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Table of Contents

 

 

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 December 31, 2011

OR

 

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

For the transition period from              to              .

Commission file number 0-11480

 

 

BIOVEST INTERNATIONAL, INC.

(Exact name of registrant as specified in its charter)

 

 

 

Delaware   41-1412084

(State or other jurisdiction of

incorporation or organization)

 

(IRS Employer

Identification Number)

324 S. Hyde Park Ave., Suite 350, Tampa, FL 33606

(Address of principal executive offices) (Zip Code)

(813) 864-2554

(Registrant’s telephone number, including area code)

 

 

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

Indicate by check mark whether the registrant has submitted electronically and posted on its corporate Web site, if any, every Interactive Data File required to be submitted and posted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit and post such files).    Yes  x    No  ¨

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, or a smaller reporting company. See the definitions of “large accelerated filer”, “accelerated filer” and “smaller reporting company” in Rule 12b-2 of the Exchange Act.

 

Large accelerated filer   ¨    Accelerated filer     ¨
Non-Accelerated filer   ¨    Smaller reporting company     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

Indicate by check mark whether the registrant has filed all documents and reports required to be filed by Sections 12, 13 or 15(d) of the Securities Exchange Act of 1934 subsequent to the distribution of securities under a Bankruptcy Plan confirmed by the Bankruptcy Court:    Yes  x    No  ¨

As of January 31, 2012, there were 144,692,772 shares of the registrant’s common stock outstanding.

 

 

 


Table of Contents

Forward-Looking Statements

Statements in this Quarterly Report on Form 10-Q 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 in “ITEM 1A. RISK FACTORS” of our Annual Report on Form 10-K for the fiscal year ended September 30, 2011 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.


Table of Contents

INDEX

BIOVEST INTERNATIONAL, INC.

 

         Page

PART I. FINANCIAL INFORMATION

  

ITEM 1.

  Financial Statements    4
  Condensed Consolidated Balance Sheets as of December 31, 2011 (unaudited) and September 30, 2011    4
  Condensed Consolidated Statements of Operations for the Three Months Ended December 31, 2011 and 2010 (unaudited)    5
  Condensed Consolidated Statement of Stockholders’ Deficit for the Three Months Ended December 31, 2011 (unaudited)    6
  Condensed Consolidated Statements of Cash Flows for the Three Months Ended December 31, 2011 and 2010 (unaudited)    7
  Notes to Condensed Consolidated Financial Statements    8

ITEM 2.

  Management’s Discussion and Analysis of Financial Condition and Results of Operations    26

ITEM 3.

  Quantitative and Qualitative Disclosures About Market Risk    31

ITEM 4.

  Controls and Procedures    32

 

PART II. OTHER INFORMATION

ITEM 1.

  Legal Proceedings    32

ITEM 1A.

  Risk Factors    33

ITEM 2.

  Unregistered Sales of Equity Securities and Use of Proceeds    33

ITEM 3.

  Defaults Upon Senior Securities    33

ITEM 4.

  (Removed and Reserved)    33

ITEM 5.

  Other Information    33

ITEM 6.

  Exhibits    34

Signatures

     35

 

3


Table of Contents

PART I. FINANCIAL INFORMATION

ITEM 1. FINANCIAL STATEMENTS

BIOVEST INTERNATIONAL, INC. AND SUBSIDIARIES

CONDENSED CONSOLIDATED BALANCE SHEETS

 

     December 31,  2011
(Unaudited)
    September 30,
2011
 
ASSETS     

Current assets:

    

Cash

   $ 147,000     $ 201,000  

Accounts receivable, net of $8,000 allowance for doubtful accounts at December 31, 2011 and September 30, 2011

     370,000       395,000  

Costs and estimated earnings in excess of billings on uncompleted contracts

     92,000       —     

Inventories

     599,000       532,000  

Prepaid expenses and other current assets

     216,000       476,000  
  

 

 

   

 

 

 

Total current assets

     1,424,000       1,604,000  

Property and equipment, net

     835,000       771,000  

Patents and trademarks, net

     224,000       231,000  

Goodwill

     2,131,000       2,131,000  

Other assets

     660,000       681,000  
  

 

 

   

 

 

 

Total assets

   $ 5,274,000     $ 5,418,000  
  

 

 

   

 

 

 
LIABILITIES AND STOCKHOLDERS’ DEFICIT     

Liabilities not subject to compromise:

    

Current liabilities:

    

Accounts payable

   $ 445,000     $ 371,000  

Accrued liabilities

     2,517,000       178,000  

Customer deposits

     146,000       116,000  

Billing in excess of costs and estimated earnings

     1,000       —     

Derivative liabilities

     1,750,000       2,117,000  

Notes payable, related party

     1,474,000       —     

Current maturities of long term debt

     24,475,000       1,063,000  
  

 

 

   

 

 

 

Total current liabilities

     30,808,000       3,845,000  

Long term debt, less current maturities

     7,324,000       30,849,000  

Long term debt, related party

     —          496,000  

Accrued interest

     705,000        2,330,000   

Other

     68,000       —     
  

 

 

   

 

 

 

Total liabilities not subject to compromise

     38,905,000       37,520,000  

Liabilities subject to compromise (Note 10)

     —          444,000  
  

 

 

   

 

 

 

Total liabilities

     38,905,000       37,964,000  

Commitments and contingencies (Note 14)

     —          —     

Stockholders’ deficit:

    

Preferred stock, $0.01 par value, 50,000,000 shares authorized; no shares issued and outstanding

     —          —     

Common stock, $0.01 par value, 300,000,000 shares authorized; 144,369,204 and 143,966,460 issued and outstanding at December 31, 2011 and September 30, 2011

     1,444,000       1,440,000   

Additional paid-in capital

     127,540,000       127,149,000   

Accumulated deficit

     (162,615,000     (161,135,000
  

 

 

   

 

 

 

Total stockholders’ deficit

     (33,631,000     (32,546,000
  

 

 

   

 

 

 

Total liabilities and stockholders’ deficit

   $ 5,274,000     $ 5,418,000   
  

 

 

   

 

 

 

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

 

4


Table of Contents

BIOVEST INTERNATIONAL, INC. AND SUBSIDIARIES

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

(Unaudited)

 

     Three Months  Ended
December 31,
 
     2011     2010  

Revenue:

    

Products

   $ 846,000     $ 307,000  

Services

     217,000       285,000  

Qualified Therapeutic Discovery Project Grant

     —          244,000  
  

 

 

   

 

 

 

Total revenue

     1,063,000       836,000  

Operating costs and expenses:

    

Cost of revenue:

    

Products

     431,000       317,000  

Services

     208,000       236,000  

Research and development expense

     774,000       242,000  

General and administrative expense

     627,000       5,298,000  
  

 

 

   

 

 

 

Total operating costs and expenses

     2,040,000       6,093,000  
  

 

 

   

 

 

 

Loss from operations

     (977,000     (5,257,000 )
  

 

 

   

 

 

 

Other income (expense):

    

Interest expense, net

     (1,045,000     (1,609,000

Gain/(loss) on derivative liabilities

     340,000       (4,619,000

Other (expense)/income, net

     (2,000     4,000   
  

 

 

   

 

 

 

Total other expense

     (707,000     (6,224,000

Loss before reorganization items and income taxes

     (1,684,000     (11,481,000

Reorganization items:

    

Gain on reorganization

     222,000       54,000  

Professional fees

     (18,000     (253,000
  

 

 

   

 

 

 

Total reorganization items

     204,000       (199,000
  

 

 

   

 

 

 

Net loss

   $ (1,480,000   $ (11,680,000
  

 

 

   

 

 

 

Loss per common share:

    

Basic and diluted

   $ (0.01   $ (0.10

Weighted average shares outstanding:

    

Basic and diluted

     144,169,225        117,201,829   

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

 

5


Table of Contents

BIOVEST INTERNATIONAL, INC. AND SUBSIDIARIES

CONDENSED CONSOLIDATED STATEMENT OF STOCKHOLDERS’ DEFICIT

THREE MONTHS ENDED DECEMBER 31, 2011

(Unaudited)

 

     Common Stock                      
     Shares      Amount      Additional
Paid-
in Capital
     Accumulated
Deficit
    Total  

Balances October 1, 2011

     143,966,460      $ 1,440,000      $ 127,149,000       $ (161,135,000   $ (32,546,000

Issuance of common shares for interest on outstanding debt

     62,387        1,000        24,000         —          25,000  

Shares issued pursuant to plan of reorganization

     340,357        3,000        295,000         —          298,000  

Employee share-based compensation

     —           —           72,000         —          72,000  

Net loss

     —           —           —           (1,480,000     (1,480,000
  

 

 

    

 

 

    

 

 

    

 

 

   

 

 

 

Balances December 31, 2011

     144,369,204      $ 1,444,000      $ 127,540,000       $ (162,615,000   $ (33,631,000
  

 

 

    

 

 

    

 

 

    

 

 

   

 

 

 

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)

 

     Three Months Ended
December 31,
 
     2011     2010  

Cash flows from operating activities:

    

Net loss

   $ (1,480,000   $ (11,680,000

Adjustments to reconcile net loss to net cash flows from operating activities before reorganization items:

    

Depreciation

     29,000        12,000   

Amortization of patents

     7,000        7,000   

Employee share-based compensation

     72,000        4,537,000   

Amortization of discount on notes payable

     279,000        135,000   

Amortization of deferred loan costs

     30,000        764,000   

Common shares issued for interest on outstanding debt

     2,000        313,000   

(Gain)/Loss on derivative liabilities

     (340,000     4,619,000   

Changes in cash resulting from changes in:

    

Operating assets

     (122,000     100,000   

Operating liabilities

     845,000        379,000   
  

 

 

   

 

 

 

Net cash flows from operating activities before reorganization items

     (678,000     (814,000
  

 

 

   

 

 

 

Reorganization items:

    

Gain on reorganization plan

     (222,000     (54,000

Decrease in accrued professional fees

     —          (278,000
  

 

 

   

 

 

 

Net change in cash flows from reorganization items

     (222,000     (332,000
  

 

 

   

 

 

 

Net cash flows from operating activities

     (900,000     (1,146,000
  

 

 

   

 

 

 

Cash flows from investing activities:

    

Purchase of property, plant and equipment

     (94,000     (97,000
  

 

 

   

 

 

 

Net cash flows from investing activities

     (94,000     (97,000

Cash flows from financing activities:

    

Repayment of notes payable and long-term debt

     (3,000     (1,998,000

Advances from related party

     866,000        250,000   

Proceeds from long-term debt

     —          7,000,000   

Proceeds from exercise of stock options

     —          6,000   

Proceeds from equipment financing

     77,000        —     

Payment of deferred financing costs

     —          (755,000
  

 

 

   

 

 

 

Net cash flows from financing activities

     940,000        4,503,000   
  

 

 

   

 

 

 

Net change in cash

     (54,000     3,260,000   

Cash at beginning of period

     201,000        206,000   
  

 

 

   

 

 

 

Cash at end of period

   $ 147,000      $ 3,466,000   
  

 

 

   

 

 

 

Supplemental disclosure of cash flow information:

    

Non-cash financing and investing transactions:

    

Issuance of warrants (Note 8)

   $ —        $ 7,376,000   

Issuance of shares for payment of principal and interest on outstanding debt (Note 8)

     25,000        4,552,000   

Issuance of shares to settle pre-petition claims (Note 8)

     298,000        52,012,000   

Increase in Class 8, Unsecured Option A Obligations (Note 8)

     63,000        —     

Cash paid for interest during period

   $ 60,000      $ 18,000   

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

 

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BIOVEST INTERNATIONAL, INC AND SUBSIDIARIES

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

THREE MONTHS ENDED DECEMBER 31, 2011 AND 2010

 

1. Description of the company:

As a result of Biovest International, Inc.’s (the “Company” or “Biovest) collaboration with the National Cancer Institute (“NCI”), Biovest is developing BiovaxID®, as a personalized therapeutic cancer vaccine for the treatment of non-Hodgkin’s lymphoma, specifically follicular lymphoma (“FL”), mantle cell lymphoma (“MCL”) and potentially other B-cell blood cancers. Both FL and MCL are generally considered to be incurable with currently approved therapies. These generally fatal diseases arise from the lymphoid tissue and are characterized by an uncontrolled proliferation and spread throughout the body of mature B-cells, which are a type of white blood cell.

