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Genzyme 10-Q 2010 Table of Contents
UNITED STATES SECURITIES AND
EXCHANGE COMMISSION
Washington, D.C.
20549
Commission File
No. 0-14680
(Exact name of registrant as
specified in its charter)
(617) 252-7500
(Registrants telephone
number, including area code)
Indicate by check mark whether the registrant (1) has filed
all reports required to be filed by Section 13 or 15(d) of
the Securities Exchange Act of 1934 during the preceding
12 months (or for such shorter period that the registrant
was required to file such reports), and (2) has been
subject to such filing requirements for the past
90 days. Yes þ No o
Indicate by check mark whether the registrant has submitted
electronically and posted on its corporate Web site, if any,
every Interactive Data File required to be submitted and posted
pursuant to Rule 405 of
Regulation S-T
(§ 232.405 of this chapter) during the preceding
12 months (or for such shorter period that the registrant
was required to submit and post such
files). Yes þ No o
Indicate by check mark whether the registrant is a large
accelerated filer, an accelerated filer, a non-accelerated
filer, or a smaller reporting company. See the definitions of
large accelerated filer, accelerated
filer and smaller reporting company in Rule
12b-2 of the Exchange Act. (Check one):
Indicate by check mark whether the registrant is a shell company
(as defined by
Rule 12b-2
of the Exchange
Act). Yes o No þ
Number of shares of Genzyme Stock outstanding as of
October 29, 2010: 258,991,017
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Throughout this
Form 10-Q,
the words we, us, our and
Genzyme refer to Genzyme Corporation as a whole, and
our board or our board of directors
refers to the board of directors of Genzyme Corporation.
This
Form 10-Q
contains forward-looking statements. These forward-looking
statements include, among others, statements regarding:
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These statements are subject to risks and uncertainties, and our
actual results may differ materially from those that are
described in this report. These risks and uncertainties include:
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We refer to more detailed descriptions of these and other risks
and uncertainties under the heading Risk Factors in
Managements Discussion and Analysis of Genzyme Corporation
and Subsidiaries Financial Condition and Results of
Operations in Part I., Item 2. of this
Form 10-Q.
We encourage you to read those descriptions carefully. We
caution investors not to place substantial reliance on the
forward-looking statements contained in this
Form 10-Q.
These statements, like all statements in this
Form 10-Q,
speak only as of the date of this report (unless another date is
indicated), and we undertake no obligation to update or revise
the statements in light of future developments.
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The United States Securities and Exchange Commission, commonly
referred to as the SEC, allows us to disclose important
information to you by referring you to other documents we have
filed with them. The information that we refer you to is
incorporated by reference into this
Form 10-Q.
Please read that information.
Genzyme®,
Cerezyme®,
Fabrazyme®,
Thyrogen®,
Myozyme®,
Lumizyme®,
Renagel®,
Renvela®,
Campath®,
Clolar®,
Evoltra®,
Mozobil®,
Thymoglobulin®,
Cholestagel®,
Synvisc®,
Synvisc-One®,
Sepra®,
Seprafilm®,
Carticel®,
Epicel®,
MACI®,
Hectorol®
and
Jonexa®
are registered trademarks of Genzyme or its subsidiaries.
Welchol®
is a registered trademark of Sankyo Pharma, Inc.
Aldurazyme®
is a registered trademark of BioMarin/Genzyme LLC.
Elaprase®
is a registered trademark of Shire Human Genetic Therapies, Inc.
Prochymal®
and
Chondrogen®
are registered trademarks of Osiris Therapeutics, Inc.
Fludara®
and
Leukine®
are registered trademarks licensed to Genzyme. All other
trademarks referred to in this
Form 10-Q
are the property of their respective owners. All rights reserved.
GENZYME
CORPORATION AND SUBSIDIARIES
FORM 10-Q,
SEPTEMBER 30, 2010
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GENZYME
CORPORATION AND SUBSIDIARIES
(Unaudited,
amounts in thousands, except per share amounts)
The accompanying notes are an integral part of these unaudited,
consolidated financial statements.
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GENZYME
CORPORATION AND SUBSIDIARIES
(Unaudited,
amounts in thousands, except par value amounts)
The accompanying notes are an integral part of these unaudited,
consolidated financial statements.
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GENZYME
CORPORATION AND SUBSIDIARIES
The accompanying notes are an integral part of these unaudited,
consolidated financial statements.
