accordance with EITF 00-19 -Accounting for Derivative Financial Instruments Indexed to, and Potentially Settled in, a Company’s Own Stock, since at the time of issuance of the notes the Company did not have sufficient authorized and unissued shares available to settle the detachable warrant contract. In accordance with EITF 00-19, all assets and liability contracts are revalued each reporting period and changes in the fair value of the contract are recorded in earnings.

On August 19, 2005 at a Special Meeting of Stockholders, a majority of holders of common stock of the Company approved an amendment to the Company’s Certificate of Incorporation to increase the number of shares of common stock authorized from 70 million shares to 110 million shares. In addition, the shareholders voted to authorize shares of common stock for conversion if required, into common stock for the 5% Notes and the Warrants. The 5% Notes and Warrants were therefore no longer restricted as to conversion into shares of common stock. The restricted proceeds from these 5% Notes and Warrants that had been held in escrow ($14,300,000) were released. The liability for the Warrants was increased by approximately $270,000 on August 19, 2005 to reflect the increase in the Company’s common stock valuation. This increase in the liability for the Warrants is reflected in the statement of operations. The Warrants liability of $3,018,000 was subsequently reclassified to permanent equity.

Also, at closing of the sale of the Company’s 5% Notes, the Company retired and exchanged the entire $10,000,000 principal amount of its 3.25% Convertible Notes, that were due in January 2006, (the “3.25% Notes”), in two separate transactions. The Company paid approximately $5,090,000, (which includes interest accrued on the 3.25% Notes) from the proceeds of the offering to retire $5,000,000 of its outstanding principal. In addition, the Company converted $5,000,000 of its outstanding 3.25% Notes for the newly issued 5% Notes.

The costs incurred as part of the transaction for private placement of the 5% Senior Convertible Notes (approximately $2,507,000) are being amortized over 36 months and are reported as interest expense. For the nine-month period ended March 31, 2006, the Company amortized $606,000 to interest expense. The unamortized portion of these costs associated with the $6,326,000 5% Senior Convertible Notes of approximately $313,000 was classified to additional paid in capital at the date of the conversion.

During the three and nine-month periods ended March 31, 2006, $5,165,000 and $6,326,000, respectively, of the 5% Notes were converted into shares of common stock at the request of the 5% Notes’ holders. The interest related payment due to the Note holders at the conversion date, including the make-whole interest payment was approximately $646,000 which was paid for in 224,000 shares of common stock for the three-month period ended March 31, 2006. For the nine-month period ended March 31,2006 the interest related payment due to the Note holders that was converted was approximately $792,000 which was paid for in 286,000 shares of common stock.

The unamortized portion of the debt discount of approximately $400,000 associated with the $6,326,000 5% Notes converted during the nine months ended March 31, 2006 was classified to additional paid in capital at the date of conversion. The amortization of debt discount was $286,000 and $1,100,000 for the three and nine-month periods ended March 31, 2006, respectively.

Total interest expense and related amortization expense for the 5% Notes for the nine-months ended March 31, 2006 was $4,601,000.

 

15


Table of Contents

In January 2004, the Company completed a $10,000,000 financing of 3.25% Senior Convertible Notes, which were due in January 2006, (the “3.25% Notes”). The notes bore interest at a fixed annual rate of 3.25% to be paid semiannually in arrears beginning in July 2004. The holder of the 3.25% Notes could convert the 3.25% Notes at any time prior to the maturity date into shares of the Company’s common stock at a conversion price of $6.09 per share. On April 29, 2005 the Company retired and exchanged the entire $10,000,000 principal amount from proceeds from the 5% Notes. One half of the total principal was retired, including accrued interest. The remaining principal was exchanged for $5,000,000 of the 5% Notes. For the nine-month period ended March 31, 2005, the Company incurred interest expense of approximately $244,000.

In May 2003, Immunomedics completed a $6,376,000 bond financing with the New Jersey Economic Development Authority, pursuant to which Immunomedics was able to refinance its capital investment in a new manufacturing facility at a rate of interest below that which would have otherwise been available. The interest rate on the bonds was approximately 4.78 % at March 31, 2006. In connection with this financing, Immunomedics granted certain security interests to the New Jersey Economic Development Authority with respect to its properties and assets, and agreed to become subject to certain customary affirmative as well as restrictive covenants, none of which it believes will affect its business or operations in any material respect. In addition, the bonds are subject to mandatory redemption, if the fair value of the Company’s collateralized assets falls below the outstanding loan balance. The Company’s collateral is recorded as restricted securities in the balance sheet. Restricted securities include highly liquid, marketable securities. At March 31, 2006, the Company’s indebtedness under this financing was approximately $2,869,000 due in equal monthly installments over the next 27 months. For the nine-month periods ended March 31, 2006 and 2005, the Company incurred interest expense of approximately $104,000 and $75,000, respectively. Interest and principal payments are due monthly.

9. Stockholders Equity

During the nine-month period ended March 31, 2006, holders of 5% Notes converted an aggregate of $6,326,000 of the 5% Notes principal and the Company paid approximately $792,000 of interest due to the Notes’ holders in shares of common stock. These transactions resulted in the issuance of an aggregate of 2,700,677 shares of the Company’s common stock.

On August 19, 2005 at a Special Meeting of Stockholders a majority of holders of common stock of the Company approved an amendment to the Company’s Certificate of Incorporation to increase the number of shares of common stock authorized from 70 million shares to 110 million shares. In addition, the shareholders voted to authorize shares of common stock for conversion if required, into common stock for the 5% Notes and the Warrants. The 5% Notes and Warrants were therefore no longer restricted as to conversion into shares of the Company’s common stock. The liability for the Warrants was increased by approximately $270,000 on August 19, 2005 to reflect the increase in the Company’s common stock valuation. This increase in the liability for the Warrants is reflected in the statement of operations and the Warrant liability of $3,018,000, was subsequently classified as permanent equity during the nine-month period ended March 31, 2006.

In August 2004, the Company sold 4,178,116 shares of its common stock, resulting in net proceeds to the Company of approximately $14,000,000. The shares were sold to institutional investors at a price of $3.61 per share. The shares of common stock were sold pursuant to an effective shelf registration statement filed with the Securities and Exchange Commission.

 

16


Table of Contents

10. Commitments and Contingencies

On December 22, 2003, the Dutch Supreme Court, in a case brought by the Company, held that Immunomedics’ Dutch part of its European patent for highly specific monoclonal antibodies against the cancer marker, carcinoembryonic antigen (CEA), was valid. The Dutch Supreme Court did not finally decide the Company’s claim of infringement. Among other things, the Supreme Court held that the Court of Appeal which had ruled that Roche had infringed Immunomedics European Patent had not given Roche sufficient opportunity to comment on an expert opinion filed by Immunomedics in which it was stated that Roche’s CEA test kit did satisfy a criterion that is generally satisfied for specific antibodies that bind to CEA. The Company has argued that the Dutch court should enforce the European Patent for all European countries for which the European Patent was validated, since Roche sold the same product in each country. The Dutch Supreme Court repeated the reasoning of the Dutch District Court that the Brussels Convention should be interpreted to permit cross-border enforcement of European patents where a related group of companies sells the same product in countries where that same patent has been validated. The Dutch Supreme Court referred this issue to the European Court of Justice (ECJ) to provide a final interpretation of the Brussels Convention on this point. On January 27, 2005, the ECJ heard oral arguments in the case, and took the matter under consideration.

We believe that the CEA patents that are the subject of our infringement action have been infringed, and we believe that the Company will prevail in the litigation, although no assurances can be given in this regard. To the extent that Roche contests or challenges our patents, or files appeals or further nullity actions, there can be no assurance that significant costs for defending such patents may not be incurred.

On May 19, 2004 and July 20, 2004, Roche filed nullity actions in German and United Kingdom courts, respectively, challenging our patents relating to an improved method of disease therapy in combination with cytotoxic agents, wherein cytokines are used to prevent, mediate or reverse radiation-induced, drug-induced or antibody-induced toxicity, especially to hematopoietic cells. On December 1, 2004, the Company agreed to settle the United Kingdom patent litigation by surrendering the United Kingdom patent. In accordance with United Kingdom legal rules, Roche made an application for payment of its attorney’s fees and other costs to the court. We agreed on a resolution with Roche, which was subsequently settled. The related charges for this litigation were included in the General and Administrative expenses in the Statement of Operations for the year ended June 30, 2005. In the German action the Company is defending the patent with amended claims and believes that it will prevail in such action. The German Patent Court has scheduled oral proceedings for August 3, 2006.

11. Subsequent Events

The Company made a semi-annual interest payment of approximately $765,000 to the 5% Note holders on May 1, 2006. This interest payment may be made in (1) cash, (2) shares of common stock or (3) a combination thereof at the discretion of the Company. The Company has decided to retire this accrued interest liability with payment of shares of common stock as defined in the debt agreement. The value of common stock and additional paid in capital will increase by $2,680 and $762,295, respectively. This transaction resulted in the issuance of 267,924 shares of common stock.

On May 9, 2006 the Company entered into a Development, Collaboration and License Agreement (the “Agreement”) with UCB, S.A., (“UCB”) providing UCB an exclusive worldwide license to develop, manufacture, market and sell epratuzumab, the Company’s humanized CD22 antibody (“Epratuzumab”), for the treatment of all autoimmune disease indications. Under the terms of the Agreement, the Company retains the rights to develop Epratuzumab in the field of oncology, and UCB has the right to acquire development and commercialization rights to Epratuzumab with respect to cancer indications at anytime prior to the first commercial sales thereof. If UCB exercises its buy-in right with respect to Epratuzumab in the field of oncology, UCB will reimburse the Company for the development cost actually incurred, plus a buy-in fee.

