424B3 1 d424b3.htm PROSPECTUS SUPPLEMENT Prospectus Supplement
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Prospectus Supplement Filed pursuant to Rule 424(b)(3)

Registration No. 333-138257

PROSPECTUS SUPPLEMENT NO. 7

DATED MAY 15, 2007

(To Prospectus Dated November 17, 2006)

BIOVEST INTERNATIONAL, INC.

18,000,000 Shares of Common Stock

This prospectus supplement supplements information contained in, and should be read in conjunction with, that certain Prospectus, dated November 17, 2006, of Biovest International, Inc. (the “Company”) as supplemented by Supplement No. 6 thereto dated April 19, 2007, Supplement No. 5 thereto dated March 28, 2007, Supplement No. 4 thereto dated February 14, 2007, Supplement No. 3 thereto dated January 19, 2007, Supplement No. 2 thereto dated December 29, 2006 and Supplement No. 1 thereto dated December 14, 2006. This prospectus supplement is not complete without, and may not be delivered or used except in connection with, the original Prospectus and Supplement Nos. 1, 2, 3, 4, 5 and 6 thereto. The Prospectus relates to the public sale, from time to time, of up to 18,000,000 shares of our common stock by the selling shareholders identified in the Prospectus.

The information attached to this prospectus supplement modifies and supersedes, in part, the information in the Prospectus, as supplemented. Any information that is modified or superseded in the Prospectus shall not be deemed to constitute a part of the Prospectus, except as modified or superseded by this prospectus supplement or Prospectus Supplement Nos. 1, 2, 3, 4, 5 and 6.

This prospectus supplement includes the attached Form 10-Q for period ending March 31, 2007, as filed by us with the Securities and Exchange Commission on May 15, 2007.

We may amend or supplement the Prospectus from time to time by filing amendments or supplements as required. You should read the entire Prospectus and any amendments or supplements carefully before you make an investment decision.

The Securities and Exchange Commission and state securities regulators have not approved or disapproved these securities or determined if this Prospectus Supplement (or the original Prospectus dated November 17, 2006, as previously supplemented) is truthful or complete. Any representation to the contrary is a criminal offense.

The date of this prospectus supplement is May 15, 2007.


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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

 


FORM 10-Q

 


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

For the quarterly period ended March 31, 2007

OR

 

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

Commission file number 0-11480

 


BIOVEST INTERNATIONAL, INC.

(Exact name of issuer as specified in its charter)

 


 

Delaware   41-1412084

(State or other jurisdiction of

incorporation or organization)

 

(IRS Employer

Identification Number)

377 Plantation Street, Worcester MA 01605

(Address of principal executive offices) (Zip Code)

(813) 864-2554

Registrant’s telephone number, including area code

 


Securities registered pursuant to Section 12(b) of the Act:

None

Securities registered pursuant to Section 12(g) of the Act:

Common Stock, par value $0.01 per share

(Title of class)

 

 


Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days.    Yes  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  ¨    Non-accelerated filer  x

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

As of April 30, 2007, there were 94,473,067 shares of the registrant’s Common Stock outstanding.

 



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Forward-Looking Statements

Statements in this quarterly report on Form 10-Q that are not strictly historical in nature are forward-looking statements. These statements may include, but are not limited to, statements about: the timing of the commencement, enrollment, and completion of our clinical trials for our product candidates; the progress or success of our product development programs; the status of regulatory approvals for our product candidates; the timing of product launches; our ability to protect our intellectual property and operate our business without infringing upon the intellectual property rights of others; and our estimates for future performance, anticipated operating losses, future revenues, capital requirements, and our needs for additional financing. In some cases, you can identify forward-looking statements by terms such as “anticipates,” “believes,” “could,” “estimates,” “expects,” “intends,” “may,” “plans,” “potential,” “predicts,” “projects,” “should,” “will,” “would,” “goal,” or other variations of these terms (including their use in the negative) or by discussions of strategies, plans or intentions. These statements are only predictions based on current information and expectations and involve a number of risks and uncertainties. The underlying information and expectations are likely to change over time. Actual events or results may differ materially from those projected in the forward-looking statements due to various factors, including, but not limited to, those set forth under the caption “Risk Factors” in “ITEM 1. BUSINESS” of our Form 10-KSB for the fiscal year ended September 30, 2006 and those set forth in our other filings with the Securities and Exchange Commission. Except as required by law, we undertake no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.

 

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INDEX

BIOVEST INTERNATIONAL, INC.

 

         Page

PART I.

 

FINANCIAL INFORMATION

  

    ITEM 1.

 

Financial Statements

  

Condensed Consolidated Balance Sheets as of March 31, 2007 (unaudited) and September 30, 2006

   4

Condensed Consolidated Statements of Operations for the Three and Six Months Ended March 31, 2007 and 2006 (unaudited)

   6

Condensed Consolidated Statement of Stockholders’ Deficit for the Six Months Ended March 31, 2007 (unaudited)

   7

Condensed Consolidated Statements of Cash Flows for the Six Months Ended March 31, 2007 and 2006 (unaudited)

   8

Notes to Condensed Consolidated Financial Statements

   10

    ITEM 2.

 

Management’s Discussion and Analysis of Financial Condition and Results of Operations

   24

    ITEM 3.

 

Quantitative and Qualitative Disclosure About Market Risk

   30

    ITEM 4.

 

Controls and Procedures

   30

PART II.

 

OTHER INFORMATION

  

    ITEM 1.

 

Legal Proceedings

   31

    ITEM 1A.

 

Risk Factors

   31

    ITEM 2.

 

Exhibits

   31

    ITEM 2.

  Unregistered Sales of Equity Securities and Use of Proceeds    31

    ITEM 3.

  Defaults Upon Senior Securities    31

    ITEM 4

  Submission of Matters to a Vote of Security Holders    31

    ITEM 5

  Other Information    31

    ITEM 6

  Exhibits    31

 

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BIOVEST INTERNATIONAL, INC., AND SUBSIDIARIES

CONDENSED CONSOLIDATED BALANCE SHEETS

 

    

March 31,

2007

(Unaudited)

  

September 30,

2006

ASSETS

     

Current assets:

     

Cash

   $ 2,027,000    $ 460,000

Restricted cash

     —        2,551,000

Accounts receivable, net of $0.02 million allowance for doubtful accounts at March 31, 2007 and September 30, 2006

     1,063,000      749,000

Costs and estimated earnings in excess of billings on uncompleted contracts

     92,000      6,000

Inventories

     474,000      228,000

Prepaid expenses and other current assets

     522,000      266,000
             

Total current assets

     4,178,000      4,260,000

Property, plant and equipment, net

     812,000      898,000

Other assets:

     

Patents and trademarks, net

     364,000      379,000

Deferred financing costs

     954,000      776,000

Reorganization value in excess of amounts allocated to identifiable assets

     2,131,000      2,131,000
             
   $ 8,439,000    $ 8,444,000
             

 

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BIOVEST INTERNATIONAL, INC., AND SUBSIDIARIES

CONDENSED CONSOLIDATED BALANCE SHEETS (Cont’d)

 

    

March 31,

2007
(Unaudited)

   

September 30,
2006

(Audited)

 

LIABILITIES AND STOCKHOLDERS’ DEFICIT

    

Current liabilities:

    

Notes Payable

   $ 1,757,000     $ 2,000,000  

Current maturities of long-term debt

     2,494,000       900,000  

Accounts payable (including $1.1 million and $0.7 million due to affiliate at March 31, 2007, and September 30, 2006 respectively)

     3,525,000       2,627,000  

Customer deposits

     374,000       392,000  

Accrued liabilities:

    

Compensation and related taxes

     1,301,000       1,521,000  

Other

     1,385,000       974,000  

Billings in excess of costs and estimated earnings on uncompleted contracts

     94,000       137,000  

Due to related party

     9,181,000       4,715,000  
                

Total current liabilities

     20,111,000       13,266,000  

Long term debt, less current maturities

     335,000       1,862,000  

Derivative liability

     426,000       236,000  
                

Total liabilities

     20,872,000       15,364,000  
                

Non-controlling interests in variable interest entities (Note 15)

     5,596,000       3,600,000  
          

Minority interest in consolidated subsidiary (Note 8)

     —         6,000,000  
          

Commitments and contingencies (Notes 13 and 14)

     —         —    

Stockholders’ deficit:

    

Preferred stock, $.01 par value, 50,000,000 shares authorized; 0 issued and outstanding

     —         —    

Common stock, $.01 par value, 300,000,000 shares authorized; 94,473,067 and 74,126,635 issued and outstanding at March 31, 2007, and September 30, 2006, respectively

     945,000       741,000  

Additional paid-in capital

     62,721,000       35,034,000  

Accumulated deficit

     (81,695,000 )     (52,295,000 )
                

Total stockholders’ deficit

     (18,029,000 )     (16,520,000 )
                
   $ 8,439,000     $ 8,444,000  
                

 

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BIOVEST INTERNATIONAL, INC., AND SUBSIDIARIES

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

(unaudited)

 

     Three Months Ended March 31,     Six Months Ended March 31,  
     2007     2006     2007     2006  

Revenues:

        

Products

   $ 677,000     $ 1,706,000     $ 1,475,000     $ 2,157,000  

Services

     875,000       583,000       1,404,000       1,217,000  
                                

Total revenues

     1,552,000       2,289,000       2,879,000       3,374,000  
                                

Operating costs and expenses:

        

Cost of sales:

        

Products

     456,000       732,000       855,000       947,000  

Services

     395,000       503,000       763,000       891,000  

Research and development

     3,131,000       2,570,000       6,065,000       5,341,000  

General and administrative

     1,889,000       1,102,000       3,160,000       1,718,000  

Impairment of investment in consolidated subsidiary (Note 8)

     —         —         3,775,000       —    

Loss on restructuring of related party royalty agreement (Note 8)

     —         —         6,637,000       —    
                                

Total operating costs and expenses

     5,871,000       4,907,000       21,255,000       8,897,000  
                                

Loss from operations

     (4,319,000 )     (2,618,000 )     (18,376,000 )     (5,523,000 )
                                

Other income (expense):

        

Interest expense, net

     (1,556,000 )     (161,000 )     (3, 591,000 )     (270,000 )

Termination of related party anti-dilution agreement (Note 8)

     —         —         (6,637,000 )     —    

Derivative loss

     (73,000 )     —         (59,000 )     —    

Related party financing cost (Note 8)

     —         —         (1,232,000 )     —    

Other expense

     —         —         (3,000 )     —    

Other income

     20,000       —         20,000       —    
                                
     (1,609,000 )     (161,000 )     (11,502,000 )     (270,000 )
                                

Net loss before non-controlling interest in loss from variable interest entities and income taxes

   $ (5,928,000 )   $ (2,779,000 )   $ (29,878,000 )   $ (5,793,000 )

Non-controlling interest in loss from variable interest entities

   $ 478,000       —       $ 478,000       —    
                                

Net loss

   $ (5,450,000 )   $ (2,779,000 )   $ (29,400,000 )   $ (5,793,000 )

Net loss per common share:

        

Basic and diluted

   $ (0.06 )   $ (0.03 )   $ (0.32 )   $ (0.07 )

Weighted average shares outstanding:

        

Basic and diluted

     94,469,400       80,390,663       90,921,766       79,522,895  

 

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BIOVEST INTERNATIONAL, INC., AND SUBSIDIARIES

CONDENSED CONSOLIDATED STATEMENT OF STOCKHOLDERS’ DEFICIT

FOR THE SIX MONTHS ENDED MARCH 31, 2007

(unaudited)

 

     Common Stock    Additional
Paid-in
Capital
   Accumulated
Deficit
    Total  

Balances at September 30, 2006

   74,126,635    $ 741,000    $ 35,034,000    $ (52,295,000 )   $ (16,520,000 )

Employee stock-based compensation

   —        —        912,000      —         912,000  

Options issued for accrued bonuses

   —        —        392,000      —         392,000  

Stock issued for related-party contract modification

   10,000,000      100,000      9,400,000      —         9,500,000  

Stock issued for related-party purchase of minority interest in consolidated subsidiary

   10,000,000      100,000      5,900,000      —         6,000,000  

Sale of stock

   326,098      4,000      264,000      —         268,000  

Exercise of stock options

   20,334      —        9,000      —         9,000  

Major stockholder expense incurred on behalf of the Company

   —        —        8,780,000      —         8,780,000  

Warrants issued to guarantee financing transaction

   —        —        2,030,000      —         2,030,000  

Net loss

   —        —        —        (29,400,000 )     (29,400,000 )
                                   

Balances at March 31, 2007

   94,473,067    $ 945,000    $ 62,721,000    $ (81,695,000 )   $ (18,029,000 )
                                   

The accompanying footnotes are an integral part of these condensed consolidated financial statements.