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GENZYME
CORPORATION AND SUBSIDIARIES
We are a global biotechnology company dedicated to making a
major impact on the lives of people with serious diseases. Our
products and services are focused on rare inherited disorders,
kidney disease, orthopaedics, cancer, transplant and immune
disease, and diagnostic testing. Our commitment to innovation
continues today with a substantial development program focused
on these fields, as well as multiple sclerosis, or MS,
cardiovascular disease, neurodegenerative diseases, and other
areas of unmet medical need.
We are organized into five financial reporting units, which we
also consider to be our reporting segments:
Effective January 1, 2010, based on changes in how we
review our business, we re-allocated certain of our business
units among our segments and adopted new names for certain of
our reporting segments. Specifically:
We report the activities of the following business units under
the caption Other: our genetic testing business
unit, which provides testing services for the oncology, prenatal
and reproductive markets; and our
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GENZYME
CORPORATION AND SUBSIDIARIES
Notes to
Unaudited, Consolidated Financial
Statements (Continued)
diagnostic products and pharmaceutical intermediates business
units. These operating segments did not meet the quantitative
threshold for separate segment reporting.
We report our corporate, general and administrative operations
and corporate science activities under the caption
Corporate.
We have revised our 2009 segment disclosures to conform to our
2010 presentation.
In May 2010, we announced our plan to pursue strategic
alternatives for our genetic testing, diagnostic products and
pharmaceutical intermediates business units. On
September 13, 2010, we entered into an agreement with
Labcorp to sell our genetic testing business unit to Labcorp for
$925.0 million in cash, subject to a working capital
adjustment. Completion of the transaction is subject to
customary closing conditions, including expiration or
termination of an applicable waiting period under the
Hart-Scott-Rodino Antitrust Improvements Act of 1976, and is
expected to occur in the fourth quarter of 2010. Transactions
for our diagnostic products and pharmaceutical intermediates
business units are targeted for the end of 2010.
As previously disclosed, on July 29, 2010, we received a
letter from Sanofi containing an unsolicited, non-binding
proposal to acquire all of our outstanding shares of common
stock for $69.00 per share in cash. Our board of directors
evaluated the proposal and unanimously rejected it on
August 11, 2010. On August 24, 2010, our financial
advisors met with Sanofis financial advisors and provided
certain non-public information relating to our business
operations and projected financial results. On August 29,
2010, we received a second letter from Sanofi that contained a
proposal identical to the one in its July 29, 2010 letter.
This proposal was again evaluated and unanimously rejected by
our board of directors. On October 4, 2010, Sanofi
commenced an unsolicited tender offer for all of our outstanding
shares of common stock for $69.00 per share in cash. Also on
October 4, 2010, our board of directors urged shareholders
to take no action with respect to the tender offer. Our board
announced that it intended to take a formal position within 10
business days of the commencement of the tender offer. On
October 7, 2010, our board voted unanimously to reject the
unsolicited tender offer and further recommended that our
shareholders not tender their shares to Sanofi pursuant to the
tender offer. The full basis for our boards recommendation
was set forth in a Solicitation/Recommendation Statement on
Schedule 14D-9,
which was filed with the SEC on October 7, 2010. On
October 22, 2010, we announced that our board had
authorized our advisors and management to explore and evaluate
alternatives for us and our assets. These efforts are intended
to assist our board of directors in being fully informed about
our value and are not authorization of a process to sell Genzyme
or any of our assets.
On November 4, 2010, we implemented the first phase of a
workforce reduction plan pursuant to which we expect to
eliminate a total of 1,000 positions by the end of 2011. The
first phase will eliminate 392 positions, including both filled
and unfilled positions, across various functions and locations.
Employees whose positions are eliminated in the first phase were
notified beginning on November 4, 2010. In the United
States, affected employees are being offered severance packages,
including severance payments, temporary healthcare coverage
assistance and outplacement services. Similar packages will be
offered to affected employees outside of the United States in
accordance with local laws. In connection with the elimination
of filled positions in the first phase of the workforce
reduction plan, we estimate incurring total charges of
$24 million to $27 million, primarily for one-time
severance benefits and facilities-related costs. These charges
are expected to occur in the fourth quarter of 2010. The 1,000
positions expected to be eliminated exclude positions within our
genetic testing business unit, for which we have entered into an
agreement to sell, and positions within our diagnostic products
and pharmaceutical intermediates business units, for which
similar transactions are targeted by the end of 2010. The
workforce reduction plan is being implemented to reduce costs
and increase efficiencies as part of a larger plan to increase
shareholder value announced in May 2010.