 

17


Table of Contents

Under the terms of the Agreement, the Company will receive in cash from UCB initial payments totaling $38 million (which includes a $25 million upfront payment, plus a $13 million reimbursement for development costs of Epratuzumab related to the clinical development of Epratuzumab in patients with systemic lupus erythematosus (“SLE”) and Sjögren’s syndrome), within ten business days of the Effective Date, (May 9, 2006). In addition, the Company is entitled to receive regulatory milestone payments, which could aggregate to a maximum of up to $145 million in cash payments and $20 million in equity investments. These milestone payments are dependent upon specific achievements in the regulatory approval process under the Agreement. The Company will also receive product royalties based upon a percentage of aggregate annual net sales under the Agreement during the product royalty term, which percentage is subject to reduction under certain circumstances. In addition, the Company will be entitled to receive sales bonuses of up to $135 million upon annual net sales reaching certain target levels. There can be no assurance that these regulatory or sales achievements will be met and therefore there can be no assurance that the Company will receive such future payments.

The Agreement calls for the creation of a global autoimmune guidance committee, with equal representation by the Company and UCB, to plan and oversee the conduct and progress of the development and commercialization of Epratuzumab. UCB has the deciding vote on the committee. UCB will be solely responsible for the development, manufacturing and commercialization of Epratuzumab for the treatment of all autoimmune indications and for the continuation of ongoing clinical trials in SLE, with the Company responsible for supplying Epratuzumab for the completion of clinical trials relating to SLE. The Company is also obligated to manufacture and supply Epratuzumab, if needed and at UCB’s request, for the initial commercial launch of Epratuzumab for the treatment of SLE and for future clinical trials relating to the treatment of Sjögren’s syndrome, if necessary. UCB will have sole responsibility for all clinical development, regulatory filings and related submissions, as well as all commercialization activities with respect to Epratuzumab in all autoimmune indications.

The Agreement commences on the Effective Date and shall terminate in accordance with the terms thereof or by mutual written consent, unless UCB decides to cease all development and commercialization of Epratuzumab pursuant to the Agreement. Either the Company or UCB has the right to terminate the Agreement by notice in writing to the other party upon or after any material breach of the Agreement by the other party, if the other party has not cured the breach within 60 days after written notice to cure has been given, with certain exceptions.

 

18


Table of Contents

ITEM 2. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS

Cautionary Note Regarding Forward-Looking Statements

The Securities and Exchange Commission encourages companies to disclose forward-looking information so that investors can better understand a company’s future prospects and make informed investment decisions. Certain statements that we may make from time to time, including, without limitation, statements contained in this Quarterly Report on Form 10-Q, constitute “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be made directly in this Quarterly Report, and they may also be made a part of this Quarterly Report by reference to other documents filed with the Securities and Exchange Commission, which is known as “incorporation by reference.”

Words such as “may,” “anticipate,” “estimate,” “expects,” “projects,” “intends,” “plans,” “believes” and words and terms of similar substance used in connection with any discussion of future operating or financial performance, identify forward-looking statements. All forward-looking statements are management’s present expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. These risks and uncertainties include, among other things: our need for additional capital to fund the current level of our research and development programs, our inability to further identify, develop and achieve commercial success for new products and technologies; the possibility of delays in the research and development necessary to select drug development candidates and delays in clinical trials; the risk that clinical trials may not result in marketable products; the risk that we may be unable to successfully finance and secure regulatory approval of and market our drug candidates; our dependence upon pharmaceutical and biotechnology collaborations; the levels and timing of payments under our collaborative agreements; uncertainties about our ability to obtain new corporate collaborations and acquire new technologies on satisfactory terms, if at all; the development of competing diagnostic and therapeutic products; our ability to protect our proprietary technologies; patent-infringement claims; risks of new, changing and competitive technologies and regulations in the United States and internationally; and other factors discussed under the heading Item 1A “Risk Factors” in this Quarterly Report on Form 10-Q.

In light of these assumptions, risks and uncertainties, the results and events discussed in the forward-looking statements contained in this Quarterly Report or in any document incorporated by reference might not occur. You are cautioned not to place undue reliance on forward-looking statements, which speak only as of the date of this Quarterly Report or the date of the document incorporated by reference in this Quarterly Report. We are not under any obligation, and we expressly disclaim any obligation, to update or alter any forward-looking statements, whether as a result of new information, future events or otherwise, except as may be required by applicable law. All subsequent forward-looking statements attributable to Immunomedics or to any person authorized to act on our behalf are expressly qualified in their entirety by the cautionary statements contained or referred to in this section.

Overview

Immunomedics is a biopharmaceutical company focused on the development of monoclonal, antibody-based products for the targeted treatment of cancer, autoimmune and other serious diseases. We have developed a number of advanced proprietary technologies that allow us to create humanized antibodies that can be used either alone in unlabeled or “naked” form, or conjugated with radioactive isotopes, chemotherapeutics or toxins, in each case to create highly targeted agents. Using these

 

19


Table of Contents

technologies, we have built a pipeline of therapeutic product candidates that utilize several different mechanisms of action. We believe that our portfolio of intellectual property, which includes approximately 90 issued patents in the United States, and more than 250 other issued patents worldwide, protects our product candidates and technologies.

We have transitioned our focus away from the development of diagnostic imaging products in order to accelerate the development of our therapeutic product candidates. Consistent with our de-emphasis on our diagnostic business, we no longer commercialize CEA-Scan®. LeukoScan® will continue to be manufactured and commercialized by the Company in territories where regulatory approvals have been granted. Furthermore, as of March 31, 2006, research and development into diagnostic product candidates was no longer a material portion of our business.

From our inception in 1982 until March 31, 2006, we had an accumulated deficit of approximately $198,000,000 and have never earned a profit. On May 9, 2006 we entered into a Development, Collaboration and License Agreement (the “Agreement”) with UCB, S.A., (“UCB”) providing UCB an exclusive worldwide license to develop, manufacture, market and sell epratuzumab, the Company’s humanized CD22 antibody (“Epratuzumab”), for the treatment of all autoimmune disease indications. Under the terms of the Agreement, we retain the rights to develop Epratuzumab in the field of oncology, and UCB has the right to acquire development and commercialization rights to Epratuzumab with respect to cancer indications at anytime prior to the first commercial sales thereof. If UCB exercises its buy-in right with respect to Epratuzumab in the field of oncology, UCB will reimburse us for the development cost actually incurred, plus a buy-in fee.

Under the terms of the Agreement, we will receive in cash from UCB initial payments totaling $38 million (which includes a $25 million upfront payment, plus a $13 million reimbursement for development costs of Epratuzumab related to the clinical development of Epratuzumab in patients with systemic lupus erythematosus (“SLE”) and Sjögren’s syndrome), within ten business days of the Effective Date. In addition, we are entitled to receive regulatory milestone payments, which could aggregate to a maximum of up to $145 million in cash payments and $20 million in equity investments. These milestone payments are dependent upon specific achievements in the regulatory approval process under the Agreement. We will also receive product royalties based upon a percentage of aggregate annual net sales under the Agreement during the product royalty term, which percentage is subject to reduction under certain circumstances. In addition, we will be entitled to receive sales bonuses of up to $135 million upon annual net sales reaching certain target levels. There can be no assurance these regulatory or sales achievements will be met and therefore there can be no assurance that we will receive such future payments.

The Agreement calls for the creation of a global autoimmune guidance committee, with equal representation by us and UCB, to plan and oversee the conduct and progress of the development and commercialization of Epratuzumab. UCB has the deciding vote on the committee. UCB will be solely responsible for the development, manufacturing and commercialization of Epratuzumab for the treatment of all autoimmune indications and for the continuation of ongoing clinical trials in SLE, and we are responsible for supplying Epratuzumab for the completion of clinical trials relating to SLE. We are also obligated to manufacture and supply Epratuzumab, if needed and at UCB’s request, for the initial commercial launch of Epratuzumab for the treatment of SLE and for future clinical trials relating to the treatment of Sjögren’s syndrome, if necessary. UCB will have sole responsibility for all clinical development, regulatory filings and related submissions, as well as all commercialization activities with respect to Epratuzumab in all autoimmune indications.

By entering into the Agreement, we have sufficient funds to continue our research and development programs for at least the next twelve months. Pursuant to the terms of the Agreement, UCB will assume the financial responsibilities of completing the clinical and regulatory submissions of Epratuzumab for SLE. We will continue to conduct our other antibody-based research and development programs for other compounds in our development pipeline in line with our corporate strategy. While epratuzumab continues to progress through the clinical trials and regulatory approval process before it is available for commercialization, our losses will continue as we continue to conduct our other research and development activities. These activities are budgeted to expand over time and will require further resources if we are to be successful. As a result, our operating losses are likely to be substantial over the next several years.

As of March 31, 2006, we had unrestricted cash, cash equivalents and marketable securities totaling $10,321,000. By entering into the Agreement, and the receipt of approximately $38 million (before fees), we will have sufficient funds to continue operations at least through the next fiscal year. We anticipate that with the transfer of the SLE clinical trials to UCB our average monthly cash outflow will be reduced.

We continue to review and evaluate opportunities for the future funding of the organization, of which there is no assurance will be obtained. These opportunities include entering into partnership arrangements for products that are at various stages of product development and financing alternatives for additional debt or equity financings. At the present time, the Company is unable to determine whether any of these future activities will be successful and, if so, the terms and timing of any definitive agreements.