 

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BIOVEST INTERNATIONAL, INC., AND SUBSIDIARIES

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS

(unaudited)

 

     Six Months Ended March 31,  
     2007     2006  

Cash flows from operating activities:

    

Net loss

   $ (29,400,000 )   $ (5,793,000 )

Adjustments to reconcile net loss to net cash flows from operating activities:

    

Depreciation

     181,000       223,000  

Amortization

     15,000       15,000  

Employee stock-based compensation

     912,000       517,000  

Impairment of investment in consolidated subsidiary

     3,775,000       —    

Loss on restructuring of related party royalty agreement

     6,637,000       —    

Related party financing fee

     1,232,000       —    

Termination of related party anti-dilution agreement

     6,637,000       —    

Amortization of discounts on notes payable

     472,000       29,000  

Amortization of deferred loan costs

     137,000       —    

Warrants issued for guarantees of financing

     2,030,000       —    

Non-controlling interest in loss of variable interest entities

     (478,000 )  

Derivative loss

     59,000       —    

Changes in cash resulting from changes in:

    

Accounts receivable

     (313,000 )     (232,000 )

Costs and estimated earnings in excess of billings on uncompleted contracts

     (86,000 )     (47,000 )

Inventories

     (246,000 )     (143,000 )

Other assets

     (256,000 )     (16,000 )

Accounts payable and accrued liabilities

     1,479,000       974,000  

Customer deposits

     (18,000 )     (87,000 )

Billings in excess of costs and estimated earnings on uncompleted contracts

     (43,000 )     3,000  
                

Net cash flows used in operating activities

     (7,274,000 )     (4,557,000 )
                

Cash flows from investing activities:

    

Purchase of property and equipment

     (94,000 )     (309,000 )

Release of restricted cash

     2,551,000       —    
                

Net cash flows from investing activities

     2,457,000       (309,000 )
                

Cash flows from financing activities:

    

Repayment of notes payable and long-term debt

     (2,622,000 )     (65,000 )

Advances from Accentia, net

     4,466,000       4,452,000  

Proceeds from long term debt

     2,105,000       —    

Proceeds from stock subscription receivable

     —         682,000  

Proceeds from sale of stock

     268,000       —    

Proceeds from exercise of stock option

     9,000       —    

Payment of deferred financing costs

     (242,000 )     —    

Proceeds from non-controlling-interest investment in variable interest entity

     2,400,000       —    
                

Net cash flows from financing activities

     6,384,000       5,069,000  
                

Net change in cash

     1,567,000       203,000  
                

Cash at beginning of period

     460,000       32,000  
                

Cash at end of period

   $ 2,027,000     $ 235,000  
                

 

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BIOVEST INTERNATIONAL, INC., AND SUBSIDIARIES

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS

(unaudited)

 

     Six Months Ended March 31,
     2007    2006

Supplemental disclosure of cash flow information:

     

Non-cash financing activities:

     

Conversion of notes payable and accrued interest to equity

   $ —      $ 5,023,000

Issuance of Common Stock to retire convertible debt

   $ —      $ 1,282,000

Restricted cash proceeds from long term note payable

   $ —      $ 7,799,000

Issuance of warrant (discount on note payable)

   $ —      $ 4,818,000

Issuance of note payable

   $ —      $ 2,981,000

Advances from Accentia to retire convertible debt into Accentia equity

   $ —      $ 3,741,000

Issuance of long term debt for accrued expense

   $ —      $ 200,000

Issuance of stock to purchase minority interest in consolidated subsidiary

   $ 6,000,000    $ —  

Stock issued for payment of accrued expenses

   $ —      $ 408,000

Options issued for accrued bonuses

   $ 392,000    $ —  

Stock compensation as prepaid expense

   $ —      $ 62,000

Cash paid for interest during period:

   $ 274,000    $ 44,000

 

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BIOVEST INTERNATIONAL, INC., AND SUBSIDIARIES

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

SIX MONTHS ENDED MARCH 31, 2007 AND 2006

(UNAUDITED)

1. Description of the company:

Biovest International, Inc. (the “Company” or “Biovest”) is a biotechnology company focused on the development of a personalized therapeutic anti-cancer vaccine for the treatment of low-grade Follicular Lymphoma (FL), which is named BiovaxID. FL is a deadly cancer of the white blood cells. This therapeutic vaccine is currently in a pivotal Phase 3 clinical trial. In September 2001, the Company entered into a Cooperative Research and Development Agreement (CRADA) with the National Cancer Institute (“NCI”) regarding the development of this therapeutic vaccine. In April 2004, the Investigational New Drug application (“IND”) for BiovaxID was transferred to the Company from the NCI. In May 2006, the FDA notified us that the FDA had granted “fast track” status to BiovaxID and further notified us of the approval of our request to utilize molecular remissions data as a new secondary endpoint in our ongoing clinical trial of BiovaxID. The Company terminated the CRADA with NCI on September 25, 2006. Included in this transaction was the termination of the NCI’s responsibility of the trial safety and monitoring oversight by the NCI Data Safety and Monitoring Board (DSMB). A new Data Monitoring Committee (DMC) has been established for the BiovaxID clinical trials.

The Company has developed an automated cell culture instrument, called AutovaxID, which reduces the manpower and production space requirements and costs associated with the production of monoclonal antibodies, a critical step in the production of personalized therapeutics and vaccines. This instrument will facilitate more efficient commercial production of BiovaxID following approval of the vaccine, if and when it is obtained. In May, 2006, the Company was informed that no further FDA review or approval is required to market the AutovaxID instruments. In December, 2006, the Company began commercially marketing the automated instrument, and acquired a facility in St. Louis, Missouri, to market, assemble and distribute the instrument through its wholly-owned subsidiary AutovaxID, Inc. Delivery of the new instruments began in March, 2007. The St. Louis facility is expected to be operational in June 2007.

The Company manufactures instruments and disposables used in hollow fiber production of cell culture products. Hollow fiber cell culture products and instruments are used by biopharmaceutical and biotech companies, medical schools, universities, research facilities, hospitals and public and private laboratories. The Company produces mammalian and insect cells, monoclonal antibodies, recombinant and secreted proteins and other cell culture products using the unique capability, expertise and proprietary advancements in cell production process known as hollow fiber perfusion. Prior to September 2005, the Company was designated as the National Cell Culture Center (“NCCC”) under a grant from the National Institutes of Health and from September 2005 through June 30, 2006, continued to provide the same services under an interim grant. Subsequent to June 30, 2006, the Company has discontinued services under the grant, and has since integrated those activities into its commercial contract manufacturing business.

As of March 31, 2007, the Company is a 77% owned subsidiary of Accentia Biopharmaceuticals, Inc. (“Accentia”).

2. Significant accounting policies:

Basis of presentation:

The accompanying unaudited condensed financial statements have been derived from unaudited interim financial information prepared in accordance with the rules and regulations of the Securities and Exchange Commission for quarterly financial statements. Certain information and note disclosures normally included in financial statements prepared in accordance with accounting principles generally accepted in the United States of America have been condensed or omitted pursuant to those rules and regulations, although the Company believes that the disclosures made are adequate to make the information presented not misleading. The interim financial statements of the Company, in the opinion of management, include all normal and recurring adjustments necessary for a fair presentation of results as of the dates and for the periods covered by the interim financial statements.

Operating results for the six months ended March 31, 2007 are not necessarily indicative of the results that may be expected for the entire fiscal year. For further information, refer to the consolidated financial statements and footnotes thereto included in the Company’s Annual Report on Form 10-KSB for the fiscal year ended September 30, 2006.

 

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BIOVEST INTERNATIONAL, INC., AND SUBSIDIARIES

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

SIX MONTHS ENDED MARCH 31, 2007 AND 2006

(UNAUDITED)

 

Consolidation policy:

The consolidated financial statements represent the consolidation of wholly-owned companies and interests in variable interest entities where the Company has a controlling financial interest or has been determined to be the primary beneficiary under Financial Accounting Standards Board (FASB) Interpretation No. 46R, Consolidation of Variable Interest Entities (“FIN 46R”). The 2007 condensed consolidated financial statements include Biovest International, Inc., its wholly owned subsidiaries Biovax, Inc., AutovaxID, Inc., Biolender LLC and Biolender II LLC; and certain variable interest entities of the company, Biovax Investments LLC, Telesis CDE Two LLC, AutovaxID Investment LLC, and St. Louis New Markets Tax Credit Fund II LLC. All significant inter-company balances and transactions have been eliminated.

Revenue recognition:

Instruments and disposables sales are recognized in the period in which the applicable products are delivered. The Company does not provide its customers with a right of return; however, deposits made by customers must be returned to customers in the event of non-performance by the Company.

Revenues from contract cell production services are recognized using the percentage-of-completion method, measured by the percentage of contract costs incurred to date to estimated total contract costs for each contract. Contract costs include all direct material, subcontract and labor costs and those indirect costs related to contract performance, such as indirect labor, insurance, supplies and tools. General and administrative costs are charged to operations as incurred. Provisions for estimated losses on uncompleted contracts are made in the period in which such losses are determined. Changes in job performance, job conditions, estimated profitability and final contract settlements may result in revisions to revenues, costs and profits and are recognized in the period such revisions are determined. Because of the inherent uncertainties in estimating costs, it is at least reasonably possible that the estimates used will change in the near term. The asset “costs and estimated earnings in excess of billings on uncompleted contracts” represents revenues recognized in excess of amounts billed. Such revenues are expected to be billed and collected within one year on uncompleted contracts. The liability “billings in excess of costs and estimated earnings on uncompleted contracts” represents billings in excess of revenue recognized.

Recent Accounting Pronouncements:

In September, 2006 the SEC staff issued Staff Accounting Bulletin No. 108, “Considering the Effects of Prior Year Misstatements when Quantifying Misstatements in Current Year Financial Statements (“SAB 108”). SAB 108 provides guidance on the process of quantifying financial statement misstatements, advising companies to use both a balance sheet (“iron curtain”) and an income statement (“rollover”) approach when quantifying and evaluating the materiality of a misstatement. The iron curtain approach quantifies a misstatement based on the effects of correcting the misstatement existing in the balance sheet at the end of the reporting period. The rollover approach quantifies a misstatement based on the amount of the error originating in the current period income statement, including the reversing effect of prior year misstatements. The use of this method can lead to the accumulation of misstatements in the balance sheet. Under the guidance of SAB 108, the Company will be required to adjust its financial statements if either the iron curtain or rollover approach results in the quantification of a material misstatement. Previously filed reports would not be amended, but would be corrected the next time the company files prior year financial statements. Companies are allowed to record a one-time cumulative effect adjustment to correct errors in prior years that previously had been considered immaterial based on their previous approach. SAB 108 is effective for the Company upon issuance of its Fiscal 2007 annual financial statements. However, early application of SAB 108 is permitted for interim periods prior to the issuance of the annual financial statements. The Company is currently assessing the effect of SAB 108, if any, on its financial position or results of operations.

In February, 2007, the Financial Accounting Standards Board (“FASB”) issued Statement No. 159, “The Fair Value Option for Financial Assets and Financial Liabilities, including an amendment of FASB Statement No. 115” (“FAS 159”). FAS 159 permits entities to choose to measure many financial instruments and certain other items at fair value that are not currently required to be measured at fair value. FAS 159 is effective for fiscal years beginning after November 15, 2007. Management is currently assessing the adoption of FAS 159, and the effect, if any, on the Company’s financial position or results of operations.

 

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NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

SIX MONTHS ENDED MARCH 31, 2007 AND 2006

(UNAUDITED)

 

Reclassifications:

Certain reclassifications have been made to the 2006 Consolidated Financial Statements to conform to the 2007 presentation.

3. Liquidity and management plans:

During the six months ended March 31, 2007, the Company incurred a net loss of $29.4 million, of which $18 million was attributable to non-cash charges resulting from three equity transactions between the Company, Accentia, and Laurus, the Company’s and Accentia’s senior lender, regarding modification and termination of certain agreements. See Note 8. At March 31, 2007, the Company had an accumulated deficit of approximately $81.7 million and working capital deficit of approximately $15.9 million. The Company has been meeting its cash requirements through proceeds from its cell culture and instrument manufacturing activities, the use of cash on hand, trade vendor credit and short-term borrowings (primarily from affiliates), the sale of stock to, and inter-company demand loans from, Accentia Biopharmaceuticals, Inc. (“Accentia”) as discussed below. The Company’s auditors issued a “going concern” uncertainty on the financial statements for the year ended September 30, 2006, citing significant losses and working capital deficits at that date, which raised substantial doubt about the Company’s ability to continue as a going concern.

Phase 3 Clinical Trial and planned commercialization expenditures:

Continued development activities related to BiovaxID, including the Phase 3 clinical trials, are expected to result in substantial, and potentially increasing, expenditures over the next several years before any revenues from this product development materialize. While the Company pursues FDA approval of BiovaxID, the Company plans, subject to the availability of financing, to make significant investments in laboratory equipment, including the development of automated cell production instruments, and potentially space and related capability necessary to support commercial vaccine production requirements anticipated upon FDA approval of BiovaxID. The Company has filed an amendment to the trial Protocol with the FDA covering its Phase 3 clinical trial to expand the trial to include patients who receive initial passive immunotherapy treatment including Rituxan®, and has added a number of Clinical Trial sites in the Ukraine and Russia in order to significantly accelerate patient accrual in the Clinical Trials. The Company anticipates that expenditures related to vaccine and equipment development and commercialization will, subject to availability of financing, increase significantly over those experienced in the past. The Company’s ability to timely access required financing will continue to be essential to support the ongoing Phase 3 clinical trial. The Company’s inability to obtain required funds or any substantial delay in obtaining required funds will have a material adverse effect on the ongoing clinical trial and commercialization efforts.

In addition, the Company established an assembly and distribution facility in December 2006, for the commercial production of AutovaxID instruments, which is anticipated to be operational in June 2007. The company began producing revenues from the sale of AutovaxID instruments in the three months ended March 31, 2007. The completion of the AutovaxID dedicated facility and anticipated start-up will require significant expenditures for leasehold improvements, construction, equipment, and personnel costs, in advance of significant revenues from the commercial sale of AutovaxID instruments. Approximately $1.4 million of the $2.0 million cash on hand at March 31, 2007 was allocated for this purpose. The Company believes the allocated funds on hand will be sufficient to complete construction and commence operations at the new assembly and distribution facility, however, there are no assurances that the facility will produce positive cash flow once it is completed and operations have commenced.

Advances to the Company by Accentia:

During the six months ended March 31, 2007, the Company borrowed an additional $4.5 million from Accentia to increase the total balance due to Accentia to $9.2 million. The advances by Accentia as of March 31, 2007 consisted of cash loans, payments made by Accentia directly to third parties on the Company’s behalf, allocated inter-company expenses, accrued interest of $0.7 million, and amounts owed in connection with the conversion of notes outstanding at the time of Accentia’s initial investment in June 2003. The $9.2 million balance of the inter-company loans is evidenced by three secured promissory demand notes.

 

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BIOVEST INTERNATIONAL, INC., AND SUBSIDIARIES

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

SIX MONTHS ENDED MARCH 31, 2007 AND 2006

(UNAUDITED)

 

Additional New Market Tax Credit financing:

On December 8, 2006, the Company through its wholly-owned subsidiary, AutovaxID, Inc., closed a financing transaction that was structured in an effort to obtain certain advantages by virtue of being located in a qualifying census tract. The Company’s new AutovaxID assembly and distribution facility is located in such a tract. The series of transactions, fully described in Note 14, resulted in the Company receiving approximately $4.5 million for facility improvements, startup-costs and general working capital.

Notes payable:

On January 16, 2007, the Company issued a promissory note to the Pulaski Bank in the amount of $1.0 million. This loan bears interest at prime less 0.5% (currently 7.75%) and is payable July 5, 2007. In addition, the Company issued an additional promissory note to Pulaski bank on March 22, 2007, in the amount of $0.75 million bearing interest at prime less 0.5% (currently 7.75%) with an original maturity date of April 21, 2007. The maturity date of the note was subsequently extended to May 21, 2007. The Company issued warrants to purchase 1,388,636 shares of the Company’s common stock to certain officers and directors in conjunction with their guarantee of these notes payable.

