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| AVRO.OB > SEC Filings for AVRO.OB > Form 10-Q on 13-Nov-2009 | All Recent SEC Filings |
13-Nov-2009
Quarterly Report
The information discussed below is derived from the unaudited consolidated
financial statements included in this Form 10-Q for the three and nine months
ended September 30, 2009 and 2008, and should be read in conjunction therewith.
Our results of operations for a particular quarter may not be indicative of
results expected during subsequent quarters or for the entire year.
Company Overview
We are an international clinical research organization ("CRO") focused on
providing our clients with global clinical research services and solutions
throughout the drug development lifecycle. We serve a variety of clients in the
pharmaceutical, biotechnology and medical device industries.
Our core competencies are in product agency registration support, trial design,
site selection, project management, medical and site monitoring, data
management, biostatistical analysis and reporting, pharmacovigilance, medical
writing, and full clinical trial management and consulting services throughout
the clinical trials lifecycle. We have the resources to directly implement or
manage Phase I through Phase IV clinical trials and have clinical trial
experience and expertise across a wide variety of therapeutic areas, including
the following core focus areas: Oncology, Cardiovascular Diseases and Medical
Devices.
We have pursued a strategy of seeking other complimentary businesses to acquire
so that we can expand our geographic presence and CRO capabilities. We believe
the expansion of our business through the acquisition of established CROs
enables us to provide a multitude of services sooner and more effectively than
if we were to build such services organically.
On October 31, 2007, we acquired Hesperion AG ("Hesperion"), an international
CRO based in Switzerland. The acquisition of Hesperion significantly
strengthened our presence in Europe and significantly improved our capabilities
to manage complex larger global clinical trials for our clients.
Our industry continues to be dependent on the research and development efforts
of pharmaceutical, biotechnology and medical device companies as major clients,
and we believe this dependence will continue. Our client list includes several
large pharmaceutical and biotechnology companies. With the strategic acquisition
of Hesperion, we have expanded our customer base, a significant portion of our
revenues are highly concentrated in a few key clients. For the nine month period
ended September 30, 2009, approximately 33% of our total net service revenues
were from two clients, representing 23%, and 10% of total net services revenues,
respectively. For the nine month period ended September 30, 2008, 22% of our
total net service revenues were from one client. Although the expansion of our
client base through the acquisitions of Averion Inc. and Hesperion has increased
our revenues, the loss of business from any of our major clients could have a
material adverse effect on us.
Our revenue growth has and will continue to be highly dependent on our ability
to attract, develop, motivate and retain skilled professionals. We closely
monitor our overall attrition rates and patterns to ensure our personnel
management strategy aligns with our growth objectives. There is intense
competition for professionals with the skills necessary to provide the type of
services we offer. If our attrition rate increases and was to be sustained at
higher levels, our growth may slow and our cost of attracting and retaining
clinical professionals could increase.
On September 4, 2009, we filed with the SEC the Information Statement related to
our going private transaction and related Reverse/Forward Stock Split. We expect
to complete the Reverse/Forward Stock Split and the related going private
transaction approximately twenty days after the Information Statement is first
mailed to our stockholders.
Backlog
Our clinical research backlog consists of anticipated net service revenue from
uncompleted projects which have been authorized by the client, through a written
contract or letter of intent. Many of our studies and projects are performed
over an extended period of time, which may be several years. Amounts included in
backlog have not yet been recognized as net service revenue in our Consolidated
Statement of Operations. Once contracted work begins, net service revenue is
recognized over the life of the contract on a fee for service or proportional
performance basis. The recognition of net service revenue reduces our backlog
while the awarding of new business increases our backlog. Our backlog for
clinical research services was approximately $80.8 million at September 30,
2009, representing an increase of approximately $25.1 million from backlog of
$55.7 million at December 31, 2008.
We believe that our backlog as of any date may not necessarily be a meaningful
predictor of future results because backlog can be affected by a number of
factors including the size and duration of contracts, many of which are
performed over several years. Additionally, contracts may be delayed or
cancelled during the course of a study. For these reasons, we might not be able
to fully realize our entire backlog as net service revenue.