The development and commercialization of successful therapeutic products is subject to numerous risks and uncertainties as discussed under the heading Risk Factors “Factors That May Affect

 

20


Table of Contents

Our Business and Results of Operations” in Item 1A “Risk Factors” of this Quarterly Report on Form 10-Q. These factors include, without limitation, the following:

 

    the financial resources available to us during any particular period may be limited as we may be unable to obtain the necessary capital or to establish a co-development partnership needed to fund all of the clinical trials, we may be forced to cancel or otherwise curtail some important trials;

 

    our ability, as well as the ability of our partners, to conduct and complete clinical trials on a timely basis;

 

    the type of therapeutic compound under investigation and nature of the disease in connection with which the compound is being studied;

 

    the time required for us to comply with all applicable federal, state and foreign legal requirements, including, without limitation, our receipt of the necessary approvals of the U.S. Food and Drug Administration (FDA); and

 

    many other factors associated with the commercial development of therapeutic products outside of our control.

Research and Development

As of March 31, 2006, we employed 16 professionals in our research and development departments and 16 professionals in our pre-clinical and clinical research departments. In addition to salaries and benefits, the other costs associated with research and development include the costs associated with producing biopharmaceutical compounds, laboratory equipment and supplies, the costs of conducting clinical trials, legal fees and expenses associated with pursuing patent protection, as well as facilities costs.

With the completion in fiscal year 2003 of the manufacturing expansion to support our research and development efforts and prepare for future commercialization of our product candidates, we believe that our facilities are adequate to support our research and development activities for the next few years without the need for any material capital expenditures.

At any one time our scientists are engaged in the research and development of multiple therapeutic compounds. Because we do not track expenses on the basis of each individual compound under investigation, but rather aggregate research and development costs for accounting purposes, it is not possible for investors to analyze and compare the expenses associated with unsuccessful research and development efforts for any particular fiscal period, with those associated with compounds that are determined to be worthy of further development. This may make it more difficult for investors to evaluate our business and future prospects.

On January 5, 2005, we received notice from the FDA that we have been granted Fast Track Product designation for epratuzumab for the treatment of patients with moderate to severe systemic lupus erythematosus (SLE). A designated fast track drug may be considered for priority review, with a shortened review time, rolling admission and accelerated approval if applicable. As a result there has been an increase in research and development expenses, primarily for the clinical development of SLE with epratuzumab in patients with lupus.

The May 9, 2006 Agreement with UCB will result in a transfer of clinical data results to date from the Company to UCB. In addition, we will transfer to UCB the technology, materials and know-how to manufacture epratuzumab. Until this transfer is completed, we will continue to manufacture epratuzumab for the SLE clinical trials and initial launch quantities if needed.

 

21


Table of Contents

Critical Accounting Policies

Our consolidated financial statements are prepared in accordance with U.S. generally accepted accounting principles, which require management to make estimates and assumptions that affect the reported amounts of assets and liabilities at the date of the financial statements and the reported amounts of revenue and expenses during the reporting period. Actual results could differ from these estimates. The following discussion highlights what we believe to be the critical accounting policies and judgments made in the preparation of these consolidated financial statements.

Revenue Recognition

Revenue from product sales is recorded when there is persuasive evidence that an arrangement exists, delivery has occurred, the price is fixed and determinable and collectability is reasonably assured. Allowances, if any, are established for uncollectible amounts, estimated product returns and discounts. Since allowances are recorded based on management’s estimates, actual amounts may vary from these estimates in the future.

Foreign Currency Risks

For subsidiaries outside of the United States that operate in a local currency environment, income and expense items are translated to United States dollars at the monthly average rates of exchange prevailing during the year, assets and liabilities are translated at the period-end exchange rates, and equity accounts are translated at historical exchange rates. Translation adjustments are accumulated in a separate component of stockholders’ equity and are included in the determination of comprehensive loss. Transaction gains and losses are included in the determination of net income.

Stock-Based Compensation

Prior to July 1, 2005, we granted stock options to our employees at an exercise price equal to the fair value of the underlying shares of common stock at the date of grant and account for these stock option grants in accordance with APB Opinion No. 25, Accounting for Stock Issued to Employees, and related interpretations. Under APB Opinion No. 25, when stock options are issued with an exercise price equal to the market price of the underlying stock on the date of grant, no compensation expense is recognized in the income statement. However, for purposes of disclosure only, we estimate the fair value of stock options through the use of option-pricing models. In determining the values to use in our option-pricing model, we make several subjective estimates about the characteristics of the underlying stock and the expected timing of option exercise. Changes to these estimates can change the fair value disclosures in our financial statements. The Company’s Board of Directors approved the acceleration of vesting of all outstanding stock options as of June 30, 2005, primarily to avoid stock based compensation charges upon the adoption of SFAS 123(R) on July 1, 2005. The exercise price of all stock options was above market value of the common stock at the time of the accelerated vesting.

Effective July 1, 2005, we adopted the fair value recognition provisions of SFAS 123(R) using the modified-prospective transition method. Under that transition method, compensation cost recognized in fiscal year 2006 includes compensation cost for all share-based compensation granted subsequent to July 1, 2005, based on the grant date fair value estimated in accordance with the provisions of Statement 123(R). Due to the accelerated vesting prior to the adoption of SFAS 123(R) noted above, the impact on the statement of operations for the nine-month period ended March 31, 2006 is not material. The results of adopting SFAS 123(R) for the prior periods have not been restated.

 

22


Table of Contents

Impairment of Assets

We review our long-lived assets for impairment, when events or changes in circumstances occur that indicate that the carrying value of the asset may not be recoverable. The assessment of possible impairment is based upon our judgment of our ability to recover the asset from the expected future undiscounted cash flows of the related operations. Actual future cash flows may be greater or less than estimated.

Results of Operations

Our results for any interim period, such as those described in the following analysis, are not necessarily indicative of the results for the entire fiscal year or any other future period.

Three-Month Period Ended March 31, 2006 Compared to 2005

Revenues

Revenues for the three-month period ended March 31, 2006 were $1,315,000, as compared to $1,089,000 for the same period in 2005, representing an increase of $226,000, or 21%. Product sales for the three-month period ended March 31, 2006 were $1,142,000, as compared to $947,000 for the same period in 2005, representing an increase of $195,000, or 21%. This increase resulted from increased sales of LeukoScan in Europe. On January 30, 2006, we received the approval from the European Regulatory Agency to market LeukoScan manufactured by our revised processes. Prior to that date, LeukoScan was sold in Europe on an emergency basis only (i.e. requested by a physician for a medical procedure). With the receipt of this approval the quantities of LeukoScan on hand manufactured by our revised processes, were made available for direct sale. License fee and other revenues of $83,000 for the three-month period ended March 31, 2006 increased $9,000 from $74,000 for the same period in 2005 due to higher activity from the licensee in Japan. Research and development revenues for the three-month period ended March 31, 2006 were $90,000, as compared to $67,000 for the same period of 2005, due to an additional grant-funded program added in 2005 and the timing of grant programs.

Costs and Expenses

Total cost and expenses for the three-month period ended March 31, 2006 were $6,008,000, as compared to $7,114,000 for the same period in 2005, representing a decrease of $1,106, 000 or 16%. Research and development expenses for the three-month period ended March 31, 2006 were $4,654,000 as compared to $5,765,000 for the same period in 2005. The decline resulted primarily from the renegotiation to a lower monthly maintenance fee for the Phase III clinical trials for SLE, including the elimination of approximately $890,000 of fees previously accrued for these trials earlier in the year. Cost of goods sold for the three-month period ended March 31, 2006 was $187,000 as compared to $218,000 for the same period in 2005, a decrease of $31,000 due to the timing of purchases, partially offset by higher sales volume. Sales and marketing expenses for the three-month period ended March 31, 2006 decreased $127,000 from $278,000 to $151,000 for the same period in 2005, as a result of the decision to de-emphasize the diagnostic imaging product line. General and administrative costs increased to $1,016,000 for the three-month period ended March 31, 2006, from $853,000 for the same period of 2005, primarily due to the timing of legal expenses and outside consulting services.

Interest Income

Interest and other income for the three-month period ended March 31, 2006 increased to $102,000 compared to $81,000 for the same period in 2005, primarily due to higher rates of return on investments partially offset by lower cash available for investments resulting from the cash used in operations.

 

23


Table of Contents

Interest Expense

Interest expense for the three-month periods ended March 31, 2006 and 2005, was approximately $1,175,000 and $110,000, respectively. The interest expense for the three-month period ended March 31, 2006 increased primarily from the $37,675,000 of 5% senior convertible notes due 2008 sold in April 2005, (5% Notes). Also included in interest expense in 2006 is the amortization expense associated with the debt issuance costs of $189,000, the debt discount of $343,000, the $646,000 of “make-whole” interest payment regarding conversion of 5% Notes into shared of common stock, and a credit of $387,000 for the change in the market value of the derivative interest liability associated with the make-whole interest provision relating to the 5% Notes. See Note 8 to our consolidated interim financial statements included in this Quarterly Report on Form 10-Q.

Foreign Currency Transactions Gain (Loss)

Foreign currency transactions were a gain of $1,000 for the three-month period ended March 31, 2006 as compared to a gain of $76,000 for the same period in 2005 primarily as a result of currency fluctuations between the dollar and the euro.

Operating Results

Net loss for the three-month period ended March 31, 2006 was $5,743,000 or $0.10 per share, as compared to $6,059,000, or $0.11 per share, for the same period in 2005. The decrease of the net loss in 2006 as compared to the net loss in the comparable period in 2005 resulted primarily from increased product sales and the $890,000 reduction of the previously accrued maintenance fees for the Phase III clinical trials for SLE, partially offset by increased interest expense from the $37,675,000 5% Notes.