Amendment to Laurus Loan:

Subsequent to March 31, 2007, the Company entered into an amendment agreement with its senior lender, Laurus, to defer payments of principal on its $7.8 million loan until August, 2007, and to allow an increase in indebtedness by $7.0 million for future bridge financing purposes. In return for the forbearance, the company issued to Laurus a right to a minimum royalty stream on AutovaxID instrument sales. See Note 6.

Additional expected financing activity:

Management expects to continue to meet its cash requirements through the use of cash on hand, trade vendor credit, short-term borrowings, debt and equity financings and strategic transactions such as collaborations and licensing. Accentia has advanced all payments required under its investment agreement obligation of $20 million. Additionally, Accentia has loaned the Company or otherwise paid on its behalf an additional $9.2 million through March 31, 2007, through the inter-company demand loans discussed above. While investments and loans from Accentia have been a primary source of financing for the Company since 2003, the Company has been informed by Accentia that provisions of certain of its loan and debenture financing agreements preclude Accentia from making any additional direct cash contributions to the Company. Accordingly, the Company’s ability to continue present operations and meet obligations for vaccine development is dependent upon the Company’s ability to obtain significant external funding in the near term from sources other than Accentia. Additional sources of funding have not been established; however, additional financing is currently being sought by the Company from a number of sources other than Accentia, including the sale of equity or debt securities, strategic collaborations, recognized research funding programs, as well as domestic and/or foreign licensing of our vaccine. Management is currently in the process of exploring various financing alternatives, and has hired an investment banking firm to assist in these efforts. There can be no assurance that the Company will be successful in securing such financing at acceptable terms, if at all. If adequate funds are not available from the foregoing sources, or if the Company determines it to otherwise be in the Company’s best interest, the Company may consider additional strategic financing options, including sales of assets or business units that are non-essential to the ongoing development or future commercialization of BiovaxID and AutovaxID, or the Company may be required to delay, reduce the scope of, or eliminate one or more of its research or development programs or curtail some or all of its commercialization efforts.

4. Concentrations of credit risk and major customer information:

The Company grants credit to customers in the normal course of business, but generally does not require collateral or any other security to support amounts due. Management performs ongoing credit evaluations of its customers. Two customers accounted for 26% and 23% of revenues for the six months ended March 31, 2007, and 38% and 39% of trade accounts receivable as of March 31, 2007. A significant amount of the Company’s revenue has been derived from export sales. The Company’s export sales were 37% of revenues for the six months ended March 31, 2007, compared to 18% for the same period in 2006. For the six months ended March 31, 2007, two countries’ sales accounted for 26% (United Kingdom) and 8% (Canada) of total revenue, while no single foreign country had sales in excess of 10% of revenues for the six months ended March 31, 2006.

 

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BIOVEST INTERNATIONAL, INC., AND SUBSIDIARIES

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

SIX MONTHS ENDED MARCH 31, 2007 AND 2006

(UNAUDITED)

 

5. Inventories:

Inventories consist of the following:

 

     March 31, 2007
(Unaudited)
   September 30,
2006

Finished goods

     73,000    $ 34,000

Work-in-process

     260,000      97,000

Raw materials

     141,000      97,000
             
   $ 474,000    $ 228,000
             

6. Long-term debt:

Long-term debt consists of the following:

 

    

March 31,

2007

(unaudited)

   

September 30,

2006

 

Note payable, Laurus Master Fund, $7,799,000 face value, variable rate (10.25% at March 31, 2007) amortizing note payable due in monthly payments through March 31, 20091

   $ 2,271,000     $ —    

Note payable, Laurus Master Fund, $2,500,000 face value, prime rate (8.25% at September 30, 2006) non-amortizing note payable, originally secured by restricted cash in escrow, due March 31, 20092

     —         906,000  

Note payable, Laurus Master Fund, $5,066,000 face value, variable rate (10.25% at September 30, 2006) amortizing note payable due in monthly payments through March 31, 20092

     —         1,448,000  

Notes payable, interest at 10%; due in 2007; convertible into common stock at $1.00 per share.

     47,000       114,000  

Note payable, legal settlement

     41,000       120,000  

Other

     110,000       88,000  

Accrued interest, long-term debt

     360,000       86,000  
                
     2,829,000       2,762,000  

Less current maturities

     (2,494,000 )     (900,000 )
                

Long-term portion of notes payable

   $ 335,000     $ 1,862,000  
                

1 This note is collateralized by all cash, restricted cash, accounts receivable, inventory, fixed assets and other assets. The notes also contain certain restrictive covenants. Pursuant to the original terms of this secured promissory note, the Company was required to make certain principal and interest payments commencing in calendar 2007. The Company did not commence making such payments when originally due and reached an understanding that such payments would not commence while the Company sought additional financing. This understanding was formalized into a letter agreement dated March 21, 2007 (the “Letter Agreement”). The Company closed a short-term borrowing of $750,000 from Pulaski Bank and this Letter Agreement became effective on April 17, 2007. In addition to formalizing and continuing Laurus’ forbearance, the Letter Agreement rescheduled future payments due from the Company to Laurus under the Note. Under the Letter Agreement past due and ongoing principal payments on the Note are deferred until August 1, 2007, when adjusted monthly principal payments of $0.3 million per month will commence. As consideration for the forbearance the Company granted to Laurus a non-cancelable royalty equal to three percent 3% of world-wide net sales of AutovaxID instruments for a period of five years commencing on the earlier of May 31, 2007 or the completion of a long term financing by the Company. Under the terms of the royalty agreement the Company’s royalty payments to Laurus are required to aggregate a minimum of $8.0 million with $0.5 million of the minimum royalty being payable on December 31, 2007 and the balance (if any), less actual royalties paid, being due at the end of the five year royalty term. In addition, upon satisfaction of certain conditions of the Letter Agreement, Laurus consented to the Company seeking and, if available, entering into bridge loans in an aggregate amount of up to $7.0 million.
2 Converted to Note Payable to Laurus Master Fund $7,799,000 face value, discussed above.

 

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NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

SIX MONTHS ENDED MARCH 31, 2007 AND 2006

(UNAUDITED)

 

Future maturities of long-term debt are as follows at March 31, 2007

 

Years ending March 31,

      

2007

   $ 2,494,000  

2008

     5,131,000  

2009

     127,000  
        

Total maturities

     7,752,000  

Less unamortized discount

     (4,923,000 )
        
   $ 2,829,000  
        

7. Notes Payable:

On January 16, 2007, the Company closed an amended and restated loan transaction (“Note 1”) with Pulaski Bank and Trust Company of St. Louis, MO (“Pulaski”), which amended the Loan Agreement dated September 5, 2006 pursuant to which Pulaski agreed to loan $1 million to the Company pursuant to an unsecured Promissory Note. The Company also closed on a second loan transaction with Pulaski Bank on March 22, 2007 (“Note 2”), pursuant to which Pulaski agreed to loan an additional $0.75 million to the Company pursuant to an unsecured Promissory Note. The balance of both notes included in the accompanying 2007 consolidated financial statements includes the principal of $1.75 million plus accrued interest of approximately $7,000.

Note 1 matures on July 5, 2007, and can be prepaid by the Company at any time without penalty. The note bears interest at the prime rate minus .05% (7.75% per annum at March 31, 2007), requiring monthly payments of interest only commencing February 2007. The note is an unsecured obligation of the Company and is subordinated to the Company’s outstanding loan to Laurus Master Fund, Ltd. The notes are guaranteed by entities and individuals affiliated with the Company or Accentia, the majority stockholder of the Company. The Company has entered into Indemnification Agreements with each of the guarantors.

In conjunction with the issuance of these notes payable the Company issued to the guarantors warrants to purchase an aggregate total of 1,388,636 shares of the Company’s Common Stock, par value $0.01 per share, at an exercise price of $1.10 per share (the “Warrants”). The Warrants will expire on January 15, 2012. Under the terms of the Warrants, the guarantors shall have piggy-back registration rights for the shares underlying the Warrants.

Note 2 matures on May 21, 2007. The note bears interest at the prime rate minus .05% (7.75% per annum as of March 31, 2007), with interest only payment due monthly. The note is an unsecured obligation of the Company and is subordinated to the Company’s outstanding loan to Laurus Master Fund, Ltd. The note is guaranteed by entities and individuals affiliated with the Company or Accentia, the majority stockholder of the Company. The Company has entered into Indemnification Agreements with each of the guarantors. The Company issued to the guarantors warrants to purchase an aggregate total of 406,817 shares of the Company’s Common Stock, par value $0.01 per share, at an exercise price of $1.10 per share. These warrants will expire on March 21, 2012. Under the terms of the warrants, the guarantors have piggy-back registration rights for the shares underlying the warrants.

The Company agreed to indemnify and hold harmless each guarantor should their guarantees be called by the Lender. In addition, in the event of default by the Company resulting in a payment to the Lender by the guarantors, the Company has agreed to compensate each affected guarantor by issuance of that number of shares of the Company’s restricted common stock determined by dividing 700% of the amount guaranteed by $1.10.

 

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NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

SIX MONTHS ENDED MARCH 31, 2007 AND 2006

(UNAUDITED)

 

8. Related Party Transactions:

Due to related party:

Due to Related Party includes amounts advanced under three secured promissory demand notes issued to Accentia Biopharmaceuticals, Inc., bearing interest at prime rate. As of March 31, 2007, the total balance owed to Accentia under these notes was $9.2 million. Related Party interest expense of $0.3 million and $0.2 million was incurred for the six months ended March 31, 2007 and 2006, respectively.

Modification and termination of agreements:

The Company borrowed $3.1 million from Accentia to facilitate the purchase of Biolender II in the New Market Tax Credit Transaction. This borrowing was evidenced by the execution of an additional promissory demand note bearing interest at prime rate and $1.1 million due under this note was paid subsequent to the closing of the December New Market Tax Credit transactions and the remaining $2.0 million is included in the March 31, 2007 balance in Due to Related Party.

On October 31, 2006, the Company entered into a series of agreements with Accentia modifying certain material terms of the relationship between the two companies. The material terms of these modifications to the previously existing agreements are summarized as follows:

 

   

The Company and Accentia entered into a Royalty Agreement that terminated and superseded the Biologics Products Commercialization Agreement (the “Biologics Commercialization Agreement”), dated August 17, 2004, between the two companies. The Biologics Commercialization Agreement had provided that Accentia was the exclusive commercialization partner for the Company’s biologic products and was entitled to 49% of the Company’s net profits from the sale of biologic products should Accentia’s ownership percentage in the Company drop below 50%. Net revenue as used in the Biologics Commercialization Agreement included all receipts from the sale, license, sub-license, joint venture or other receipts from the biologic products less all expenses including the costs of product acquisition, research, manufacture, sales, distribution, commercialization and governmental regulation. The new Royalty Agreement provides that Accentia is no longer the Company’s exclusive commercialization partner and replaces the share of net profits with a 19.5% royalty based on net sales and license revenue of biologics products. The products and territory subject to the Royalty Agreement remain identical to those terms as previously contained in the Biologics Commercialization Agreement. In consideration for Accentia entering into this Royalty Agreement, the Company agreed to issue to Accentia 5 million new shares of the Company’s common stock with a fair value of $4.8 million on the date of modification. No royalty expense relating to the Royalty Agreement was incurred during the six months ended March 31, 2007. A charge to the Company of $4.8 million was recorded in operating expense and is included in “loss on restructuring related party royalty agreement”.

 

   

The Company and Accentia entered into a Termination Agreement under which Accentia agreed to immediately terminate its absolute anti-dilution rights that were granted to Accentia pursuant to the First Right of Refusal Agreement dated June 16, 2003 with the Company. In consideration of Accentia’s termination of the First Right of Refusal Agreement, Biovest issued to Accentia 5 million new shares of the Company’s common stock with a fair value of $4.8 million on the date of the termination agreement. A charge to the Company of $4.8 million was recorded in Other Expense as a cost of terminating the agreement, and is included in “termination of related party anti-dilution agreement.

 

   

The Company and Accentia entered into a Purchase Agreement whereby the Company purchased Accentia’s 70.5% ownership interest in Biolender, LLC (“Biolender”). Biolender is the entity that was formed by Accentia and the Company to participate in the Company’s New Market Tax Credit enhanced financing that closed in April 2006. In consideration of the sale of this interest in Biolender, the Company agreed to issue to Accentia 10 million new shares of the Company’s common stock, representing the negotiated value of the purchased interest. The Company accounted for the acquisition of this majority interest in Biolender at Accentia’s $6.0 million historical cost due to the common control ownership of Accentia and the Company.

 

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NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

SIX MONTHS ENDED MARCH 31, 2007 AND 2006

(UNAUDITED)

 

8. Related Party Transactions (continued):

 

   

In order to consummate the foregoing transactions, the Company and Accentia were required to obtain the consent of Accentia’s senior lender, Laurus Master Fund, Ltd. (“Laurus”), under Accentia’s loan agreement with Laurus. In consideration for providing such consent, the Company and Accentia entered into an agreement with Laurus pursuant to which Laurus consented to the above-described transactions and certain other transactions, and Accentia issued to Laurus a warrant to purchase 10 million outstanding shares of the Company’s common stock owned by Accentia at an exercise price of $.01 per share. The warrant expires in October 2012. The $8.8 million fair value of the Accentia warrant, which was granted for the benefit of the Company, has been recorded as a capital contribution in the statement of operations in the Company’s consolidated financial statements for the six months ended March 31, 2007. A portion of the warrant’s cost was also allocated to a provision in the consent whereby Accentia was allowed to increase its inter-company loan with Biovest to a total of 9.6 million in order to facilitate the New Markets Tax Credit financing transaction (see Note 14). This allocation has been recorded as a financing fee in the statement of operations for the six months ended March 31, 2007. The $8.8 million charge was allocated as follows in the statement of operations:

 

• Investment in Biolender LLC (immediately impaired)

   $ 3,775,000

• Loss on restructuring of related party royalty agreement

     1,887,000

• Related party financing fee

     1,231,000

• Termination of related party anti-dilution agreement

     1,887,000
      
   $ 8,780,000
      

9. Income taxes:

No provision for income taxes has been recorded for the six months ended March 31, 2007 and 2006 due to the losses incurred during the periods. At March 31, 2007, the Company has net operating loss carry forwards of approximately $50.6 million available to offset future taxable income, which will begin to expire in 2020.

