ITEM 7. MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS
OF OPERATIONS
The following discussion should be read in conjunction with the consolidated
financial statements and the related notes that appear elsewhere in this
document.
All statements in this annual report that are not historical are
"forward-looking statements" within the meaning of Section 21E of the Securities
Exchange Act as amended, including statements regarding our strategic
initiatives, anticipated cost savings, return to profitability and integration
of and synergies related to eBioscience, as well as all other statements
regarding our "goals," "expectations," "beliefs," "intentions," "strategies" or
the like. Such statements are based on our current expectations and are subject
to a number of factors and uncertainties that could cause actual results to
differ materially from those described in the forward-looking statements. Actual
results or business conditions may differ materially from those projected or
suggested in such forward-looking statements as a result of various factors,
including, but not limited to, our capacity to identify and capitalize upon
emerging market opportunities; risks relating to our ability to acquire new
businesses and technologies and successfully integrate and realize the
anticipated strategic benefits and cost savings or other synergies thereof,
including our acquisition of eBioscience, in a cost-effective manner while
minimizing the disruption to our business; risks that eBioscience's future
performance may not be consistent with its historical performance; risks
relating to our ability to make scheduled payments of the principal of, to pay
interest on or to refinance our indebtedness; risks relating to our ability to
develop and successfully commercialize new products and services; uncertainties
related to cost and pricing of Affymetrix products; fluctuations in overall
capital spending in the academic and biotechnology sectors; changes in
government funding policies; our dependence on collaborative partners; the size
and structure of our current sales, technology and technical support
organizations; uncertainties relating to our suppliers and manufacturing
processes; risks relating to our ability to achieve and sustain higher levels of
revenue, higher gross margins and reduced operating expenses; uncertainties
relating to technological approaches; global credit and financial market
conditions; personnel retention; uncertainties relating to the FDA and other
regulatory approvals; competition; risks relating to intellectual property of
others and the uncertainties of patent protection and litigation; volatility of
the market price of our common stock; unpredictable fluctuations in quarterly
revenues; and the risk factors disclosed under Part I, Item 1A of this Annual
Report on Form 10-K for the year ended December 31, 2012. We expressly disclaim
any obligation or undertaking to release publicly any updates or revisions to
any forward-looking statements contained herein to reflect any change in our
expectations with regard thereto or any change in events, conditions or
circumstances on which any such statements are based, except as required by law.
Overview
We are a leading provider of life science tools and molecular diagnostic
products that enable parallel analysis of biological systems at the gene,
protein and cell level. We sell our products to genomic research centers,
academic institutions, government and private laboratories, as well as
pharmaceutical, diagnostic and biotechnology companies. Over 48,000
peer-reviewed papers have been published based on work using our products. We
have approximately 1,100 employees worldwide and maintain sales and distribution
operations across the United States, Europe, Latin America and Asia.
Our operations consist of two reportable segments, Affymetrix Core and
eBioscience. Affymetrix Core accounted for approximately 80% of total revenue
and eBioscience accounted for approximately 13% of total revenue during the year
ended December 31, 2012. The remaining 7% of total revenue came from our
Corporate business unit which was not deemed an operating segment.
Affymetrix Core is divided into three business units with each business unit
having its own research and marketing groups to better serve customers and
respond quickly to the market needs. In addition, the business units share
common corporate services that provide capital, infrastructure, resources and
functional support, allowing them to focus on core technological strengths to
compete and innovate in their markets. The following describes the three
business units that form Affymetrix Core:
· Expression: This business unit develops and markets the Company's GeneChip gene
expression products and services, and the QuantiGene® line of low-to-mid-plex
RNA measurement products.
· Genetic Analysis and Clinical Applications: This business unit develops and
markets the Company's genotyping, such as the Axiom® product line, and arrays
with clinical research applications, such as the CytoScan® cytogenetics arrays.
· Life Science Reagents: This business unit develops and sells reagents, enzymes,
purification kits and biochemicals used by life science researchers.
eBioscience is operated as a separate business unit after the acquisition with
its own research and marketing and manufacturing groups, but shares common
corporation services with Affymetrix Core:
· eBioscience: This reportable segment specializes in the development,
manufacturing, marketing and distribution of research tools in the areas of
flow cytometry, immunoassays, microscopic imaging and other protein-based
analyses.