Nine-Month Period Ended March 31, 2006 Compared to 2005

Revenues

Revenues for the nine-month period ended March 31, 2006 were $2,201,000, as compared to $3,204,000 for the same period in 2005, representing a decrease of $1,003,000, or 31%. Product sales for the nine-month period ended March 31, 2006 were $1,685,000, as compared to $2,806,000 for the same period in 2005, representing a decrease of $1,121,000, or 40%. This decline resulted from our not having European Regulatory approval to market LeukoScan manufactured by our revised processes until January 30, 2006. Until that date LeukoScan was sold in Europe on an emergency basis only (i.e. requested by a physician for a medical procedure), while the European regulatory authorities completed their validation of our manufacturing process revisions. With the receipt of this approval the quantities of LeukoScan on hand manufactured by our revised processes, were made available for direct sale. License fee and other revenues of $247,000 for the nine-month period ended March 31, 2006 decreased $16,000 from $263,000 for the same period in 2005 due to the fewer licensee programs in place during the year. Research and development revenues for the nine-month period ended March 31, 2006 were $269,000 as compared to $134,000 for the same period of 2005 due to an additional grant-funded program in 2006 and the timing of grant programs.

Costs and Expenses

Total costs and expenses for the nine-month period ended March 31, 2006 were $21,338,000, as compared to $21,396,000 for the same period in 2005, representing a decrease of $58,000 or less than 1%.

 

24


Table of Contents

Research and development expenses for the nine month period ended March 31, 2006 were $17,432,000 as compared to $17,284,000 for the same period in 2005, representing an increase of $148,000 or 1%. This expense growth resulted primarily from increased spending for process validation, production activity for clinical trials as well as the patient enrollment for the Phase III clinical trials for SLE, partially offset by the reduction of $890,000 of previously accrued maintenance fees for the Phase III clinical trials for SLE. Cost of goods sold for the nine-month period ended March 31, 2006 was $388,000 as compared to $544,000 for the same period in 2005, a decrease of $156,000 due primarily to lower sales volume. Sales and marketing expenses for the nine month period ended March 31, 2006 decreased $212,000 from $703,000 to $491,000 for the same period in 2005, as a result of the decision to de-emphasize the diagnostic imaging product line. General and administrative costs were $3,027,000 for the nine-month period ended March 31, 2006, compared to $2,865,000 for the same period of 2005, an increase of $162,000 or 6%. This increase was the result of higher legal expenses and professional services.

Loss on Changes in Fair Value of Warrants

For the nine month period ended March 31, 2006 we recorded an expense of $270,000 for the liability for warrants issued as part of issuance of the 5% Notes. The increase in the valuation of the liability for the warrants was due to the increase in the market price of the Company’s common stock from $1.71 per share on June 30, 2005 to $1.88 on August 19, 2005 (the date of the Special Meeting of Stockholders to authorize the increase of the number of shares of our common stock) at which time the value of the warrants were reclassified to equity.

Litigation Settlement

In September 2004 a patent infringement suit with Cytogen, Inc. and C.R. Bard was settled for an undisclosed amount without any admission of fault or liability. In connection with the settlement, we settled legal fees associated with the suit with the attorneys representing it in the case. For the quarter ended September 30, 2004, we recorded in other income a litigation settlement gain in the amount of $1,111,750, which includes the reversal of legal fees previously accrued for this patent suit.

Interest Income

Interest and other income of $417,000 for the nine-month period ended March 31, 2006 increased by $157,000 from $260,000 for the same period in 2005, primarily due to higher rates of return on investments and increased cash available for investments resulting from the April 2005 debt financing.

Interest Expense

Interest expense for the nine-month periods ended March 31, 2006 increased to approximately $4,706,000, as compared to $319,000 for the same period in 2005. The interest expense for the nine-month period ended March 31, 2006 increased primarily from the $37,675,000 of the 5% Notes sold in April 2005. Included in interest expense in 2005 is the amortization expense associated with the debt issuance costs of $606,000 and the debt discount of $1,325,000 and the $792,000 of “make-whole” interest payment regarding the conversion of the 5% Notes into shares of common stock. Also included in interest expense is $578,000 for the change in the market value of the derivative interest liability associated with the make-whole interest provision relating to the 5% Notes. The increase for the derivative interest liability was a result of the increase in the market price of the Company’s common stock to $2.95 per share as of March 31, 2006. See Note 8 to our consolidated interim financial statements included in this Quarterly Report on Form 10-Q.

 

25


Table of Contents

Foreign Currency Transactions Gain (Loss)

Foreign currency transactions were a gain of $1,000 for the nine-month period ended March 31, 2006 as compared to a gain of $44,000 for the same period in 2005, resulting primarily from currency fluctuations between the dollar and the euro.

Operating Results

Net loss for the nine-month period ended March 31, 2006 was $23,107,000 or $0.42 per share, as compared to $16,664,000, or $0.31 per share, for the same period in 2005. The increase of the net loss in 2006 as compared to the net loss in the comparable period in 2005 resulted primarily from lower product sales of LeukoScan in the earlier part of the year and increased interest expense resulting from the $37,675,000 of the 5% Notes. In addition, the 2005 results included a net litigation settlement gain of $1,112,000,

Liquidity and Capital Resources

At March 31, 2006, we had working capital of $3,724,000, representing a decrease of $19,602,000 from our working capital balance of $23,326,000 at June 30, 2005. The net decrease in working capital resulted principally from the net loss allocable to our common stockholders during the nine-month period ended March 31, 2006 of $23,107,000. At March 31, 2006 we had long-term debt, net of discounts of $30,528,000, (5% Notes due 2008 - $28,934,000 and the New Jersey Economic Development Authority - $1,594,000).

During the nine-month period ending March 31, 2006, we converted $6,326,000 of the 5% Notes into shares of our common stock at the request of certain 5% Note holders. The accrued interest related to these converted 5% Notes ($792,000) was paid in shares of common stock. As a result of these transactions, 2,700,677 shares of our common stock were issued representing principal and accrued interest due to such holders under the terms of the 5% Indenture.

During the nine-month period ended March 31, 2006 the value of the derivative interest liability associated with the make-whole interest provision of the 5% Notes increased by approximately $578,000 as a result of the increase in the market price of the Company’s common stock.

The May 9, 2006 Agreement with UCB will provide us with approximately $38 million (before fees) of initial cash payments for the worldwide licensing rights of epratuzumab for autoimmune disease indications, as well as the for reimbursement of previously incurred costs for epratuzumab product development and clinical trials expenses for SLE. We anticipate that the Company will have adequate funding for at least the next twelve months to conduct our other research and development programs for other compounds in our development pipeline in line with our corporate strategy, as well as other operating expenses and capital expenditures.

We are continuing to pursue various financing alternatives as market conditions permit through collaborative development, marketing and distribution agreements and additional debt or equity financings. We continue to evaluate various programs to raise additional capital and to seek additional revenues from the licensing of our proprietary products and technologies. At the present time, we are unable to determine whether any of these future activities will be successful and, if so, the terms and timing of any definitive agreements.

 

26


Table of Contents

We are unable to determine whether any of these future activities will be successful and, if so, the terms and timing of any definitive agreements. Please refer to the section Item 1A “Risk Factors” in this Quarterly Report on Form 10-Q.

Contractual Commitments

Our major contractual obligations relate to an operating lease for our facility, a loan from the New Jersey Economic Development Authority used to fund the expansion of our facility, a clinical research organization contract to administer our Phase III clinical trials for SLE, the issuance of the 5% Notes and employment contracts in effect for the Company’s Chairman of the Board and the President and Chief Executive Officer. We have identified and quantified the significant commitments in the following table for the fiscal years ending June 30:

 

(in thousands)    Payments Due by Period

Contractual Obligation

   2006    2007    2008    2009    2010    Thereafter    Total

Operating Lease(1)

   $ 136    $ 552    $ 556    $ 556    $ 556    $ 8,542    $ 10,898

NJEDA Loan(2)

   $ 329      1,301      1,284      —        —        —      $ 2,914

Long Term Contract(3)

   $ 1,223            —        —        —      $ 1,223

5% Senior Convertible Notes(4)

   $ 850      1,589      32,934      —        —        —      $ 35,373

Employment Contracts(5)

   $ 153      441      100      100      —        —      $ 794
                                                

TOTAL

   $ 2,691    $ 3,883    $ 34,874    $ 656    $ 556    $ 8,542    $ 51,202

(1) In November 2001, we renewed our operating lease for our Morris Plains, New Jersey facility for an additional term of 20 years expiring in October 2021 at an annual base rate of $545,000, which included an additional 15,000 square feet. The rent is fixed for the first five years and increases every five years thereafter.
(2) In May 2003, we obtained a loan for $6,376,000 at a variable interest rate through the New Jersey Economic Development Authority, repayable monthly in 60 equal installments.
(3) On June 1, 2005, we entered into an agreement with PPD Development LP to operate on the Company’s contract research organization to manage the Phase III clinical trials for SLE. Under the terms of the Agreement with UCB, UCB will assume the responsibility of financing and managing the SLE clinical trials. Subsequent to the 2006 fiscal year no additional funding will be required by us to PPD.
(4) On April 29, 2005, we completed a $37,675,000 private placement financing through the issuance of 5% senior convertible notes due April 29, 2008. Interest payments are due semi-annually beginning November 29, 2005, payable in cash or shares of common stock at our option. The holders of the notes may convert the notes at any time prior to April 29, 2009 at a conversion price of $2.62 per share, subject to adjustment based on the anti-dilution provision. During the nine months ended March 31, 2006 approximately $6,326,000 of notes and accrued interest were converted into shares of common stock. In addition, the holders received warrants that may be converted into shares of common stock at a conversion price of $2.98 per share.
(5) Employment contracts for the Chairman of the Board and Chief Strategic Officer, and the President and Chief Executive Officer will expire on June 30, 2006. The salary compensation

 

27


Table of Contents

for the Chairman of the Board and Chief Strategic Officer has been voluntarily deferred until the financial situation of the Company improves. The executive bonus program was deferred and will be reevaluated by the Board of Directors at the conclusion of the 2006 fiscal year.

