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| VXGN.OB > SEC Filings for VXGN.OB > Form 10-K on 18-Mar-2008 | All Recent SEC Filings |
18-Mar-2008
Annual Report
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. We do not expect these savings to be materially offset by any anticipated
increases in other expenses.
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. Costs of
the restructuring were $1.1 million. The cash outflow of this RIF was
$0.9 million during 2007 and is expected to be $0.2 million during 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 October 2007, we amended our lease agreement, dated October 26, 1998. The
Lease Amendment calls for us to relinquish occupancy of one of our two buildings
subject to the lease, effective March 1, 2008. The Lease Amendment will reduce
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 the Merger Agreement with 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. Upon the terms and subject to the conditions set forth in
the Merger Agreement, we will issue, and holders of Raven Series D preferred
stock will receive, approximately 32 million shares of our common stock (subject
to adjustment in certain conditions as described in the Merger Agreement), such
that following the consummation of the transactions contemplated by the Merger
Agreement, our current stockholders will own approximately 50.9% of the combined
company and current Raven Series D preferred stockholders will own approximately
49.1% of the combined company. The merger is intended to qualify as a tax-free
reorganization under the provisions of Section 368(a) of the Code. The merger is
subject to customary closing conditions, including approval by our stockholders.
A special meeting of our stockholders has been called for March 28, 2008 to vote
on, among other things, a proposal to approve the issuance of our shares in the
proposed merger. If approved by stockholders, the merger is expected to close
in early April 2008.
The October 2007 Lease Amendment and the November 2007 announcement of the
proposed merger with Raven acted as triggers for an assessment of an impairment
of our equipment and leasehold improvements in our California manufacturing and
office facilities. Based on the impairment analysis performed, we recorded an
impairment charge of $10.7 million for the quarter ended December 31, 2007. The
impairment charge primarily includes $6.2 million relating to the write-down of
our manufacturing facility to fair market value based on discussions with sales
agents and our attempts to market the facility previously, and $3.2 million
relating to the anticipated sale or abandonment of software and other
information technology assets and their consequential write-down to fair market
value.
Because our stockholders will own approximately 50.9% of the voting stock of the
combined company after the merger and have four out of seven Board seats, we
expect to be the acquiring company for accounting purposes in accordance with
accounting principles generally accepted in the United States. Accordingly, the
assets and liabilities of Raven will be recorded as of the merger closing date
at their estimated fair values.
Celltrion
Celltrion, Inc., or Celltrion, is a development stage 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.
Prior to implementing the consolidation provisions within FIN 46R, we had
reflected our investment in Celltrion in our Consolidated Financial Statements
using the equity method. All comparative financial data included in this report
for periods prior to January 1, 2004 reflects our accounting for Celltrion as an
equity method investee and consolidates the accounts of Celltrion from
January 1, 2004 through June 30, 2005.
In September 2005, we entered into agreements to sell 1.2 million of our shares
in Celltrion to a group of Korean investors and raise $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 to 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 and 2006, we held a nominal ownership interest in
Celltrion.
Significant Debt Transaction
In April 2005, we raised aggregate net proceeds of $29.7 million through a
private placement of $31.5 million of Convertible Senior Subordinated Notes, or
Notes, due April 1, 2010. The Notes have the following terms:
• semi-annual payments of interest in cash at a rate of 5 1/2%, due April
1 and October 1;
• convert, at the option of the holder, into shares of our common stock at an initial conversion price of $14.76 per share subject to adjustment;
• provisionally redeemable at our option for a redemption price of 100% of the principal amount of the Notes to be redeemed, plus accrued and unpaid interest, plus an interest make-whole payment, under certain circumstances, including among others, that the closing price of our common stock has exceeded $22.14 per share, subject to adjustment, for at least 20 trading days within a period of 30 consecutive trading days;
• constitute our senior subordinated obligations; and
• if a change in control occurs, as defined in the indenture, on or prior to the stated maturity of the Notes, in certain circumstances the holders of the Notes may require us to repurchase the Notes and pay a make-whole premium to the holders of the Notes. If the stock price on the effective date of redemption is less than $12.30 per share, no make-whole premium will be paid. If the holders request such a repurchase, we or our successor entity, may choose to pay in cash, common stock or a combination of cash and common stock. This feature constitutes a put-option derivative liability.
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.
Bridge Loan
In November 2007, we entered into a loan agreement with Raven, or Bridge Loan,
which provides for us to lend Raven up to $6 million in the aggregate, beginning
December 1, 2007. Under the Bridge Loan, we are obligated to provide monthly
loan advances to Raven based on a schedule attached to the Bridge Loan. Our
obligations to make loan advances to Raven will end on the earliest to occur of
(1) the closing of the merger, (2) April 1, 2008, (3) 30 days after a
termination of the Merger Agreement other than for breach, or (4) immediately if
we terminate the Merger Agreement, either because of a breach by Raven or
because we decide to pursue an alternative transaction as permitted in the
Merger Agreement and we pay the $2 million break up fee specified in the Merger
Agreement.
