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VXGN.OB > SEC Filings for VXGN.OB > Form 10-Q on 14-Aug-2008All Recent SEC Filings

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Form 10-Q for VAXGEN INC


14-Aug-2008

Quarterly Report


ITEM 2. MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
Special Note Regarding Forward-Looking Statements This discussion and analysis should be read in conjunction with our Annual Report on Form 10-K for the year ended December 31, 2007, and our unaudited condensed consolidated financial statements and related notes thereto appearing in Item 1 of this Quarterly Report on Form 10-Q. In addition to the other information contained or incorporated by reference in this Quarterly Report on Form 10-Q, you should carefully consider the risk factors described in Part II - Item 1A herein when evaluating an investment in our common stock. This Quarterly Report includes "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933, or Securities Act, and Section 21E of the Securities Exchange Act of 1934, or Exchange Act. All statements other than statements of historical fact are "forward-looking statements" for purposes of these provisions, including any statements of the plans and objectives of management for future operations, any statements regarding future operations, any statements concerning proposed new products or services, any statements regarding pending or future mergers or acquisitions, any statements regarding future economic conditions or performance, and any statement of assumptions underlying any of the foregoing. In some cases, forward-looking statements can be identified by the use of terminology such as "may," "will," "expects," "plans," "anticipates," "estimates," "potential" or "continue" or the negative thereof or other comparable terminology.
There can be no assurance that such expectations or any of the forward-looking statements will prove to be correct, and actual results could differ materially from those projected or assumed in the forward-looking statements. Our forward-looking statements are subject to inherent risks and uncertainties including, but not limited to, the risk factors set forth in this Quarterly Report. Factors that could cause or contribute to such differences include, but are not limited to, our limited cash resources, our ability to finance our research, our significant corporate and Securities and Exchange Commission, or SEC, related expenses and limited revenue to offset these expenses, availability of appropriate prospective acquisitions or investment opportunities, litigation and the risks discussed in our other SEC filings. All forward-looking statements and reasons why results may differ included in this Quarterly Report are made as of the date hereof, and we assume no obligation to update any such forward-looking statement or reason why actual results might differ. When used in the report, unless otherwise indicated, "we," "our" and "us" refers to VaxGen.
OVERVIEW
We are a biopharmaceutical company focused on the development, manufacture and commercialization of biologic products for the prevention and treatment of human infectious disease. We were incorporated in 1995 and formed to complete the development of an investigational recombinant protein vaccine intended to prevent infection by human immunodeficiency virus. In 2002, we broadened our product development portfolio to also include biodefense vaccines. On August 6, 2004, we announced that we had received notification from Nasdaq that our stock would discontinue trading on Nasdaq effective August 9, 2004. This action followed our appeal to Nasdaq for a listing extension after not meeting the stated time requirements to file Quarterly Reports on Form 10-Q for the quarters ended March 31 and June 30, 2004, respectively. We became current again in our filing of reports with the SEC on October 4, 2007. Our common stock is currently quoted on the OTC Bulletin Board under the symbol VXGN.OB. In September 2002, we were awarded a $20.9 million cost-plus contract, or 2002 Anthrax Contract, from the National Institute of Allergy and Infectious Diseases, or NIAID, to develop a new anthrax vaccine candidate and to create a feasibility plan for how we would manufacture an emergency stockpile of 25 million doses of the vaccine. On September 30, 2003, NIAID awarded us a second cost-plus contract, or 2003 Anthrax Contract, valued at $80.3 million for the advanced development of our anthrax vaccine candidate, collectively referred to as Anthrax Contracts.
In November 2004, we were awarded a contract for $877.5 million to provide 75 million doses of our recombinant anthrax vaccine, or rPA102, to the U.S. government Strategic National Stockpile, or SNS, for civilian defense, or SNS Contract. In November 2006, we received a clinical hold notification from the Food and Drug Administration, or FDA, that postponed the initiation of the second Phase 2 trial for rPA102. On December 19, 2006, the U.S. Department of Health and Human Services, or HHS, terminated for default the SNS Contract. HHS based the decision on its determination that we "failed to successfully cure the condition endangering performance and failed to" meet a milestone imposed by HHS that required us to initiate a clinical trial of the vaccine candidate by December 18, 2006. Following the HHS decision, we ceased actively developing rPA102, scaled back our biodefense activities and are actively pursuing strategic and other alternatives.
In December 2006, we announced the termination of the SNS Contract by HHS. As a result, we implemented a reduction in force, or RIF, in January 2007. The cash outflow of the RIF was $3.5 in 2007. Beginning in April 2007, wage savings per month were $0.7 million and $0.2 million, respectively, for Research and Development, or R&D, and General and Administrative, or G&A. In addition, we did not renew an office space lease that expired at the end of May 2007. This lease, coupled with utilities and maintenance, reduced expenses by $0.2 million per month.
In May 2007, we further reduced our workforce to decrease operating costs. The cash outflow of this RIF was $0.6 million during 2007. This RIF mostly impacted R&D. Beginning in July 2007, additional wage savings were $0.1 million per month. The RIFs in January 2007 and May 2007 have reduced our cash disbursements by approximately $1.2 million per month since June 30, 2007. We do not expect these savings to be materially offset by any anticipated increases in other expenses.