Effects of Inflation

We do not believe that inflation has had a material impact on our business, sales or operating results during the periods presented.

 

28


Table of Contents

ITEM 3. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK

The following discussion about our exposure to market risk of financial instruments contains forward-looking statements under the Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those described due to a number of factors, including uncertainties associated with general economic conditions and conditions impacting our industry. See “Cautionary Note Regarding Forward-Looking Statements” under Item 2 above.

Our holdings of financial instruments are comprised primarily of corporate debt securities and municipal bonds. All such instruments are classified as securities available for sale at March 31, 2006. We do not invest in portfolio equity securities or commodities or use financial derivatives for trading purposes. Our debt security portfolio represents funds held temporarily pending use in our business and operations. We manage these funds accordingly. We seek reasonable assuredness of the safety of principal and market liquidity by investing in rated fixed income securities while at the same time seeking to achieve a favorable rate of return. Our market risk exposure consists principally of exposure to changes in interest rates. Our holdings also are exposed to the risks of changes in the credit quality of issuers. We typically invest in highly liquid debt instruments with fixed interest rates.

The table below presents the principal amounts of the restricted and unrestricted marketable securities and the related weighted-average interest rates by fiscal year of maturity for our investment portfolio as of March 31, 2006:

 

     2006     2007     2008    2009    2010    Total     Fair
Value
     (in thousands)

Fixed rate

   $ 1,236     $ 3,035     —      —      —      $ 4,271     $ 4,243

Average interest rate

     3.35 %     1.72 %   —      —      —        2.19 %     —  

 

29


Table of Contents

ITEM 4. CONTROLS AND PROCEDURES

(a) Disclosure Controls and Procedures: We maintain controls and procedures designed to ensure that we are able to collect the information we are required to disclose in the reports we file with the SEC, and to record, process, summarize and disclose this information within the time periods specified in the rules promulgated by the SEC. Our Chief Executive and Chief Financial Officers are responsible for establishing and maintaining these disclosure controls and procedures (as defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act) and, as required by the rules of the SEC, to evaluate their effectiveness. Based on their evaluation of our disclosure controls and procedures as of the end of the period covered by this Quarterly Report on Form 10-Q, our Chief Executive and Chief Financial Officers believe that these procedures are effective to ensure that we are able to collect, process and disclose the information we are required to disclose in the reports we file with the SEC within the required time periods.

(b) Changes in Internal Controls. There were no significant changes in our internal control over financial reporting (as defined in Rules 13a-15(f) and 15d-15(f) under the Exchange Act), identified in connection with the evaluation of such internal control that occurred during our last fiscal quarter, that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.

 

30


Table of Contents

PART II. OTHER INFORMATION

ITEM 1. LEGAL PROCEEDINGS

On December 22, 2003, the Dutch Supreme Court, in a case brought by the Company, held that Immunomedics’ Dutch part of its European patent for highly specific monoclonal antibodies against the cancer marker, carcinoembryonic antigen (CEA), was valid. The Dutch Supreme Court did not finally decide the Company’s claim of infringement. Among other things, the Supreme Court held that the Court of Appeal which had ruled that Roche had infringed Immunomedics European Patent had not given Roche sufficient opportunity to comment on an expert opinion filed by Immunomedics in which it was stated that Roche’s CEA test kit did satisfy a criterion that is generally satisfied for specific antibodies that bind to CEA. The Company has argued that the Dutch court should enforce the European Patent for all European countries for which the European Patent was validated, since Roche sold the same product in each country. The Dutch Supreme Court repeated the reasoning of the Dutch District Court that the Brussels Convention should be interpreted to permit cross-border enforcement of European patents where a related group of companies sells the same product in countries where that same patent has been validated. The Dutch Supreme Court referred this issue to the European Court of Justice (ECJ) to provide a final interpretation of the Brussels Convention on this point. On January 27, 2005, the ECJ heard oral arguments in the case, and took the matter under consideration.

We believe that the CEA patents that are the subject of our infringement action have been infringed, and we believe that the Company will prevail in the litigation, although no assurances can be given in this regard. To the extent that Roche contests or challenges our patents, or files appeals or further nullity actions, there can be no assurance that significant costs for defending such patents may not be incurred.

On May 19, 2004 and July 20, 2004, Roche filed nullity actions in German and United Kingdom courts, respectively, challenging our patents relating to an improved method of disease therapy in combination with cytotoxic agents, wherein cytokines are used to prevent, mediate or reverse radiation-induced, drug-induced or antibody-induced toxicity, especially to hematopoietic cells. On December 1, 2004, the Company agreed to settle the United Kingdom patent litigation by surrendering the United Kingdom patent. In accordance with United Kingdom legal rules, Roche made an application for payment of its attorney’s fees and other costs to the court. We agreed on a resolution with Roche, which was subsequently settled. The related charges for this litigation were included in the General and Administrative expenses in the Statement of Operations. In the German action the Company is defending the patent with amended claims and believes that it will prevail in such action.

There were no other legal proceedings nor any material developments during the fiscal quarter ended March 31, 2006 in any of the legal proceedings described in Item 3 of our Annual Report on Form 10-K for the fiscal year ended June 30, 2005. The German Patent Court has scheduled oral proceedings for August 3, 2006.

 

31


Table of Contents

ITEM 1A. RISK FACTORS

Factors That May Affect Our Business and Results of Operations

Our business is subject to certain risks and uncertainties, each of which could materially adversely affect our business, financial condition, cash flows and results of operations.

Risks Relating to Our Business, Operations and Product Development

We have a long history of operating losses and it is likely that our operating expenses will continue to exceed our revenues for the foreseeable future.

We have incurred significant operating losses since our formation in 1982, and have never earned a profit since that time. As of March 31, 2006, we had an accumulated deficit of approximately $198,000,000, including a net loss of $23,107,000 for the nine-month period ended March 31, 2006. In May 2006, we entered into an Agreement with UCB, granting UCB the exclusive, worldwide license to develop, manufacture, market and sell eparatuzumub, our humanized CD22 antibody, for all autoimmune disease indications. The only significant revenue we have earned to date has come from the limited sale of our two diagnostic imaging products in Europe and, to a lesser degree, the United States. We had previously licensed epratuzumab to Amgen in 2001, which agreement was terminated in April 2004. In addition, we have made the strategic decision to de-emphasize sales of our diagnostic products and focus on our therapeutic pipeline. We have never received revenue from the commercialization of any therapeutic product. We expect to continue to experience significant operating losses as we invest further in our research and development activities while simultaneously attempting to develop and commercialize our other therapeutic product candidates. If we are unable to develop commercially viable therapeutic products, it is likely that we will never achieve significant revenues or become profitable, either of which would jeopardize our ability to continue as a going concern.

Our most advanced therapeutic product candidates are still only in the clinical development stage, and will require us to raise capital in the future in order to fund further expensive and time-consuming studies before they can even be submitted for final regulatory approval.

Our most advanced therapeutic product candidates are still in the clinical development stage and will not be available for commercial sale any time soon, if ever. In order to complete the clinical development process for each of our product candidates, it will be necessary to invest significant financial resources, and devote a great deal of time and effort, just to reach the point where an application for final FDA or foreign regulatory approval can be submitted. In addition, we will need to raise additional capital to finance the costly process of obtaining approval for any of our current products should we get to that stage of product development.

Clinical trials involve the administration of a product candidate to patients who are already extremely ill, making patient enrollment often difficult and expensive. Moreover, even in ideal circumstances where the patients can be enrolled and then followed for the several months or more required to complete the study, the trials can be suspended, terminated or otherwise fail for any number of reasons, including:

 

    later-stage clinical trials may raise safety or efficacy concerns not readily apparent in earlier trials;

 

    unforeseen difficulties in manufacturing the product candidate in compliance with all regulatory requirements and in the quantities needed to complete the trial may be cost-prohibitive;

 

32


Table of Contents
    during the long trial process, alternative therapies may become available which make further development of the product candidate impracticable; and

 

    if we are unable to obtain the additional capital we need to fund all of the clinical trials we foresee, we may forced to cancel or otherwise curtail some important trials.

Any failure or substantial delay in successfully completing clinical trials for our product candidates, particularly the ongoing trials for our most advanced product candidate, epratuzumab, could severely harm our business and results of operation.

Once the clinical development process has been successfully completed, our ability to derive revenues from the sale of therapeutics will depend upon our first obtaining FDA as well as foreign regulatory approvals, all of which are subject to a number of unique risks and uncertainties.

Even if we are able to demonstrate the safety and efficacy of our product candidates in clinical trials, if we fail to gain timely approval to commercialize our product candidates from the FDA and other foreign regulatory authorities, we will be unable to generate the revenues we will need to build our business. These approvals may not be granted on a timely basis, if at all, and even if and when they are granted they may not cover all the indications for which we seek approval. For example, while we may develop a product candidate with the intention of addressing a large, unmet medical need, the FDA may only approve the use of the drug for indications affecting a relatively small number of patients, thus greatly reducing the market size and our potential revenues. The approvals may also contain significant limitations in the form of warnings, precautions or contraindications with respect to conditions of use, which could further narrow the size of the market. Finally, even after approval can be obtained, we may be required to recall or withdraw a product as a result of newly discovered safety or efficacy concerns, either of which would have a materially adverse effect on our business and results of operations.

In order to become a profitable biopharmaceutical company, we will need to raise significant amounts of additional capital. Because it can be difficult for a small-cap company like ours to raise equity capital on acceptable terms, we cannot assure you that we will be able to obtain the necessary capital when we need it, or on acceptable terms, if at all.

Even if our technologies and product candidates are superior, if we lack the capital needed to bring our future products to market, we will never be successful. We have obtained the capital necessary to fund our research and development programs to date primarily from the following sources:

 

    $38,000,000 from UCB to be paid under the May 2006 Agreement to license the rights to develop, manufacture and commercialize epratuzumab for the treatment of all autoimmune disease indications.