The loans to be made under the Bridge Loan are intended to provide working
capital for Raven's business operations and its continued development of its
technology. The loans will not be used for transaction expenses or for severance
or retention of Raven employees.
Upon the closing of the merger, the loans will be forgiven. If the merger does
not close and Raven has not breached the Merger Agreement and neither party has
elected to pursue an alternative transaction, then the loans are to be repaid in
full on June 1, 2009. If the Merger Agreement is terminated because of a breach
by Raven, then the loans are subject to repayment 60 days after termination. If
the Merger Agreement is terminated because Raven has determined to pursue an
alternative transaction, the loans are subject to repayment on the earlier of
10 days after the termination or the closing of the Raven alternative
transaction. The loans are subject to repayment in full if there is an event of
default under the promissory note. The loans are also subject to mandatory
prepayment if the merger does not close and Raven obtains equity or debt
financing. In that event, the amount of prepayment will be 10% of the amount of
the proceeds of any equity or debt financing up to $5 million, and will be 20%
of the amount of the proceeds of any equity or debt financing in excess of
$5 million.
The loans are subordinated to the interests of Raven's senior lender, Venture
Lending and Leasing, or VLL. The loans are senior to the loans made by Raven's
Series D preferred stockholders under a note purchase agreement between such
stockholders and Raven dated November 12, 2007. At any time, we can prepay the
amount of indebtedness that Raven owes to VLL, and upon such repayment, the
loans will be increased by the amount paid to VLL and the loans will
automatically become secured by all of Raven's intellectual property. At
December 31, 2007, we had loaned Raven $1.3 million under the Loan Agreement.
Subsequent Events
Bridge Loan to Raven
In January and February 2008, we loaned Raven an additional $1.4 million and
$1.4 million, respectively, under the Bridge Loan (see Note 4 to the
Consolidated Financial Statements).
Note Repurchase
In February 2008, we repurchased two of our Notes due in 2010 in an aggregate
principal amount of $1.5 million at a purchase price of $0.8 million, plus
accrued interest.
Second Merger Amendment
In February 2008, we entered into Amendment No. 2 to the Merger Agreement,
whereby the parties decreased our guaranteed closing cash balance from
$64.0 million to $63.2 million in recognition of our repurchase of $1.5 million
principal amount of our outstanding Notes.
Registration of Shares
In February 2008, our registration statement on Form S-1 became effective.
CRITICAL ACCOUNTING POLICIES AND ESTIMATES
Our significant accounting policies are described in Note 2 to the Consolidated
Financial Statements. 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 and we expect that such
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
collectibility is reasonably assured.
Property and Equipment
We have a significant investment in long-lived 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; and the depreciation of software over the remaining
estimated useful life prior to abandonment, which is expected in May 2008.
Because the leasehold improvements related to the building being vacated under
the Lease Amendment were abandoned upon vacating the building in February 2008,
the fair market value of these assets as of December 31, 2007 was estimated
based on the depreciation of these assets for the remaining two months of their
useful lives.
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. Note that a merger with Raven would not be
considered a change of control for this purpose. We assessed the probability of
a change in control at 40% at December 31, 2007. A 5% increase or decrease in
this assumption would result in a change in fair value of the derivative
liability of approximately $0.3 million to $0.4 million. Changes in value are
recorded as non-cash valuation adjustments within other income (expense) in our
consolidated statements of operations. At December 31, 2007, we estimated the
fair value of the derivative liability associated with the Notes to be
$3.5 million.
Stock-based Compensation Expense
Effective January 1, 2006, we adopted the fair value recognition provisions of
FAS 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 FAS 123R. Under the
fair value recognition provisions of FAS 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, or 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 10 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, or FIN 48. Effective January 1, 2007,
we adopted FIN 48 and FIN 48-1; see Note 11 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, 2007, 2006 and 2005
Revenue
Year Ended December 31, Annual Percent Change
2007 2006 2005 2007/2006 2006/2005
(in thousands)
Research contracts and grants $ 4,098 $ 13,205 $ 29,073 (69 %) (55 %)
Other services 913 - - * *
Related party services - 1,631 866 (100 %) 88 %
Total revenues $ 5,011 $ 14,836 $ 29,939 (66 %) (50 %)
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* Calculation not meaningful.
Revenue 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 and 2005 primarily related to work performed under our Anthrax Contracts. These revenues decreased from 2005 to 2006 as a result of the timing of our anthrax development activities, which were decreasing throughout 2006 as our activities transitioned from the cost-plus Anthrax Contracts to the SNS Contract. Related party services revenues in 2006 and for the last six months of 2005 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. Related party services revenues for the first six months of 2005 were eliminated due to the consolidation of Celltrion. Celltrion did not earn any revenues during the period of consolidation of their results with those of the Company through June 30, 2005. 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 . . .
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