|
Quotes & Info
|
| VXGN.OB > SEC Filings for VXGN.OB > Form 10-K on 18-Mar-2009 | All Recent SEC Filings |
18-Mar-2009
Annual Report
As a result of the termination of the 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.
Celltrion
Celltrion is an FDA licensed biologics manufacturing company incorporated on
February 26, 2002. Since that date, its principal activities have consisted of
design, construction and operation of a manufacturing facility in Incheon,
Republic of Korea, and partially funding the construction of our U.S.
biopharmaceutical manufacturing facility, as well as raising capital and
recruiting scientific and management personnel.
As a part of the initial capitalization of Celltrion and as part of the
Celltrion joint venture agreement we signed with various Korean entities,
including Nexol Co., Ltd., or Nexol, we made an in-kind contribution to
Celltrion of the license and sub-license of certain cell-culture technology used
for the manufacture of pharmaceutical products. We received 7.8 million shares
of Celltrion's common stock for this contribution, representing approximately
48% of the then-outstanding shares. During 2004, we adopted the provisions of
Financial Accounting Standards Board Interpretation No. 46, Consolidation of
Variable Interest Entities (as revised) - an interpretation of ARB No. 51, or
FIN 46R, and determined that Celltrion was a variable interest entity from its
inception in the first quarter of 2002 and that we were its primary beneficiary.
Accordingly, our Consolidated Financial Statements include the results of
Celltrion as a variable interest entity, effective January 1, 2004. Prior to
January 1, 2004 and our implementation of the consolidation provisions within
FIN 46R, we had reflected our investment in Celltrion in our Consolidated
Financial Statements using the equity method.
In September 2005, we entered into agreements to sell 1.2 million of our shares
in Celltrion to a group of Korean investors and raised $15.1 million in gross
proceeds. Nexol purchased 250,000 of these shares. Subsequent to this
transaction, Nexol and its affiliates, collectively, became the largest
stockholder of Celltrion. Upon this reconsideration event, we were no longer the
primary beneficiary of Celltrion and, in accordance with FIN 46R, Celltrion was
deconsolidated from our consolidated financial statements; therefore, from
July 1, 2005 through June 30, 2006, our investment in Celltrion was again
accounted for under the equity method.
During June and December 2006, we received aggregate gross proceeds of
$130.3 million from the sale of substantially all of our Celltrion common stock
to Nexol and affiliates of Nexol. As a result, we were no longer entitled to
hold two seats on Celltrion's board of directors or appoint a Representative
Director. Accordingly, we no longer had the ability to exercise significant
influence over operating and financial policies of Celltrion, and beginning
July 1, 2006, we accounted for our investment in Celltrion under the cost
method. At December 31, 2007, we held a nominal ownership interest in Celltrion.
During 2008 a public market developed for Celltrion common stock in the Republic
of Korea. Based on the market price of Celltrion common stock, the value of our
Celltrion investment was $0.3 million at December 31, 2008.
Significant Debt Transactions
In April 2005, we raised aggregate net proceeds of $29.7 million through a
private placement of $31.5 million of Notes, due April 1, 2010. During 2008 we
repurchased the $31.5 million of Notes for $25.4 million resulting in a gain
from note repurchase of $4.9 million, net of $0.6 million of unamortized
discount and $0.6 million of deferred financing costs.
Significant Equity Transaction
In February 2006, we raised net proceeds of $25.2 million through a private
placement of 3.5 million shares of common stock at $7.70 per share to a group of
accredited institutional investors. We also issued to the investors five-year
warrants initially exercisable to purchase 698,637 shares of common stock at an
exercise price of $9.24 per share. Because we did not file all of our delinquent
periodic reports with the SEC by January 31, 2007, the warrants became
exercisable for an additional 698,630 shares of common stock, at a price of
$9.24 per share.
Subsequent Events
In February 2009, a lawsuit was filed against VaxGen by plaintiffs, Oyster Point
Tech Center, LLC. The plaintiffs generally allege that the Company defaulted on
the lease on the 349 Oyster Point, South San Francisco facility. The complaint
seeks possession of the premises and the balance of lease plus unpaid rent and
expenses totaling $22.4 million, as well as an award of plaintiffs' attorneys'
fees and costs.
We may incur substantial expenses in defending against such claim, and it is not
presently possible to accurately forecast the outcome. We do not believe, based
on current knowledge, that the foregoing legal proceeding are likely to have a
material adverse effect on its financial position, results of operations or cash
flows. In the event of a determination adverse to VaxGen, we may incur
substantial monetary liability that could have a material adverse effect on the
Company's financial position, results of operations or cash flows.