Three clinical trials conducted under the Company’s investigational new drug application (“IND”) have studied BiovaxID in non-Hodgkin’s lymphoma (“NHL”). These studies include a Phase 2 clinical trial and a Phase 3 clinical trial in patients with FL, as well as a Phase 2 clinical trial in MCL patients. BiovaxID has demonstrated statistically significant Phase 3 clinical benefit by prolonging disease-free survival in FL patients treated with BiovaxID. The Company believes that these clinical trials have demonstrated that BiovaxID, which is personalized and autologous (derived from a patient’s own tumor cells), has an excellent safety profile and is effective in the treatment of these life-threatening diseases.

To support the Company’s planned commercialization of BiovaxID, the Company developed an automated cell culture instrument called AutovaxID®. The Company believes that AutovaxID has significant potential application in the production of a broad range of patient-specific medicines, such as BiovaxID as well as, other monoclonal antibodies. The Company is collaborating with the U.S. Department of Defense (“DoD”) to further develop AutovaxID and to explore potential production of additional vaccines, including vaccines for viral indications such as influenza. AutovaxID is automated and computer controlled to improve cell production reliability and to maximize cell production. AutovaxID uses a disposable production unit which the Company anticipates will minimize the need for Federal Food and Drug Administration (“FDA”) required “clean rooms” in the production process and provides for robust and dependable manufacturing while complying with the industry current good manufacturing practices (“cGMP”) standards. AutovaxID has a small footprint and supports scalable production.

The Company also manufactures instruments and disposables used in the hollow-fiber production of cell culture products. Biovest’s hollow-fiber cell culture products and instruments are used by biopharmaceutical and biotechnology companies, medical schools, universities, research facilities, hospitals and public and private laboratories. The Company also produces mammalian and insect cells, monoclonal antibodies, recombinant and secreted proteins and other cell culture products using The Company’s unique capability, expertise and proprietary advancements in the cell production process known as hollow fiber perfusion.

The Company’s business consists of three primary business segments: development of BiovaxID and potentially other B-cell blood cancer vaccines; the manufacture and sale of AutovaxID and other instruments and consumables; and commercial production of cell culture products and services.

As of December 31, 2011, the Company’s parent Accentia Biopharmaceuticals, Inc. (“Accentia”) owned 61% of the Company’s outstanding common stock.

On November 10, 2008, the Company, along with its subsidiaries, Biovax, Inc., AutovaxID, Inc., Biolender LLC and Biolender II LLC (collectively, the “Debtors”) filed voluntary petitions for reorganization under Chapter 11 of the United States Bankruptcy Code (“Chapter 11”) in the U.S. Bankruptcy Court for the Middle District of Florida, Tampa Division (the “Bankruptcy Court”). On August 16, 2010, the Company filed its First Amended Joint Plan of Reorganization, and, on October 25, 2010, the Company filed its First Modification to the First Amended Joint Plan of Reorganization (collectively and as amended and supplemented, the “Plan”). On November 2, 2010, the Bankruptcy Court entered an Order Confirming Debtors’ First Amended Joint Plan of Reorganization Under Chapter 11 of the Bankruptcy Code (the “Confirmation Order”). The Company emerged from Chapter 11 protection, and the Plan became effective, on November 17, 2010 (the “Effective Date”). On the Effective Date and pursuant to the Plan, the Company’s subsidiaries, Biovax, Inc., AutovaxID, Inc., Biolender LLC and Biolender II LLC were dissolved. The accompanying condensed consolidated financial statements have been prepared assuming the Company will continue as a going concern.

 

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BIOVEST INTERNATIONAL, INC AND SUBSIDIARIES

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

THREE MONTHS ENDED DECEMBER 31, 2011 AND 2010

 

2. Significant accounting policies:

Basis of presentation:

The accompanying unaudited condensed consolidated 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 (“GAAP”) 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 three months ended December 31, 2011, 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-K for the fiscal year ended September 30, 2011.

Principles of consolidation:

The unaudited condensed consolidated financial statements include Biovest Europe, Limited, a wholly owned subsidiary of the Company. Biovest Europe, Limited was incorporated in the United Kingdom effective June 29, 2011.

All significant inter-company balances and transactions have been eliminated.

Accounting for reorganization proceedings:

Accounting Standards Codification (“ASC”) Topic 852—Reorganizations, which is applicable to companies in Chapter 11, generally does not change the manner in which financial statements are prepared. However, it does require that the financial statements for periods subsequent to the filing of the Chapter 11 petition distinguish transactions and events that are directly associated with the reorganization from the ongoing operations of the business. Revenues, expenses, realized gains and losses, and provisions for losses that can be directly associated with the reorganization and restructuring of the business must be reported separately as reorganization items in the statements of operations beginning in the quarter ended December 31, 2008. The balance sheet must distinguish prepetition liabilities subject to compromise from both those prepetition liabilities that are not subject to compromise and from post-petition liabilities. Liabilities that may be affected by a plan of reorganization must be reported at the amounts expected to be allowed by the Bankruptcy Court, even if they may be settled for lesser amounts. In addition, cash provided by reorganization items must be disclosed separately in the statement of cash flows. The Company became subject to ASC Topic 852 effective on November 10, 2008, emerged from Chapter 11 protection on November 17, 2010 and has segregated those items as outlined above for all reporting periods between such dates.

Pursuant to the Plan, holders of existing voting shares of the Company’s common stock immediately before Plan confirmation received more than 50 percent of the voting shares of the emerging entity, thus the Company did not adopt fresh-start reporting upon emergence from Chapter 11. The Company instead followed the guidance as described in ASC 852-45-29 for entities which do not qualify for fresh-start reporting. Liabilities compromised by the Plan were stated at present values of amounts to be paid, and forgiveness of debt was reported as an extinguishment of debt and classified in accordance with ASC Topic 225.

Use of estimates in the preparation of financial statements:

The preparation of condensed consolidated financial statements in conformity with GAAP require management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosures about contingent assets and liabilities at the dates of the condensed consolidated financial statements and the reported amounts of revenues and expenses during the reporting periods. Actual results could differ from those estimates.

Inventories:

Inventories are recorded at the lower of cost or market with cost determined using the first-in, first-out (“FIFO”) method.

Property and equipment:

Property and equipment are recorded at cost. Depreciation for property and equipment is computed using the straight-line method over the estimated useful lives of three to seven years. Leasehold improvements are amortized over the shorter of their economic lives or the lease term.

 

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BIOVEST INTERNATIONAL, INC AND SUBSIDIARIES

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

THREE MONTHS ENDED DECEMBER 31, 2011 AND 2010

2. Significant accounting policies (continued):

 

Goodwill:

Goodwill relates to the Company’s cell culture and instrument manufacturing segments located in Minneapolis (Coon Rapids), Minnesota, which continue to be profitable segments of the Company. Goodwill is tested for impairment annually or whenever there is an impairment indication. The Company has not recorded any impairment losses as a result of these evaluations.

Patents and trademarks:

Costs incurred in relation to patent applications are capitalized as deferred patent costs. If and when a patent is issued, the related patent application costs are transferred to the patent account and amortized over the estimated useful life of the patent. If it is determined that a patent will not be issued, the related patent application costs are charged to expense at the time such determination is made. Patent and trademark costs are recorded at historical cost. Patent and trademark costs are being amortized using the straight-line method over their estimated useful lives of six years for patents and twenty years for trademarks.

Deferred financing costs:

Deferred financing costs include fees paid in cash or through the issuance of warrants in conjunction with obtaining notes payable and long-term debt and are amortized over the term of the related financial instrument.

Carrying value of long-lived assets:

The carrying values of the Company’s long-lived assets are evaluated whenever events or changes in circumstances indicate that the carrying amount might not be recoverable. This assessment may be based upon management’s experience in the industry, historical and projected sales, current backlog, and expectations of undiscounted future cash flows. The Company reviews the valuation and amortization of those long-lived assets to determine possible impairment by comparing the carrying value to projected undiscounted future cash flows of the related assets. During the quarter ended December 31, 2011, the Company noted no events that would give it reason to believe that impairment on the Company’s long-lived assets is necessary.

Financial instruments:

Financial instruments, as defined in ASC Topic 825, consist of cash, evidence of ownership in an entity and contracts that both (i) impose on one entity a contractual obligation to deliver cash or another financial instrument to a second entity, or to exchange other financial instruments on potentially unfavorable terms with the second entity and (ii) conveys to that second entity a contractual right (a) to receive cash or another financial instrument from the first entity or (b) to exchange other financial instruments on potentially favorable terms with the first entity. Accordingly, the Company’s condensed consolidated financial instruments consist of cash, accounts receivable, accounts payable, accrued liabilities, notes payable, long-term debt, and derivative financial instruments.

The Company carries cash, accounts receivable, accounts payable, and accrued liabilities at historical costs. The respective estimated fair values of these assets and liabilities approximate carrying values due to their current nature. The Company also carries notes payable and long-term debt at historical cost less discounts from warrants issued as loan financing costs; however, fair values of these debt instruments are estimated for disclosure purposes based upon the present value of the estimated cash flows at market interest rates applicable to similar instruments.

Fair value of financial assets and liabilities:

The Company measures the fair value of financial assets and liabilities in accordance with GAAP which defines fair value, establishes a framework for measuring fair value, and requires certain disclosures about fair value measurements.

GAAP defines fair value as the exchange price that would be received for an asset or paid to transfer a liability (an exit price) in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants on the measurement date. GAAP also establishes a fair value hierarchy, which requires an entity to maximize the use of observable inputs and minimize the use of unobservable inputs when measuring fair value. GAAP describes three levels of inputs that may be used to measure fair value:

Level 1 – quoted prices in active markets for identical assets or liabilities

Level 2 – quoted prices for similar assets and liabilities in active markets or inputs that are observable

Level 3 – inputs that are unobservable (for example cash flow modeling inputs based on assumptions)

 

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BIOVEST INTERNATIONAL, INC AND SUBSIDIARIES

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

THREE MONTHS ENDED DECEMBER 31, 2011 AND 2010

2. Significant accounting policies (continued):

Fair value of financial assets and liabilities (continued):

 

The Company generally does not use derivative financial instruments to hedge exposures to cash-flow, market or foreign-currency risks. However, the Company and its consolidated subsidiaries have entered into certain other financial instruments and contracts, such as debt financing arrangements and freestanding warrants with features that are either (i) not afforded equity classification, (ii) embody risks not clearly and closely related to host contracts, or (iii) may be net-cash settled by the counterparty. These instruments are required to be carried as derivative liabilities, at fair value.

The Company uses the Black-Scholes option valuation technique because it embodies all of the requisite assumptions (including trading volatility, estimated terms and risk free rates) necessary to measure the fair value of these instruments. Estimating fair values of derivative financial instruments requires the development of significant and subjective inputs that may, and are likely to, change over the duration of the instrument with related changes in internal and external market factors. In addition, option-based techniques are highly volatile and sensitive to changes in the Company’s trading market price and the trading market price of various peer companies, which have historically had high volatility. Since derivative financial instruments are initially and subsequently carried at fair value, the Company’s income will reflect the volatility in these estimate and assumption changes.

The Company reports its derivative liabilities at fair value on the accompanying condensed consolidated balance sheets as of December 31, 2011 and September 30, 2011 (Note 9).

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 and, as such, are not recognized as revenue until product delivery. 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 the 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. 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.

Grant revenue:

Grant revenue is the result of the Company being awarded the Qualifying Therapeutic Discovery Program Grant from the federal government during 2010. In accordance with the terms of the Qualifying Therapeutic Discovery Program Grant, grant revenue is recognized up to fifty percent (50%) of the reimbursable expenses incurred during 2010.

Research and development expenses:

The Company expenses research and development expenditures as incurred. Such costs include payroll and related costs, facility costs, consulting and professional fees, equipment rental and maintenance, lab supplies, and certain other indirect cost allocations that are directly related to research and development activities.

Shipping and handling costs:

Shipping and handling costs are included as a component of cost of revenue in the accompanying condensed consolidated statements of operations.