Deferred tax assets are reduced by a valuation allowance if, based on the weight of the available evidence, it is more likely than not (a likelihood of more than 50%) that some portion or all of the deferred tax assets will not be realized. The Company has recorded a deferred tax asset valuation allowance of approximately $ 25.0 million, which fully offsets all deferred tax assets.

 

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NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

SIX MONTHS ENDED MARCH 31, 2007 AND 2006

(UNAUDITED)

 

10. Stock based compensation:

The fair value of each option award is estimated on the date of grant using the Black-Scholes valuation model that uses assumptions for expected volatility, expected dividends, expected term, and the risk-free interest rate. Expected volatilities are based on historical volatility of the Company’s stock and other factors estimated over the expected term of the options. The expected term of options granted is derived using the “simplified method” which computes expected term as the average of the sum of the vesting term plus the contract term. The risk-free rate is based on the U.S. Treasury yield curve in effect at the time of grant for the period of the expected term.

Common stock options exercised and outstanding during the six months ended March 31, 2007 are as follows:

Employee Stock Options:

 

     Shares     Weighted
Average Price
   Weighted
Average Term
   Aggregate
Intrinsic Value

Outstanding at September 30, 2006

   6,366,141     $ 0.73      

Granted

   2,901,382     $ 0.74      

Exercised

   (15,000 )   $ 0.50      

Canceled

   (222,621 )   $ 0.86      
                  

Outstanding at March 31, 2007

   9,029,902     $ 0.73    7.71    $ 24,020
                  

Exercisable at March 31, 2007

   7,361,642     $ 0.75    7.45    $ 22,813
                  

Non-vested employee stock options:

 

Non-vested Shares

   Shares     Weighted Avg
Grant-Date
Fair Value

Non-vested at September, 30, 2006

   1,997,562     $ 0.48

Granted

   704,167       0.32

Vested

   (1,016,247 )     0.48

Canceled

   (17,222 )     0.58
        

Non-vested at December 31, 2006

   1,668,260     $ 0.42
        

Common stock warrants issued and exercisable are as follows:

 

Warrants

   Shares     Weighted
Average Price

Outstanding at September 30, 2006

   17,298,126     $ 0.20

Issued

   4,182,269       1.10

Exercised

   (5,334 )     0.38

Canceled

   (100,346 )     3.74
        

Outstanding at March 31, 2007

   21,374,715       0.36
        

Exercisable at March 31, 2007

   19,144,715     $ 0.26
        

 

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NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

SIX MONTHS ENDED MARCH 31, 2007 AND 2006

(UNAUDITED)

 

11. Derivative liability:

The changes in the derivative liability are as follows:

 

Balance, September 30, 2006

   $ 236,000

Allocation of Laurus debt for New Market Tax Credit Transaction, December, 2006

     131,000

Loss on derivative

     59,000
      

Balance, March 31, 2007

   $ 426,000
      

12. Segment information:

The Company operates in three identifiable industry segments. The Company’s Cell Culture products and services is engaged in the production and contract manufacturing of biologic drugs and cell production for research institutions worldwide. The Instruments and Disposables segment is engaged in the development, manufacture and marketing of patented cell culture systems, equipment and consumable parts to pharmaceutical, diagnostic and biotechnology companies, as well as leading research institutions worldwide. The Therapeutic Vaccine segment, which has generated no revenues to date, is focused on developing BiovaxID, as described earlier.

The Company’s facilities expenses and other assets are not distinguished among the identifiable segments. Revenue and cost of sales information about the Company’s segments are as follows:

 

     Three Months Ended
March 31,
    Six Months Ended
March 31,
 
     2007     2006     2007     2006  

Revenues

        

Cell Culture Services

   875,000     583,000     1,404,000     1,217,000  

Instruments and Disposables

   677,000     1,706,000     1,475,000     2,157,000  
                        

Total Revenues

   1,552,000     2,289,000     2,879,000     3,374,000  
                        

Cost of Sales

        

Cell Culture Services

   395,000     503,000     763,000     891,000  

Instruments and Disposables

   456,000     732,000     855,000     947,000  
                        

Total Cost of Sales

   851,000     1,235,000     1,618,000     1,838,000  
                        

Gross Margin ($)

   701,000     1,054,000     1,261,000     1,536,000  

Gross Margin (%)

   45 %   46 %   44 %   46 %

13. Commitments and contingencies:

Legal proceedings:

The Company is not a party to any material legal proceedings, and management is not aware of any threatened legal proceedings, that could cause a material adverse impact on the Company’s business, assets, or results of operations. However, from time to time the Company is subject to various legal proceedings in the normal course of business, some of which is covered by insurance.

 

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NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

SIX MONTHS ENDED MARCH 31, 2007 AND 2006

(UNAUDITED)

 

13. Commitments and Contingies ( continued ):

Facility lease:

In connection with the New Market Tax Credit transaction on December 8, 2006, the Company entered into a lease for a 24,000 square foot facility in St. Louis, Missouri, for the sole purpose of assembling and distributing the AutovaxID instrument. The lease, which has a base term of approximately 3 years, calls for base rent payments of approximately $0.1 million annually, and provides a $12,000 allowance for tenant improvements.

14. New Market Tax Credit Transactions:

On December 8, 2006, the Company through its wholly owned subsidiary, AutovaxID, Inc. (“AutovaxID”) closed a financing transaction (the “Transaction”) that was structured in an effort to obtain certain perceived advantages and enhancements from the New Markets Tax Credit regulations adopted under the auspices of the United States Department of the Treasury in 2002 to provide incentive for investing in businesses located in “qualifying census tracts,” or areas with a median income below the poverty line. AutovaxID is presently located in a qualifying census tract, and the New Plant (as defined below) will be located in a qualifying census tract.

In the Transaction, AutovaxID entered into a QLICI Loan Agreement where St. Louis New Markets Tax Credit Fund-II, LLC (the “CDE”) made a loan to AutovaxID, evidenced by a Subordinated Promissory Note dated as of December 8, 2006, in the principal amount of $7,700,000 (“CDE Loan”). The CDE Loan has a maturity date of December 8, 2036 and is described in more detail below. The following parties were involved in the Transaction: AutovaxID, Accentia Biopharmaceuticals, Inc., Biovest’s majority shareholder (“Accentia”), Biolender II, LLC (“Biolender II”), the CDE, St. Louis Development Corporation (“SLDC”), AutovaxID Investment LLC (“Leverage Fund”), U.S. Bancorp Community Investment Corporation (“USBCIC”) and Laurus Master Fund, Ltd. (“Laurus”).

Under a License and Asset Purchase Agreement dated as of December 8, 2006, Biovest granted a nonexclusive license to the intellectual property enabling AutovaxID to manufacture and sell automated cell culture instruments in the United States, Canada and Mexico (the “License”), which license will become exclusive upon the occupancy by AutovaxID of a space located at 1031 Macklind Avenue, St. Louis, Missouri (the “New Plant”). Biovest also agreed to sell AutovaxID certain equipment (the “Equipment”) upon the occupancy by AutovaxID of the New Plant. AutovaxID was asked to use its best efforts to occupy the New Plant by March 31, 2007, and must occupy the new plant by June 15, 2007. Although the Company did not complete renovations by March 31, 2007, the construction is on track to make the required deadline. As full purchase price for the License and related business opportunity, AutovaxID paid Biovest $5.6 million. Upon the attainment of occupancy of the New Plant, AutovaxID will pay Biovest fair market value for the Equipment, which is estimated to be $0.9 million.

Previously, on March 31, 2006 in contemplation of the Transaction and other prior New Markets Tax Credit financings and other financings, Biovest closed a financing transaction with Laurus pursuant to which Laurus purchased from Biovest a secured promissory note in the principal amount of $7,799,000 (the “Laurus Note”). Under the terms of the Laurus Note, $7.5 million of the principal amount was deposited into a restricted bank account of Biovest (the “Restricted Account”) pursuant to a restricted account agreement between Biovest and Laurus. Accentia, Analytica International, Inc. (formerly The Analytica Group, Inc.) and Laurus also entered into an Amended and Restated Stock Pledge Agreement pledging Accentia’s shares of TEAMM Pharmaceuticals, Inc., Analytica International, Inc., Biovest and others (including AutovaxID and Biolender II, who were added as obligors by way of joinder) to secure the obligations owed to Laurus as a result of the Laurus Note and Transaction.

On December 8, 2006, Accentia loaned to Biovest $3.1 million pursuant to a Secured Promissory Note (the “Accentia Note”). Under the terms of the Accentia Note, interest shall accrue at a rate equal to the prime rate, payable upon demand of Accentia. Biovest shall pay principal and interest as follows: (a) $1.1 million was paid to Accentia upon the closing of the Transaction and (b) the remaining $2.0 million of principal and all accrued and unpaid interest shall be paid by Biovest upon demand by Accentia. In contemplation of the Transaction, Biovest formed Biolender II, LLC as a Delaware limited liability company. On December 8, 2006, $2.5 million was released from the Restricted Account created under the Laurus Note, which together with the amount loaned to Biovest under the Accentia Note funded the purchase of a 100% equity interest in Biolender II for the benefit of Biovest. The entire equity interest in Biolender II owned by Biovest has been pledged to Laurus as collateral to secure the Laurus Note.

 

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BIOVEST INTERNATIONAL, INC., AND SUBSIDIARIES

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

SIX MONTHS ENDED MARCH 31, 2007 AND 2006

(UNAUDITED)

 

14. New Market Tax Credit Transactions ( continued ):

Upon the completion of the funding of Biolender II by Biovest and receipt of $2.4 million from USBCIC via an equity investment in the Leverage Fund, Biolender II and the Leverage Fund entered into a Loan and Security Agreement pursuant to which Biolender II made a loan to the Leverage Fund in the principal amount of $5.6 million (the “Leverage Loan”), evidenced by a promissory note dated as of December 8, 2006 payable from the Leverage Fund to Biolender II (the “Leverage Note”). The Leverage Note becomes due on December 10, 2013.

Interest on the Leverage Loan accrues on the outstanding principal amount of the Leverage Loan at the rate of 8.00% per annum, non-compounding, commencing on December 8, 2006 until May 9, 2014; and shall be payable in arrears on an annual basis commencing on the first business day after December 31, 2006. Any remaining accrued and unpaid interest shall be payable in one installment on the maturity date. All interest on the Leverage Loan shall accrue based on the actual number of days elapsed and calculated based on a year of three hundred and sixty (360) days. The outstanding principal amount on the Leverage Loan is due on maturity in cash.

The Leverage Fund then contributed $8.0 million equity to the CDE (the “QEI Contribution”), which equity is expected to constitute a “qualified equity investment” (“QEI”) under the New Markets Tax Credit Program authorized by Section 45D of the Internal Revenue Code of 1986, as amended, and the rules and regulations promulgated thereunder (collectively, the “Code” and the program the “NMTC Program”) and administered by the Community Development Financial Institutions Fund of the United States Treasury Department (“CDFI Fund”). All of Leverage Fund’s interest in the CDE has been pledged to Biolender II as collateral for the Leverage Note. The QEI Contribution resulted in $3.12 million of tax credits allocated to USBIC.

The proceeds of the QEI Contribution were used by the CDE to fund the CDE Loan, which is expected to constitute a “qualified low-income community investment” (“QLICI”) under the NMTC Program. AutovaxID’s business is and will be conducted within a United States population census tract which constitutes a Low-Income Community under the NMTC Program. As a condition of making the equity contribution to the Leverage Fund, USBCIC required AutovaxID to indemnify it under a Tax Credit and Reimbursement and Indemnity Agreement against any loss of the tax credits as a result of the CDE Loan to constitute a QLICI and certain other conditions generally known as a recapture event.

The following describes certain material terms of the CDE Loan and transactional warrants related to the Transaction:

 

 

The CDE Loan has a principal amount of $7.7 million and matures on December 8, 2036. Pursuant to a call right, for a period of six months starting on December 8, 2013, the CDE will have the right to call for the repayment of the CDE Loan in the amount of $5.7 million, in full satisfaction of the principal on the CDE Loan. Interest on the outstanding principal amount of the CDE Loan shall accrue at the rate of 5.82% per annum, non-compounding and shall be payable in arrears on an annual basis commencing on January 2, 2007 and continuing until maturity. The CDE Loan is guaranteed by Biovest.

 

 

The CDE Loan is secured by a second lien on all assets of AutovaxID for the benefit of the CDE pursuant to a Second-Lien Security Agreement between AutovaxID and the CDE dated as of December8, 2006. Laurus has a senior lien on the assets of AutovaxID through the security agreement from Biovest to Laurus, which AutovaxID joined by way of a Joinder Agreement.

 

 

The CDE Loan shall be due and payable by AutovaxID in full on the maturity date of the CDE Loan. However, if the CDE exercises its call right pursuant to the CDE Loan, then the CDE Loan becomes due and payable 30 days after the date on which the CDE delivers notice of said exercise. The call requires and amount of $5.7 million to be paid, in full satisfaction of the principal on the CDE Loan, together with all accrued but unpaid interest.

 

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BIOVEST INTERNATIONAL, INC., AND SUBSIDIARIES

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

SIX MONTHS ENDED MARCH 31, 2007 AND 2006

(UNAUDITED)

 

14. New Market Tax Credit Transactions ( continued ):

 

 

AutovaxID has the right to prepay the CDE Loan at any time, provided that, if it prepays the CDE Loan on or before May 8, 2014, (i) it prepays the entire CDE Loan amount, (ii) the CDE consents to such prepayment and USBCIC and the managing member of the CDE agree on the reinvestment of such proceeds in an alternative investment that would qualify as a QLICI and (iii) AutovaxID or the Individual Guarantors (as defined below) under the Tax Credit and Reimbursement and Indemnity Agreement pay to USBCIC the recapture amount so specified in such agreement.

 

 

All indebtedness owed by AutovaxID and its subsidiaries to the CDE, including its right to receive payments of principal and interest under the CDE Loan, is expressly subordinate to the extent set forth under the Telesis Subordination Agreement dated as of December 8, 2006 entered into by Laurus, the CDE, USBCIC, AutovaxID and Biovest.