CRITICAL ACCOUNTING POLICIES AND ESTIMATES
Our significant accounting policies are described in Note 2 to the Consolidated
Financial Statements included herein. Our discussion and analysis of our
operating results and financial condition are based upon our Consolidated
Financial Statements, which have been prepared in accordance with accounting
principles generally accepted in the United States of America. The preparation
of the financial statements requires us to make estimates, judgments and
assumptions that affect the reported amounts of assets, liabilities, revenues,
expenses and related disclosures. We base our estimates on historical experience
and on various other assumptions that we believe to be reasonable under the
circumstances; we review our estimates on an ongoing basis. While we believe our
estimates, judgments and assumptions are reasonable, the inherent nature of
estimates is that actual results will likely be different from the estimates
made. We believe that our critical accounting estimates have the following
attributes: (1) we are required to make judgments and assumptions about matters
that are uncertain at the time of the estimate; (2) our use of reasonably
different assumptions would change our estimates and (3) changes in estimates
could have a material effect on our financial condition or results of
operations. Our estimates, particularly estimates of the fair value of the
embedded derivatives associated with our Notes have changed significantly from
period to period. We expect that our estimates will continue to fluctuate in
future periods. Application of the following critical accounting policies and
estimates requires us to exercise judgments that affect our financial
statements.
Revenue Recognition
Substantially all of our revenues to date relate to cost-plus-fixed-fee
contractual arrangements with agencies of the U.S. government. Revenue is
recognized as work is performed, based on allowable actual costs incurred. We
generally issue invoices on a monthly basis. Under cost-plus-fixed-fee
contracts, we are reimbursed for allowable costs and receive a fixed fee, which
is negotiated and specified in the contract. Revenues for the fixed fee portion
are recognized when milestones are achieved and accepted by the customer.
Contract costs include direct and indirect research and development costs and
allowable indirect general and administrative expenses.
U.S. government contracts and subcontracts are subject to annual audit, various
profit and cost controls and standard provisions for termination at the
convenience of the U.S. government. In April 2007, our direct and indirect
contract costs were settled with the U.S. government and NIAID agreed to pay us
$11.0 million.
For non-government arrangements, the Company recognizes revenues in accordance
with SEC Staff Accounting Bulletin, or SAB, No. 104, Revenue Recognition in
Financial Statements. In such instances, revenues are recognized when there is
persuasive evidence of an arrangement, delivery has occurred or services have
been performed, the selling price to the buyer is fixed or determinable and
collectability is reasonably assured.
Property and Equipment
We estimate that the undiscounted future cash flows expected to result from the
use of these assets and compare it to the current carrying value of these
assets. Any adverse change in the estimate of these undiscounted future cash
flows could necessitate an impairment charge that would adversely affect
operating results if the fair market value of the assets is less than the net
book value. We estimate useful lives for our assets based on historical
experience, estimates of assets' commercial lives, and the likelihood of
technological obsolescence. Should the actual useful life of a class of assets
differ from the estimated useful life, we would record an impairment charge. We
review useful lives and obsolescence and we assess commercial viability of these
assets periodically.
For the year ended December 31, 2007, we recorded an impairment charge of
$10.7 million triggered by the Merger Agreement signed in November 2007 as well
as the October 2007 Lease Amendment. The impairment recognized the write-down of
the manufacturing facility, equipment, certain software and leasehold
improvements. The Company estimated the fair market value of the impaired assets
related to the Merger Agreement based on estimated realizable value upon sale of
the facility determined by discussions with sales agents and efforts to date in
the marketing of the facility; discussions with resellers relating to the
manufacturing equipment.
During 2008 the Company committed to a plan to sell the equipment and leasehold
improvements related to its California manufacturing facility. These assets met
the criteria for, and have been classified as "held for sale" in accordance with
FASB No. 144, Accounting for the Impairment or Disposal of Long-Lived Assets
("SFAS 144").
Assets Held for Sale
We use the criteria in SFAS 144 to determine when an asset is classified as
"held for sale." Upon classification as "held for sale," the long-lived asset or
asset group is measured at the lower of its carrying amount or fair value less
cost to sell, depreciation is ceased and the asset or asset group is separately
presented on the Consolidated Balance Sheets. When an asset or asset group meets
the SFAS 144 criteria for classification as held for sale within the
Consolidated Balance Sheets, we do not retrospectively adjust prior period
balance sheets to conform to current year presentation.