Application of Critical Accounting Estimates
Our consolidated financial statements have been prepared in accordance with
accounting principles generally accepted in the United States, or GAAP.
Preparation of these financial statements requires us to make estimates and
assumptions that affect the reported amount of revenue and expenses, assets and
liabilities and the disclosure of contingent assets and liabilities. We consider
an accounting estimate to be critical to the preparation of our financial
statements when both of the following are present:
• the estimate is complex in nature or requires a high degree of
judgment; and
• the use of different estimates and assumptions could have a material impact on the consolidated financial statements.
We have discussed the development and selection of our critical accounting
estimates and related disclosures with the Audit Committee of our Board of
Directors. Those estimates critical to the preparation of our consolidated
financial statements are listed below.
Revenue Recognition
Our services are performed under both time-and-material and fixed-price
arrangements. All revenue is recognized pursuant to GAAP. Revenue is recognized
as work is performed and amounts are earned. We consider amounts to be earned
once evidence of an arrangement has been obtained, services are delivered, fees
are fixed or determinable and collectability is reasonably assured. For
contracts with fees billed on a time-and-materials basis, we generally recognize
revenue over the period of performance.
Revenue arrangements with multiple deliverables are divided into separate units
of accounting if the deliverables in the arrangement meet the following
criteria: (1) the delivered item has value to the client on a stand-alone basis;
(2) there is objective and reliable evidence of the fair value of undelivered
items; and (3) delivery of any undelivered item is probable. Arrangement
consideration is allocated among the separate units of accounting based on their
relative fair values, with the amount allocated to the delivered item being
limited to the amount that is not contingent on the delivery of additional items
or meeting other specified performance conditions.
Fixed-price contracts are accounted for under the proportional performance
method based on assumptions regarding the estimated completion of the project.
Under the proportional performance method, we estimate the
percentage-of-completion by comparing the actual number of work hours performed
or units delivered to date to the estimated total number of hours or units
required to complete each engagement. The use of the proportional performance
method requires significant judgment relative to estimating total contract
revenue and costs to completion, including assumptions and estimates relative to
the length of time to complete the project, the nature and complexity of the
work to be performed and anticipated changes in other contract-related costs.
Estimates of total contract revenue and costs to completion are continually
monitored during the term of the contract and are subject to revision as the
contract progresses. Unforeseen circumstances may arise during an engagement
requiring us to revise our original estimates and may cause the estimated
profitability to decrease. When revisions in estimated contract revenue and
efforts are determined, such adjustments are recorded in the period in which
they are first identified. Provisions for estimated losses on individual
contracts are made in the period in which the loss first becomes known.
Depending on the specific contractual provisions and nature of the deliverable,
revenue may be recognized as interim deliverables are achieved or when final
deliverables have been accepted.
Our accounting policy for recognizing revenue for terminated projects requires
us to perform a reconciliation of study activities versus the activities set
forth in the contract. We negotiate with the client, pursuant to the terms of
the existing contract, regarding the wind up of existing study activities in
order to clarify which services the client wants us to perform. Once we and the
client agree on the reconciliation of study activities and the agreed upon
services have been performed by us, we would record the additional revenue
provided collectability is reasonably assured.
Our operations have experienced, and may continue to experience,
period-to-period fluctuations in net service revenue and results from
operations. Because we generate a large proportion of our revenue from services
performed at hourly rates, our revenue in any period is directly related to the
number of employees and the number of hours worked by those employees during
that period. Our results of operations in any one quarter can fluctuate
depending upon, among other things, the number of weeks in a quarter, the number
and related contract value of ongoing client engagements, the commencement,
postponement and termination of engagements in the quarter, the mix of revenue,
the extent of cost overruns, employee hiring, vacation patterns, exchange rate
fluctuations and other factors.
Goodwill
We review goodwill for impairment on an annual basis in conjunction with our
year end reporting date of December 31. Averion operates as one reporting unit
and goodwill is evaluated based on this approach.