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In June 2007, we terminated by mutual consent our agreement with the Chemo-Sero-Therapeutic Research Institute of Japan, or Kaketsuken, to co-develop a next-generation, attenuated smallpox vaccine, LC16m8, for use in the United States and elsewhere. Under the terms of the termination agreement, we transferred to Kaketsuken or its designee all reports, data and materials and all intellectual property rights that relate to conducting non-clinical and clinical development of LC16m8 in the U.S. In return, Kaketsuken has released us from all ongoing obligations.
In September 2007, we further reduced our workforce to decrease operating costs. Restructuring costs included employee termination and benefit costs. The estimated cash outflow of this RIF is $1.1 million. The cash outflow of this RIF was $0.9 million during 2007 and $0.3 million during the six months ended June 30, 2008. Beginning in October 2007, additional wage savings were $0.3 million per month. We do not expect these savings to be materially offset by any anticipated increases in other expenses.
In April 2008, the Company restructured its workforce to reduce operating expenses as a result of the termination of the proposed merger between VaxGen and Raven by decreasing its workforce of twenty-two employees by approximately 75 percent. During the second quarter of 2008, the Company incurred and paid restructuring costs of $1.0 million for one-time employee termination costs associated with this action.
The following table summarizes the restructuring charges and expenditures relating to the 2007 and 2008 restructurings (in thousands):

                                                             Consolidation
                                                               of Excess
                                             Workforce      Facilities and
                                             Reduction           Other           Total
  Restructuring Costs
  Costs incurred                            $     4,368     $         1,006     $  5,374
  Amounts paid                                   (4,068 )            (1,006 )     (5,074 )

  Balance accrued as of December 31, 2007           300                   -          300
  Costs incurred                                    985                   -          985
  Amounts paid                                   (1,285 )                 -       (1,285 )

  Balance accrued as of June 30, 2008       $         -     $             -     $      -

In October 2007, we amended our lease agreement, dated October 26, 1998, or Lease Amendment. Per the Lease Amendment, we relinquished our occupancy of one of our two buildings subject to the lease on March 1, 2008. The Lease Amendment reduced our lease obligations by $12.2 million over the remaining lease term, which runs through December 31, 2016. We paid a surrender fee to the landlord of $0.1 million. Under the Lease Amendment, the amount of the $2.4 million letter of credit we delivered in favor of the landlord was reduced by $1.0 million, with further reductions over the remaining term of the lease upon our achievement of financial benchmarks.
In November 2007, we entered into an Agreement and Plan of Merger, as amended in December 2007 and February 2008, or Merger Agreement, with Raven biotechnologies, inc., or Raven. Raven is a private, development stage biopharmaceutical company focused on the discovery, development and commercialization of monoclonal antibody-based products for the treatment of cancer.
On March 28, 2008, we entered into a Termination of Merger Agreement, Acknowledgment and Amendment to Loan Agreement and Secured Promissory Note (the "Termination Agreement and Amendment"), terminating the Agreement and Plan of Merger between Raven and two of our wholly-owned subsidiaries and amending the terms of our bridge loan to Raven. The balance on the loan was $6.0 million as of June 30, 2008 which was repaid in full by Raven in July 2008. Under the Termination Agreement and Amendment, the parties mutually agreed to terminate the Merger Agreement effective immediately. The Company recorded $2.3 million of costs, primarily professional fees, related with the proposed merger during the six months ended June 30, 2008.
As a result of the termination of proposed merger with Raven, the Company is considering various alternate strategic transactions to return value to its stockholders. If the Company is unable to identify and complete an alternate strategic transaction, the Company will liquidate. The financial statements do not include any adjustments that might result from the outcome of this uncertainty.
On May 2, 2008, we completed the sale of all assets and rights related to its recombinant protective antigen (rPA) anthrax vaccine product candidate and related technology to Emergent BioSolutions, Inc., or Emergent. Under the terms of the transaction, Emergent paid us $2 million upon execution of the definitive agreement and may be obligated to pay up to an additional $8 million in milestone payments, plus specified percentages of future net sales. On July 31, 2008, the Company was notified by Emergent that conditions had been satisfied that triggered a $1.0 million milestone payment from Emergent to VaxGen in relation to this transaction. This payment will be recorded as other income in the third quarter of 2008.