 

 

Under a Put Option Agreement, starting on December 9, 2013, USBCIC will have the right to require Biolender II to purchase the equity interest of the Leverage Fund during a three month exercise period. Biolender II shall have the obligation to acquire the member’s interest in the Leverage Fund under this Put Option Agreement for the payment to USBCIC for $0.1 million. Furthermore, under a Purchase Option Agreement, for a three month period after the expiration of the put option and to the extent that the put option was not exercised, Biolender II will have to option to purchase USBCIC’s equity interests in the Leverage Fund based on the fair market value of the equity interests at that time.

15. Variable Interest Entities:

Accounting for the NMTC financing arrangement:

The Company evaluated the structure of the NMTC financing arrangement and entities so involved under the context of FIN46. FIN46 provides a framework for determining whether certain entities should be consolidated (irrespective of equity ownership) based upon a variable interests model. This model determines the control and consolidation based upon potential variability in gains and losses of the entity being evaluated for consolidation. Generally, a variable interest holder that absorbs a majority of the entity’s expected losses, if they occur, receives a majority of the entity’s expected residual return, if they occur, or both is identified as the primary beneficiary for consolidation purposes.

The Company concluded that the Fund and the CDE met the definition of variable interest entity. However, for the Company to be required to apply the provisions of the Interpretation, it must have a variable interest in the entity. Variable interests in a variable interest entity are contractual, ownership or other money interests in an entity that change with changes in the value of the net assets of the entity. The following table illustrates the variable interests have been identified in each of the entities considered by the Company and the related holder:

 

Variable Interest Holder

 

Variable Interests Fund

 

Variable Interests CDE

Biovest and its Related Parties  

Senior beneficial interest

Guaranty Agreement

Indemnification Agreement

Put (VIE Equity)

Call (VIE Equity)

 

Senior beneficial interest

Guarantee Agreement

Fund     VIE Equity (99.9%)
US Bancorp   VIE Equity (99.9%)   Tax Credit Rights
Autovax Investment LLC   VIE Equity (0.01%)  
St. Louis Development Corporation     VIE Equity (0.01%)

The above table illustrates the weight of the variable interests that are held by the Company. In addition, in performing quantitative valuation, the Company afforded significant weight to the guarantee agreement, indemnification and put feature, the preponderance of which limit the equity investor’s risk of loss on the venture. In evaluating both qualitative and quantitative considerations, the Company has concluded that its variable interests in the entity absorb most of the entities’ losses and should, therefore, consolidate the entities under the scope of FIN46.

 

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BIOVEST INTERNATIONAL, INC., AND SUBSIDIARIES

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

SIX MONTHS ENDED MARCH 31, 2007 AND 2006

(UNAUDITED)

 

15. Variable Interest Entities (continued):

Assets of $8.0 million and liabilities of $7.7 million of the variable interest entities identified above, are limited to the instruments referred to in the description of the NMTC financing arrangement above. In accordance with consolidation principles, these assets and liabilities are eliminated in consolidation leaving the non-controlling interests of US Bancorp and St. Louis Development Corporation reflected on the Company’s March 31, 2007 condensed consolidated balance sheet as non controlling interests in variable interest entities. The warrants issued to the guarantors were expensed based upon their fair values. All intercompany accounts will continue to be eliminated so long as (i) the entities meet the definition of variable interest entities and (ii) the Company is the primary beneficiary.

 

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

Overview

Our major focus is the development of our personalized therapeutic cancer vaccine for the treatment of low-grade Follicular Lymphoma (FL), which we have named BiovaxID. However, we anticipate placing an increasing emphasis on our planned commercial manufacture and marketing of our automated instrument, AutovaxID. FL is a deadly cancer of the white blood cells. This therapeutic vaccine is currently in a pivotal Phase 3 clinical trial. In September 2001, we entered into a Cooperative Research and Development Agreement (CRADA) with the NCI regarding the development of this therapeutic vaccine. In April 2004, the Investigational New Drug application (“IND”) for BiovaxID was transferred to us from the NCI. In May 2006, the FDA notified us that the FDA has granted “fast track” status to BiovaxID and further notified us of the approval of our request to utilize molecular remissions data as a new secondary endpoint in our ongoing clinical trial of BiovaxID. The Company terminated the CRADA with NCI on September 25, 2006. Included in this transaction was the termination of the NCI’s responsibility of the trial safety and monitoring oversight by the NCI Data Safety and Monitoring Board (DSMB). A new independent Data Monitoring Committee (DMC) has been established for the BiovaxID clinical trials. The current independent DMC is composed of two physicians with oncology training and experience, and one biostatistician trained and experienced in clinical trials data analysis.

The DMC met on January 16, 2007 to review the study’s data for safety and efficacy. The study report reviewed during this meeting was the same data set reviewed previously by the NCI DSMB in the spring of 2006. It was the unanimous opinion of the committee that the current BiovaxID clinical trial study, with PACE as the chemotherapy in Segment A, should continue and enrollment into this study should proceed as quickly as possible. The Company plans to continue the trial as recommended and has expanded the number of sites participating in the BiovaxID clinical trial in order to accelerate patient accrual.

The DMC will continue to meet on a regular basis to monitor the data to ensure the safety of the subjects participating in this clinical trial. Their next regularly scheduled meeting is planned for June 2007, at which point they will be provided with an updated data set for review. The Company has recently augmented its plans with respect to its Phase 3 clinical trials and planned commercialization expenditures. See footnote 3 “Liquidity and management plans” for additional discussion of the ongoing clinical trial.

We also manufacture instruments and disposables used in the hollow fiber production of cell culture products. Our hollow fiber cell culture products and instruments are used by biopharmaceutical and biotech companies, medical schools, universities, research facilities, hospitals and public and private laboratories. We have developed an automated cell production instrument, AutovaxID, which we plan to use in the production of BiovaxID vaccines if approved and to market it on a commercial basis.

We also produce mammalian and insect cells, monoclonal antibodies, recombinant and secreted proteins and other cell culture products using our unique capability, expertise and proprietary advancements in the cell production process known as hollow fiber perfusion. Prior to September 2005, we were designated as the National Cell Culture Center “NCCC” under a grant from the National Institutes of Health and from September 2005 through June 30, 2006, we continued to provide the same services under an interim grant. We are discontinuing activities as the designated NCCC and we plan to integrate these activities into our commercial contract manufacturing business.

Critical Accounting Policies and Estimates

Our financial statements have been prepared in accordance with accounting principles generally accepted in the United States. The preparation of these financial statements requires the Company to make significant estimates and judgments that affect the reported amounts of assets, liabilities, revenues, expenses and related disclosure of contingent assets and liabilities. The Company evaluates its estimates, including those related to bad debts, inventories, intangible assets, contingencies and litigation on an ongoing basis. The Company bases its estimates on historical experience and on various other assumptions that are believed to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources. Actual results may differ from these estimates under different assumptions or conditions.

 

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We believe the following critical accounting policies, among others, involve the more significant judgments and estimates used in the preparation of our financial statements:

Revenues from contract cell production services are recognized using the percentage-of-completion method, measured by the percentage of contract costs incurred to date to estimated total contract costs for each contract. Because of the inherent uncertainties in estimating costs, it is at least reasonably possible that the estimates used will change in the near term.

Contract costs related to cell culture production include all direct material, subcontract and labor costs and those indirect costs related to contract performance, such as indirect labor, insurance, supplies and tools. We believe that actual costs incurred in contract cell production services is the best indicator of the performance of the contractual obligations, because the costs relate primarily to the amount of labor incurred to perform such services. The deliverables inherent in each of our cell culture production contracts are not output driven, but rather driven by a pre-determined production run. The duration of our cell culture production contracts range typically from 2 to 14 months.

We maintain allowances for doubtful accounts for estimated losses resulting from the inability of our customers to make required payments. If the condition of our customers were to deteriorate, resulting in an impairment of their ability to make payments, additional allowances may be required.

Inventories are recorded at the lower of cost or market. Write-downs of inventories to market value are based upon contractual provisions and obsolescence, as well as assumptions about future demand and market conditions. If assumptions about future demand change and/or actual market conditions are less favorable than those projected by management, additional write-downs of inventories may be required.

In assessing the recoverability of our amounts recorded as intangible assets, significant assumptions regarding the estimated future cash flows and other factors to determine the fair value of the respective assets must be made, as well as the related estimated useful lives. If these estimates or their related assumptions change in the future as a result of changes in strategy and/or market conditions, we may be required to record impairment charges.

The Company accounts for stock-based compensation based on the Financial Accounting Standards Board (FASB) Statement of Financial Accounting Standards (SFAS) No. 123 (Revised 2004), “Share-Based Payment” (SFAS 123R) which requires expensing of stock options and other share-based payments based on the fair value of each option awarded. The fair value of each option is estimated on the date of grant using the Black-Scholes valuation model. This model requires management to estimate the expected volatility, expected dividends, and expected term as inputs to the valuation model.

The consolidated financial statements represent the consolidation of wholly-owned companies and interests in joint ventures where the Company has a controlling financial interest or has been determined to be the primary beneficiary under Financial Accounting Standards Board (FASB) Interpretation No. 46, Consolidation of Variable Interest Entities (“FIN 46”). All significant inter-company balances and transactions have been eliminated.

Results of Operations

Revenues. Total revenues for the three and six months ended March 31, 2007 were $1.6 million and $2.9 million respectively, which represents a decrease of $0.7 million or 48% over the three months ended March 31, 2006, and a decrease of $0.5 million or 17% over the six months ended March 31, 2006. Both the three and six months ended March 31, 2006 included the sale of three Xcellerator units, the largest model in our line of cell culture instrumentation. There were no comparable sales of this instrument in the same periods ending March 31, 2007. Sales of our other instrumentation were similar year over year.

Gross Margin. The overall gross margin as a percentage of sales for the three months ended March 31, 2007 decreased slightly from 46% to 45% compared to the same period in fiscal 2006. The gross margin for the six months ended March 31, 2007 also decreased from 46% to 44%. The differences in Xcellerator sales discussed above resulted in the minor decline in margin.

Operating Expenses. Research and development expenses increased by $0.6 million or 22% for the three months ended March 31, 2007 and increased $0.7 million or 14% for the six months ended March 31, 2007 compared to the same periods in 2006. This increase relates to the company’s expansion of the number of sites participating in the BiovaxID clinical trial.

 

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General and administrative expenses increased $0.8 million and $1.4 million for the three and six months ended March 31, 2007 compared with the three and six months ended March 31, 2006. This increase is attributed primarily to the accrual of a discretionary bonus for full time employees, an overall increase in staffing levels, and an increase in professional fees rendered in connection with the New Markets Tax Credit Transaction discussed in footnote 14 to the Financial Statements above.

As discussed in Note 8 to the financial statements, $3.8 million was charged as an operating expense related to Laurus’ consent to the Company purchase of Accentia’s interest in Biolender, and $6.6 million was charged as an operating expense in connection with the restructuring of the Company’s royalty agreement with Accentia.

Other Income (Expense). As discussed in Note 8 to the financial statements, other expense for the first three months of fiscal 2007 includes a $6.6 million loss incurred upon termination of the anti-dilution agreement with Accentia and a $1.2 million charge related to obtaining a consent from one of Accentia’s lenders to permit additional advances to the Company by Accentia. Other expense for the three and six months ended March 31, 2007 and 2006 also includes contractual interest charges and amortization of discounts regarding the Laurus Financing, interest on our demand notes to Accentia, interest on other long-term debt, and short-term loans from affiliates. Total interest expense for the three months ended March 31, 2007 and 2006 was $1.6 million and $0.2 million respectively. Total interest expense for the six months ended March 31, 2007 and 2006 was $3.6 million and $0.3 million respectively. In addition, other expense for the first six months of fiscal 2007 includes a $59,000 loss on derivative liabilities. As the derivative did not exist during the first six months of fiscal 2006, there is no comparable loss.

Liquidity and Capital Resources

The Company has historically had significant losses from operations and these losses continued during the three months ended March 31, 2007 resulting in a net operating cash flow deficit of $7.3 million. At March 31, 2007 the Company had an accumulated deficit of approximately $81.7 million and working capital deficit of approximately $15.9 million. . At March 31, 2007, the Company had $2.0 in cash of which the Company had allocated $1.4 to the establishment and start-up of its new facility dedicated to the manufacture of AutovaxID instruments. The Company has been meeting its cash requirements through proceeds from its cell culture and instrument manufacturing activities, the use of cash on hand, trade vendor credit and short-term borrowings (primarily from affiliates), as well as the sale of stock to and inter-company demand notes from Accentia. Since 2003, Accentia has been a primary source of financing for the Company; however, the Company has been informed by Accentia that provisions of certain of its loan and debenture financing agreements preclude Accentia from making any additional direct cash contributions to the Company. Accordingly, the Company’s ability to continue present operations and to continue its ongoing clinical trial is dependent upon the Company’s ability to obtain significant external funding in the near term from sources other than Accentia. The Company’s auditors issued a “going concern” uncertainty on the financial statements for the year ended September 30, 2006, citing significant losses and working capital deficits at that date, which raised substantial doubt about the Company’s ability to continue as a going concern. The need for funds is expected to grow as we continue our trials.

During the three and six months ended March 31, 2007, we received net advances of $0.4 million and $4.0 million respectively, from Accentia. The Company’s total net advances in excess of the $20 million investment agreement aggregated $9.2 million as of March 31, 2007, consisting of cash loans, payments by Accentia directly to third parties and allocated inter-company expenses, accrued interest, and amounts owed in connection with the conversion of notes outstanding at the time of Accentia’s initial investment in June 2003. The $9.2 million is evidenced by three secured promissory demand notes.

New Market Tax Credits

On December 8, 2006, we, through our wholly owned subsidiary, AutovaxID, Inc. (“AutovaxID”) closed a financing transaction (the “Transaction”) that was structured in an effort to obtain certain perceived advantages and enhancements from the New Markets Tax Credit regulations adopted under the auspices of the United States Department of the Treasury in 2002 to provide incentive for investing in businesses located in “qualifying census tracts,” or areas with a median income below the poverty line. AutovaxID is presently located in a qualifying census tract, and our facility as discussed below is located in a qualifying census tract.