Long-lived assets
Our long-lived assets include finite-life intangible assets, property and
equipment and long-term notes receivable. We evaluate the recoverability of our
long-lived assets whenever events or changes in circumstances indicate that
their carrying amounts may not be recoverable. Such circumstances would include
a significant decrease in the market price of a long-lived asset, a significant
adverse change to the manner in which the asset is being used or its physical
condition, or a history of operating or cash flow losses associated with the use
of the asset. In addition, changes to the expected useful lives of these
long-lived assets may also be an indicator of impairment. Recoverability of
assets to be held and used is measured by a comparison of the carrying amount of
an asset to future undiscounted net cash flows expected to be generated by the
asset. If such assets are considered to be impaired, the impairment to be
recognized is measured by the amount by which the carrying value of the assets
exceeds the fair value of the assets and the resulting losses are included in
the statement of operations.
Share-Based Compensation
The grant date fair value of each stock option is based on the underlying price
on the date of grant and is determined using an option pricing model. The option
pricing model requires the use of estimates and assumptions as to (a) the
expected volatility of the price of the stock underlying the stock option,
(b) the expected life of the option, (c) the risk free rate for the expected
life of the option and (d) forfeiture rates. The Company is currently using the
Black-Scholes option pricing model to determine the grant date fair value of
each stock option.
Share-based compensation expense recognized during a period is based on the
value of the portion of share-based awards that is ultimately expected to vest
during the period. The Company uses historical data to estimate pre-vesting
option forfeitures.
Expected volatility is calculated based on a blended weighted average of
historical information of the Company's stock and the weighted average of
historical information of similar public entities for which historical
information is available. The Company will continue to use a weighted average
approach using its own historical volatility and other similar public entity
volatility information until historical volatility of the Company is relevant to
measure expected volatility for future option grants. The expected life of the
option assumption is based on the simplified or "safe-haven" method. The risk
free rate is based on the U.S. Treasury bond rate commensurate with the expected
life of the option. Forfeiture rates are estimated based upon past voluntary
termination behavior and past option forfeitures.
We believe there is a high degree of subjectivity involved when using
option-pricing models to estimate share-based compensation. Option-pricing
models were developed for use in estimating the value of traded options that
have no vesting or hedging restrictions, are fully transferable and do not cause
dilution. Because our share-based payments have characteristics different from
those of freely traded options and because changes in the subjective input
assumptions can materially affect our estimates of fair values (such as
attrition), in our opinion, existing valuation models, including Black-Scholes,
may not provide reliable measures of the fair values of our share-based
compensation. Consequently, there is a risk that our estimates of the fair
values of our share-based compensation awards on the grant dates may bear little
resemblance to the actual values realized upon the exercise, expiration, early
termination, or forfeiture of those share-based payments in the future. Certain
share-based payments, such as employee stock options, may expire worthless or
otherwise result in zero intrinsic value as compared to the fair values
originally estimated on the grant date and reported in our financial statements.
Alternatively, value may be realized from these instruments that is
significantly in excess of the fair values originally estimated on the grant
date and reported in our financial statements. There is currently no
market-based mechanism or other practical application to verify the reliability
and accuracy of the estimates stemming from these valuation models, nor is there
a means to compare and adjust the estimates to actual values. Although the fair
value of employee share-based awards is determined using an option-pricing model
that value may not be indicative of the fair value observed in a market
transaction between a willing buyer and willing seller. If factors change and we
employ different assumptions in future periods than those currently applied and
those previously applied in determining our pro forma amounts, the compensation
expense that we record in the future may differ significantly from what we have
reported during the periods for the three and nine months periods ending
September 30, 2009 and 2008, respectively.
Income Taxes
The calculation of our tax liabilities involves dealing with uncertainties in
the application of complex tax regulations in multiple jurisdictions. We record
liabilities for estimated tax obligations in the United States and other tax
jurisdictions. Determining the consolidated provision for income tax expense,
tax reserves, deferred tax assets and liabilities and related valuation
allowance, if any, involves judgment. We calculate and provide for income taxes
in the jurisdictions in which we operate, including the United States,
Switzerland, Germany, Israel, the United Kingdom, France, Austria, the
Netherlands, and several eastern European countries. It is our policy to file
tax returns as prescribed by the tax laws of the jurisdictions in which we
operate. We are not currently under examination by any federal, state or local
taxing jurisdiction. The 2002 to 2008 tax years for which we have filed tax
returns with federal, state and local taxing jurisdictions remain subject to
examination. In the normal course of business, we conduct operations in various
state and local taxing jurisdictions. We may have exposure for examination or
tax assessment by a state or local taxing jurisdiction where we have not
historically filed tax returns. We believe any such potential tax assessment
would not have a material impact on our financial position or results of
operations. Our overall effective tax rate fluctuates due to a variety of
factors, including changes in the geographic mix or estimated level of annual
pretax income, the ability to utilize our accumulated net operating loss
carryforwards and newly enacted tax legislation in each of the jurisdictions in
which we operate.