We have one additional business unit, the Corporate business unit, which is
comprised primarily of revenue from royalty arrangements, and field revenue from
services provided to customers by the Company. Its manufacturing operations are
based on platforms that are used to produce various products that serve multiple
applications and markets. The Corporate business unit is not deemed to be an
operating segment.
All of our business units sell their products through our Global Commercial
Organization comprised of sales, field application and engineering support, and
marketing personnel. We market and distribute our products directly to customers
in North America, Japan and major European markets. In these markets, we have
our own sales, service and application support personnel responsible for
expanding and managing their respective customer bases. In other markets, such
as Mexico, India, the Middle East and Asia Pacific, including the People's
Republic of China, we sell our products principally through third party
distributors that specialize in life science supply. For molecular diagnostic
and industrial applications market opportunities, we supply our partners with
arrays and instruments, which they incorporate into diagnostic products and
assume the primary commercialization responsibilities.
Acquisition of eBioscience Holding Company, Inc.
On June 25, 2012, we completed our acquisition of eBioscience, a privately-held
company based in San Diego, California engaged in the development, manufacture
and sale of flow cytometry and immunoassay reagents for immunology and oncology
research and diagnostics (the "Acquisition") pursuant to an Amended and Restated
Agreement and Plan of Merger dated May 3, 2012 (the "Acquisition Agreement").
We believe the Acquisition is a good strategic fit for Affymetrix, allowing us
to expand our addressable markets and continue to diversify our business beyond
genomics discovery into cell and protein analysis. We believe eBioscience will
enable us to further expand into downstream markets where validation and testing
activity leverages the results of basic discovery research to achieve a more
thorough understanding of disease states, and ultimately, new and/or improved
diagnostics and therapeutics.
We intend to operate eBioscience as a separate business unit to minimize or
avoid any disruption of services, while taking advantage of immediate
opportunities to create efficiencies. We expect to achieve certain commercial
synergies between the two companies, including cross-selling opportunities and
complementary distribution channels, as well as realize benefits from certain
research and development synergies.
The Acquisition purchase price totaled $314.9 million, plus $17.5 million in
other fees and expenses incurred since the transaction began, including $8.5
million of underwriting and financing fees, and was financed through a
combination of cash on hand, the liquidation of available-for-sale securities,
proceeds from the Term Loan of aggregate principal amount of $85.0 million
provided under our Senior Secured Credit Facility and the issuance of $105.0
million principal amount of our 4.00% Notes.
Reportable Operating Segments
To better serve our markets subsequent to our acquisition of eBioscience, during
the year ended December 31, 2012, we have organized our business units into two
reportable operating segments: Affymetrix Core and eBioscience.
Affymetrix Core represents the aggregate of the Expression, Genetic Analysis and
Clinical Applications and Life Science Reagents business units with each having
its own development, manufacturing and marketing groups. The business units will
share common corporate services that provide capital, infrastructure, resources
and functional support. These corporate services will be included in the
Corporate business unit.
eBioscience is organized as a separate business unit in order to minimize
disruption of its existing operations, and we evaluate the performance of
eBioscience separately from Affymetrix Core's performance based on its revenue
and income (loss) from operations. For the year ended December 31, 2012, the
eBioscience reportable operating segment had $37.0 million in net revenue and
$8.8 million in operating loss, from the Acquisition Date.
The Corporate business unit is not aggregated into either of the two operating
segments and will be disclosed in the "other" category. See "Item 8. Financial
Statements and Supplementary Data-Note 17. Segment and Geographic Information"
for more information on our reportable operating segments.
Overview of Fiscal Year 2012 and Strategic Initiatives
We have faced declining financial performance over the past several years.
Traditionally, a significant portion of our business was in the well-established
gene expression business where our GeneChip® Expression product line comprised
of at least 50% of our revenue as we concentrated on selling these products in
the basic research market focused on discovery research. Declining sales and
intense competition from newer technologies such next generation sequencing in
this business has led to decreasing revenue annually since 2007.
Since Frank Witney became our President and Chief Executive Officer in July
2011, we have begun shifting our resources and focus areas from a dependency on
our Expression business unit to a more diversified portfolio with broader
revenue stream capabilities that can reach into the growing markets for
translational medicine and molecular diagnostics. In 2012, Affymetrix Core
reported lower overall revenue of $7.2 million as compared to 2011, primarily
due to a $17.4 million decrease in our Expression business unit resulting from a
lower volume of sales. Revenue from this business unit was approximately 40% of
our business in 2012 as compared to over 50% in 2011. This decrease was
partially offset by an $11.8 million increase in our Genetic Analysis and
Clinical Applications business unit due to an increased volume of sales in our
Cytogenetics line of products which more than doubled in 2012 from 2011.