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In July 2008, the Company repurchased $22.0 million principal amount of its convertible senior subordinated notes at a purchase price of $18.0 million plus $0.3 million in accrued interest. As a result of these transactions, the Company will record in other income a gain on note redemptions of $3.5 million in the third quarter of 2008.
Celltrion
For the six months ended June 30, 2006, our investment in Celltrion, Inc., or Celltrion, a company developing and operating a mammalian cell culture biomanufacturing facility in the Republic of Korea, was accounted for under the equity method. At June 30, 2006, our ownership interest in Celltrion was 8%. During June and December 2006, we received gross proceeds of $130.3 million from the sale of substantially all of our Celltrion common stock. At December 31, 2007 and June 30, 2008, we held a nominal ownership interest in Celltrion.
CRITICAL ACCOUNTING POLICIES AND ESTIMATES Reference should be made to Item 7, Management's Discussion and Analysis of Financial Condition and Results of Operations, in our Annual Report on Form 10-K for the fiscal year ended December 31, 2007, filed with the SEC in March 2008, for a description of our critical accounting policies. There have been no significant changes to our policies since we filed that report, other than those mentioned below.
Assets Held for Sale
The Company considers an asset held for sale when all of the following criteria per SFAS 144, Accounting for the Impairment or Disposal of Long-Lived Assets, ("SFAS 144") are met:
a) Management commits to a plan to sell the asset;

b) The asset is available for immediate sale in its present condition;

c) An active marketing plan to sell the asset has been initiated at a reasonable price;

d) The sale of the asset is probable within one year; and,

e) It is unlikely that significant changes to the plan to sell the asset will be made.

Upon designation of a property as an asset held for sale and in accordance with the provisions of SFAS 144, the Company records the carrying value of the property at the lower of its carrying value or its estimated fair market value, less estimated selling costs, and the Company ceases depreciation of the asset. All losses and gains on assets sold and held for sale (including any related impairment charges) are included in "loss from operations" in the Condensed Consolidated Statement of Operations. All assets held for sale and the liabilities related to these assets are separately disclosed in the Condensed Consolidated Balance Sheet. The amount the Company will ultimately realize could differ from the amount recorded in the financial statements. Adoption of SFAS 157
Effective January 1, 2008, the Company adopted the provisions of SFAS No. 157, Fair Value Measurement ("SFAS 157") with respect to its financial assets and liabilities only. Effective January 1, 2008, the Company also adopted SFAS No. 159, The Fair Value Option for Financial Assets and Financial Liabilities - Including an Amendment of FASB Statement No. 115 ("SFAS 159"), which permits entities to choose to measure many financial instruments and certain other items at fair value that are not currently required to be measured at fair value. The Company did not elect to adopt the fair value option under SFAS 159. SFAS 157 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 at the measurement date. SFAS 157 establishes a three-level fair value hierarchy that prioritizes the inputs used to measure fair value. This hierarchy requires entities to maximize the use of observable inputs and minimize the use of unobservable inputs. The three levels of inputs used to measure fair value are as follows:
• Level 1 - Quoted prices in active markets for identical assets or liabilities.