In the Transaction, AutovaxID entered into a QLICI Loan Agreement where St. Louis New Markets Tax Credit Fund-II, LLC (the “CDE”) made a loan to AutovaxID, evidenced by a Subordinated Promissory Note dated as of December 8, 2006, in the principal amount of $7.7 million (“CDE Loan”). The CDE Loan has a maturity date of December 8, 2036 and is described in more detail below. The following parties were involved in the Transaction: AutovaxID, Accentia Biopharmaceuticals, Inc., Biovest’s majority

 

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shareholder (“Accentia”), Biolender II, LLC (“Biolender II”), the CDE, St. Louis Development Corporation (“SLDC”), AutovaxID Investment LLC (“Leverage Fund”), U.S. Bancorp Community Investment Corporation (“USBCIC”) and Laurus Master Fund, Ltd. (“Laurus”).

Under a License and Asset Purchase Agreement dated as of December 8, 2006, Biovest granted a nonexclusive license to the intellectual property enabling AutovaxID to manufacture and sell automated cell culture instruments in the United States, Canada and Mexico (the “License”), which license will become exclusive upon the occupancy by AutovaxID of a new facility located at 1031 Macklind Avenue, St. Louis, Missouri (the “New Plant”). Biovest also agreed to sell AutovaxID certain equipment (the “Equipment”) to AutovaxID upon the occupancy by AutovaxID of the New Plant. AutovaxID must occupy the new plant by June 15, 2007. As full purchase price for the License and related business opportunity, AutovaxID paid Biovest $5.6 million. Upon the attainment of occupancy of the New Plant, AutovaxID will pay Biovest fair market value for the Equipment, which is estimated to be $0.9 million.

Previously, on March 31, 2006 in contemplation of the Transaction and other prior New Markets Tax Credit financings and other financings, Biovest closed a financing transaction with Laurus pursuant to which Laurus purchased from Biovest a secured promissory note in the principal amount of $7.8 million (the “Laurus Note”). Under the terms of the Laurus Note, $7.5 million of the principal amount was deposited into a restricted bank account of Biovest (the “Restricted Account”) pursuant to a restricted account agreement between Biovest and Laurus. Accentia, Analytica International, Inc. (formerly The Analytica Group, Inc.) and Laurus also entered into an Amended and Restated Stock Pledge Agreement pledging Accentia’s shares of TEAMM Pharmaceuticals, Inc., Analytica International, Inc., Biovest and others (including AutovaxID and Biolender II, who were added as obligors by way of joinder) to secure the obligations owed to Laurus as a result of the Laurus Note and Transaction.

On December 8, 2006, Accentia loaned to Biovest $3.1 million pursuant to a Secured Promissory Note (the “Accentia Note”). Under the terms of the Accentia Note, interest accrues at a rate equal to the prime rate, payable upon demand of Accentia. Biovest shall pay principal and interest as follows: (a) $1.1 million was paid to Accentia upon the closing of the Transaction and (b) the remaining $2.0 million of principal and all accrued and unpaid interest shall be paid by Biovest upon demand by Accentia.

In contemplation of the Transaction, Biovest formed Biolender II, LLC as a Delaware limited liability company. On December 8, 2006, $2.5 million was released from the Restricted Account created under the Laurus Note, which together with the amount loaned to Biovest under the Accentia Note funded the purchase of a 100% equity interest in Biolender II for the benefit of Biovest. The entire equity interest in Biolender II owned by Biovest has been pledged to Laurus as collateral to secure the Laurus Note.

Upon the completion of the funding of Biolender II by Biovest and receipt of $2.4 million from USBCIC via an equity investment in the Leverage Fund, Biolender II and the Leverage Fund entered into a Loan and Security Agreement pursuant to which Biolender II made a loan to the Leverage Fund in the principal amount of $5.6 million (the “Leverage Loan”), evidenced by a promissory note dated as of December 8, 2006 payable from the Leverage Fund to Biolender II (the “Leverage Note”). The Leverage Note becomes due on December 10, 2013.

Interest on the Leverage Loan accrues on the outstanding principal amount of the Leverage Loan at the rate of 8.00% per annum, non-compounding, commencing on December 8, 2006 until May 9, 2014; and is payable in arrears on an annual basis commencing on the first business day after December 31, 2006. Any remaining accrued and unpaid interest is payable in one installment on the maturity date. All interest on the Leverage Loan shall accrue based on the actual number of days elapsed and calculated based on a year of three hundred and sixty (360) days. The outstanding principal amount on the Leverage Loan is due on maturity in cash.

The Leverage Fund then contributed $8.0 million equity to the CDE (the “QEI Contribution”), which equity is expected to constitute a “qualified equity investment” (“QEI”) under the New Markets Tax Credit Program authorized by Section 45D of the Internal Revenue Code of 1986, as amended, and the rules and regulations promulgated thereunder (collectively, the “Code” and the program the “NMTC Program”) and administered by the Community Development Financial Institutions Fund of the United States Treasury Department (“CDFI Fund”). All of Leverage Fund’s interest in the CDE has been pledged to Biolender II as collateral for the Leverage Note. The QEI Contribution resulted in an allocation of $3.1 million tax credits to USBCIC

The proceeds of the QEI Contribution were used by the CDE to fund the CDE Loan, which is expected to constitute a “qualified low-income community investment” (“QLICI”) under the NMTC Program. AutovaxID’s business is and will be conducted within a United States population census tract which constitutes a Low-Income Community under the NMTC Program. As a condition of

 

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making the equity contribution to the Leverage Fund, USBCIC required AutovaxID to indemnify it under a Tax Credit and Reimbursement and Indemnity Agreement against any loss of the tax credits as a result of the CDE Loan to constitute a QLICI and certain other conditions generally known as a recapture event.

The following describes certain material terms of the CDE Loan and transactional warrants related to the Transaction:

 

   

The CDE Loan has a principal amount of $7.7 million and matures on December 8, 2036. Pursuant to a call right, for a period of six months starting on December 8, 2013, the CDE will have the right to call for the repayment of the CDE Loan in the amount of $5.7 million, in full satisfaction of the principal on the CDE Loan. Interest on the outstanding principal amount of the CDE Loan shall accrue at the rate of 5.82% per annum, non-compounding and shall be payable in arrears on an annual basis commencing on January 2, 2007 and continuing until maturity. The CDE Loan is guaranteed by Biovest.

 

   

The CDE Loan is secured by second lien on all assets of AutovaxID for the benefit of the CDE pursuant to a Second-Lien Security Agreement between AutovaxID and the CDE dated as of December 8, 2006. Laurus has a senior lien on the assets of AutovaxID through the security agreement from Biovest to Laurus, which AutovaxID joined by way of a Joinder Agreement.

 

   

The CDE Loan shall be due and payable by AutovaxID in full on the maturity date of the CDE Loan. However, if the CDE exercises its call right pursuant to the CDE Loan, then the CDE Loan becomes due and payable on the date of such call for the amount of $5.7 million, in full satisfaction of the principal on the CDE Loan, together with all accrued but unpaid interest.

 

   

AutovaxID has the right to prepay the CDE Loan at any time, provided that, if it prepays the CDE Loan on or before May 8, 2014, (i) it prepays the entire CDE Loan amount, (ii) CDE consents to such prepayment and USBCIC and the managing member of the CDE agree on the reinvestment of such proceeds in an alternative investment that would qualify as a QLICI and (iii) AutovaxID or the Individual Guarantors (as defined below) under the Tax Credit and Reimbursement and Indemnity Agreement pay to USBCIC the recapture amount so specified is such agreement.

 

   

All indebtedness owed by AutovaxID and its subsidiaries to the CDE, including its right to receive payments of principal and interest under the CDE Loan, is expressly subordinate to the extent set forth under the Telesis Subordination Agreement dated as of December 8, 2006 entered into by Laurus, the CDE, USBCIC, AutovaxID and Biovest.

 

   

Under a Put Option Agreement, starting on December 9, 2013, USBCIC will have the right to require Biolender II to purchase the equity interests of the Leverage Fund during a three month exercise period. Biolender II shall have the obligation to acquire the member’s interest in the Leverage Fund under this Put Option Agreement for the payment to USBCIC of $0.1 million. Furthermore, under a Purchase Option Agreement, for a three month period after the expiration of the put option and to the extent that the put option was not exercised, Biolender II will have the option to purchase USBCIC’s equity interests in the Leverage Fund based on the fair market value of the equity interests at that time.

Notes Payable

On January 16, 2007, the Company closed an amended and restated loan transaction (“Note 1”) with Pulaski Bank and Trust Company of St. Louis, MO (“Pulaski”), which amended the Loan Agreement dated September 5, 2006 pursuant to which Pulaski agreed to loan $1 million to the Company pursuant to an unsecured Promissory Note. The Company also closed on a second loan transaction with Pulaski Bank on March 22, 2007 (“Note 2”), pursuant to which Pulaski agreed to loan an additional $0.75 million to the Company pursuant to an unsecured Promissory Note. The balance of both notes included in the accompanying 2007 consolidated financial statements includes the principal of $1.75 million plus accrued interest of approximately $7,000.

Note 1 matures on July 5, 2007, and can be prepaid by the Company at any time without penalty. The note bears interest at the prime rate minus .05% (7.75% per annum at March 31, 2007), requiring monthly payments of interest only commencing February 2007. The note is an unsecured obligation of the Company and is subordinated to the Company’s outstanding loan to Laurus Master Fund, Ltd. The notes are guaranteed by entities and individuals affiliated with the Company or Accentia, the majority stockholder of the Company. The Company has entered into Indemnification Agreements with each of the guarantors.

In conjunction with the issuance of these notes payable the Company issued to the guarantors warrants to purchase an aggregate total of 1,388,636 shares of the Company’s Common Stock, par value $0.01 per share, at an exercise price of $1.10 per share (the “Warrants”). The Warrants will expire on January 15, 2012. Under the terms of the Warrants, the guarantors shall have piggy-back registration rights for the shares underlying the Warrants.

 

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Note 2 matures on May 21, 2007. The note bears interest at the prime rate minus .05% (7.75% per annum as of March 31, 2007), with interest only payment due monthly. The note is an unsecured obligation of the Company and is subordinated to the Company’s outstanding loan to Laurus Master Fund, Ltd. The note is guaranteed by entities and individuals affiliated with the Company or Accentia, the majority stockholder of the Company. The Company has entered into Indemnification Agreements with each of the guarantors. The Company issued to the guarantors warrants to purchase an aggregate total of 406,817 shares of the Company’s Common Stock, par value $0.01 per share, at an exercise price of $1.10 per share. These warrants will expire on March 21, 2012. Under the terms of the warrants, the guarantors shall have piggy-back registration rights for the shares underlying the warrants.

The Company agreed to indemnify and hold harmless each guarantor should their guarantees be called by the Lender by agreeing to compensate each affected guarantor by an issuance of restricted common stock equal to 700% of the amount of their guarantee.

As previously disclosed in the section describing New Market Tax Credits above, the Company has a secured promissory note in the principal amount of $7,799,000 (the “Note”) to the Laurus Master Fund, Ltd. (“Laurus”). Pursuant to the original terms of the Note, the Company was required to make certain principal and interest payments commencing in calendar 2007. We did not commence making such payments when originally due and reached an understanding that such payments would not commence while the Company sought additional financing. This understanding was formalized into a letter agreement dated March 21, 2007 (the “Letter Agreement”). the Company closed a short-term borrowing of $750,000 from Pulaski Bank and this Letter Agreement became effective on April 17, 2007. In addition to formalizing and continuing Laurus’ forbearance, the Letter Agreement rescheduled future payments due from the Company to Laurus under the Note. Under the Letter Agreement past due and ongoing principal payments on the Note are deferred until August 1, 2007, when adjusted monthly principal payments of $0.3 million per month will commence. As consideration for the forbearance the Company granted to Laurus a non-cancelable royalty equal to three percent 3% of world-wide net sales of AutovaxID instruments for a period of five years commencing on the earlier of May 31, 2007 or the completion of a long term financing by the Company. Under the terms of the royalty agreement our royalty payments to Laurus are required to aggregate a minimum of $8.0 million with $0.5 million of the minimum royalty being payable on December 31, 2007 and the balance (if any), less actual royalties paid, being due at the end of the five year royalty term. In addition, upon satisfaction of certain conditions of the Letter Agreement, Laurus consented to the Company seeking and, if available, entering into bridge loans in an aggregate amount of up to $7.0 million.

Operating Capital and Capital Expenditure Requirements:

Our ability to continue our present operations and meet our obligations for vaccine development and commercialize our automated cell culture instrument is dependent upon our ability to continue obtaining significant external funding. Our independent registered accountants have expressed substantial doubt as to our ability to continue as a going concern for the year ended September 30, 2006, citing significant losses and working capital deficits. See Note 3 in the notes to the financial statements. As previously discussed Accentia has advanced all payments required under its investment agreement obligation of $20 million. Additionally, Accentia has loaned the Company a net $9.2 million through March 31, 2007, including the inter-company demand loans discussed above. Accentia has informed us that terms of certain existing financing agreements prohibit any further loans or investments by Accentia in the Company. Additional sources of funding have not been established; however, additional financing is currently being sought by the Company from a number of sources other than Accentia, including the sale of equity or debt securities, strategic collaborations, recognized research funding programs, as well as domestic and/or foreign licensing of our vaccine. Management is currently in the process of exploring various financing alternatives, and has hired an investment banking firm to assist in these efforts. There can be no assurance that we will be successful in securing such financing at acceptable terms, if at all. If adequate funds are not available from the foregoing sources, or if the Company determines it to otherwise be in the Company’s best interest, the Company may consider additional strategic financing options, including sales of assets or business units that are non-essential to the ongoing development or future commercialization of BiovaxID and AutovaxID, or the Company may be required to delay, reduce the scope of, or eliminate one or more of its research or development programs or postpone or reduce some or all of its commercialization efforts.

Fluctuations in Operating Results

The Company’s operating results may vary significantly from quarter to quarter or year to year, depending on factors such as timing of biopharmaceutical development and commercialization of products by the Company’s customers, the timing of increased research and development and sales and marketing expenditures, the timing and size of orders and the introduction of new products or processes by the Company. Consequently, revenues, profits or losses may vary significantly from quarter to quarter or year to year, and revenue or profits in any period will not necessarily be indicative of results in subsequent periods.