As we enter 2013, we continue to execute on a strategy developed by Dr. Witney
and our management team where we will realign our product portfolio, stabilize
our core business and position our company for growth and increasing
profitability. We expect this transformation to take several years, and have
categorized this plan into three phases.
· Phase 1 (2011-2012) -Portfolio Realignment. During this phase, we reorganized
ourselves into business units to sharpen our business focus based on target
markets. We also launched CytoScan®, our growing cytogenetic microarray product
line, grew our Axiom genotyping platform aggressively and acquired eBioscience.
We believe these actions will lead to a stabilization of our core business and
the realignment of our product portfolio will position us for growth.
· Phase II (2013-2014) - Profitability, Strengthen Balance Sheet, Development of
Newer Product Lines. In the beginning of 2013, we implemented a corporate
restructuring with a goal of accelerating our path to profitability. We expect
the corporate restructuring is expected to result in annualized savings of
approximately $25 million based on 2013 run rates, of which $5 million is
expected to be in cost of goods sold. Our priorities for this phase will be to
achieve profitability, repay our senior secured debt, successfully
commercialize our newer product lines (CytoScan®, Axiom® and QuantiGene® lines,
as well as our eBioscience products) and invest in new product offerings. In
addition, we will train and refocus our global commercial organization to
expand our reach to customers in the translational medicine, molecular
diagnostics and applied markets.
· Phase III (2015 -2016) - Strategic Flexibility, Expansion of Product Lines;
Growth. Our goal is to have a strong balance sheet in this phase that will
provide us with the flexibility to make strategic acquisitions. In addition, we
aim to grow revenues with developed product lines and new product offerings in
the translational medicine and molecular diagnostic markets.
CRITICAL ACCOUNTING POLICIES & ESTIMATES
General
The following section of Management's Discussion and Analysis of Financial
Condition and Results of Operations is based upon our consolidated financial
statements, which have been prepared in accordance with U.S. Generally Accepted
Accounting Principles ("US GAAP"). The preparation of these financial statements
requires management to make estimates and assumptions that affect the reported
amounts of assets, liabilities, revenue and expenses, and related disclosure of
contingent assets and liabilities. Management bases its estimates on historical
experience and on various other assumptions that are believed to be reasonable
under the circumstances, the results of which form the basis for making
judgments about the carrying values of assets and liabilities that are not
readily apparent from other sources. Actual results may differ from these
estimates under different assumptions or conditions.
Our significant accounting policies are fully described in "Item 8. Financial
Statements and Supplementary Data-Note 2. Summary of Significant Accounting
Policies." However, certain accounting policies are particularly important to
the reporting of our financial position and results of operations and require
the application of significant judgment by our management. An accounting policy
is deemed to be critical if it requires an accounting estimate to be made based
on assumptions about matters that are highly uncertain at the time the estimate
is made, and if different estimates that reasonably could have been used, or
changes in the accounting estimates that are reasonably likely to occur
periodically, could materially impact the financial statements. Management
believes the following critical accounting policies reflect its more significant
estimates and assumptions used in the preparation of the consolidated financial
statements.
REVENUE RECOGNITION
We enter into contracts to sell our products and, while the majority of our
sales agreements contain standard terms and conditions, there are agreements
that contain multiple elements or non-standard terms and conditions. As a
result, significant contract interpretation is sometimes required to determine
the appropriate accounting, including whether the deliverables specified in a
multiple element arrangement should be treated as separate units of accounting
for revenue recognition purposes, and if so, how the value of the arrangement
should be allocated among the deliverable elements, when and how to recognize
revenue for each element, and the period over which revenue should be
recognized.
INVENTORIES
We enter into inventory purchases and commitments so that we can meet future
shipment schedules based on forecasted demand for our products. The business
environment in which we operate is subject to rapid changes in technology and
customer demand. We perform a detailed assessment of inventory each period,
which includes a review of, among other factors, demand requirements, product
life cycle and development plans, component cost trends, product pricing,
product expiration and quality issues. Based on this analysis, we record
adjustments to inventory for potentially excess, obsolete or impaired goods,
when appropriate, in order to report inventory at net realizable value. These
inventory adjustments may be required if actual demand, component costs,
supplier arrangements, or product life cycles differ from our estimates. Any
such adjustments would result in a charge to our results of operations.