• Level 2 - Inputs other than quoted prices included in Level 1, such as quoted prices for similar assets and liabilities in active markets; quoted prices for identical or similar assets and liabilities in markets that are not active; or other inputs that are observable or can be corroborated by observable market data.

• Level 3 - Unobservable inputs that are supported by little or no market activity and that are significant to the fair value of the assets or liabilities. This includes certain pricing models, discounted cash flow methodologies and similar techniques that use significant unobservable inputs.


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Our adoption of SFAS 157 did not have a material impact on our consolidated financial statements. The Company has segregated all financial assets and liabilities that are measured at fair value on a recurring basis (at least annually) into the most appropriate level within the fair value hierarchy based on the inputs used to determine the fair value at the measurement date in the table below.
Our cash equivalents and investments are classified within Level 1 or Level 2 of the fair value hierarchy because they are valued using quoted market prices in active markets, broker or dealer quotations, or alternative pricing sources with reasonable levels of price transparency. The types of instruments valued based on quoted market prices in active markets include most U.S. government and agency securities, sovereign government obligations, and money market securities. Such instruments are generally classified within Level 1 of the fair value hierarchy.
The types of instruments valued based on other observable inputs include investment-grade corporate bonds, mortgage-backed and asset-backed products, state, municipal and provincial obligations. Such instruments are generally classified within Level 2 of the fair value hierarchy.
We value certain embedded features issued in connection with the financing of our Convertible Notes in 2005 as a derivative liability. We estimate the fair value of our derivative liability each quarter using the Monte Carlo Simulation methodology. This methodology allows flexibility in incorporating various assumptions such as probabilities of certain triggering events. The valuations are based on the information available as of the various valuation dates. Factors affecting the amount of this liability include the market value of our common stock, the estimated volatility of our common stock, our market capitalization, the risk-free interest rate and other assumptions such as the probability of a change in control event. Of these valuation parameters, management's assessment of the probability of a change in control is the most subjective and also has the greatest influence on fair value. Changes in value are recorded as non-cash valuation adjustments within other income (expense) in our consolidated statements of operations. The derivative is classified within level 3 of the fair value hierarchy.
Based on the results of our fair value measurement of our derivative liability, we recognized a valuation gain of $0.7 million and valuation loss of $1.0 million for the three and six months ended June 30, 2008, respectively, which was included in other income (expense), net in our condensed consolidated statements of operations. The carrying value of our derivative liability was $4.5 million as of June 30, 2008.

RESULTS OF OPERATIONS
Comparison of Fiscal Quarters and Six Months Ended June 30, 2008 and 2007
Revenues


                   Three Months Ended         Percent         Six Months Ended         Percent
                        June 30,               Change             June 30,              Change
                  2008           2007        2008/2007       2008          2007       2008/2007
                     (in thousands)


Revenues $ 15 $ 198 -92 % $ 293 $ 4,382 -93 %

Revenues for the six months ended June 30, 2008 were from service revenues earned as part of a consulting services agreement with Celltrion to provide technical assistance related to the design, engineering and start-up of Celltrion's manufacturing facility. VaxGen recognized $15,000 and $0.2 million from Celltrion during the three months ended June 30, 2008 and 2007, respectively; and $0.3 million and $0.5 million from Celltrion during the six months ended June 30, 2008 and 2007, respectively. Revenues for the six months ended June 30, 2007 include $3.9 million from our Anthrax Contracts principally reflecting the 2007 reimbursement of restructuring costs as a result of the termination of the Anthrax Contracts in December 2006.
Revenues earned in one period are not indicative of revenues to be earned in future periods. Following the HHS decision to terminate its contract with us, we ceased actively developing our anthrax vaccine, scaled back our biodefense activities and are actively pursuing strategic and other alternatives; therefore, we are unable to predict revenues, if any, for the remainder of 2008. Research and development expenses