 

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NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

THREE MONTHS ENDED DECEMBER 31, 2011 AND 2010

2. Significant accounting policies (continued):

 

Stock-based compensation:

The Company has accounted for stock-based compensation under the provisions of ASC Topic 718 – Stock Compensation, which, requires the use of the fair-value based method to determine compensation for all arrangements under which employees and others receive shares of stock or equity instruments (warrants and options). 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 peer companies 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.

Recent accounting pronouncements:

In September 2011, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) 2011-08, Intangibles—Goodwill and Other (Topic 350), Testing Goodwill for Impairment (“ASU 2011-08”), to allow entities to use a qualitative approach to test goodwill for impairment. ASU 2011-08 permits an entity to first perform a qualitative assessment to determine whether it is more likely than not that the fair value of a reporting unit is less than its carrying value. If it is concluded that this is the case, it is necessary to perform the currently prescribed two-step goodwill impairment test. Otherwise, the two-step goodwill impairment test is not required. ASU 2011-08 is effective for the Company beginning October 1, 2012, and earlier adoption is permitted. The Company is currently evaluating the impact of the pending adoption of ASU 2011-08 on its condensed consolidated financial statements.

In December 2011, the FASB issued ASU 2011-11, Disclosures about Offsetting Assets and Liabilities (“ASU 2011-11”), to facilitate comparison of financial statements between those entities that prepare their statements on the basis of GAAP and those that prepare their statements on the basis of the International Financial Reporting Standards (“IFRS”). ASU 2011-11 requires an entity to disclose information about offsetting and related arrangements to enable users of its financial statements to understand the effect of those arrangements on its financial position. The amendment is effective for the Company beginning January 1, 2013 with retrospective application to all prior periods presented. The Company does not expect the adoption to have a material impact on its condensed consolidated financial statements.

3. Liquidity and management plans:

At December 31, 2011, the Company had an accumulated deficit of approximately $162.6 million and working capital deficit of approximately $29.4 million. The Company’s independent auditors issued a “going concern” qualification on the consolidated financial statements for the year ended September 30, 2011, 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.

Regulatory strategy and commercialization expenditures:

Two Phase 2 clinical trials and one Phase 3 clinical trial have been completed studying BiovaxID® for the indication of FL and MCL. The Company is in the process of conducting clinical pre-filing discussions with domestic and international regulatory agencies to discuss the potential regulatory approval pathway for BiovaxID. The Company is focusing on its plans to seek regulatory approval for BiovaxID for the treatment of FL and these clinical pre-filing regulatory agency meetings are anticipated to confirm the next steps and requirements in the regulatory process.

In preparing for these regulatory meetings, the Company is continuing its analyses of the data available from its Phase 2 and Phase 3 clinical trials, so that the Company can have comprehensive discussions regarding the safety and efficacy results for BiovaxID. In addition, the Company continues to advance its efforts to comply with various regulatory validations and comparability requirements related to the Company’s manufacturing process and facility.

The Company also anticipates conducting separate discussions with various regulatory agencies regarding regulatory approval for BiovaxID for the treatment of MCL and Waldenstrom’s Macroglobulinemia, a rare B-cell subtype of NHL.

 

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NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

THREE MONTHS ENDED DECEMBER 31, 2011 AND 2010

3. Liquidity and management plans (continued):

 

Chapter 11 Plan of Reorganization:

On November 17, 2010 (the “Effective Date”), the Company emerged from Chapter 11 protection as a fully restructured organization. Through the provisions of the Company’s Plan of Reorganization (the “Plan”), the Company was able to restructure the majority of its debt into a combination of long-term notes and equity, while preserving common shares held by existing shareholders. The following is a summary of certain material provisions of the Plan. The summary does not purport to be complete and is qualified in its entirety by reference to all of the provisions of the Plan.

 

   

Exit Financing: On the Effective Date, the Company issued secured convertible notes in the aggregate principal amount of $7.04 million to twelve accredited investors along with two separate types of warrants to the investors. The Series A Warrants granted the right to purchase an aggregate of 8,733,096 shares of the Company’s common stock at $1.20 per share and the Series B Warrants granted the investors the right to purchase 1,076,930 shares of the Company’s common stock at $0.001 per share. On December 22, 2010, all of the Series B Exchange Warrants were exercised on a cashless basis and 1,075,622 shares of the Company’s common stock were issued to the Buyers.

 

   

Corps Real Note: On the Effective Date, the Company executed and delivered, favor of Corps Real, LLC (“Corps Real”) a secured convertible promissory note (the “Corps Real Note”) in an original principal amount equal to $2,291,560 which also allows the Company to draw up to an additional $0.9 million on the Corps Real Note. The Corps Real Note matures on November 17, 2012 and all principal and accrued but unpaid interest is due on such date. The Corps Real Note is secured by a first priority lien on all of the Company’s assets.

 

   

Laurus/Valens Secured Claims: On the Effective Date, the Company issued to Laurus Master Fund, Ltd. (in liquidation) (“Laurus”), PSource Structured Debt Limited (“PSource”), Valens Offshore SPV I, Ltd. (“Valens I”), Valens Offshore SPV II, Corp. (“Valens II”), Valens U.S. SPV I, LLC (“Valens U.S.”) (collectively, “Valens”), and LV Administrative Services, Inc., as administrative and collateral agent for Laurus, PSource, and Valens (“LV” and together with Laurus, PSource, Valens, and each of their respective affiliates, “Laurus/Valens”) two new term notes. One term note in the original aggregate principal amount of $24.9 million, in compromise and satisfaction of secured claims prior to the Effective Date (the “Laurus/Valens Term A Notes”). The Laurus/Valens Term A Notes mature on November 17, 2012. A second term note in the original aggregate principal amount of $4.16 million, in compromise and satisfaction of secured claims prior to the Effective Date (the “Laurus/Valens Term B Notes”). The Laurus/Valens Term B Notes mature on November 17, 2013. The Laurus/Valens Term A Notes and the Laurus/Valens Term B Notes are secured by a lien on all of the Company’s assets, junior only to the priority lien to Corps Real and to certain permitted liens. On November 18, 2010, the Company prepaid the Laurus/Valens Term A Notes in an amount equal to $1.4 million from the proceeds received from the Exit Financing (discussed above).

 

   

Plan Distributions to Unsecured Creditors: On the Effective Date, the Company became obligated to pay certain of its unsecured creditors approximately $2.7 million in cash together with interest at five percent (5%) per annum in one installment on March 27, 2014.

The Qualifying Therapeutic Discovery Project:

On October 31, 2010, the Company received notice from the U.S. Internal Revenue Service (“IRS”) that it was approved to receive a Federal grant in the amount of approximately $0.24 million under the Qualifying Therapeutic Discovery Project. The Qualifying Therapeutic Discovery Project tax credit is provided under new section 48D of the Internal Revenue Code, enacted as part of the Patient Protection and Affordable Care Act of 2010. The credit is a tax benefit targeted to therapeutic discovery projects that show a reasonable potential to:

 

   

Result in new therapies to treat areas of unmet medical need or prevent, detect or treat chronic or acute diseases and conditions,

   

Reduce the long-term growth of health care costs in the United States, or

   

Significantly advance the goal of curing cancer within 30 years.

Allocation of the credit will also take into consideration which projects show the greatest potential to create and sustain high-quality, high-paying U.S. jobs and to advance U.S. competitiveness in life, biological and medical sciences. The funds were awarded to support the advancement of BiovaxID®.

 

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NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

THREE MONTHS ENDED DECEMBER 31, 2011 AND 2010

3. Liquidity and management plans (continued):

 

Minneapolis, Minnesota Facility Lease:

On December 2, 2010, the Company entered into a lease agreement (the “Lease”) with JMS Holdings, LLC (the “Landlord”) for continued use and occupancy of the Company’s existing facility in Minneapolis (Coon Rapids), Minnesota. The Lease has an initial term of ten years, with provisions for extensions thereof, and will allow the Company to continue and to expand its operations in the Minneapolis (Coon Rapids) facility which it has occupied for over 25 years. The Lease also contains provisions regarding a strategic collaboration whereby the Landlord, with cooperation in the form of loans from the City of Coon Rapids and the State of Minnesota, has agreed to construct certain improvements to the leased premises to allow the Company to perform good manufacturing practices (“GMP”) manufacturing of biologic products in the Minneapolis (Coon Rapids) facility, with the costs of the construction to be amortized over the term of the Lease. In connection with this strategic agreement, the Company issued to the Landlord a warrant (the “Warrant”) to purchase up to one million shares of the Company’s common stock, vesting 60 days from the date of issuance, with an initial exercise price of $1.21 per share and a term of five years from the earlier to occur of (i) the date that the shares underlying the Warrant become registered (the Company has agreed to file a registration statement including the shares underlying the Warrant within one year of the date of issuance) or (ii) the date that the shares become otherwise freely-tradable pursuant to Rule 144. Resale of the underlying shares is subject to restrictions pursuant to Rule 144 and certain agreed lock-up provisions.

Additional expected financing activity:

Management intends to attempt to meet its cash requirements through proceeds from the Corps Real Note, from its cell culture and instrument manufacturing activities, the use of cash on hand, trade vendor credit, short-term borrowings, debt and equity financings, and strategic transactions such as collaborations and licensing. The Company’s ability to continue present operations, pay its liabilities as they become due, and meet its obligations for vaccine development is dependent upon the Company’s ability to obtain significant external funding in the short term. Additional sources of funding have not been established; however, additional financing is currently being sought by the Company 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 BiovaxID®. Management is currently in the process of exploring these various financing alternatives. There can be no assurance that the Company will be successful in securing such financing at acceptable terms, if at all. Accordingly, the Company’s ability to continue present operations, pay the Company’s existing liabilities as they become due, and the completion of the detailed analyses of the Company’s clinical trial is dependent upon its ability to obtain significant external funding in the near term, which raises substantial doubt about the Company’s ability to continue as a going concern. If adequate funds are not available from the foregoing sources in the near term, 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 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. Accounts Receivable, concentrations of credit risk and major customers:

Financial instruments that subject the Company to concentrations of credit risk include cash and accounts receivable.

Accounts receivable are customer obligations due under normal trade terms for products sold to distributors and retail customers. The Company performs ongoing credit evaluations of customers’ financial condition, but does not require collateral or any other security to support amounts due. Management reviews accounts receivable on a monthly basis to determine if any receivables will potentially be uncollectible. The allowance for doubtful accounts contains a specific accrual for accounts receivable balances that are considered potential bad debts and a general accrual for remaining possible bad debts. Any accounts receivable balances that are determined to be uncollectible are written off to the allowance. Based on the information available, management believes that the allowance for doubtful accounts as of the quarter ended December 31, 2011 is adequate. However, actual write-offs might exceed the recorded allowance.

Three customers accounted for 55% of revenues for the three months ended December 31, 2011, while two customers accounted for 37% of revenues for the same period in the prior fiscal year. Three customers accounted for 67% of trade accounts receivable as of December 31, 2011, compared to five customers that accounted for 69% of trade accounts receivable as of September 30, 2011. A significant amount of the Company’s revenue has been derived from export sales. The Company’s export sales were 34% of revenues for the three months ended December 31, 2011, compared to 24% for the same period in the prior fiscal year. For the three months ended December 31, 2011 and 2010, sales to customers in the United Kingdom accounted for 27% and 25% of total revenue, respectively.