 

    Approximately $237,000,000 from the public and private sale of our debt and equity securities through March 31, 2006;

 

    $18,000,000 from Amgen under our epratuzumab licensing agreement, which was terminated in 2004; and

 

    limited product sales of CEA-Scan® and LeukoScan®, licenses, grants and interest income from our investments.

With the recent Agreement with UCB and anticipated receipt of the initial payments related thereto we will have sufficient funds for our research and development programs through the next twelve months. We intend to continue expending substantial capital on our research and development programs. We will eventually need to raise additional capital in order to obtain the necessary regulatory approvals and then commercialize our other therapeutic products. Our capital requirements are dependent on numerous factors, including:

 

    the rate at which we progress our research programs and the number of product candidates we have in pre-clinical and clinical development at any one time;

 

33


Table of Contents
    the cost of conducting clinical trials involving patients in the United States, Europe and possibly elsewhere;

 

    our need to establish the manufacturing capabilities necessary to produce the quantities of our product candidates we project we will need;

 

    the time and costs involved in obtaining FDA and foreign regulatory approvals;

 

    the cost of first obtaining, and then defending, our patent claims and other intellectual property rights; and

 

    our ability to enter into licensing and other collaborative agreements to help off-set some of these costs.

There may be additional cash requirements for many reasons, including, but not limited to, changes in our research and development plans, the need for unexpected capital expenditures or costs associated with any acquisitions of other businesses, assets or technologies that we may choose to undertake. If we deplete our existing capital resources, we will be required to either obtain additional capital quickly, or else significantly reduce our operating expenses and capital expenditures, either of which could have a material adverse effect on us.

Our ability to raise future capital on acceptable terms will depend not only upon our operating performance, but also on conditions in the public and private debt and equity markets, as well as the overall performance of other companies in the biopharmaceutical and biotechnology sectors. Financing may not be available to us when we need it on terms we find acceptable, if at all. Furthermore, the terms of any such debt or equity financing may include covenants which limit our future ability to manage the business, contain preferences, privileges and rights superior to those enjoyed by holders of our common stock or cause substantial dilution to our existing stockholders.

If we cannot successfully and efficiently manufacture the compounds that make up our products and product candidates, our ability to sell products and conduct clinical trials will be impaired.

Our ability to conduct our pre-clinical and clinical research and development programs depends, in large part, upon our ability to manufacture our proprietary compounds in accordance with FDA and other regulatory requirements. While we have completed construction on the major expansion of our manufacturing facilities in New Jersey in anticipation of our current and future needs, we have no historical experience in manufacturing these compounds in significant quantities, and we may not be able to do so in the quantities and with the degree of purity that is required. As with any new manufacturing facility, it may be some time before we become aware of any deficiencies in either the design of the new facility or the in construction itself. Any interruption in manufacturing at this site, whether by natural acts or otherwise, would significantly and adversely affect our operations, and delay our research and development programs.

Our future success will depend upon our ability to first obtain and then adequately protect our patent and other intellectual property rights, as well avoiding the infringement of the rights of others.

Our future success will be highly dependent upon our ability to first obtain and then defend the patent and other intellectual property rights necessary for the commercialization of our product candidates. We have filed numerous patent applications on the technologies and processes that we use in the United States and certain foreign countries. Although we have obtained a number of issued U.S. patents to date, the patent applications owned or licensed by us may not result in additional patents being issued. Moreover, these patents may not afford us the protection we need against competitors with similar technologies or products.

 

34


Table of Contents

The successful development of therapeutic products frequently requires the application of multiple technologies that may be subject to the patent or other intellectual property rights of third parties. Although we believe it is likely we will need to license technologies and processes from third parties in the ordinary course of our business, we are not currently aware of any material conflict involving our technologies and processes with any valid patents or other intellectual property rights owned or licensed by others. In the event that a third party were to claim such a conflict existed, they could sue us for damages as well as seek to prevent us from commercializing our product candidates. It is possible that a third party could successfully claim that our products infringe on their intellectual property rights. Uncertainties resulting from the litigation and continuation of patent litigation or other proceedings could have a material adverse effect on our ability to compete in the marketplace. Any patent litigation or other proceeding, even if resolved in our favor, would require significant financial resources and management time. Some of our competitors may be able to sustain these costs more effectively than we can because of their substantially greater financial and managerial resources. If a patent litigation or other proceeding is resolved unfavorably to us, we may be enjoined from manufacturing or selling our products without a license from the other party, in addition to being held liable for significant damages. We may not be able to obtain any such license on commercially acceptable terms, if at all.

In addition to our reliance on patents, we attempt to protect our proprietary technologies and processes by relying on trade secret laws, nondisclosure and confidentiality agreements and licensing arrangements with our employees and other persons who have access to our proprietary information. These agreements and arrangements may not provide meaningful protection for our proprietary technologies and processes in the event of unauthorized use or disclosure of such information. In addition, our competitors may independently develop substantially equivalent technologies and processes or otherwise gain access to our trade secrets or technology, either of which could materially and adversely affect our competitive position.

We face substantial competition in the biotechnology industry and may not be able to compete successfully against one or more of our competitors.

The biotechnology industry is highly competitive, particularly in the area of diagnostic and therapeutic oncology products. In recent years, there have been extensive technological innovations achieved in short periods of time, and it is possible that future technological changes and discoveries by others could result in our products and product candidates quickly becoming uncompetitive or obsolete. A number of companies, including Biogen Idec, Genentech, Glaxo SmithKline, Hoffmann-LaRoche, Human Genome Sciences, Ligand Pharmaceuticals, Millennium Pharmaceuticals, Protein Design Laboratories, Genmab, Medarex, Abgenix, Bristol-Myers Squibb and Schering AG, are engaged in the development of therapeutic autoimmune and oncology products. Many of these companies have significantly greater financial, technical and marketing resources than we do. In addition, many of these companies have more established positions in the pharmaceutical industry and are therefore better equipped to develop, commercialize and market oncology products. Even some smaller competitors may obtain a significant competitive advantage over us if they are able to discover or otherwise acquire patentable inventions, form collaborative arrangements or merge with larger pharmaceutical companies.

We expect to face increasing competition from universities and other non-profit research organizations. These institutions carry out a significant amount of research and development in the field of antibody-based technologies, and they are increasingly aware of the commercial value of their findings. As a result, they are demanding greater patent and other proprietary rights, as well as licensing and future royalty revenues.

 

35


Table of Contents

We may be liable for contamination or other harm caused by hazardous materials that we use in the operations of our business.

In addition to laws and regulations enforced by the FDA, we are also subject to regulation under various other foreign, federal, state and local laws and regulations. Our manufacturing and research and development programs involve the controlled use of viruses, hazardous materials, chemicals and various radioactive compounds. The risk of accidental contamination or injury from these materials can never be completely eliminated, and if an accident occurs we could be held liable for any damages that result, which could exceed our available resources.

The nature of our business exposes us to significant liability claims, and our insurance coverage may not be adequate to cover any future claims.

The use of our compounds in clinical trials and any future sale exposes us to liability claims that could be substantial. These claims might be made directly by healthcare providers, medical personnel, patients, consumers, pharmaceutical companies and others selling or distributing our compounds. While we currently have product liability insurance that we consider adequate for our current needs, we may not be able to continue to obtain comparable insurance in the future at an acceptable cost, if at all. If for any reason we cannot maintain our existing or comparable liability insurance, our ability to clinically test and market products could be significantly impaired. Moreover, the amount and scope of our insurance coverage, as well as the indemnification arrangements with third parties upon which we rely, may be inadequate to protect us in the event of a successful product liability claim. Any successful claim in excess of our insurance coverage could materially and adversely affect our financial condition and operating results.

The loss of any of our key employees could adversely affect our operations.

We are heavily dependent upon the talents of Dr. Goldenberg, our Chief Strategic Officer and Ms. Sullivan, our President and Chief Executive Officer, as well as certain other key personnel. If Dr. Goldenberg, Ms. Sullivan or any of our other key personnel were to unexpectedly leave our company, our business and results of operations could be materially and adversely affected. In addition, as our business grows we will need to continue to attract additional management and scientific personnel. Competition for qualified personnel in the biotechnology and pharmaceutical industries is intense, and we may not be successful in our recruitment efforts. If we are unable to attract, motivate and retain qualified professionals, our operations could be materially and adversely affected.

Certain potential for conflicts of interest, both real and perceived, exist which could result in expensive and time-consuming litigation.

Certain members of our senior management and Board of Directors have relationships and agreements, both with us as well as among themselves and their respective affiliates, which create the potential for both real, as well as perceived, conflicts of interest. These include Dr. David M. Goldenberg, our Chairman and Chief Strategic Officer, Ms. Cynthia L. Sullivan, our President and Chief Executive Officer, and certain companies with which we do business, including the Center for Molecular Medicine and Immunology, also known as the Garden State Cancer Center, or CMMI. For example, Dr. Goldenberg is the President and a Trustee of CMMI, a not-for-profit cancer research center that we use to conduct certain research activities. For the nine-month period ended March 31, 2006, we reimbursed CMMI a total of $47,000 for research activities conducted on our behalf. Further, Dr. Goldenberg’s employment agreement with us permits him to devote more of his time working for CMMI than for us, and other key personnel of our Company also have responsibilities to both CMMI and us.

 

36


Table of Contents

As a result of these and other relationships, the potential for both real and perceived conflicts of interest exists and disputes could arise over the allocation of funds, research projects and ownership of intellectual property rights. In addition, in the event that we become involved in stockholder litigation regarding these potential conflicts, we might be required to devote significant resources and management time defending the company from these claims, which could adversely affect our results of operations.