                              Three Months Ended            Percent           Six Months Ended          Percent
                                   June 30,                  Change               June 30,               Change
                            2008             2007          2008/2007         2008          2007        2008/2007
                                (in thousands)                                 (in thousands)
Research and

development expenses $ - $ 4,836 -100 % $ 1,387 $ 11,925 -88 %


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Research expenses include the costs of internal personnel, outside contractors, allocated overhead and laboratory supplies. The Company ceased operations during the first quarter of 2008 and therefore no research and development expenses were incurred during the second quarter of 2008. Research and development expenses during the second quarter of 2007 included $1.5 million of labor and related expenses, and $3.3 million of facilities and overhead costs. The decrease in research and development expenses in the six months ended June 30, 2008 over the comparable period in 2007 was primarily due to:
• Labor and related expenses, which decreased by $3.3 million primarily due to no research and development expenses during the second quarter of 2008 and decreased headcount following multiple reductions in force during 2007; and

• Facilities and overhead costs, which decreased by $7.4 million due to reduced operations and consolidation of facilities during the first quarter of 2008 and no research and development expenses during the second quarter of 2008.

We expect to incur no research and development expenses during the remainder of 2008.
General and administrative expenses

                             Three Months Ended          Percent           Six Months Ended          Percent
                                  June 30,                Change               June 30,               Change
                             2008           2007        2008/2007         2008          2007        2008/2007
                               (in thousands)
General and
administrative

expenses $ 3,545 $ 4,796 -26 % $ 8,945 $ 11,374 -21 %

General and administrative expenses consist primarily of compensation costs, occupancy costs including depreciation expense, fees for accounting, legal and other professional services and other general corporate expenses. The decrease in general and administrative expenses in the three months ended June 30, 2008 over the comparable period of 2007 was primarily due to lower consultant and outside labor costs which decreased $1.4 million in the three months ending June 30, 2008 versus the comparable 2007 period resulting from non-recurring costs incurred during the second quarter of 2007 to file multiple SEC filings.
The decrease in general and administrative expenses in the six months ended June 30, 2008 over the comparable period of 2007 was primarily due to:
• Labor and benefits, which decreased by $0.9 million primarily associated with the 2007 and 2008 reductions in force; and

• Consultant and outside labor costs, which decreased by $1.9 million due to non-recurring costs incurred during the first six months of 2007 to file multiple SEC filings.

We expect quarterly general and administrative expenses to decrease during the remainder of 2008 due to our 2007 and 2008 reductions in force and the termination of our proposed merger agreement with Raven. Restructuring expenses

                             Three Months Ended           Percent           Six Months Ended          Percent
                                  June 30,                 Change               June 30,               Change
                            2008            2007         2008/2007         2008          2007        2008/2007
                               (in thousands)

Restructuring expenses $ 985 $ 566 74 % $ 985 $ 4,283 -77 %

During the three months ended June 30, 2008 and June 30, 2007, we reduced our workforce to reduce operating costs. Restructuring costs included employee termination and benefit costs. Restructuring expenses for the six months ended June 30, 2007 also reflect a reduction in January 2007. The January 2007 restructuring costs include $2.7 million for employee termination benefits and $1.0 million for costs associated with consolidation of our facilities in California.


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Impairment of assets held for sale

                               Three Months Ended            Percent             Six Months Ended            Percent
                                    June 30,                  Change                 June 30,                 Change
                              2008             2007         2008/2007          2008             2007        2008/2007
                                 (in thousands)
Impairment of assets

held for sale $ 8,498 $ - 100 % $ 8,498 $ - 100 %

Based on the lack of success in finding a buyer for its facility and expectation of need to dismantle to sell, the Company performed an impairment assessment of the facility as of June 30, 2008. At June 30, 2008, the Company estimated that the fair market values of these assets were less than the carrying values of these assets by $8.5 million, which was recorded as an impairment of assets held for sale in the statement of operations for the three and six months ended June 30, 2008. The impairment includes all leasehold improvements relating to the facility of approximately $6.5 million, as these items will have no future economic benefit. The Company used the market approach to determine fair market value of its assets held for sale.
Other income (expense)

                                           Three Months Ended          Six Months Ended
                                                June 30,                   June 30,
                                            2008          2007         2008         2007
                                             (in thousands)             (in thousands)
   Interest expense                      $     (601 )    $  (612 )   $ (1,369 )   $ (1,223 )
   Interest income                              534        1,279        1,249        2,519
. . .
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