During 2008, we committed to a plan to sell our equipment and leasehold
improvements related to our California manufacturing facility. These assets have
met the criteria for, and have been classified as "held for sale" in accordance
with SFAS 144.
For the year ended December 31, 2008, we recorded an impairment charge of $8.8
million resulting from the lack of success in finding a buyer for our facility
and expectation of the need to dismantle to sell.
Valuation of Derivative Instruments
We value certain embedded features issued in connection with the financing of
our 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. At December 31, 2008, due to our
repurchase of the entire $31.5 million of Notes, the derivative liability was
reduced to zero.
Stock-based Compensation Expense
Effective January 1, 2006, we adopted the fair value recognition provisions of
SFAS 123R, using the modified prospective transition method, and therefore have
not restated prior periods' results. Under this method we recognize compensation
expense for all stock-based payments granted after January 1, 2006, and prior to
but not yet vested as of January 1, 2006, in accordance with SFAS 123R. Under
the fair value recognition provisions of SFAS 123R, we recognize stock-based
compensation net of an estimated forfeiture rate and only recognize compensation
cost for those shares expected to vest on a straight-line basis over the
requisite service period of the award. Prior to FAS 123R adoption, we accounted
for stock-based payments under Accounting Principles Board Opinion No. 25,
Accounting for Stock Issued to Employees, ("APB 25"), and accordingly,
recognized compensation expense for options that were granted at an exercise
price below their deemed fair market value and for modifications to options.
Determining the appropriate fair value model and calculating the fair value of
stock-based payment awards require the input of various highly-subjective
assumptions, including the expected life of the stock-based payment awards, our
stock price volatility and the expected forfeiture rate of our options.
Management determined the expected stock price volatility assumption based upon
our historical volatility. We believe this method of computing volatility is
more reflective and a better indicator of the expected future volatility, than
using an average of a comparable market index or of a comparable company in the
same industry. The expected term of options granted was derived from the
short-cut method described in SEC's Staff Accounting Bulletin No. 107. The
risk-free rate for the expected term of the option is based on the U.S. Treasury
yield curve in effect at the time of grant. The assumptions used in calculating
the fair value of stock-based payment awards represent management's best
estimates, but these estimates involve inherent uncertainties and the
application of management judgment. As a result, if factors change and we use
different assumptions, our stock-based compensation expense could be materially
different in the future. In addition, we are required to estimate the expected
forfeiture rate and only recognize expense for those shares expected to vest. If
our actual forfeiture rate is materially different from our estimate, the
stock-based compensation expense could be significantly different from what we
have recorded in the current period. See Notes 2 and 11 to the Consolidated
Financial Statements for more information regarding stock-based compensation.
Income Taxes
In July 2006, the Financial Accounting Standards Board, or FASB, issued FASB
Interpretation No. 48, Accounting for Uncertainty in Income Taxes - an
interpretation of FASB Statement No. 109 ("FIN 48"). Effective January 1, 2007,
we adopted FIN 48 and FIN 48-1; see Note 12 to the Consolidated Financial
Statements for more information regarding our income tax policies. We have filed
tax returns with positions that may be challenged by the tax authorities. These
positions relate to, among others, deductibility of certain expenses, expenses
included in our research and development tax credit computations, as well as
other matters. Although the outcome of tax audits is uncertain, in management's
opinion, adequate provisions for income taxes have been made for potential
liabilities resulting from such matters. We regularly assess the tax positions
for such matters and include reserves for those differences in position. The
reserves are utilized or reversed once the statute of limitations has expired
and/or at the conclusion of the tax examination. We believe that the ultimate
outcome of these matters will not have a material impact on our financial
position, financial operations or liquidity.