Given that autoimmune and cancer therapeutics such as the ones we are developing can cost upwards of $20,000 per treatment, even if our product candidates become available for sale it is likely that federal and state governments, insurance companies and other payers of health care costs will try to first limit the use of these drugs to certain patients, and may be reluctant to provide a level of reimbursement that permits us to earn a significant profit on our investment, if any.

Our ability to successfully commercialize therapeutic products will depend, in significant part, on the extent to which hospitals can obtain appropriate reimbursement levels for the cost of our products and related treatment. Third-party payers are increasingly challenging the prices charged for diagnostic and therapeutic products and related services. In addition, legislative proposals to reform health care or reduce government insurance programs may result in lower prices or the actual inability of prospective customers to purchase our products. Furthermore, even if reimbursement is available, it may not be available at price levels sufficient for us to realize a positive return on our investment.

Risks Related to Government Regulation of our Industry

Our industry and we are subject to intense regulation from the U.S. Government and such other governments and quasi-official regulatory bodies where our products are and product candidates may be sold.

These governmental and other regulatory risks include:

 

    Clinical development is a long, expensive and uncertain process, delay and failure can occur at any stage of our clinical trials;

 

    Our clinical trials are dependent on patient enrollment and regulatory approvals, we do not know whether our planned trials will begin on time, or at all, or will be completed on schedule or at all;

 

    The FDA or other regulatory authorities do not approve a clinical trial protocol or place a clinical trial on hold;

 

    If the clinical development process is completed successfully, our ability to derive revenues from the sale of therapeutics will depend on our first obtaining FDA or other comparable foreign regulatory approvals, each of which are subject to unique risks and uncertainties;

 

    There is no assurance that we will receive FDA or corollary foreign approval for any of our product candidates for any indication; we are subject to government regulation for the commercialization of our product candidates;

 

    We have not received regulatory approval in the United States or any foreign jurisdiction for the commercial sale of any of our product candidates; and

 

    We may be liable for contamination or other harm caused by hazardous materials used in the operations of our business.

 

37


Table of Contents

Risks Related to Our Securities

Our common stock may be delisted from the NASDAQ National Market System (“NASDAQ NMS”).

If the bid price of our common stock falls below $1.00 for an extended period, or we are unable to continue to meet NASDAQ’s listing maintenance standards for any other reason, our common stock could be delisted from the NASDAQ. In recent months, the bid price on our common stock has been below $2.00.

If our stock is not accepted for listing on the NASDAQ NMS, we will make every possible effort to have it listed on the Over the Counter Bulletin Board (the “OTC Bulletin Board”). If our Common Stock were to be traded on the OTC Bulletin Board, the Securities Exchange Act of 1934, as amended, and related Securities and Exchange Commission (“SEC”) rules would impose additional sales practice requirements on broker-dealers that sell our securities. These rules may adversely affect the ability of stockholders to sell our common stock and otherwise negatively affect the liquidity, trading market and price of our common stock.

If our common stock would not be able to be traded on the OTC Bulletin Board, we would make every effort to have it available for trading on the National Quotation Bureau’s Pink Sheets (the “Pink Sheets”). The Pink Sheets market consists of security firms who act as market makers in the stocks, usually, of very small companies. The bid and asked prices are not quoted electronically, but are quoted daily in “hard copy” which is delivered to firms that subscribe. Stocks that trade in the Pink Sheets are usually not as liquid as those that trade in electronic markets and, often time, the difference between the bid and the asked prices are substantial. As a result, if our common stock were traded on the Pink Sheets, there would likely be a further negative affect on the liquidity, trading market and price of our common stock even compared to that we might suffer if we were traded on the OTC Bulletin Board.

As a result of the above, we cannot assure you that our common stock will be listed on a national securities exchange, a national quotation service, the OTC Bulletin Board or the Pink Sheets or, if it is to be listed, whether or not there would be an interruption in the trading of our common stock. We believe that the listing of our stock on a recognized national trading market, such as the NASDAQ NMS, is an important part of our business and strategy. Such a listing helps our stockholders by providing a readily available trading market with current quotations. Without that, stockholders may have a difficult time getting a quote for the sale or purchase of our stock, the sale or purchase of our stock would likely be made more difficult and the trading volume and liquidity of our stock would likely decline. The absence of such a listing may adversely affect the acceptance of our common stock as currency or the value accorded it by other parties. In that regard, listing on a recognized national trading market will also affect the company’s ability to benefit from the use of its operations and expansion plans, including for use in licensing agreements, joint ventures, the development of strategic relationships and acquisitions, which are critical to our business and strategy and none of which is currently the subject of any agreement, arrangement or understanding, with respect to any future financing or strategic relationship it may undertake. The delisting from NASDAQ NMS would result in negative publicity and would negatively impact our ability to raise capital in the future.

If we were delisted from the NASDAQ NMS, we may become subject to the trading complications experienced by “Penny Stocks” in the over-the-counter market.

Delisting from the NASDAQ NMS may depress the price of our common stock such that we may become a penny stock. The SEC generally defines a penny stock as an equity security that has a market price of less than $5.00 per share or an exercise price of less than $5.00 per share, subject to specific exemptions. The market price of our common stock is currently less than $5.00 per share. “Penny Stock” rules require, among other things, that any broker engaging in a purchase or sale of our securities provide

 

38


Table of Contents

its customers with: (i) a risk disclosure document, (ii) disclosure of market quotations, if any, (iii) disclosure of the compensation of the broker and its salespersons in the transaction and (iv) monthly account statements showing the market values of our securities held in the customer’s accounts.

A broker would be required to provide the bid and offer quotations and compensation information before effecting the transaction. This information must be contained on the customer’s confirmation. Generally, brokers are less willing to effect transactions in penny stocks due to these additional delivery requirements. These requirements may make it more difficult for stockholders to purchase or sell our Common Stock. Because the broker, not us, prepares this information, we would not be able to assure that such information is accurate, complete or current.

Conversion of our 5% Notes and exercise of our Warrants will dilute the ownership interest of existing stockholders and could adversely affect the market price of our common stock.

The conversion of some or all of our 5% Notes and Warrants will dilute the ownership interests of existing stockholders. Any sales in the public market of the common stock issuable upon such conversion and exercise could adversely affect prevailing market prices of our common stock. In addition, the existence of the 5% Notes and Warrants may encourage short selling by market participants.

Our 5% Notes and Warrants have full-ratchet anti-dilution protection which will cause additional dilution to stockholders if triggered.

The conversion price of our 5% Notes and exercise price of our Warrants are subject to adjustment for issuances of common stock and common stock equivalents at prices less than the applicable conversion price and exercise price, respectively, which means such conversion and exercise prices are automatically reduced to the lower price. In the event the anti-dilution protections of the 5% Notes and Warrants are triggered, stockholders would suffer immediate dilution.

Our indebtedness and debt service obligations may adversely affect our cash flow.

As of March 31, 2006, our debt service obligation on the 5% Notes was $31,349,000. We intend to fulfill our current debt service obligations, including repayment of the principal from cash generated by our operations and from our existing cash and investments, as well as the proceeds from potential licensing agreements and additional financing from equity or debt transactions. If we are unable to generate sufficient cash to meet these obligations and need to use existing cash or liquidate investments in order to fund our current debt service obligations, including repayment of the principal, we may have to delay or curtail research and development programs.

We may add additional lease line to finance capital expenditures and may obtain additional long-term debt and line of credit. If we issue other debt securities in the future, our debt service obligations will increase further.

Our indebtedness could have significant additional negative consequences, including, but not limited to:

 

    requiring the dedication of a substantial portion of our expected cash flow from operations to service our indebtedness, thereby reducing the amount of our expected cash flow available for other purposes, including capital expenditures;

 

    increasing our vulnerability to general adverse economic and industry conditions;

 

    limiting our ability to obtain additional financing;

 

    limiting our flexibility in planning for, or reacting to, changes in our business and the industry in which we compete; and

 

    placing us at a possible competitive disadvantage to less leveraged competitors and competitors that have better access to capital resources.

 

39


Table of Contents

We may not have the ability to raise the funds necessary to finance any required redemptions of our outstanding 5% Notes, which might constitute a default by us.

If a Designated Event (as the term is defined in the Indenture under which the 5% Notes were issued) occurs prior to maturity, we may be required to redeem all or part of the 5% Notes. We may not have enough funds to pay the redemption price for all tendered 5% Notes. Although the indenture governing the 5% Notes allows us in certain circumstances to pay the applicable redemption prices in shares of our common stock, if a Designated Event were to occur, we may not have sufficient funds to pay the redemption prices for all the 5% Notes tendered.

We have not established a sinking fund for payment of our outstanding 5% Notes, nor do we anticipate doing so. In addition, any future credit agreements or other agreements relating to our indebtedness may contain provisions prohibiting redemption of our outstanding 5% Notes under certain circumstances, or expressly prohibit our redemption of our outstanding 5% Notes upon a Designated Event or may provide that a Designated Event constitutes an Event of Default under that agreement. If a Designated Event occurs at a time when we are prohibited from purchasing or redeeming our 5% Notes, we could seek the consent of our lenders to redeem our outstanding 5% Notes or attempt to refinance this debt. If we do not obtain consent, we would not be permitted to purchase or redeem our outstanding 5% Notes, including the offered 5% Notes. Our failure to redeem tendered 5% Notes would constitute an Event of Default under the Indenture, which might constitute a default under the terms of our other indebtedness. As a result, we may not be able to fulfill our obligations under the 5% Notes and our stockholders could lose all or part of their investment.

Our outstanding convertible notes, options and warrants may adversely affect our ability to consummate future equity-based financings due to the dilution potential to future investors.