 

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NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

THREE MONTHS ENDED DECEMBER 31, 2011 AND 2010

 

5. Inventories:

Inventories consist of the following:

 

     December 31,  2011
(Unaudited)
     September 30, 2011  

Raw materials

   $ 462,000      $ 462,000  

Work-in-process

     110,000        —     

Finished goods

     27,000        70,000  
  

 

 

    

 

 

 
   $ 599,000      $ 532,000  
  

 

 

    

 

 

 

6. Minnesota facility lease:

On December 2, 2010, the Company entered into a Lease Agreement (the “Lease”) with JMS Holdings, LLC (the “Landlord”) for continued use and occupancy of the Company’s existing facility in Minneapolis (Coon Rapids), Minnesota. The Lease contains provisions regarding a strategic collaboration whereby the Landlord has agreed to construct certain improvements to the leased premises to allow the Company to perform GMP manufacturing of biologic products in the Minneapolis (Coon Rapids) facility, including the manufacture of BiovaxID®. Over $1.5 million in facility improvements have been made to the premises. These improvements were financed by the Company through a combination of cash on hand (approximately $0.175 million), promissory notes from the City of Coon Rapids, Minnesota and the State of Minnesota (in the aggregate amount of $0.353 million), and an increase to the base rent charged in order to recoup the costs of construction incurred by the Landlord (approximately $1.0 million) over the initial term (ten years) of the Lease. In connection with the Lease, the Company issued to the Landlord a warrant to purchase up to one million shares of the Company’s common stock. As a result of these transactions, the Company recorded an asset for the fair value of the warrant issued to the Landlord (approximately $0.825 million), and leasehold improvements in the amount of $0.55 million. These costs will be amortized over the ten year term of the lease. The respective carrying values of these assets are $0.743 million and $0.519 million as of December 31, 2011.

7. Related party transactions:

Notes payable, related party consists of the following:

 

     December 31,  2011
(Unaudited)
    September 30, 2011  

Accentia promissory demand note

   $ 780,000      $ —     

Corps Real Note

     2,292,000        2,292,000   

Unamortized discount on Corps Real Note

     (1,598,000     (1,796,000
  

 

 

   

 

 

 
   $ 1,474,000      $ 496,000   
  

 

 

   

 

 

 

Corps Real Note:

On November 17, 2010, the Company issued a secured convertible promissory note (the “Corps Real Note”) in the principal amount of $2,291,560 to Corps Real, LLC (“Corps Real”). Corps Real, as well as, the majority owner of Corps Real are both managed by Ronald E. Osman, a shareholder and a director of the Company. The Corps Real Note allows the Company to draw up to an additional $0.9 million on the principal balance. The Corps Real Note matures on November 17, 2012 and all principal and accrued but unpaid interest is due on such date. Interest accrues and is payable on the outstanding principal amount of the Corps Real Note at a fixed rate of sixteen percent (16%) per annum, with interest in the amount of ten percent (10%) to be paid monthly and interest in the amount of six percent (6%) to accrue and be paid on the maturity date. The Company may prepay the Corps Real Note in full, without penalty, at any time, and Corps Real may convert all or a portion of the outstanding balance of the Corps Real Note into shares of the Company’s common stock at a conversion rate of $0.75 per share. The Corps Real Note is secured by a first priority lien on all of the Company’s assets.

The Corps Real Note was evaluated under the provisions of ASC 470-20, and was recorded at an initial discount of $2.1 million charged to additional paid-in capital representing the intrinsic value of the beneficial conversion feature associated with the Corps Real Note. The discount will be amortized to interest expense using the effective interest method over the two year term of the Corps Real Note.

 

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NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

THREE MONTHS ENDED DECEMBER 31, 2011 AND 2010

7. Related party transactions (continued):

 

Accentia promissory demand note:

Notes payable, related party consists of approximately $0.8 million advanced to the Company from Accentia in the form of cash loans, payments directly to third parties on the Company’s behalf and allocated inter-company expenses. Included in this balance is approximately $0.2 million, representing the fair value of shares to be issued by Accentia in settlement of the claim filed by Clinstar, LLC against the Company in the Company’s Chapter 11 proceedings (Note 10).

8. Long-term debt:

Long-term debt consists of the following:

 

     December 31,
2011
(Unaudited)
    September 30,
2011
 

Class 8, Unsecured Option A Obligations

   $ 2,833,000      $ 2,770,000   

Class 8, Unsecured Option C Notes

     796,000        1,049,000   

Exit Financing ($1.266 million principal less $1.068 million discount)

     198,000        118,000   

Coon Rapids Economic Development Authority Loan

     345,000        348,000   

Laurus/Valens Term A Notes

     23,467,000        23,467,000   

Laurus/Valens Term B Notes

     4,160,000        4,160,000   
  

 

 

   

 

 

 
     31,799,000        31,912,000   

Less: current maturities

     (24,475,000     (1,063,000
  

 

 

   

 

 

 
   $ 7,324,000      $ 30,849,000   
  

 

 

   

 

 

 

Future maturities of long-term debt are as follows:

 

Years ending December 31,

      

2012

   $ 25,543,000   

2013

     4,174,000   

2014

     2,848,000   

2015

     15,000   

2016 thereafter

     287,000   
  

 

 

 

Total maturities

     32,867,000   

Less unamortized discount

     (1,068,000
  

 

 

 
   $ 31,799,000   
  

 

 

 

Class 8, Unsecured Option A Obligations:

On the Effective Date, the Company became obligated to certain of its unsecured creditors in the original aggregate principal amount of approximately $2.7 million in cash together with interest at five percent (5%) per annum to be paid in one installment on March 27, 2014 (the “Option A Obligations”). As of December 31, 2011, this obligation increased by $0.121 million due to an amendment made to the Company’s listing of unsecured creditors, allowing a previously unfiled claim for professional services rendered with respect to the Phase 3 clinical trial for BiovaxID®, as well as the addition of an unsecured claim by the Company’s former landlord in St. Louis, Missouri. The unsecured claim by the Company’s former landlord had previously been recorded as a liability subject to compromise on the Company’s consolidated balance sheet as of September 30, 2011. As the final Option A Obligations differed from the previously recorded liability, the Company recorded a $0.066 million gain on reorganization for the three months ended December 31, 2011.

 

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NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

THREE MONTHS ENDED DECEMBER 31, 2011 AND 2010

8. Long-term debt (continued):

 

Class 8, Unsecured Option C Notes:

On the Effective Date, the Company became obligated to certain of its unsecured creditors in the original aggregate principal amount of approximately $2.0 million. Each such unsecured creditor received an amount equal to 100% of such unsecured creditors’ allowed Class 8 unsecured claim (including post-petition interest under the Plan at the rate of three percent (3%) per annum) in a combination of debt and equity resulting in the issuance of a total of $1.8 million in new notes (the “Option C Notes”), as well as 0.2 million shares of the Company’s common stock, using an effective conversion rate equal to $1.66 per share. The Option C Notes bear interest at seven percent (7%) and are convertible into the Company’s common stock in seven quarterly installments beginning on February 17, 2011 as follows:

 

   

provided that the average of the volume weighted average prices for the Company’s common stock for the ten consecutive trading days immediately preceding each quarterly conversion date (“Ten Day VWAP”) is at least $1.00 per share, one-eighth (1/8th) of the Option C Notes plus accrued interest will be automatically converted into shares of the Company’s common stock at a conversion rate equal to the Ten Day VWAP;

 

   

should the Ten Day VWAP be less than $1.00 per share, the Option C Notes will not automatically convert into shares of the Company’s common stock, but will instead become payable at maturity (August 17, 2012), unless the Option C Note holder elects to convert one-eighth (1/8th) of its Option C Notes plus accrued interest into shares of the Company’s common stock at a conversion rate equal to $1.00 per share;

 

   

any portion of the Option C Notes and any Option C interest that are outstanding at maturity (August 17, 2012) will be due and payable in full, at the election of Biovest in either cash or in shares of the Company’s common stock at a conversion rate equal to the Ten Day VWAP;

 

   

if, at any time prior to August 17, 2012, the Ten Day VWAP is at least $1.50 per share, an Option C Note holder, at its option, may convert any or all of the Option C Notes plus the then accrued and unpaid interest into shares of the Company’s common stock at a conversion rate equal to the Ten Day VWAP used for the initial conversion on the Effective Date ($1.66 per share); and

 

   

if, at any time prior to August 17, 2012, the volume weighted average price for the Company’s common stock is at least $1.88 per share for thirty (30) consecutive trading days, the Company, at its option, may require the conversion of the then aggregate outstanding balance of the Option C Notes plus the then accrued and unpaid Option C Note interest at a conversion rate equal to the Ten Day VWAP used for the initial conversion on the Effective Date ($1.66 per share).

At each quarterly conversion date, from February 17, 2011, and through December 17, 2011 with the Ten Day VWAP at less than $1.00 per share, the holders of the Option C Notes elected to convert one-eighth (1/8th) of the Option C Notes plus accrued interest into shares of the Company’s common stock at a conversion rate equal to $1.00 per share, resulting in the aggregate issuance of 1,173,252 shares of the Company’s common stock.

Exit Financing:

On October 19, 2010, the Company completed a financing as part of its Plan (the “Exit Financing”). Pursuant to the Exit Financing, the Company issued secured convertible notes in the original aggregate principal amount of $7.0 million (the “Initial Notes”) and warrants to purchase shares of the Company’s common stock warrants to a total of twelve accredited investors (the “Buyers”). Pursuant to the Exit Financing, the Company issued two separate types of warrants to the Buyers, Series A Warrants (the “Initial Series A Warrants”) and Series B Warrants (the “Initial Series B Warrants”).

On the Effective Date: (a) the Initial Notes were exchanged pursuant to the Plan for new unsecured convertible notes (the “Exchange Notes”) in the original aggregate principal amount of $7.04 million, (b) the Initial Series A Warrants were exchanged the Plan for new warrants to purchase a like number of shares of Company common stock (the “Series A Exchange Warrants”), and (c) the Initial Series B Warrants were exchanged pursuant to the Plan for new warrants to purchase a like number of shares of the Company’s common stock (the “Series B Exchange Warrants”).

 

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NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

THREE MONTHS ENDED DECEMBER 31, 2011 AND 2010

8. Long-term debt (continued):

Exit Financing (continued):

 

The following are the material terms and conditions of the Exchange Notes:

 

   

the Exchange Notes mature on November 17, 2012, and all principal and accrued but unpaid interest is due on such date;

 

   

interest accrues and is payable on the outstanding principal amount of the Exchange Notes at a fixed rate of seven percent (7%) per annum (with a fifteen percent (15%) per annum default rate), and is payable monthly in arrears. The first interest payment was made on December 1, 2010;

 

   

interest payments are payable at the Company’s election in either cash or subject to certain specified conditions, in shares of the Company’s common stock;

 

   

the Company may from time to time, subject to certain conditions, redeem all or any portion of the outstanding principal amount of the Exchange Notes for an amount, in cash, equal to 110% of the sum of the principal amount being redeemed and certain make-whole interest payments;

 

   

the Buyers may convert all or a portion of the outstanding balance of the Exchange Notes into shares of the Company’s common stock at a conversion rate of $0.91 per share, subject to anti-dilution adjustments in certain circumstances; and

 

   

in the event that the average of the daily volume weighted average price of the Company’s common stock is at least 150% of the then-effective conversion price for any ten (10) consecutive trading days, the Company, at its option, may upon written notice to the Buyers, convert the then outstanding balance of the Exchange Notes into shares of the Company’s common stock at the conversion price then in effect under the Exchange Notes.

The following are the material terms and conditions of the Series A Exchange Warrants:

 

   

the Series A Exchange Warrants give the Buyers the right to purchase an aggregate of 8,733,096 shares of the Company’s common stock;

 

   

the Series A Exchange Warrants have an exercise price of $1.20 per share and expire on November 17, 2017; and

 

   

if the Company issues or sells any options or convertible securities after the issuance of the Series A Exchange Warrants that are convertible into or exchangeable or exercisable for shares of common stock at a price which varies or may vary with the market price of the shares of common stock, including by way of one or more reset(s) to a fixed price, the Buyers have the right to substitute any of the applicable variable price formulations for the exercise price upon exercise of the warrants held.

On December 22, 2010, the Series B Exchange Warrants were exercised on a cashless basis and an aggregate of 1,075,622 shares of the Company’s common stock were issued to the Buyers.

As of December 31, 2011, a total of $5.8 million in principal on the Exchange Notes had been converted to common stock, resulting in the issuance to the Buyers of approximately 6.9 million shares of the Company’s common stock. The remaining principal balance outstanding on the Exchange Notes is $1.3 million as of December 31, 2011.

The Exchange Notes and Series A Exchange Warrants contain conversion and adjustment features properly classified as derivative instruments required to be recorded at fair value (Note 9). As a result, the Exchange Notes have been recorded at a discount which will be amortized to interest expense over two years.