RESULTS OF OPERATIONS
Comparison of Years Ended December 31, 2008, 2007 and 2006
Revenue
Year Ended December 31, Annual Percent Change
2008 2007 2006 2008/2007 2007/2006
(in thousands)
Research contracts and grants $ - $ 4,098 $ 13,205 -100 % -69 %
Other services 293 913 - -68 % *
Related party services - - 1,631 * -100 %
Total revenues $ 293 $ 5,011 $ 14,836 -94 % -66 %
|
* Calculation not meaningful
Revenues for 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. Revenue for 2007 was primarily driven by expensed activity reimbursed by the U.S. government. Research contracts and grants revenue in 2007 primarily related to the reimbursement of restructuring costs resulting from the termination of our SNS Contract in December 2006. Research contracts and grants revenue in 2006 primarily related to work performed under our Anthrax contracts. Related party services revenues in 2006 were earned as part of a consulting services agreement with Celltrion to provide technical assistance related to the design, engineering and construction of Celltrion's manufacturing facility. The amounts earned vary with the level of services required. We provided $0.9 million of services to Celltrion in 2007, which is included in other services revenue, as Celltrion is no longer considered to be a related party due to our sale of substantially all of our investment in Celltrion during 2006. Revenues earned in one period are not indicative of revenues to be earned in future periods. We do not expect any revenues in 2009. Research and development expenses
Year Ended December 31, Annual Percent Change
2008 2007 2006 2008/2007 2007/2006
(in thousands)
Research and development
expenses $ 1,387 $ 19,653 $ 49,001 -93 % -60 %
|
Research expenses include costs associated with research and testing of our
product candidates prior to reaching the development stage and include the costs
of internal personnel, outside contractors, allocated overhead and laboratory
supplies. Product development expenses include costs of preclinical development
and conducting clinical trials, costs of internal personnel, drug supply costs,
research fees charged by outside contractors, allocated overhead and
co-development costs. Since inception, our research and development activities
have been concentrated upon the development, manufacture and commercialization
of biologic products for the prevention and treatment of human infectious
disease. In 2008 and 2007, these costs primarily related to maintaining our
manufacturing facility and prior research findings in support of our evaluation
of various strategic transactions. We ceased research and development activities
during the first quarter of 2008.
The decrease in research and development expenses in 2008 compared to 2007 was
primarily due to:
• Labor and related expenses, which decreased by $5.8 million primarily due
to no research and development expenses incurred after the first quarter
of 2008 and decreased headcount following multiple reductions in force
during 2007 and 2008; and
• Facilities and overhead costs, which decreased by $12.4 million due to reduced operations and consolidation of facilities during the first quarter of 2008 and no research and development expenses incurred after the first quarter of 2008.
The decrease in research and development expenses in 2007 compared to 2006 was
primarily due to:
• Labor and related expenses, which decreased by $10.9 million primarily due
to decreased headcount following multiple reductions in force during 2007;
• Facilities overhead costs, which decreased by $7.9 million due to reduced operations;
• Consultant and outside labor costs, which decreased by $6.5 million due to reduced operations; and
• Allocated overhead costs, which decreased by $4.1 million primarily due to reduced operations.
We expect to incur no research and development expenses during 2009. General and administrative expenses
Year Ended December 31, Annual Percent Change
2008 2007 2006 2008/2007 2007/2006
(in thousands)
General and
administrative expenses $ 12,700 $ 20,437 $ 27,683 -38 % -26 %
|
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 2008 compared to 2007 was
primarily due to:
• Labor and benefits, which decreased by $2.4 million primarily associated
with the 2007 and 2008 reductions in force; and
• Consultant and outside labor costs, which decreased by $4.5 million due to non-recurring costs incurred during 2007 to file multiple SEC filings.
The decrease in general and administrative expenses in 2007 compared to 2006 was
primarily due to:
• Labor and related expenses, which decreased by $5.6 million primarily due
to decreased headcount following multiple reductions in force during 2007;
• Consultant and outside labor costs, which decreased by $2.9 million due to reduced operations and reimbursements to Celltrion for their costs for U.S. GAAP audits and reviews performed on our behalf, which decreased by $1.4 million;
• Facilities, supplies and other expenses, which decreased by $2.8 million as we eliminated facilities and reduced operations; and
• Partially offset by allocations to research and development expense for facilities and other overhead costs, which decreased $4.1 million (which increased general and administrative expenses).
We expect quarterly general and administrative expenses to decrease during 2009
due to our 2008 reductions in force and the termination of our proposed merger
agreement with Raven.
Impairment of Assets Held for Sale
Year Ended December 31, Annual Percent Change
2008 2007 2006 2008/2007 2007/2006
(in thousands)
Impairment of assets
held for sale $ 8,848 $ - $ - * *
|
* Calculation not meaningful
Based on the lack of success in finding a buyer for our facility and the expectation of a need to dismantle to sell, we performed impairment assessments of our manufacturing facilities at 349 Oyster Point Blvd., South San Francisco, during 2008. Based on these assessments, we estimated that the fair market values of these assets were less than the carrying values of these assets by $8.8 million, which was recorded as an impairment of assets held for sale in the statement of operations for the year ended December 31, 2008. The impairment includes all leasehold improvements relating to the facility of approximately $6.5 million, as these items are not expected to have any future economic . . .
|
|