Potential Dilutive Effect of Outstanding Stock Options, Warrants and Convertible Debt

We have outstanding options, warrants and convertible debt (“Stock Rights”) pursuant to which we may be required to issue additional shares of our Common Stock. These dilutive securities are described in footnotes to our Consolidated Financial Statements for the fiscal year ended September 30, 2006, which were filed as part of our 10-KSB. Additionally, as part of our Investment Agreement with Accentia, we granted Accentia the right to maintain its then 81% ownership of our Common Stock in the event of the exercise of certain Stock Rights (the “Accentia First Right of Refusal Agreement”). The Accentia First Right of Refusal entitles Accentia to purchase that number of shares of our Common Stock necessary to maintain its then 81% ownership after the exercise of certain Stock Rights at an aggregate purchase price equal to the total amount paid in the exercise of such Stock Rights. Pursuant to the New Market Tax Credit Financing, Accentia sold back 10 million shares of our common stock, and further declined to exercise of its First Right of Refusal regarding all shares of stock issued from October 1, 2005 through September 30, 2006. On October 31, 2006, Accentia agreed to terminate its anti-dilution (First Right of Refusal) agreement with Biovest in exchange for 5.0 million shares of common stock.

 

Shares Issued and Outstanding at March 31, 2007

   94,473,067

Options

   9,029,902

Warrants

   21,374,715

Convertible Notes

   47,817
    

Total

   124,925,501
    

 

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ITEM 3. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK

We expect to continue to incur substantial operating losses in the future. We will not receive any product revenue until BiovaxID™ has been approved by the FDA or similar regulatory agencies in other countries and successfully commercialized. We currently anticipate that our cash, cash equivalents and marketable securities, together with cash flow generated from our collaborations, fund raising and potential commercial partnering opportunities currently in process will be sufficient to fund our operations at least through the next twelve months. However, we will need to raise substantial additional funds to continue our operations and bring future products to market. We cannot be certain that our efforts will be successful or that we will be able to raise sufficient funds to complete the development and commercialization of BiovaxID™, should it be approved. Additionally, we plan to continue to evaluate licensing opportunities that would fit with our strategy. Any such transaction would likely increase our funding needs in the future.

Our future funding requirements will depend on many factors, including but not limited to:

 

   

the size and complexity of our research and development programs;

 

   

the scope and results of our clinical trials;

 

   

continued scientific progress in our research and development programs;

 

   

the time and expense involved in seeking regulatory approvals;

 

   

competing technological and market developments;

 

   

acquisition, licensing and protection of intellectual property rights; and

 

   

the cost of establishing manufacturing capabilities and conducting commercialization activities.

Until we can generate a sufficient amount of product revenue to finance our cash requirements, which we may never do, we expect to finance future cash needs primarily through public or private equity offerings, debt financings or strategic collaborations and partnering. If we are successful in raising additional funds through the issuance of equity securities, investors likely will experience dilution, or the equity securities may have rights, preferences or privileges senior to those of the holders of our common stock. If we raise funds through the issuance of debt securities, those securities would have rights, preferences and privileges senior to those of our common stock. We do not know whether additional funding will be available on acceptable terms, or at all. If we are not able to secure additional funding when needed, we may have to delay, reduce the scope of, or eliminate one or more of our clinical trials or research and development programs.

 

ITEM 4. CONTROLS AND PROCEDURES

An evaluation was performed under the supervision and with the participation of our management, including the Chief Executive Officer, or CEO, and Chief Financial Officer, or CFO, of the effectiveness of the design and operation of our disclosure controls and procedures as of March 31, 2007, and for the period covered by this report. Based on that evaluation, our management, including the CEO and CFO, concluded that our disclosure controls and procedures are effective as of March 31, 2007, and for the period covered by this report, to ensure that information required to be disclosed in the reports that Biovest files or submits under the Securities Exchange Act of 1934 is recorded, processed, summarized and reported within the time periods specified in the Securities and Exchange Commission’s rules and forms. There have been no significant changes in our internal control over financial reporting or in other factors in the first six months of fiscal 2007 that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.

 

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PART II. OTHER INFORMATION

 

ITEM 1. LEGAL PROCEEDINGS

From time to time we are subject to various legal proceedings in the normal course of business, some of which are covered by insurance. Management believes that these proceedings will not have a material adverse effect on our business or on the financial statements.

 

ITEM 1A. RISK FACTORS

An investment in our securities involves a high degree of risk. Except asset forth herein, there have been no material changes to the risk factors previously disclosed in the Annual Report on Form 10-KSB for the year ended September 30, 2006 filed on December 29, 2006. You should consider carefully all of the material risks described in such Annual Report of Form 10-KSB before making a decision to invest in our securities. If any of the events described therein occur, our business, financial conditions and results of operations may be materially adversely affected. In that event, the trading price of our securities could decline, and you could lose all or part of your investment.

We will need substantial additional financing but our access to capital funding is uncertain.

During prior years, we met our cash requirements through the use of cash on hand, the sale of common stock, and short-term loans from affiliates. In 2003, we entered into an Investment Agreement with Accentia. The aggregate investment commitment received from Accentia was $20 million, which consisted of cash and a combination of short and long-term notes. In August 2004, we entered into an Amendment to the Investment Agreement with Accentia (the “Amendment”). This Amendment provided that Accentia would use reasonable efforts (without altering the terms of Promissory Note executed as part of the Investment Agreement) to advance funds under a Line of Credit Promissory Note and General Security Agreement. Amounts advanced under the Line of Credit Promissory Note were credited against installments as they became due and payable under the outstanding Promissory Note. As of October 2005, Accentia had advanced all payments required under its investment agreement obligation of $20 million. Additionally, Accentia has loaned us or otherwise paid on our behalf an additional $9.2 million through March 31, 2007, as represented by three secured promissory demand loans. Additionally, we have borrowed funds from third parties and have arranged for financing for our subsidiaries Biovax and AutovaxID. Since much of this indebtedness is secured by all of our assets, including the assets of our subsidiaries, our creditors may be able to foreclose on our assets if we are unable to meet our obligations as they become due.

Our ability to continue present operations is dependent upon our ability to obtain significant external funding. We have received a report from our independent registered public accounting firm on our consolidated financial statements for the fiscal years ended September 30, 2006 and 2005 in which our auditors have included explanatory paragraphs indicating that our significant net losses and working capital deficiency cause substantial doubt about the Company’s ability to continue as a going concern. As of March 31, 2007, Biovest had cash of $2.0 million, of which $1.4 million was set aside by us for anticipated start-up expenses associated with our new AutovaxID facility. Under the terms of certain existing financing agreements, including a recent private placement of convertible notes in February 2007 by Accentia, Accentia is prohibited from providing any further funding to the Company. Accordingly, we will need to raise substantial additional capital from sources other than Accentia in the very near future in order to continue the clinical trials for BiovaxID and continue our operations. The Company is currently seeking additional financing from a number of sources, including the sale of equity or debt securities, strategic collaborations, recognized research funding programs, as well as domestic and/or foreign licensing of our AutovaxID instrument and our BiovaxID vaccine. The Company’s management is currently in the process of exploring various financing alternatives, and has hired investment consultants to assist in these efforts. If the Company raises funds through the issuance of equity securities, Accentia’s equity interest in the Company could be substantially diminished. We cannot be certain that additional funding will be available on acceptable terms or at all. If adequate funds are not available from the foregoing sources, or if we determine it to otherwise be in our best interests, we may consider additional strategic financing options, including sales of assets or business units, or we may be required to delay, reduce the scope of, or eliminate one or more of our research or development programs or curtail some of our commercialization efforts.

 

ITEM 2. UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS

Unregistered Sales of Equity Securities

None.

Options Exercised

In the six months ended March 31, 2007, 15,000 common stock options were exercised.

 

ITEM 3. DEFAULTS UPON SENIOR SECURITIES

None.

 

ITEM 4. SUBMISSION OF MATTERS TO A VOTE OF SECURITY HOLDERS

None.

 

ITEM 5. OTHER INFORMATION

None.

 

I TEM 6. EXHIBITS

The following exhibits are filed as part of, or incorporated by reference into, this quarterly report on Form 10-Q.

 

Exhibit

Number

  

Description

10.1    Agreement between American Defense International, Inc. and the Company dated February 8, 2007.
10.2    Promissory Note between Pulaski Bank and the Company dated April 22, 2007.
31.1    Certification of Chairman of the Board and Chief Executive Officer pursuant to Section 302 of Sarbanes – Oxley Act.
31.2    Certification of Chief Financial Officer pursuant to Section 302 of Sarbanes – Oxley Act.
32.1    Certification of Chairman of the Board and Chief Executive Officer pursuant to Section 906 of Sarbanes – Oxley Act.
32.2    Certification of Chief Financial Officer pursuant to Section 906 of Sarbanes – Oxley Act

 

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SIGNATURES

In accordance with the requirements of the Exchange Act, the registrant caused this report to be signed on its behalf by the undersigned, thereto duly authorized.

 

     BIOVEST INTERNATIONAL, INC.
     (Registrant)
Date: May 15, 2007     

/s/ Steven R. Arikian

     Steven R. Arikian, M.D.
     Chairman of the Board; Chief Executive Officer; Director
     (Principal Executive Officer)
Date: May 15, 2007     

/s/ James A. McNulty

     James A. McNulty, CPA
     Chief Financial Officer
     (Principal Financial Officer and Principal Accounting Officer)

 

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Exhibit 10.1

AGREEMENT

This Agreement is made and entered into as of this 8th day of February, 2007, by and between American Defense International, Inc., a government relations, consulting, and international business development firm having its principal office at 1100 New York Avenue, NW, Suite 630, Washington, DC 20005(“ADI”) and BioVest International, Inc. having its principal office at 450 Park Avenue South, New York, N.Y. 10016 (“BioVest”)

W I T N E S S E T H:

WHEREAS, ADI wishes to provide government relations, consulting, and business development services to BioVest and

WHEREAS, BioVest wishes to obtain the services of ADI as set forth in accordance with this agreement.

NOW THEREFORE, in consideration of the foregoing recitals and the mutual covenants, terms, conditions, and agreements hereafter provided, the parties mutually agree as follows:

1.      Effective Date.      This Agreement shall take effect on February 15, 2007 and shall continue through February 14, 2008. Following the expiration of the initial term hereof, this Agreement shall automatically be renewed for successive one (1) year terms, unless either party gives the other written notice of intent not to renew at least thirty (30) days prior to the expiration of the then-existing term. Notwithstanding the foregoing, BioVest may terminate this Agreement at any time upon (60) days written notice to ADI.

However, if during the course of this contract ADI pursues a Congressional appropriation request for BioVest, BioVest cannot exercise its 60 day termination clause referenced above.


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2.      Services and Compensation.      ADI shall provide consulting and business development services to BioVest. BioVest and ADI shall agree as to the nature and extent of the services to be provided.

As compensation for its services, BioVest initially agrees to pay $60,000 annually, payable in equal monthly installments of $5,000 per month for the services of ADI. Such payment shall be due on the fifteenth day of each month beginning on February 15, 2007.

BioVest agrees to increase the monthly compensation to $7,500 per month upon completion of all the mutually agreed objects stated in Attachment A and outlined below:

  a.) Completion of 6 meetings/presentations arranged by ADI with senior officials of the offices cited in the (Attachment A) for BioVest.
  b.) Completion of a meeting with senior staff of the Senate Health Committee or the Chairman’s Chief of Staff.

3.      Expenses.      BioVest will reimburse ADI for all reasonable pre-approved expenses made in the performance of its duties under this Agreement. Routine reimbursable disbursements will include messenger service, telephone calls, transportation, meals, lodging, and travel.

4.      Indemnification.      BioVest shall indemnify and hold ADI harmless from and against any and all liability, loss, damage, cost or expense (including reasonable attorney’s fees) resulting from the acts or omissions, negligence or intentional wrongdoing of BioVest. ADI shall indemnify and hold BioVest harmless from and against any and all liability, loss, damage, cost or expense resulting from the acts or omissions, negligence or intentional wrongdoing of ADI.

5.       Independent Contractor.      ADI will act as an independent contractor in the performance of its duties under this Agreement. ADI is not responsible for the acts of BioVest or representations made by BioVest upon which ADI acts in providing services under this Agreement.

6.      Assignment.      This agreement may not be assigned by BioVest or ADI without the prior written consent of both parties.


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7.      Non-Disclosure.      ADI agrees to hold all BioVest proprietary information and intellectual property in trust and confidence. ADI agrees not to publish, disseminate, or disclose such information without the prior written consent of BioVest.

8.      Applicable Law.      This Agreement shall be construed, interpreted, and governed by and in accordance with the laws of the District of Columbia without regard to the principles of conflicts of laws.

9.      Notices.      Notices shall be sent to the parties at the addresses first set forth above. Any person to whom notice may be given hereunder may from time to time change said address by written notice through the U.S. mail service or equivalent service such as Federal Express.

10.      Severability.      If a court of competent jurisdiction declares that any term or provision of this agreement is invalid or unenforceable then: 1) the remaining terms and provisions shall be unimpaired, and 2) the invalid or unenforceable term or provision shall be deemed replaced by a term or provision that is valid and enforceable and that comes closest to expressing the intention of the invalid or unenforceable terms or provisions.

11.      Entire Agreement.      This Agreement constitutes the entire agreement among the parties with respect to the matters contained herein. Any modification or amendment to this Agreement must be made only by written mutual consent of both parties.


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IN WITNESS WHEREOF, the parties have executed this Agreement, the day, month, and year first above written.

 

BioVest International, Inc.
By:  

/s/ Steven Arikian

      Steven Arikian, M.D.
      CEO and Chairman
American Defense International, Inc.
By:  

/s/ Michael Herson

  Michael Herson
  President


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LOGO

Pulaski Bank PROMISSORY NOTE Principal $750,000.00

Loan Date 04-22-2007 Maturity 05-21-2007 Loan No 600-7011175 Call/Coll Account 1206 Officer 008 Initials

References in the shaded area are for Lender’s use only and do not limit the applicability of this document to any particular loan or item. Any item above containing “***” has been omitted due to text length limitations.

Borrower: BIOVEST INTERNATIONAL INC. Lender: PULASKI BANK 324 South Hyde Park Avenue, Suite 350 12300 OLIVE BLVD Tampa, FL 33606 ST LOUIS, MO 63141 Principal Amount: $750,000.00 Initial Rate: 7.750% Date of Note: April 22, 2007

PROMISE TO PAY. BIOVEST INTERNATIONAL INC. (“Borrower”) promises to pay to PULASKI BANK (“Lender”), or order, in lawful money of the United States of America, the principal amount of Seven Hundred Fifty Thousand & 00/100 Dollars ($750,000.00), together with interest on the unpaid principal balance from April 21, 2007, until paid in full.