 

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NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

THREE MONTHS ENDED DECEMBER 31, 2011 AND 2010

8. Long-term debt (continued):

 

Coon Rapids Economic Development Authority Loans:

On May 6, 2011, the Company closed two financing transactions with the Economic Development Authority for the City of Coon Rapids and the Minnesota Investment Fund, which provide capital to help add workers and retain high-quality jobs in the State of Minnesota. The Company issued two secured promissory notes in the aggregate amount of $0.353 million, which amortize over 240 months, with a balloon payment of $0.199 million due on May 1, 2021 (the “Notes”). The Notes bear interest as follows (yielding an effective interest rate of 4.1%):

 

   

Months 1-60 at 2.5% interest

 

   

Months 61-80 at 5.0% interest

 

   

Months 81-100 at 7.0% interest

 

   

Months 101-120 at 9.0% interest

The Company may prepay the Notes at any time prior to maturity without penalty. Proceeds from the transaction in the amount of $0.353 million were used to fund capital improvements made to the Company’s existing manufacturing facility in Minneapolis (Coon Rapids), Minnesota.

Laurus/Valens Term A and Term B Notes:

On the Effective Date, the Company issued two new notes (the “Laurus/Valens Term A Notes” and “Laurus/Valens Term B Notes”) in the aggregate principal amount of $29.06 million to Laurus Master Fund, Ltd. (in liquidation) (“Laurus”), PSource Structured Debt Limited (“PSource”), Valens Offshore SPV I, Ltd. (“Valens I”), Valens Offshore SPV II, Corp. (“Valens II”), Valens U.S. SPV I, LLC (“Valens U.S.”) (collectively, “Valens”), and LV Administrative Services, Inc., as administrative and collateral agent for Laurus, PSource, and Valens (“LV” and together with Laurus, PSource, Valens, and each of their respective affiliates, “Laurus/Valens”) in compromise and satisfaction of secured claims prior to the Effective Date.

The following are the material terms and conditions of the Laurus/Valens Term A Notes:

 

   

the original principal amount of the Laurus/Valens Term A Notes was $24.9 million;

   

the Laurus/Valens Term A Notes mature on November 17, 2012;

   

interest accrues at the rate of eight percent (8%) per annum (with a twelve (12%) percent per annum default rate), and is payable at the time of any principal payment or prepayment of principal;

   

the Company may prepay the Laurus/Valens Term A Notes, without penalty, at any time; and

   

the Company is required to make mandatory prepayments under the Laurus/Valens Term A Notes as follows:

   

a prepayment equal to thirty percent (30%) of the net proceeds (i.e., the gross proceeds received less any investment banking or similar fees and commissions and legal costs and expenses incurred by the Company) of certain capital raising transactions (with certain exclusions), but only up to the then outstanding principal and accrued interest under the Laurus/Valens Term A Notes;

   

from any intercompany funding by Accentia to the Company (with certain exceptions and conditions); and

   

a prepayment equal to fifty percent (50%) the of positive net cash flow of the Company for each fiscal quarter after the Effective Date, less the amount of certain capital expenditures on certain biopharmaceutical products of the Company made during such fiscal quarter or during any prior fiscal quarter ending after November 17, 2010.

On November 18, 2010, the Company prepaid the Laurus/Valens Term A Notes in an amount equal to $1.4 million from the proceeds received in the Company’s Exit Financing (described above).

 

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BIOVEST INTERNATIONAL, INC AND SUBSIDIARIES

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

THREE MONTHS ENDED DECEMBER 31, 2011 AND 2010

8. Long-term debt (continued):

 

Laurus/Valens Term A and Term B Notes (continued):

The following are the material terms and conditions of the Laurus/Valens Term B Notes:

 

   

the original principal amount of the Laurus/Valens Term B Notes was $4.16 million;

 

   

the Laurus/Valens Term B Notes mature on November 17, 2013;

 

   

interest accrues at the rate of eight (8%) percent per annum (with a twelve (12%) percent per annum default rate), and is payable at the time of any principal payment or prepayment of principal;

 

   

the Company may prepay the Laurus/Valens Term B Notes, without penalty, at any time; and

 

   

provided that the Laurus/Valens Term A Notes have been paid in full, the Company is required to make mandatory prepayments under the Laurus/Valens Term B Notes from any intercompany funding by Accentia to the Company (with certain exceptions and conditions), but only up to the outstanding principal and accrued interest under the Laurus/Valens Term B Notes.

With the prior written consent of Laurus/Valens, the Company may convert all or any portion of the outstanding principal and accrued interest under either the Laurus/Valens Term A Notes or the Laurus/Valens Term B Notes into shares of the Company’s common stock. The number of shares of the Company’s common stock issuable on such a conversion is equal to (a) an amount equal to the aggregate portion of the principal and accrued and unpaid interest thereon outstanding under the applicable Laurus/Valens Term A Notes or the Laurus/Valens Term B Notes being converted, divided by (b) ninety percent (90%) of the average closing price publicly reported (or reported by Pink Sheets, LLC) for shares of the Company’s common stock for the ten (10) trading days immediately preceding the date of the notice of conversion. The Laurus/Valens Term A Notes and the Laurus/Valens Term B Notes are secured by a lien on all of the Company’s assets, junior only to the lien granted to Corps Real and to certain permitted liens.

9. Derivative liabilities:

The Company does not use derivative financial instruments to hedge exposures to cash-flow, market or foreign-currency risks. However, the Company and its consolidated subsidiaries have entered into certain other financial instruments and contracts, such as debt financing arrangements and freestanding warrants with features that are either (i) not afforded equity classification, (ii) embody risks not clearly and closely related to host contracts, or (iii) may be net-cash settled by the counterparty. These instruments are required to be carried as derivative liabilities, at fair value.

The following table discloses the fair value of the Company’s derivative liabilities and their location in the accompanying condense consolidated balance sheets as of December 31, 2011 and September 30, 2011. The Company held no derivative assets at either reporting date.

 

     Liability Derivatives  
     December 31, 2011
(unaudited)
     September 30, 2011  
     Balance Sheet Location    Fair Value      Balance Sheet Location    Fair Value  

Derivatives not designated as hedging instruments

           

Series A Exchange Warrants (Note 8)

   Derivative Liabilities    $ 1,672,000       Derivative Liabilities    $ 1,998,000   

Conversion option on Exit Financing (Note 8)

   Derivative Liabilities      —         Derivative Liabilities      1,000   

Shares due per compromise order

   Derivative Liabilities      78,000       Derivative Liabilities      118,000   
     

 

 

       

 

 

 

Total derivatives not designated as hedging instruments

      $ 1,750,000          $ 2,117,000   
     

 

 

       

 

 

 

 

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BIOVEST INTERNATIONAL, INC AND SUBSIDIARIES

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

THREE MONTHS ENDED DECEMBER 31, 2011 AND 2010

9. Derivative liabilities (continued):

 

Shares due per compromise order:

On the Effective Date, one of the holders of the Company’s 2008 secured debentures elected to convert the entire outstanding principal balance of $0.3 million plus accrued interest into 550,000 shares of the Company’s common stock, issuable in eight quarterly installments of 68,750 shares, beginning on November 17, 2010. The remaining 206,250 shares of the Company’s common stock issuable have been recorded as a derivative liability at fair value on the Company’s balance sheet as of December 31, 2011.

The following table summarizes assets and liabilities measured at fair value on a recurring basis for the periods presented:

 

      December 31, 2011
(unaudited)
     September 30, 2011  

Fair Value Measurements

Using:

   Level 1      Level 2      Level 3      Total      Level 1      Level 2      Level 3      Total  

Liabilities

                       

Derivative Liabilities

   $ —         $ 1,750,000       $ —         $ 1,750,000       $ —         $ 2,117,000       $ —         $ 2,117,000   

10. Liabilities subject to compromise:

On the Effective Date, the Company settled the majority of its pre-petition claims. Footnote 3 contains a summary of certain material provisions of the Plan. For the quarter ended December 31, 2011, the Company settled an outstanding Class 8 unsecured claim in the approximate amount of $0.135 million through the issuance of a Class 8 Unsecured Option A Obligation (Note 8) resulting in a $0.066 million gain on reorganization recorded on the Company’s condensed consolidated statement of operations.

On February 1, 2012, the Company settled the last of its pre-petition claims. The claimant, Clinstar, LLC (“Clinstar”) had filed two identical proofs of claim in the amount of $0.385 million; one against the Company, in its Chapter 11 proceeding, and another against the Company’s majority shareholder, Accentia, in Accentia’s Chapter 11 proceeding. Through an order by the Bankruptcy Court, Clinstar’s claim against the Company was denied, and Clinstar’s claim against Accentia was allowed, resulting in Accentia’s issuance of 283,186 shares of Accentia common stock in full satisfaction of the claim. The Company has recorded the settlement of this claim in the accompanying condensed, consolidated financial statements, resulting in a $0.16 million gain on reorganization for the three months ending December 31, 2011, and an increase of $0.15 million to the balance of the Accentia promissory demand note (Note 7), representing the Company’s intent to reimburse Accentia for the fair value of the shares Accentia issued to settle the claim.

11. Accrued interest:

Interest accrued on the Company’s outstanding debt is as follows:

 

     December 31,  2011
(Unaudited)
     September 30, 2011  

Corps Real Note

   $ 176,000       $ 141,000   

Exit Financing

     7,000         7,000   

Laurus/Valens Term A Notes

     2,109,000         1,636,000   

Laurus/Valens Term B Notes

     374,000         290,000   

Class 8, Unsecured Option A Obligations

     331,000         288,000   

Class 8, Unsecured Option C Notes

     17,000         9,000   

Coon Rapids Economic Development Authority Loans

     1,000         1,000   
  

 

 

    

 

 

 

Total accrued interest

   $ 3,015,000       $ 2,372,000   

Current

   $ 2,310,000       $ 42,000   

Non-Current

   $ 705,000       $ 2,330,000   

The current portion of accrued interest has been recorded in current accrued liabilities on the accompanying condensed consolidated balance sheets presented.

 

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BIOVEST INTERNATIONAL, INC AND SUBSIDIARIES

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

THREE MONTHS ENDED DECEMBER 31, 2011 AND 2010

 

12. 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 peer company stock due to the limited trading history of the Company’s common stock, as well as 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. This method is used because the Company does not currently have adequate historical option exercise or forfeiture information as a basis to determine expected 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 outstanding and exercisable as of December 31, 2011 are as follows:

 

      Shares     Weighted
Avg.
Exercise
Price
     Weighted  Avg.
Contractual
Life (yrs)
     Aggregate
Intrinsic  Value
 

Outstanding at October 1, 2011

     27,081,886      $ 0.56         7.41       $ 2,273,550   

Granted

     100,000       0.39         10.0         —     

Exercised

     —          —           

Cancelled

     (84,936     1.26         
  

 

 

         

Outstanding at December 31, 2011

     27,096,950        0.56         7.17         1,932,375   
  

 

 

         

Exercisable at December 31, 2011

     25,576,950      $ 0.54         7.08       $ 1,932,375   

Non-vested employee stock options:

 

      Shares     Weighted  Avg.
Grant-Date
Fair Value
     Aggregate Intrinsic
Value
 

Non-vested at October 1, 2011

     1,425,000      $ 0.81      

Granted

     100,000        0.27      

Vested

     (5,000     0.93      

Cancelled

     —          —        
  

 

 

      

Non-vested at December 31, 2011

     1,520,000      $ 0.78       $ —     
  

 

 

      

Approximately $0.2 million in compensation expense will be recognized over the next two years as a result of the vesting of shares.

Common stock warrants outstanding and exercisable as of December 31, 2011 are as follows:

 

      Shares      Weighted
Avg. Price
     Aggregate Intrinsic
Value
 

Outstanding at October 1, 2011

     26,966,815       $ 0.84      

Issued

     —           —        

Exercised

     —           —        

Cancelled

     —           —        
  

 

 

       

Outstanding at December 31, 2011

     26,966,815         0.84       $ 418,635   
  

 

 

       

Exercisable at December 31, 2011

     26,666,815       $ 0.83       $ 418,635   

 

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BIOVEST INTERNATIONAL, INC AND SUBSIDIARIES

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

THREE MONTHS ENDED DECEMBER 31, 2011 AND 2010

 

13. Segment information:

The Company operates in three (3) identifiable industry segments. The Company’s Cell Culture Products and Services segment 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 is focused on developing BiovaxID® and received a federal grant in the amount of approximately $0.244 million under the Qualified Therapeutic Discovery Project, for the quarter ended December 31, 2010. In the current fiscal quarter, the Company recognized $0.100 million as a result of a sharing agreement involving the data from the Company’s Phase 3 clinical trial for BiovaxID®. The Company has met all obligations required under the data sharing agreement and does not anticipate earning any further revenue under the agreement.