Applicable transfer pricing regulations require that transactions between and
among our subsidiaries be conducted at an arm's-length price. On an ongoing
basis we estimate an appropriate arm's-length price and use such estimate for
our intercompany transactions.
On an ongoing basis, we evaluate whether a valuation allowance is needed to
reduce our deferred tax assets to the amount that is more likely than not to be
realized. This evaluation considers the weight of all available evidence,
including both future taxable income and ongoing prudent and feasible tax
planning strategies. In the event that we determine that we will not be able to
realize a recognized deferred tax asset in the future, an adjustment to the
valuation allowance would be made resulting in a decrease in income in the
period such determination was made. Likewise, should we determine that we will
be able to realize all or part of an unrecognized deferred tax asset in the
future, an adjustment to the valuation allowance would be made resulting in an
increase to income (or equity in the case of excess stock option tax benefits).
Deferred income taxes are provided under the liability method. The liability
method requires that deferred tax assets and liabilities be determined based on
the difference between the financial reporting and tax bases of assets and
liabilities using the tax rate expected to be in effect when the taxes will
actually be paid or refunds received. In estimating future tax consequences, we
generally consider all expected future events other than the enactment of
changes in tax law or rates. If it is more likely than not that some portion or
all of a deferred tax asset will not be realized, a valuation allowance is
recorded.
Recent Accounting Standards
See Note 3 to the accompanying consolidated financial statements for a
discussion of accounting standards adopted during the nine months ended
September 30, 2009 and recent accounting standards not yet adopted.
Results of Operations
Three months ended September 30, 2009 and 2008
The following table presents an overview of our results of continuing operations
for the three months ended September 30, 2009 and 2008.
September 30, 2009 September 30, 2008
(in thousands) $ % of revenue $ % of revenue
Net service revenue $ 17,269 100 % $ 15,900 100 %
Direct expenses 8,230 48 % 9,868 62 %
SG&A expense 4,730 27 % 5,878 37 %
Depreciation and amortization 776 4 % 1,011 6 %
Net operating income (loss) 3,533 20 % (857 ) (5 )%
Other income (expense) (2,433 ) (14 )% (1,061 ) (6 )%
Income (loss) before income tax expense 1,100 6 % (1,918 ) (12 )%
Income tax expense 629 (4 )% 122 (1 )%
Net income (loss) $ 471 3 % $ (2,040 ) (13 )%
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Net service revenue for the three months ending September 30, 2009 increased
$1.4 million to $17.3 million as compared to $15.9 million for the three months
ending September 30, 2008. The 2009 results include $2.1 million in previously
deferred revenue recognized as a large contract was signed during July of 2009.
A significant portion of this revenue related to services delivered during 2009,
but prior to the September, 2009 quarter. Absent the aforementioned contract,
net service revenue for the current period declined slightly as compared to the
three months ending September 30, 2008. The absence of revenue growth is
attributable to a lower level of contract signings during the prior year which
would have contributed to 2009 revenue as those engagements developed during the
current year period. We have been able to offset this reduction with new
business project signings and a progression of those projects to revenue
producing engagements during 2009. Newly signed contracts during the three
months ended September 30, 2009 were $37.3 million as compared to $17.2 million
during the comparable period in 2008.
Direct expenses consist primarily of compensation, related payroll taxes and
fringe benefits for our project-related staff and contracted personnel, and
other expenses directly related to specific contracts. Direct expenses decreased
by $1.6 million to $8.2 million for the three months ended September 30, 2009
from $9.9 million for the three months ended September 30, 2008. As a percentage
of net service revenues, direct expenses decreased to 48% during the three
months ended September 30, 2009 from 62% during the comparative period in 2008.