BUSINESS COMBINATIONS
To account for our acquisition of eBioscience, we used the acquisition method of
accounting which requires us to allocate the fair value of the total
consideration transferred to tangible and identifiable intangible assets
acquired and liabilities assumed based on their estimated fair values on the
date of the acquisition, with the difference between the net assets acquired and
the total consideration transferred recorded as goodwill. The fair values
assigned, defined as the price that would be received to sell an asset or paid
to transfer a liability in an orderly transaction between willing market
participants, are based on significant estimates and assumptions determined by
management. These estimates and assumptions are inherently uncertain and subject
to refinement, as a result, during the adjustment period, which may be up to one
year from the acquisition date, we may record adjustments to the assets acquired
or liabilities assumed with any corresponding offset to goodwill. Upon
conclusion of the measurement period or final determination of the values of
assets acquired or liabilities assumed, whichever comes first, any subsequent
adjustments are recorded to our Consolidated Statements of Operations.
We used a discounted cash flow method to assign fair values to acquired
identifiable intangible assets. This method requires significant management
judgment to forecast future operating results and establish residual growth
rates and discount factors. These models are based on reasonable estimates and
assumptions given available facts and circumstances, including industry
estimates and averages, as of the acquisition dates and are consistent with the
plans and estimates that we use to manage our business. If the subsequent actual
results and updated projections of the underlying business activity change
compared with the estimates and assumptions used to develop these values, we
could experience impairment charges. In addition, we have estimated the economic
lives of certain acquired assets and these lives are used to calculate
depreciation and amortization expense. If our estimates of the economic lives
change, depreciation or amortization expenses could be accelerated or slowed.
GOODWILL, INTANGIBLE ASSETS AND OTHER LONG-LIVED ASSETS - IMPAIRMENT ASSESSMENTS
We review goodwill for impairment on an annual basis and whenever events or
changes in circumstances indicate that its carrying value may not be
recoverable. We first conduct an assessment of qualitative factors to determine
whether it is more likely than not that the fair value of a reporting unit is
less than its carrying amount. If we determine that it is more likely than not
that the fair value of a reporting unit is less than its carrying amount, we
then conduct a two-step test for impairment of goodwill. In the first step, the
fair value of our reporting units is compared to their carrying values. If the
fair values of the reporting units exceed the carrying value of the net assets,
goodwill is not considered impaired and no further analysis is required. If the
carrying values of the net assets exceed the fair values of the reporting units,
then the second step of the impairment test must be performed in order to
determine the implied fair value of the goodwill. If the carrying value of the
goodwill exceeds the implied fair value, then an impairment loss equal to the
difference would be recorded. For 2012, we conducted our annual goodwill
impairment analysis during the fourth quarter of 2012 and concluded that it is
not more likely than not that the fair value of the applicable reporting unit is
less than its carrying amount.
We regularly review our finite-lived intangible assets and other long-lived
assets to determine if the carrying values are impaired. A review is performed
when an event occurs that may indicate the potential for impairment. If
indicators of impairment exist, we assess the recoverability of the affected
finite-lived intangible assets and other long-lived assets by determining
whether the carrying amount of such assets exceeds the undiscounted expected
future cash flows associated with such assets. If so, an impairment charge is
recorded for the excess.
NON-MARKETABLE EQUITY SECURITIES
As part of our strategic efforts to gain access to potential new products and
technologies, we invest in a limited partnership investment fund that is
accounted for under the equity method. We periodically review our investment for
impairment; however, the impairment analysis requires significant judgment in
identifying events or circumstances that would likely have significant adverse
effect on the fair value of the investment. The analysis may include assessment
of the investee's (i) revenue and earnings trend, (ii) business outlook for its
products and technologies, (iii) liquidity position and the rate at which it is
using its cash, and (iv) likelihood of obtaining subsequent rounds of financing.
If an investee obtains additional funding at a valuation lower than our carrying
value, we presume that the investment is other than temporarily impaired. We
have experienced impairments due to the decline in the value of certain of our
non-marketable investments over the past few years.