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
December 31,
 
     2011     2010  

Revenues

    

Instruments and Disposables

   $ 746,000      $ 307,000   

Cell Culture Services

     217,000        285,000   

Therapeutic Vaccine

     100,000        244,000   
  

 

 

   

 

 

 

Total Revenues

     1,063,000        836,000   

Cost of Sales

    

Instruments and Disposables

     431,000        317,000   

Cell Culture Services

     208,000        236,000   
  

 

 

   

 

 

 

Total Cost of Sales

   $ 639,000      $ 553,000   

Gross Margin ($)

   $ 424,000      $ 283,000   

Gross Margin (%)

     40%        34%   

14. Commitments and contingencies:

Bankruptcy proceedings:

On November 10, 2008, the Company filed a voluntary petition for reorganization under Chapter 11 of the United States Bankruptcy Code (“Chapter 11”) in the U.S. Bankruptcy Court for the Middle District of Florida, Tampa Division (the “Bankruptcy Court”). On August 16, 2010, the Company filed its First Amended Joint Plan of Reorganization, and on October 25, 2010, the Company filed the First Modification to the First Amended Joint Plan of Reorganization (collectively and as amended and supplemented, the “Plan”). On November 2, 2010, the Bankruptcy Court entered an Order Confirming Debtors’ First Amended Joint Plan of Reorganization Under Chapter 11 of the Bankruptcy Code (the “Confirmation Order”). The Company emerged from Chapter 11 protection, and the Plan became effective, on November 17, 2010 (the “Effective Date”). Notwithstanding the effectiveness of the Plan, the Bankruptcy Court retains jurisdiction to adjudicate any remaining issues regarding, inter alia, the validity, amount, and method of payment of claims filed in connection with the Company’s Chapter 11 proceeding. Accordingly, the Company anticipates that there may be ongoing proceedings before the Bankruptcy Court to resolve any filed objections or disputes as to claims filed in the Chapter 11 proceeding.

 

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BIOVEST INTERNATIONAL, INC AND SUBSIDIARIES

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

THREE MONTHS ENDED DECEMBER 31, 2011 AND 2010

14. Commitments and contingencies (continued):

 

Other proceedings:

On August 4, 2008, the Company was served with a summons and complaint filed in California Superior Court on behalf of Clinstar LLC for breach of contract for non-payment of certain fees for clinical trial studies and pass-through expenses in the amount of $385,000. Upon the filing of the Company’s Chapter 11 petition on November 10, 2008, this litigation was automatically stayed pursuant to provisions of federal bankruptcy law. Clinstar filed two identical proofs of claim regarding its breach of contract for non-payment litigation in the amount of $0.385 million, one against the Company, in its bankruptcy proceeding and another against the Company’s majority shareholder Accentia, in its bankruptcy proceeding. Both the Company and Accentia objected to Clinstar’s filing of Clinstar’s proofs of claim. On February 1, 2012, by order of the Bankruptcy Court, Clinstar’s proof of claim against the Company was denied and Clinstar’s proof of claim against Accentia was allowed. Upon the full satisfaction of Clinstar’s proof of claim against Accentia through the issuance of 283,186 shares of Accentia common stock at a conversion price of $1.36 per share as required by Accentia’s Bankruptcy Plan with an effective date of November 17, 2010, Clinstar shall have no further claims against the Company or Accentia for breach of contract for non-payment.

Except for the foregoing, the Company is not 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.

Facility leases:

On December 2, 2010, the Company entered into a lease agreement (the “Lease”) for its approximate 35,000 square feet facility in Minneapolis (Coon Rapids), Minnesota, which is used for offices, a laboratory, manufacturing, and warehousing areas to support the production of perfusion cell culture equipment and contract cell culture services. The Lease has a ten year term and provides for certain improvements to the facility, which have been financed and performed principally by the landlord, as well as through government grant loans from city and state agencies in Minnesota. These improvements, which were completed as of September 30, 2011, include the construction of a GMP vaccine manufacturing space. Rent expense for the years ended September 30, 2011 and 2010, under the Lease was approximately $0.3 million for each year. Total rent payments for years 1-5 under the Lease will be $0.43 million per year. Total rent payments for years 6-10 under the Lease will be $0.5 million per year. The Company also has the right to extend the term of the Lease for two additional five year periods at the greater of base rent in effect at the end of the ten year initial lease term, or market rates in effect at the end of the ten year initial lease term.

The Company also shares office space with the Company’s majority shareholder, Accentia, and utilizes the space as the Company’s principal executive and administrative offices. Accentia leases approximately 7,400 square feet of office space in Tampa, Florida. The lease expires on December 31, 2014 and is cancelable by either party with 120 days prior notice.

The Company anticipates that its facilities will meet its needs during fiscal 2012. The Company anticipates that as its development of BiovaxID® advances and as the Company prepares for the future commercialization of its products, its facilities requirements will increase.

Cooperative Research and Development Agreement:

In September 2001, the Company entered into a definitive cooperative research and development agreement (“CRADA”) with the NCI for the development and ultimate commercialization of patient-specific vaccines for the treatment of non-Hodgkin’s low-grade follicular lymphoma. The terms of the CRADA, as amended, included, among other things, a requirement to pay $0.5 million quarterly to NCI for expenses incurred in connection with the ongoing Phase 3 clinical trial. Since the transfer to the Company of the IND application for development of this vaccine, which occurred in April 2004, these payments to NCI have been reduced to a small fraction of this original obligation (approximately $0.2 million per year). On September 25, 2006, the Company provided written notice to the NCI in accordance with the terms of the CRADA to terminate the CRADA at the end of the sixty (60) day notice period. Under the terms of the CRADA, the Company is obligated to continue to provide vaccine to the NCI at no charge for purposes of the NCI’s studies that are within the scope of the CRADA if the Company were to abandon work on the vaccine.

 

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BIOVEST INTERNATIONAL, INC AND SUBSIDIARIES

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

THREE MONTHS ENDED DECEMBER 31, 2011 AND 2010

14. Commitments and contingencies (continued):

 

Food and Drug Administration:

The FDA has extensive regulatory authority over biopharmaceutical products (drugs and biological products), manufacturing protocols and procedures and the facilities in which mammalian proteins will be manufactured. Any new bioproduct intended for use in humans (including, to a somewhat lesser degree, in vivo biodiagnostic products), is subject to rigorous testing requirements imposed by the FDA with respect to product efficacy and safety, possible toxicity and side effects. FDA approval for the use of new bioproducts (which can never be assured) requires several rounds of extensive preclinical testing and clinical investigations conducted by the sponsoring pharmaceutical company prior to sale and use of the product. At each stage, the approvals granted by the FDA include the manufacturing process utilized to produce the product. Accordingly, the Company’s cell culture systems used for the production of therapeutic or biotherapeutic products are subject to significant regulation by the FDA under the Federal Food, Drug and Cosmetic Act, as amended.

Product liability:

The contract production services for therapeutic products offered exposes an inherent risk of liability as the proteins or other substances manufactured, at the request and to the specifications of customers, could foreseeably cause adverse effects. The Company obtains agreements from contract production customers indemnifying and defending the Company from any potential liability arising from such risk. There can be no assurance, however, that the Company will be successful in obtaining such agreements in the future or that such indemnification agreements will adequately protect the Company against potential claims relating to such contract production services. The Company may also be exposed to potential product liability claims by users of its products. A successful partial or completely uninsured claim against the Company could have a material adverse effect on the Company’s operations.

Stanford University Agreement:

In September 2004, the Company entered into an agreement (“Stanford Agreement”) with Stanford University (“Stanford”) allowing exclusive worldwide rights to use two proprietary hybridoma cell lines that are used in the production of BiovaxID® through 2019. Under the Stanford Agreement, the Company is obligated to pay an annual maintenance fee of $0.01 million. The Stanford Agreement also provides that the Company pay Stanford $0.1 million within one (1) year following FDA approval of BiovaxID, and following approval, the Company is required to pay Stanford a running royalty of the higher of $50 per patient or 0.05% of revenues received by the Company for each BiovaxID patient treated using this cell line. This running royalty will be creditable against the yearly maintenance fee. The Company’s agreement with Stanford obligates the Company to diligently develop, manufacture, market, and sell BiovaxID and to provide progress reports to Stanford regarding these activities. The Company can terminate this agreement at any time upon thirty (30) days’ prior written notice and Stanford can terminate the agreement upon a breach of the agreement by the Company that remains uncured for thirty (30) days after written notice of the breach from Stanford.

Royalty Agreements:

On the Effective Date and pursuant to the Plan, the Company, Accentia, and Laurus/Valens entered into agreements whereby Accentia terminated and cancelled all of its royalty interest and Laurus/Valens reduced its royalty interest in BiovaxID® and the Company’s other biologic products. As a result of the foregoing agreements, the aggregate royalty obligation on BiovaxID and the Company’s other biologic products was reduced from 35.25% to 6.30%. Additionally, Laurus/Valens’s royalty interest on the AutovaxID® instrument was reduced from 3.0% to no obligation, including the elimination of the $7.5 million minimum royalty obligation.

 

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

When you read this section of this Quarterly Report on Form 10-Q, it is important that you also read the financial statements and related notes included elsewhere in this Form 10-Q. This section of this Quarterly Report contains forward-looking statements that involve risks and uncertainties, such as statements of our plans, objectives, expectations, and intentions. We use words such as “anticipate,” “estimate,” “plan,” “project,” “continuing,” “ongoing,” “expect,” “believe,” “intend,” “may,” “will,” “should,” “could,” and similar expressions to identify forward-looking statements. Our actual results could differ materially from those anticipated in these forward-looking statements for many reasons, including the matters discussed under the caption “Item 1A. Risk Factors” in our Annual Report on Form 10-K for the fiscal year ended September 30, 2011 and other risks and uncertainties discussed in our other filings with the Securities and Exchange Commission.

Overview

As a result of our collaboration with the National Cancer Institute (“NCI”), Biovest International, Inc. is developing BiovaxID® as a personalized therapeutic cancer vaccine for the treatment of non-Hodgkin’s lymphoma, specifically follicular lymphoma (“FL”), mantle cell lymphoma (“MCL”) and potentially other B-cell cancers. Both FL and MCL are generally considered to be incurable with currently approved therapies. These generally fatal diseases arise from the lymphoid tissue and are characterized by an uncontrolled proliferation and spread throughout the body of mature B-cells, which are a type of white blood cell.

Three clinical trials conducted under our Investigational New Drug Application (“IND”) have studied BiovaxID in non-Hodgkin’s lymphoma (“NHL”). These studies include a Phase 2 clinical trial and a Phase 3 clinical trial in patients with FL, as well as a Phase 2 clinical trial in MCL patients. BiovaxID has demonstrated statistically significant Phase 3 clinical benefit by prolonging disease-free survival in FL patients treated with BiovaxID. We believe that these clinical trials have demonstrated that BiovaxID, which is personalized and autologous (derived from a patient’s own tumor cells), has an excellent safety profile and is effective in the treatment of these life-threatening diseases.

To support our planned commercialization of BiovaxID, we developed an automated cell culture instrument called AutovaxID®. We believe that AutovaxID has significant potential application in the production of a broad range of patient-specific medicines, such as BiovaxID, and potentially for various vaccines, including vaccines for influenza and other contagious diseases. We are collaborating with the U.S. Department of Defense (“DoD”) to further develop AutovaxID and to explore potential production of additional vaccines, including vaccines for viral indications such as influenza. AutovaxID is automated and computer controlled to improve cell production reliability and to maximize cell production. AutovaxID uses a disposable production unit which we anticipate will minimize the need for Federal Food and Drug Administration (“FDA”) required “clean rooms” in the production process and provides for robust and dependable manufacturing while complying with the industry current good manufacturing practices (“cGMP”) standards. AutovaxID has a small footprint and supports scalable production.