Due to the number of shares of common stock we are obligated to issue pursuant to outstanding convertible notes, options and warrants, potential investors may not purchase our future equity offerings at market price because of the potential dilution such investors may suffer as a result of the exercise of the outstanding convertible notes, options and warrants.

Our outstanding 5% Notes and related Warrants may adversely affect our ability to consummate future equity-based financings due to the restrictive covenants contained in the Indenture pursuant to which the 5% Notes were issued and Warrant Agreement under which the Warrants were issued.

Holders of our 5% Notes have certain rights that may inhibit our ability to raise additional capital. Those rights include (a) full-ratchet anti-dilution protection in the event we sell securities at a price lower than the applicable conversion or exercise price of the 5% Notes or Warrants and (b) the right to pro rata participation in any future financing.

The market price of our common stock has fluctuated widely in the past, and is likely to continue to fluctuate widely based on a number of factors, many of which are beyond our control.

The market price of our common stock has been, and is likely to continue to be, highly volatile. Furthermore, the stock market generally and the market for stocks of relatively small biopharmaceutical companies like ours have from time to time experienced, and likely will again experience, significant price and volume fluctuations that are unrelated to actual operating performance.

 

40


Table of Contents

From time to time, stock market analysts publish research reports or otherwise comment upon our business and future prospects. Due to a number of factors, we may fail to meet the expectations of securities analysts or investors and our stock price would likely decline as a result. These factors include:

 

    announcements by us, any future alliance partners or our competitors of clinical results, technological innovations, product sales, new products or product candidates and product development timelines;

 

    the formation or termination of corporate alliances;

 

    developments or disputes concerning our patent or other proprietary rights, and the issuance of patents in our field of business to others;

 

    government regulatory action;

 

    period-to-period fluctuations in the results of our operations; and

 

    developments and market conditions for emerging growth companies and biopharmaceutical companies, in general.

In addition, Internet “chat rooms” have provided forums where investors make predictions about our business and prospects, oftentimes without any real basis in fact, that readers may trade on.

In the past, following periods of volatility in the market prices of the securities of companies in our industry, securities class action litigation has often been instituted against those companies. If we face such litigation in the future, it would result in substantial costs and a diversion of management’s attention and resources, which could negatively impact our business.

Our principal stockholder can significantly influence all matters requiring the approval by our stockholders.

As of March 31, 2006, Dr. Goldenberg, our Chairman and Chief Strategic Officer, together with certain members of his family including Ms. Cynthia L. Sullivan, our President and Chief Executive Officer, who is Dr. Goldenberg’s wife, and other affiliates, controlled the right to vote approximately 15.7% of our fully diluted common stock. As a result of this voting power, Dr. Goldenberg has the ability to significantly influence the outcome of substantially all matters that may be put to a vote of our stockholders, including the election of our directors.

We have adopted anti-takeover provisions that may frustrate any unsolicited attempt to acquire our Company or remove or replace our directors and executive officers.

Provisions of our certificate of incorporation, our by-laws and Delaware corporate law could make it more difficult for a third party to acquire control of our Company in a transaction not approved by our Board of Directors. For example, we have adopted a stockholder rights plan that makes it more difficult for a third party to acquire control of our Company without the support of our Board of Directors. In addition, our Board of Directors may issue up to ten million shares of preferred stock and determine the price, rights, preferences and privileges, including voting and conversion rights, of these shares without any further vote or action by our stockholders. The issuance of preferred stock could have the effect of delaying, deterring or preventing an unsolicited change in control of our company, or could impose various procedural and other requirements that could make it more difficult for holders of our common stock to effect certain corporate actions, including the replacement of incumbent directors and the completion of transactions opposed by the incumbent Board of Directors. The rights of the holders of our common stock would be subject to, and may be adversely affected by, the rights of the holders of any preferred stock that may be issued in the future.

We are also subject to Section 203 of the Delaware General Corporation Law (“DGCL”), which prohibits us from engaging in a business combination with any “interested” stockholder (as defined in Section 203 of the DGCL) for a period of three years from the date the person became an interested stockholder, unless certain conditions are met.

 

41


Table of Contents

There are limitations on the liability of our directors, and we may have to indemnify our officers and directors in certain instances.

Our certificate of incorporation limits, to the maximum extent permitted under Delaware law, the personal liability of our directors for monetary damages for breach of their fiduciary duties as directors. Our bylaws provide that we will indemnify our officers and directors and may indemnify our employees and other agents to the fullest extent permitted by law. These provisions may be in some respects broader than the specific indemnification provisions under Delaware law. The indemnification provisions may require us, among other things, to indemnify such officers and directors against certain liabilities that may arise by reason of their status or service as directors or officers (other than liabilities arising from willful misconduct of a culpable nature), to advance their expenses incurred as a result of any proceeding against them as to which they could be indemnified and to obtain directors’ and officers’ insurance. Section 145 of the DGCL provides that a corporation may indemnify a director, officer, employee or agent made or threatened to be made a party to an action by reason of the fact that he or she was a director, officer, employee or agent of the corporation or was serving at the request of the corporation, against expenses actually and reasonably incurred in connection with such action if he or she acted in good faith and in a manner he or she reasonably believed to be in, or not opposed to, the best interests of the corporation, and, with respect to any criminal action or proceeding, had no reasonable cause to believe his or her conduct was unlawful. Delaware law does not permit a corporation to eliminate a director’s duty of care and the provisions of our certificate of incorporation have no effect on the availability of equitable remedies, such as injunction or rescission, for a director’s breach of the duty of care.

We believe that our limitation of officer and director liability assists us to attract and retain qualified employees and directors. However, in the event an officer, a director or the board of directors commits an act that may legally be indemnified under Delaware law, we will be responsible to pay for such officer(s) or director(s) legal defense and potentially any damages resulting therefrom. Furthermore, the limitation on director liability may reduce the likelihood of derivative litigation against directors, and may discourage or deter stockholders from instituting litigation against directors for breach of their fiduciary duties, even though such an action, if successful, might benefit our stockholders and us. Given the difficult environment and potential for incurring liabilities currently facing directors of publicly-held corporations, we believe that director indemnification is in our and our stockholders’ best interests because it enhances our ability to attract and retain highly qualified directors and reduce a possible deterrent to entrepreneurial decision-making.

Nevertheless, limitations of director liability may be viewed as limiting the rights of stockholders, and the broad scope of the indemnification provisions contained in our certificate of incorporation and bylaws could result in increased expenses. Our board of directors believes, however, that these provisions will provide a better balancing of the legal obligations of, and protections for, directors and will contribute positively to the quality and stability of our corporate governance. Our board of directors has concluded that the benefit to stockholders of improved corporate governance outweighs any possible adverse effects on stockholders of reducing the exposure of directors to liability and broadened indemnification rights.

We are exposed to potential risks from recent legislation requiring companies to evaluate controls under Section 404 of the Sarbanes-Oxley Act.

The Sarbanes-Oxley Act requires that we maintain effective internal controls over financial reporting and disclosure controls and procedures. Among other things, we must perform system and process evaluation and testing of our internal controls over financial reporting to allow management to

 

42


Table of Contents

report on, and our independent registered public accounting firm to attest to, our internal controls over financial reporting, as required by Section 404 of the Sarbanes-Oxley Act. Compliance with Section 404 requires substantial accounting expense and significant management efforts. Our testing, or the subsequent review by our independent registered public accounting firm, may reveal deficiencies in our internal controls that would require us to remediate in a timely manner so as to be able to comply with the requirements of Section 404 each year. If we are not able to comply with the requirements of Section 404 in a timely manner each year, we could be subject to sanctions or investigations by the SEC, the NASDAQ NMS or other regulatory authorities that would require additional financial and management resources and could adversely affect the market price of our common stock.

We may pay vendors in stock as consideration for their services; this may result in stockholder dilution, additional costs and difficulty retaining certain vendors.

In order for us to preserve our cash resources, we may in the future pay vendors, including alliance partners, in shares, warrants or options to purchase shares of our common stock rather than cash. Payments for services in stock may materially and adversely affect our stockholders by diluting the value of outstanding shares of our common stock. In addition, in situations where we agree to register the shares issued to a vendor, this will generally cause us to incur additional expenses associated with such registration. Paying vendors in shares, warrants or options to purchase shares of common stock may also limit our ability to contract with the vendor of our choice should that vendor decline payment in stock.

We do not intend to pay dividends on our common stock. Until such time as we pay cash dividends our stockholders must rely on increases in our stock price for appreciation.

We have never declared or paid dividends on our common stock. We intend to retain future earnings to develop and commercialize our products and therefore we do not intend to pay cash dividends in the foreseeable future. Until such time as we determine to pay cash dividends on our common stock, our stockholders must rely on increases in our common stock’s market price for appreciation.

 

43


Table of Contents

ITEM 6. EXHIBITS

 

  10.1 Change of Control and Severance Agreement, dated as of March 19, 2006, by and between the Company and Gerard G. Gorman (incorporated by reference to Exhibit 10.1 to the Company’s Current Report on Form 8-K, dated March 10, 2006).

 

  31.1 Certification of Chief Executive Officer pursuant to Section 302(a) of the Sarbanes-Oxley Act of 2002.

 

  31.2 Certification of Chief Financial Officer pursuant to Section 302(a) of the Sarbanes-Oxley Act of 2002.

 

  32.1 Certifications of Chief Executive Officer and Chief Financial Officer pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.

 

44


Table of Contents

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.

 

  IMMUNOMEDICS, INC.
May 10, 2006   By:  

/s/ Cynthia L. Sullivan

    Cynthia L. Sullivan
    President and Chief Executive Officer
    (Principal Executive Officer)
May 10, 2006   By:  

/s/ Gerard G. Gorman

    Gerard G. Gorman
    Vice President, Finance, and Chief Financial Officer
    (Principal Financial and Accounting Officer)

 

45