INCOME TAXES
Income tax expense is based on pretax financial accounting income. Under the
asset and liability method, deferred tax assets and liabilities are determined
based on the difference between the financial statement and tax basis of assets
and liabilities using enacted tax rates in effect for the year in which the
differences are expected to reverse. We must assess the likelihood that the
resulting deferred tax assets will be realized. To the extent we believe that
realization is not more likely than not, we establish a valuation allowance.
Significant estimates are required in determining our provision for income
taxes, our deferred tax assets and liabilities, any valuation allowance to be
recorded against our deferred tax assets, and reserves for income tax related
uncertainties. Some of these estimates are based on interpretations of existing
tax laws or regulations. Various internal and external factors may have
favorable or unfavorable effects on our future effective tax rate. These factors
include, but are not limited to, changes in overall levels, character, or
geographical mix of pretax earnings, changes in tax laws, regulations and/or
rates, changing interpretations of existing tax laws or regulations, changes in
the valuation of our deferred tax assets or liabilities, levels of research and
development spending, nondeductible expenses, applicability of tax holidays,
ultimate outcomes of income tax audits, and income tax impacts of any business
combination transactions or changes in our equity structure.
The total amount of unrecognized tax benefits as of December 31, 2012 was
approximately $20.4 million. If recognized, the amount of unrecognized tax
benefits that would impact income tax expense is $5.3 million. As of December
31, 2012, we do not anticipate any material changes to the amount of
unrecognized tax benefit during the next twelve months.
We classify interest and penalties related to tax positions as components of
income tax expense. For the year ended December 31, 2012, the amount of accrued
interest and penalties related to tax uncertainties was approximately $0.2
million for a total cumulative amount of $1.1 million of non-current income
taxes payable as of December 31, 2012.
We file U.S. federal, state, and foreign income tax returns in jurisdictions
with varying statutes of limitations. In significant foreign jurisdictions, the
2007 through 2012 tax years generally remain subject to examination by their
respective tax authorities.
CONTINGENCIES
We are subject to legal proceedings principally related to intellectual property
matters. Based on the information available at the balance sheet dates, we
assess the likelihood of any adverse judgments or outcomes to these matters, as
well as potential ranges of probable losses. If losses are probable and
reasonably estimable, we will record a reserve which may change in the future
due to new developments in each matter.
ACCOUNTING FOR SHARE-BASED COMPENSATION
We account for employee share-based compensation by estimating the fair value of
our employee stock awards, employee stock purchase plan awards and
performance-based restricted stock units at the date of grant using the
Black?Scholes option?pricing model, which requires the use of certain subjective
assumptions. The most significant of these assumptions are our estimates of the
expected term, volatility and forfeiture rates of the awards. The expected stock
price volatility assumption was determined using a combination of historical and
implied volatility of our common stock. We determined that blended volatility is
more reflective of market conditions and a better indicator of expected
volatility than historical volatility. The estimate of these key assumptions is
based on historical information and judgment regarding market factors and
trends. As required under the accounting rules, we review our valuation
assumptions at each grant date and, as a result, we are likely to change our
valuation assumptions used to value employee share-based awards granted in
future periods.
US GAAP requires that employee share-based compensation costs be recognized over
the requisite service period, or the vesting period, in a manner similar to all
other forms of compensation paid to employees.
RESULTS OF OPERATIONS
The following discussion compares the historical results of operations for the
years ended December 31, 2012, 2011 and 2010.
PRODUCT SALES
The components of product sales are as follows:
Dollars in
thousands Dollar Percentage
Year ended December 31, change from change from
2012 2011 2010 2011 2010 2011 2010
Consumables $ 247,687 $ 224,972 $ 252,165 $ 22,715 $ (27,193 ) 10 % (11 )%
Instruments 18,376 16,301 25,578 2,075 (9,277 ) 13 (36 )
Total
product
sales $ 266,063 $ 241,273 $ 277,743 $ 24,790 $ (36,470 ) 10 (13 )
|
Excluding eBioscience revenue of $37.0 million, product revenue for 2012
decreased by $12.2 million or 5% primarily due to lower Genechip® chips and
reagents sales as a result of lower volume. This decrease was partially offset
by higher instrument revenue from clinical GeneChip® Scanner 3000Dx sales due to
greater volumes partially offset by lower overall average selling price.
. . .