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 biotechnology companies, medical schools, universities, research facilities, hospitals and public and private laboratories. 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.

Our business consists of three primary business segments: development of BiovaxID and potentially other B-cell blood cancer vaccines; the manufacture and sale of AutovaxID and other instruments and consumables; and commercial production of cell culture products and services.

 

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Corporate Overview

We were incorporated in Minnesota in 1981, under the name Endotronics, Inc. In 1993, our name was changed to Cellex Biosciences, Inc. In 2001, we changed our corporate name to Biovest International, Inc. and changed our state of incorporation from Minnesota to Delaware.

In April 2003, we entered into an Investment Agreement with Accentia Biopharmaceuticals, Inc. (“Accentia”). As a result of this agreement, in June 2003, we became a subsidiary of Accentia through the sale of shares of our authorized but unissued common and preferred stock then representing approximately 81% of our equity outstanding immediately after the investment. The aggregate investment commitment initially received from Accentia was $20 million. We continued to be a reporting company under

Section 12(g) of the Securities Exchange Act of 1934 following the investment of Accentia.

As of December 31, 2011, Accentia owned approximately 61% of our issued and outstanding capital stock.

On November 10, 2008, we and our wholly-owned subsidiaries filed voluntary petitions for reorganization under Chapter 11 of the United States Bankruptcy Code. Our reorganization case was jointly administered with the reorganization case of our parent company, Accentia, under Case No. 8:08-bk-17795-KRM. On August 16, 2010, we filed our First Amended Joint Plan of Reorganization, and, on October 25, 2010, we filed the First Modification to the First Amended Joint Plan of Reorganization (collectively and as amended and supplemented, the “Plan”). On November 2, 2010, the U.S. Bankruptcy Court for the Middle District of Florida, Tampa Division (the “Bankruptcy Court”) entered an Order Confirming Debtors’ First Amended Joint Plan of Reorganization Under Chapter 11 of the Bankruptcy Code (the “Confirmation Order”). We emerged from Chapter 11 protection, and the Plan became effective, on November 17, 2010 (the “Effective Date”).

 

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Results of Operations

Revenues. Total revenues for the three months ended December 31, 2011 were $1.1 million, compared to revenues of $0.8 million for the three months ended December 31, 2010. Included in product revenue for the current fiscal year is $0.1 million resulting from a sharing agreement involving the data from our Phase 3 clinical trial for BiovaxID®. Prior year’s results do not contain comparable revenue. We have met all obligations required under the data sharing agreement and do not anticipate earning any further revenue under the agreement.

Instrument sales in the current quarter were approximately $0.75 million, representing an increase of $0.44 million over the same quarter in the prior fiscal year. Compared to the previous year, we sold an additional seven instruments, accounting for an increase of approximately $0.24 million. We also sold an additional cultureware, tubing sets and other disposable products and supplies for use with our instrument product line which accounts for the remaining increase over the prior year.

On October 31, 2010, we were approved to receive a federal grant in the amount of approximately $0.244 million under the Qualifying Therapeutic Discovery Project. The credit is a tax benefit targeted to therapeutic discovery projects that show a reasonable potential to result in new therapies to treat areas of unmet medical need or prevent, detect or treat chronic or acute diseases and conditions; reduce the long-term growth of health care costs in the U.S.; or significantly advance the goal of curing cancer within 30 years. Allocation of the credit will also take into consideration which projects show the greatest potential to create and sustain high-quality, high-paying U.S. jobs and to advance U.S. competitiveness in life, biological and medical sciences. The funds were awarded to support the advancement of BiovaxID.

Gross Margin. The overall gross margin as a percentage of sales for the three months ended December 31, 2011 increased from 34% to 40% when compared to the three months ended December 31, 2010. Since a relatively high percentage of our costs are of a fixed nature, the increase in revenues, as discussed above, was a significant driver toward the increase in our gross margin. Additionally, the $0.1 million recognized from our data sharing agreement had a negligible amount of associated costs of sales, as the agreement simply required us to share our data set resulting from our Phase 3 clinical trial for BiovaxID®.

Operating Expenses. Research and development expenses have increased by $0.532 million for the three months ended December 31, 2011 compared to the same period in fiscal 2011. This is primarily attributable to an increase in wages and laboratory supplies as we continue to analyze the available data from our clinical trials and plan to seek accelerated and/or conditional approval with the FDA and international regulatory agencies. We have also expanded our manufacturing facility in Minneapolis (Coon Rapids), Minnesota, financing over $1.5 million in facility improvements which will provide us increased capacity in the manufacture of biologic products, including the manufacture of BiovaxID®. As a result, our facility lease costs have increased from the prior year.

 

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General and administrative expenses have decreased by $4.671 million when compared to the same quarter of the previous fiscal year. Upon the Effective Date of our Plan, which occurred in the first quarter of the prior fiscal year, a number of our incentive stock options previously issued to our employees and to the members of our Board of Directors became vested, resulting in a non-cash charge of approximately $4.537 million to general and administrative expense for the three months ended December 31, 2010. Stock compensation expense for the current fiscal quarter was significantly less, amounting to $0.072 million.

Other Income (Expense). Other expense for the three months ended December 31, 2011 includes contractual interest charges and amortization of discounts regarding the Laurus/Valens Term A and Term B Notes, the Corps Real Note, the Exit Financing, and other long term notes issued to our unsecured creditors as a result of our Plan, which are described below. As a result of restructuring our debt to a combination of long term notes and equity, interest expense decreased by $0.564 million from the three months ended December 31, 2010.

Other expense also includes a gain of $0.34 million and a loss of $4.619 million on derivative liabilities for the three months ended December 31, 2011 and 2010, respectively. The previous year’s loss results from conversion features associated with our then outstanding debt, as well as outstanding warrants which contained contingent exercise provisions. The value of these liabilities varied directly with the trading price of our outstanding common stock. As a result of our Plan, these conversion features no longer exist, and the contingent exercise provisions associated with the warrants have been eliminated.

In connection with our emergence from bankruptcy, we entered into a $7.0 million exit financing with an accredited investor group using Roth Capital Partners, LLC as placement agent. This exit financing consists of a two year secured note which is convertible into shares of our common stock, as well as warrants which have contingent exercise provisions. The conversion features associated with the exit financing have been recorded as a derivative liability which we are required to record at fair value. The value of the liabilities varies directly with the trading price of our outstanding common stock, accounting for the current quarter gain.

Reorganization Items.

Gain on Reorganization: We recognized a gain of $0.22 million and $0.06 million for the three months ended December 31, 2011 and 2010, respectively, as a result of the settlement of our prepetition claims through our Chapter 11 proceedings. Pursuant to the Plan, holders of existing voting shares immediately before confirmation received more than fifty percent (50%) of the voting shares of the emerging entity, thus we did not adopt fresh-start reporting upon emergence from Chapter 11. We instead followed the guidance as described in ASC 852-45-29 for entities which do not qualify for fresh-start reporting. Liabilities compromised by our Plan were stated at present values of amounts to be paid, and forgiveness of debt has been reported as an extinguishment of debt resulting in the gain on reorganization.

Professional Fees: $0.02 million and $0.25 million were incurred for the quarters ending December 31, 2011 and 2010, respectively, for legal fees and U.S. Trustee fees paid as a result of our Chapter 11 proceedings. As our Plan was confirmed on November 17, 2010, our professional fees have declined considerably.

Liquidity and Capital Resources

At December 31, 2011, we had an accumulated deficit of approximately $162.6 million and working capital deficit of approximately $29.4 million. Our goal is to meet our cash requirements through additional public or private equity investment, short or long term debt financing or strategic relationships such as investments or licenses. Our ability to continue present operations and to continue our detailed analysis of our clinical trial results is dependent upon our ability to obtain significant external funding, which raises substantial doubt about our ability to continue as a going concern. The need for funds is expected to grow as we continue our efforts to commercialize both BiovaxID® and AutovaxID®. Additional sources of funding have not been established; however, additional financing is currently being sought by us 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 vaccine. Management is currently in the process of exploring various financing alternatives. 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 we determine it to otherwise be in our best interest, we may consider additional strategic financing options, including sales of assets, 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 or all of our commercialization efforts.

 

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Chapter 11 Plan of Reorganization

On November 17, 2010 (the “Effective Date”), we successfully completed our reorganization and formally exited Chapter 11 as a fully restructured organization. Through the provisions of the Plan, we were able to restructure the majority of our debt into a combination of long-term notes and equity, while preserving common stock shares held by existing stockholders. The following is a summary of certain material provisions of the Plan. The summary does not purport to be complete and is qualified in its entirety by reference to all of the provisions of the Plan.

Exit Financing

On October 19, 2010, we completed a financing as part of our Plan (the “Exit Financing”). Pursuant to the Exit Financing, we issued secured convertible notes in the aggregate original principal amount of $7.0 million (the “Initial Notes”) and warrants to purchase shares of our common stock (the “Initial Warrants”) to a total of twelve (accredited investors (the “Buyers”). Pursuant to the Exit Financing, we issued two separate types of Initial Warrants to the Buyers, Series A Warrants (the “Initial Series A Warrants”) and Series B Warrants (the “Initial Series B Warrants”).

On the Effective Date: (a) the Initial Notes were exchanged pursuant to the terms of the Plan for new unsecured convertible notes (the “Exchange Notes”) in the aggregate original principal amount of $7.04 million, (b) the Initial Series A Warrants were exchanged pursuant to the terms of the Plan for new warrants with the right to purchase an aggregate of 8,733,096 shares of our common stock (the “Series A Exchange Warrants”), and (c) the Initial Series B Warrants were exchanged pursuant to the terms of the Plan for new warrants to purchase a like number of shares of our common stock (the “Series B Exchange Warrants”). On December 22, 2010, the Series B Exchange Warrants were exercised on a cashless basis and 1,075,622 shares of our common stock were issued to the Buyers.

As of December 31, 2011, a total of $5.8 million in principal on the Exchange Notes had been converted into shares of our common stock, resulting in the issuance to the Buyers of approximately 6.9 million shares of our common stock. The remaining principal balance outstanding on the Exchange Notes is $1.3 million as of December 31, 2011.

Corps Real, LLC

On the Effective Date, we executed and delivered in favor of Corps Real, LLC (“Corps Real”), a secured convertible promissory note (the “Corps Real Note”) in an original principal amount of $2,291,560, which allows us to draw up to an additional $0.9 million on the Corps Real Note. The Corps Real Note replaces the $3.0 million secured line of credit promissory note dated December 22, 2008. The Corps Real Note matures on November 17, 2012 and all principal and accrued but unpaid interest is due on such date. The Corps Real Note is secured by a first priority lien on all of our assets. As of December 31, 2011, the outstanding principal amount of the Corps Real Note, as issued on the Effective Date, has remained unchanged.

Laurus/Valens (Class 2)

On the Effective Date, we issued two new term notes to Laurus Master Fund, Ltd. (in liquidation) (“Laurus”), PSource Structured Debt Limited (“PSource”), Valens Offshore SPV I, Ltd. (“Valens Offshore I”), Valens Offshore SPV II, Corp. (“Valens Offshore II”), Valens U.S. SPV I, LLC (“Valens U.S.) (collectively, “Valens”), and LV Administrative Services, Inc., as administrative and collateral agent for Laurus, PSource, and Valens (“LV” and together with Laurus, PSource, Valens, and each of their respective affiliates, “Laurus/Valens”). One term note, in the original aggregate principal amount of $24.9 million, was issued in compromise and satisfaction of secured claims prior to the Effective Date (the “Laurus/Valens Term A Notes”). The Laurus/Valens Term A Notes mature on November 17, 2012. The second term note, in the original aggregate principal amount of $4.16 million, was also issued in compromise and satisfaction of secured claims prior to the Effective Date (the “Laurus/Valens Term B Notes”). The Laurus/Valens Term B Notes mature on November 17, 2013. The Laurus/Valens Term A Notes and the Laurus/Valens Term B Notes are secured by a lien on all of our assets, junior only to the priority lien to Corps Real and to certain permitted liens. On November 18, 2010, we prepaid the Laurus/Valens Term A Notes in an amount equal to $1.4 million from the proceeds received from the Exit Financing (discussed above).