PAYMENT. Borrower will pay this loan in one principal payment of $750,000.00 plus interest on May 21, 2007. This payment due on May 21, 2007, will be for all principal and all accrued interest not yet paid. Unless otherwise agreed or required by applicable law, payments will be applied first to any accrued unpaid interest; then to principal; then to any late charges; and then to any unpaid collection costs. The annual interest rate for this Note is computed on a 365/360 basis; that is, by applying the ratio of the annual interest rate over a year of 360 days, multiplied by the outstanding principal balance, multiplied by the actual number of days the principal balance is outstanding. Borrower will pay Lender at Lender’s address shown above or at such other place as Lender may designate in writing.

VARIABLE INTEREST RATE. The interest rate on this Note is subject to change from time to time based on changes in an independent index which is the Wall Street Journal Prime Rate of Interest. This is the base rate on corporate loans posted by at least 75% of the nation’s largest banks (the “Index”). The Index is not necessarily the lowest rate charged by Lender on its loans. If the Index becomes unavailable during the term of this loan, Lender may designate a substitute index after notifying Borrower. Lender will tell Borrower the current Index rate upon Borrower’s request. The interest rate change will not occur more often than each day. Borrower understands that Lender may make loans based on other rates as well. The Index currently is 8.250% per annum. The interest rate to be applied to the unpaid principal balance during this Note will be at a rate of 0.500 percentage points under the Index, resulting in an initial rate of 7.750% per annum. NOTICE: Under no circumstances will the interest rate on this Note be more than the maximum rate allowed by applicable law.

PREPAYMENT. Borrower may pay without penalty all or a portion of the amount owed earlier than it is due. Early payments will not, unless agreed to by Lender in writing, relieve Borrower of Borrower’s obligation to continue to make payments under the payment schedule. Rather, early payments will reduce the principal balance due. Borrower agrees not to send Lender payments marked “paid in full”, “without recourse”, or similar language. If Borrower sends such a payment, Lender may accept it without losing any of Lender’s rights under this Note, and Borrower will remain obligated to pay any further amount owed to Lender. All written communications concerning disputed amounts, including any check or other payment instrument that indicates that the payment constitutes “payment in full” of the amount owed or that is tendered with other conditions or limitations or as full satisfaction of a disputed amount must be mailed or delivered to: PULASKI BANK, 12300 OLIVE BLVD, ST LOUIS, MO 63141.

LATE CHARGE. If a payment is more than 15 days late, Borrower will be charged 5.000% of the regularly scheduled payment or $5.00, whichever is less.

INTEREST AFTER DEFAULT. Upon default, including failure to pay upon final maturity, at Lender’s option, and if permitted by applicable law, Lender may add any unpaid accrued interest to principal and such sum will bear interest therefrom until paid at the rate provided in this Note (including any increased rate). Upon default, the interest rate on this Note shall be increased by adding a 2.000 percentage point margin (“Default Rate Margin”). The Default Rate Margin shall also apply to each succeeding interest rate change that would have applied had there been no default. However, in no event will the interest rate exceed the maximum interest rate limitations under applicable law.

DEFAULT. Each of the following shall constitute an event of default (“Event of Default”) under this Note:

Payment Default. Borrower fails to make any payment when due under this Note.

Other Defaults. Borrower fails to comply with or to perform any other term, obligation, covenant or condition contained in this Note or in any of the related documents or to comply with or to perform any term, obligation, covenant or condition contained in any other agreement between Lender and Borrower.

Default in Favor of Third Parties. Borrower or any Grantor defaults under any loan, extension of credit, security agreement, purchase or sales agreement, or any other agreement, in favor of any other creditor or person that may materially affect any of Borrower’s property or Borrower’s ability to repay this Note or perform Borrower’s obligations under this Note or any of the related documents.

False Statements. Any warranty, representation or statement made or furnished to Lender by Borrower or on Borrower’s behalf under this Note or the related documents is false or misleading in any material respect, either now or at the time made or furnished or becomes false or misleading at any time thereafter.

Insolvency. The dissolution or termination of Borrower’s existence as a going business, the insolvency of Borrower, the appointment of a receiver for any part of Borrower’s property, any assignment for the benefit of creditors, any type of creditor workout, or the commencement of any proceeding under any bankruptcy or insolvency laws by or against Borrower.

Creditor or Forfeiture Proceedings. Commencement of foreclosure or forfeiture proceedings, whether by judicial proceeding, self-help, repossession or any other method, by any creditor of Borrower or by any governmental agency against any collateral securing the loan. This includes a garnishment of any of Borrower’s accounts, including deposit accounts, with Lender. However, this Event of Default shall not apply if there is a good faith dispute by Borrower as to the validity or reasonableness of the claim which is the basis of the creditor or forfeiture proceeding and if Borrower gives Lender written notice of the creditor or forfeiture proceeding and deposits with Lender monies or a surety bond for the creditor or forfeiture proceeding, in an amount determined by Lender, in its sole discretion, as being an adequate reserve or bond for the dispute.

Events Affecting Guarantor. Any of the preceding events occurs with respect to any Guarantor of any of the indebtedness or any Guarantor dies or becomes incompetent, or revokes or disputes the validity of, or liability under, any guaranty of the indebtedness evidenced by this Note. In the event of a death, Lender, at its option, may, but shall not be required to, permit the Guarantor’s estate to assume unconditionally the obligations arising under the guaranty in a manner satisfactory to Lender, and, in doing so, cure any Event of Default.

Change in Ownership. Any change in ownership of twenty-five percent (25%) or more of the common stock of Borrower.

Adverse Change. A material adverse change occurs in Borrower’s financial condition, or Lender believes the prospect of payment or performance of this Note is impaired.

Insecurity. Lender in good faith believes itself insecure.

Cure Provisions. If any default, other than a default in payment is curable and if Borrower has not been given a notice of a breach of the same provision of this Note within the preceding twelve (12) months, it may be cured if Borrower, after receiving written notice from Lender demanding cure of such default: (1) cures the default within twenty (20) days; or (2) if the cure requires more than twenty (20) days, immediately initiates steps which Lender deems in Lender’s sole discretion to be sufficient to cure the default and thereafter continues and completes all reasonable and necessary steps sufficient to produce compliance as soon as reasonably practical.

LENDER’S RIGHTS. Upon default, Lender may declare the entire unpaid principal balance under this Note and all accrued unpaid interest immediately due, and then Borrower will pay the amount.

ATTORNEY’S FEES; EXPENSES. Lender may hire or pay someone else to help collect this Note if Borrower does not pay. Borrower will pay Lender that amount. This includes, subject to any limits under applicable law, Lender’s attorneys’ fees and Lender’s legal expenses whether or not there is a lawsuit, including attorneys’ fees and expenses for bankruptcy proceedings (including efforts to modify or vacate any automatic stay or injunction), and appeals. If not prohibited by applicable law, Borrower also will pay any court costs, in addition to all other sums provided by law.

GOVERNING LAW. This Note will be governed by federal law applicable to Lender and, to the extent not preempted by federal law, the laws of the State of Missouri without regard to its conflicts of law provisions. This Note has been accepted by Lender in the State of Missouri.

CHOICE OF VENUE. If there is a lawsuit, Borrower agrees upon Lender’s request to submit to the jurisdiction of the courts of ST LOUIS County,


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LOGO

Loan No: 600-7011175 PROMISSORY NOTE (Continued) Page 2

State of Missouri.

DISHONORED ITEM FEE. Borrower will pay a fee to Lender of $25.00 if Borrower makes a payment of Borrower’s loan and the check or preauthorized charge with which Borrower pays is later dishonored.

RIGHT OF SETOFF. To the extent permitted by applicable law, Lender reserves a right of setoff in all Borrower’s accounts with Lender (whether checking, savings, or some other account). This includes all accounts Borrower holds jointly with someone else and all accounts Borrower may open in the future. However, this does not include any IRA or Keogh accounts, or any trust accounts for which setoff would be prohibited by law. Borrower authorizes Lender, to the extent permitted by applicable law, to charge or setoff all sums owing on the debt against any and all such accounts.

COLLATERAL. This loan is unsecured.

PRIOR NOTE. This note represents a renewal of a Promissory Note under the same loan number dated March 22, 2007.

SUCCESSOR INTERESTS. The terms of this Note shall be binding upon Borrower, and upon Borrower’s heirs, personal representatives, successors and assigns, and shall inure to the benefit of Lender and its successors and assigns.

GENERAL PROVISIONS. If any part of this Note cannot be enforced, this fact will not affect the rest of the Note. Lender may delay or forgo enforcing any of its rights or remedies under this Note without losing them. Borrower and any other person who signs, guarantees or endorses this Note, to the extent allowed by law, waive presentment, demand for payment, and notice of dishonor. Upon any change in the terms of this Note, and unless otherwise expressly stated in writing, no party who signs this Note, whether as maker, guarantor, accommodation maker or endorser, shall be released from liability. All such parties agree that Lender may renew or extend (repeatedly and for any length of time) this loan or release any party or guarantor or collateral; or impair, fail to realize upon or perfect Lender’s security interest in the collateral; and take any other action deemed necessary by Lender without the consent of or notice to anyone. All such parties also agree that Lender may modify this loan without the consent of or notice to anyone other than the party with whom the modification is made. The obligations under this Note are joint and several.

ORAL AGREEMENTS OR COMMITMENTS TO LOAN MONEY, EXTEND CREDIT OR TO FOREBEAR FROM ENFORCING REPAYMENT OF A DEBT INCLUDING PROMISES TO EXTEND OR RENEW SUCH DEBT ARE NOT ENFORCEABLE, REGARDLESS OF THE LEGAL THEORY UPON WHICH IT IS BASED THAT IS IN ANY WAY RELATED TO THE CREDIT AGREEMENT. TO PROTECT YOU (BORROWER(S)) AND US (LENDER) FROM MISUNDERSTANDING OR DISAPPOINTMENT, ANY AGREEMENTS WE REACH COVERING SUCH MATTERS ARE CONTAINED IN THIS WRITING, WHICH IS THE COMPLETE AND EXCLUSIVE STATEMENT OF THE AGREEMENT BETWEEN US, EXCEPT AS WE MAY LATER AGREE IN WRITING TO MODIFY IT.

PRIOR TO SIGNING THIS NOTE, BORROWER READ AND UNDERSTOOD ALL THE PROVISIONS OF THIS NOTE, INCLUDING THE VARIABLE INTEREST RATE PROVISIONS. BORROWER AGREES TO THE TERMS OF THE NOTE.

BORROWER ACKNOWLEDGES RECEIPT OF A COMPLETED COPY OF THIS PROMISSORY NOTE.

BORROWER:

BIOVEST INTERNATIONAL INC.

By:

Steven Arikian, Chairman and CEO of BIOVEST

INTERNATIONAL INC.

LASER PRO Lending, Ver. 5.31.00.004 Copr. Harland Financial Solutions, Inc. 1997, 2007. All Rights Reserved. - MO W:\PROSUITE\CFI\LPL\D20.FC TR-721


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Exhibit 31.1

CERTIFICATION

I, Steven R. Arikian, certify that:

1. I have reviewed this quarterly report on Form 10-Q of Biovest International, Inc. for the three and six months ended March 31, 2007;

2. Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the periods covered by this report;

3. Based on my knowledge, the consolidated financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;

4. The registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:

a. Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;

b. Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;

c. Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and

d. Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and

5. The registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):

a. All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and

b. Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.

Date: May 15, 2007

 

By:  

/s/ Steven R. Arikian

  Steven R. Arikian, M.D.
  Chief Executive Officer; Chairman of the Board; Director

 


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Exhibit 31.2

CERTIFICATION

I, James A. McNulty, certify that:

1. I have reviewed this quarterly report on Form 10-Q of Biovest International, Inc. for the three and six months ended March 31, 2007;

2. Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the periods covered by this report;

3. Based on my knowledge, the consolidated financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;

4. The registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:

a. Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;

b. Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;

c. Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and

d. Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and

5. The registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):

a. All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and

b. Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.

Date: May 15, 2007

 

By:  

/s/ James A. McNulty

  James A. McNulty, CPA
  Chief Financial Officer


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Exhibit 32.1

CERTIFICATION

In connection with the Quarterly Report on Form 10-Q of Biovest International, Inc. (the “Company”) for the three and six months ended March 31, 2007, as filed with the Securities and Exchange Commission on the date hereof (the “Form 10-Q”), I, Steven R. Arikian, Chairman of the Board and Chief Executive Officer of the Company, hereby certify, pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, that:

(1) The form 10-Q fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934, as amended: and

(2) The information contained in the Form 10-Q fairly presents, in all material respects, the financial condition and results of operations of the Company.

Dated: May 15, 2007

 

/s/ Steven R. Arikian

Steven R. Arikian, M.D.
Chief Executive Officer; Chairman of the Board; Director

This certification accompanies the Form 10-Q to which it relates, is not deemed filed with the Securities and Exchange Commission, and is not to be incorporated by reference into any filing of Accentia Biopharmaceuticals, Inc. under the Securities Act of 1933, as amended, or the Securities Exchange Act of 1934, as amended (whether made before or after the date of the Form 10-Q), irrespective of any general incorporation language contained in such filing.


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Exhibit 32.2

CERTIFICATION

In connection with the Quarterly Report on Form 10-Q of Biovest International, Inc. (the “Company”) for the three and six months ended March 31, 2007, as filed with the Securities and Exchange Commission on the date hereof (the “Form 10-Q”), I, James A. McNulty, Chief Financial Officer of the Company, hereby certify, pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, that:

(1) The form 10-Q fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934, as amended: and

(2) The information contained in the Form 10-Q fairly presents, in all material respects, the financial condition and results of operations of the Company.

Dated: May 15, 2007

 

/s/ James A. McNulty

James A. McNulty, CPA
Chief Financial Officer

This certification accompanies the Form 10-Q to which it relates, is not deemed filed with the Securities and Exchange Commission, and is not to be incorporated by reference into any filing of Accentia Biopharmaceuticals, Inc. under the Securities Act of 1933, as amended, or the Securities Exchange Act of 1934, as amended (whether made before or after the date of the Form 10-Q), irrespective of any general incorporation language contained in such filing.