The favorable variance in direct expenses as a percentage of net service
revenues is principally the result of $2.1 million in revenue recognized during
the comparative 2009 period where the services related to that revenue and the
associated costs had occurred and been recorded in earlier periods.
Selling, general and administrative expenses included the salaries, wages, and
benefits of all administrative, financial and business development personnel and
all support and overhead expenses not directly related to specific contracts.
Selling, general and administrative expenses for the three months ended
September 30, 2009 were $4.7 million, or 27% of net service revenue, as compared
to $5.9 million, or 37% of net service revenue for the three month period ended
September 30, 2008. The decrease in expenses of $1.2 million was primarily due
to certain staff reductions and cost efficiencies during the current period as
compared with the prior year. We undertook a complete review and expense
reduction initiative in all SG&A departments during the fourth quarter of 2008
continuing into the first quarter of 2009 which has evidenced itself here.
Reductions in professional fees, travel, recruiting costs, and computer hardware
and software costs all contributed to our savings in this area.
Depreciation expense remained flat at $0.4 million for the three months ended
September 30, 2009 and 2008, respectively. Amortization expense decreased to
$0.4 million for the three months ended September 30, 2009 from $0.6 million for
the three months ended September 30, 2008, primarily due to the reduction in
carrying values assigned to finite life intangibles due to the impairment and
associated write-down of those assets during the quarter ended December 31,
2008.
Other income and expense is comprised primarily of interest charges on our
outstanding notes, the amortization of the original issue discount on the Senior
Secured Notes issued in conjunction with the Hesperion acquisition, and foreign
exchange gains and losses. Net interest expense increased to $0.9 million for
the three months ended September 30, 2009, as compared to $0.5 million for the
same period in 2008, due to the increase in the principal amount outstanding as
a result of notes issued during June of 2008. In addition, we incurred
approximately $1.2 million of non-cash expense for the amortization of the
original issue discount on debt issued in connection with the Hesperion
acquisition. During the three months ended September 30, 2009, we experienced
foreign currency exchange losses of approximately $0.4 million as compared to
foreign currency exchange gains of $0.5 million during the prior year period.
This current quarter loss was primarily due to the net effects of a weaker U.S.
dollar against the Swiss franc and the Euro. We carry a Euro denominated note on
our U.S. books as a result of the acquisition of Hesperion. This note is in the
amount of EUR 2.5 million and is due during the latter half of 2010. In
addition, we have receivable and payable balances on the books of our Swiss
subsidiary that are denominated in currencies other than the functional currency
of that subsidiary, the Swiss franc. As foreign exchange rates change from
period to period these receivables and payables are revalued resulting in an
offsetting gain or loss in the income statement.
The reductions in direct costs and SG&A expense enabled us to achieve net income
of $0.5 million for the three month period ended September 30, 2009 as compared
to a net loss of $2.0 million, for the three months ended September 30, 2008.
Nine months ended September 30, 2009 and 2008
The following table presents an overview of our results of continuing operations
for the nine months ended September 30, 2009 and 2008.
September 30, 2009 September 30, 2008
(in thousands) $ % of revenue $ % of revenue
Net service revenue $ 48,860 100 % $ 50,339 100 %
Direct expenses 26,295 54 % 29,326 58 %
SG&A expense 14,805 30 % 18,325 36 %
Depreciation and amortization 2,358 5 % 3,058 6 %
Net operating income (loss) 5,402 11 % (370 ) (1 )%
Other income (expense) (6,240 ) (13 )% (4,804 ) (10 )%
Loss before income tax expense (838 ) (2 )% (5,174 ) (10 )%
Income tax expense 837 (2 )% 212 (1 )%
Net loss $ (1,675 ) (3 )% $ (5,368 ) (11 )%
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Net service revenue for the nine months ending September 30, 2009 decreased $1.5 million to $48.9 million as compared to $50.3 million for the nine months ending September 30, 2008. The 2008 results include $3.3 million in previously deferred revenue recognized as a large contract was signed during June 2008. Approximately $1.7 million of this revenue related to services delivered prior to 2008. Absent of the aforementioned 2008 contract, net service revenue for the . . .
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