As of December 31, 2011, our indebtedness under the Laurus/Valens Term A Notes was $23.5 million. As of December 31, 2011, the outstanding principal amounts of the Laurus/Valens Term B Notes, as issued on the Effective Date, have remained unchanged.

 

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Unsecured Option A Obligations (Class 8)

On the Effective Date, we became obligated to certain of our unsecured creditors in the principal amount of approximately $2.7 million in cash together with interest at five percent (5%) per annum to be paid in one installment on March 27, 2014 (the “Option A Obligations”). As of December 31, 2011, the outstanding principal amounts of the Option A Obligations, as issued on the Effective Date, have increased by $0.12 million due to an amendment made to our listing of unsecured creditors, allowing a previously unfiled claim for professional services rendered with respect to our clinical trial for BiovaxID®, as well as the addition and settlement of an unsecured claim by our former landlord in St. Louis, Missouri.

Unsecured Option C Notes (Class 8)

On the Effective Date, we became obligated to certain of our unsecured creditors in the principal amount of approximately $2.0 million. Each such unsecured creditor received an amount equal to 100% of such unsecured creditors’ allowed Class 8 unsecured claim (including post-petition interest under the Plan at the rate of three percent (3%) per annum) in a combination of debt and equity resulting in the issuance of a total of $1.8 million in new notes (the “Option C Notes”), as well as 0.2 million shares of our common stock, at a conversion rate equal to $1.66 per share. The Option C Notes bear interest at seven percent (7%) and are convertible into our common stock in seven quarterly installments beginning on February 17, 2011.

At each quarterly conversion date, from February 17, 2011 through December 17, 2011, with the Ten Day VWAP at less than $1.00 per share, the holders of the Option C Notes elected to convert one-eighth of the Option C Notes plus accrued interest into shares of our common stock at a conversion rate equal to $1.00 per share, resulting in the aggregate issuance of 1,173,252 shares of our common stock.

Minneapolis, Minnesota Facility Lease

On December 2, 2010, we entered into a lease agreement (the “Lease”) with JMS Holdings, LLC (the “Landlord”) for continued use and occupancy of our existing facility in Minneapolis (Coon Rapids), Minnesota. The Lease contains provisions regarding a strategic collaboration whereby the Landlord agreed to construct certain improvements to the leased premises to allow us to perform GMP manufacturing of biologic products in the Minneapolis facility, including the manufacture of BiovaxID®. Over $1.5 million in improvements have been made to the Minneapolis facility. These improvements have been financed by us through a combination of cash on hand (approximately $0.175 million), promissory notes from the City of Coon Rapids, Minnesota and the State of Minnesota in the aggregate amount of $0.353 million (as described below), and an increase to the base rent charged in order to recoup the costs of construction incurred by the Landlord (approximately $1.0 million) over the initial term (ten years) of the Lease.

Minnesota Promissory Notes

On May 6, 2011, we closed two financing transactions with the Economic Development Authority for the City of Coon Rapids and the Minnesota Investment Fund (State of Minnesota), which provide capital to help add workers and retain high-quality jobs in the State of Minnesota. We issued two secured promissory notes in the aggregate amount of $0.353 million, which amortize over 240 months, with a balloon payment of $0.199 million due on May 1, 2021 (“Minnesota Promissory Notes”). Proceeds from the transaction in the amount of $0.353 million were used to fund capital improvements made to our existing manufacturing facility in Minneapolis (Coon Rapids), Minnesota.

Fluctuations in Operating Results:

Our 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 our customers, the timing and size of orders for instrumentation and cultureware, and the timing of increased research and development of BiovaxID®, and will be impacted by our planned marketing launch of the AutovaxID® instrument. Consequently, revenues, profits or losses may vary significantly from quarter to quarter or year to year, and revenue or profits or losses in any period will not necessarily be indicative of results in subsequent periods.

 

ITEM 3. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK

Not Applicable.

 

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ITEM 4. CONTROLS AND PROCEDURES

Evaluation of Disclosure Controls and Procedures

Under the supervision and with the participation of our management, including our chief executive officer (principal executive officer) and chief financial officer (principal financial officer), we conducted an evaluation of our disclosure controls and procedures, as such term is defined under Rule 13a-15(e) promulgated under the Securities Exchange Act of 1934, as amended (the “Exchange Act”). Based on this evaluation, our chief executive officer and chief financial officer concluded that our disclosure controls and procedures were effective as of the end of the period covered by this Quarterly Report on Form 10-Q to ensure that information required to be disclosed in the reports that we file or submit under the Exchange Act is recorded, processed, summarized and reported, within the time periods specified in the SEC’s rules and forms. These disclosure controls and procedures include controls and procedures designed to ensure that information required to be disclosed by us in the reports we file or submit is accumulated and communicated to management, including our chief executive officer and chief financial officer, as appropriate to allow timely decisions regarding required disclosure.

Changes in Internal Control Over Financial Reporting

There have been no changes in our internal control over financial reporting identified in connection with this evaluation that occurred during the quarter ended December 31, 2011 that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.

PART II.         OTHER INFORMATION

 

ITEM  1. LEGAL PROCEEDINGS

Bankruptcy proceedings:

On November 10, 2008, we, along with our subsidiaries, filed a voluntary petition for reorganization under Chapter 11 of the United States Bankruptcy Code (“Chapter 11”) in the U.S. Bankruptcy Court for the Middle District of Florida, Tampa Division (the “Bankruptcy Court”). On August 16, 2010, we filed our First Amended Joint Plan of Reorganization, and, on October 25, 2010, we filed the First Modification to the First Amended Joint Plan of Reorganization (collectively and as amended and supplemented, the “Plan”). On November 2, 2010, the Bankruptcy Court entered an Order Confirming Debtors’ First Amended Joint Plan of Reorganization Under Chapter 11 of the Bankruptcy Code (the “Confirmation Order”), which approved and confirmed the Plan, as modified by the Confirmation Order. We emerged from Chapter 11 protection, and the Plan became effective, on November 17, 2010 (the “Effective Date”). Notwithstanding the effectiveness of the Plan, the Bankruptcy Court retains jurisdiction to adjudicate any remaining issues regarding, inter alia, the validity, amount, and method of payment of claims filed in connection with our Chapter 11 proceeding. Accordingly, we anticipate that there may be ongoing proceedings before the Bankruptcy Court to resolve any filed objections or disputes as to claims filed in the Chapter 11 proceeding.

Other proceedings:

On August 4, 2008, we were served with a summons and complaint filed in California Superior Court on behalf of Clinstar LLC for breach of contract for non-payment of certain fees for clinical trial studies and pass-through expenses in the amount of $0.385 million. Upon the filing of our Chapter 11 petition on November 10, 2008, this litigation was automatically stayed pursuant to provisions of federal bankruptcy law. Clinstar filed two identical proofs of claim regarding its breach of contract for non-payment litigation in the amount of $0.385 million, one against us Company, in our bankruptcy proceeding and another against our majority shareholder, Accentia, in its bankruptcy proceeding. We, along with Accentia objected to Clinstar’s filing of Clinstar’s proofs of claim. On January 31, 2012, by order of the Bankruptcy Court, Clinstar’s proof of claim against us was denied and Clinstar’s proof of claim against Accentia was allowed. Upon the full satisfaction of Clinstar’s proof of claim against Accentia through the issuance of 283,186 shares of Accentia common stock at a conversion price of $1.36 per share as required by Accentia Bankruptcy Plan with an effective date of November 17, 2010, Clinstar shall have no further claims against us or Accentia for breach of contract for non-payment.

Except for the foregoing, we are not party to any material legal proceedings, and management is not aware of any threatened legal proceedings that could cause a material adverse impact on our business, assets, or results of operations.

 

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ITEM 1A. RISK FACTORS

There have been no material changes from the risk factors disclosed in Item 1A of Part I of our Annual Report on Form 10-K for the year ended September 30, 2011.

 

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

During the quarter ended December 31, 2011, we issued the following securities, which were not registered under the Securities Act of 1933, as amended (the “Securities Act”):

 

  1. During the three months ended December 31, 2011, pursuant to our Plan (with an effective date of November 17, 2010) and Section 1145 of the United States Bankruptcy Code, we issued an aggregate of 402,744 shares of our common stock in satisfaction of allowed claims under our Plan, with conversion prices ranging from $0.35 to $1.66 per share and issuance dates between October 1, 2011 and December 31, 2011.

 

  2. On November 29, 2011, we issued an incentive stock option award agreement (the “Gangemi Option Award”) to J. David Gangemi, Ph.D. pursuant to the October 17, 2011 Consultant Agreement between our Company and Dr. Gangemi. In consideration for services to be rendered to us by Dr. Gangemi, the Gangemi Option Award granted Dr. Gangemi an option to purchase 100,000 shares of our common stock at an exercise price of $0.39 per share and will vest upon the achievement of certain developmental milestones.

We claimed exemption from registration under the Securities Act for the issuances of securities in the transactions described in paragraph 1 above by virtue of Section 1145(a) of the United States Bankruptcy Code in that such issuances were made under our Plan in exchange for claims against, or interests in, our Company.

We claimed exemption from registration under the Securities Act for the sale and issuance of securities in the transaction described in paragraph 2 above by virtue of Section 4(2) of the Securities Act and by virtue of Rule 701 promulgated under the Securities Act, in that they were offered and sold either pursuant to a written compensatory plan or pursuant to a written contract relating to compensation, as provided by Rule 701. Such sale and issuance did not involve any public offering, were made without general solicitation or advertising, and the purchaser represented his intention to acquire the securities for investment only and not with view to or for sale in connection with any distribution thereof, and appropriate legends were (or will be) affixed to the share certificate and instrument issued (or to be issued) in such transaction. The recipient had adequate access, through his relationships with us, to information about us.

No underwriters were employed in any of the above transactions.

 

ITEM 3. DEFAULTS UPON SENIOR SECURITIES

None.

 

ITEM 4. (Removed and Reserved.)

 

ITEM 5. OTHER INFORMATION

None.

 

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ITEM 6. EXHIBITS

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

 

Exhibit
Number
 

Description of Document

31.1  

Rule 13a-14(a)/15d-14(a) Certifications of Chief Executive Officer (Principal Executive Officer).

31.2  

Rule 13a-14(a)/15d-14(a) Certifications of Acting Chief Financial Officer (Principal Financial Officer).

32.1  

18 U.S.C. Section 1350 Certifications of Chief Executive Officer.

32.2  

18 U.S.C. Section 1350 Certifications of Acting Chief Financial Officer.

  101**+   The following financial information from Biovest International, Inc.’s Quarterly Report on Form 10-Q for the quarter ended December 31, 2011, formatted in XBRL (eXtensible Business Reporting Language): (i) Condensed Consolidated Balance Sheets as of December 31, 2011 and September 30, 2011, (ii) Condensed Consolidated Statements of Operations for the three months ended December 31, 2011 and 2010, (iii) Condensed Consolidated Statements of Stockholders’ Deficit for the three months ended December 31, 2011, (iv) Condensed Consolidated Statements of Cash Flows for the three months ended December 31, 2011 and 2010, and (v) the Notes to Condensed Consolidated Financial Statements.

 

** Pursuant to Rule 406T of Regulation S-T, these interactive data files are deemed not filed or part of a registration statement or prospectus for purposes of Sections 11 or 12 of the Securities Act of 1933, are deemed not filed for purposes of Section 18 of the Securities Exchange Act of 1934, and otherwise are not subject to liability under these sections.
+ Submitted electronically with this Quarterly Report.

 

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SIGNATURES

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

 

            BIOVEST INTERNATIONAL, INC.
      (Registrant)
Date: February 10, 2012      

/s/ Samuel S. Duffey

      Samuel S. Duffey, Esq.
      Chief Executive Officer; President; General Counsel
      (Principal Executive Officer)
Date: February 10, 2012      

/s/ Brian D. Bottjer

      Brian D. Bottjer, CPA
      Acting Chief Financial Officer; Controller
      (Principal Financial Officer and Principal Accounting Officer)

 

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