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GENZYME
CORPORATION AND SUBSIDIARIES
Notes to
Unaudited, Consolidated Financial
Statements (Continued)
Our unaudited, consolidated financial statements for each period
include the statements of operations, balance sheets and
statements of cash flows for our operations taken as a whole. We
have eliminated all intercompany items and transactions in
consolidation. We have reclassified certain 2009 data to conform
to our 2010 presentation. We prepare our unaudited, consolidated
financial statements following the requirements of the SEC for
interim reporting. As permitted under these rules, we condense
or omit certain footnotes and other financial information that
are normally required by accounting principles generally
accepted in the United States, or U.S. GAAP.
These financial statements include all normal and recurring
adjustments that we consider necessary for the fair presentation
of our financial position and results of operations. Since these
are interim financial statements, you should also read our
audited, consolidated financial statements and notes included in
Exhibit 99 to our
Form 8-K
filed with the SEC on June 14, 2010. Revenues, expenses,
assets and liabilities can vary from quarter to quarter.
Therefore, the results and trends in these interim financial
statements may not be indicative of results for future periods.
The balance sheet data as of December 31, 2009 that is
included in this
Form 10-Q
was derived from our audited financial statements but does not
include all disclosures required by U.S. GAAP.
Our unaudited, consolidated financial statements for each period
include the accounts of our wholly owned and majority owned
subsidiaries. All intercompany accounts and transactions have
been eliminated in consolidation. We account for our investments
in entities not subject to consolidation using the equity method
of accounting if we have a substantial ownership interest (20%
to 50%) in or exercise significant influence over the entity.
Our consolidated net income (loss) includes our share of the
earnings or losses of these entities. From January 1, 2008
to December 31, 2009, we consolidated the results of
BioMarin/Genzyme LLC, an entity we formed with BioMarin
Pharmaceutical Inc., or BioMarin, in 1998, because we determined
that we were the primary beneficiary of BioMarin/Genzyme LLC.
Upon consolidation of the entity, we recorded the assets and
liabilities of BioMarin/Genzyme LLC in our consolidated balance
sheets at fair value. Effective January 1, 2010, in
accordance with new guidance we adopted for consolidating
variable interest entities, we no longer consolidate the results
of BioMarin/Genzyme LLC because we determined that the entity
does not have a primary beneficiary under the new guidance. As a
result, we deconsolidated BioMarin/Genzyme LLC and no longer
record the assets and liabilities in our consolidated balance
sheets. Instead, effective January 1, 2010, we began to
record our portion of BioMarin/Genzyme LLCs results in
equity in loss of equity method investments in our consolidated
statements of operations.
In May 2010, we announced our plan to pursue strategic
alternatives for our genetic testing, diagnostic products and
pharmaceutical intermediates business units. As part of this
plan, on September 13, 2010, we entered into an agreement
to sell our genetic testing business unit to Labcorp, as
described in Note 1., Description of Business,
to these consolidated financial statements. Our diagnostic
products business unit had revenue of approximately
$167 million for the year ended December 31, 2009 and
approximately $112 million for the nine months ended
September 30, 2010. Revenue from our pharmaceutical
intermediates business unit for the same periods was
significantly less in comparison.
As of September 1, 2010, the applicable assets and
liabilities of all three business units have been classified as
held for sale in the accompanying consolidated balance sheets
and depreciation and amortization of the applicable assets
ceased as of such date. In addition, as no significant
involvement or continuing cash flows are expected from, or to be
provided to, the genetic testing and diagnostic products
businesses following the consummation of a sale transaction,
both businesses have been reported as discontinued operations in
our consolidated statements of operations.
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GENZYME
CORPORATION AND SUBSIDIARIES
Notes to
Unaudited, Consolidated Financial
Statements (Continued)
For all periods presented, our consolidated balance sheets have
been recast to reflect the presentation of assets held for sale
and our consolidated statements of operations have been recast
to reflect the presentation of discontinued operations.
Revenue
Recognition Recent Healthcare Reform
Legislation
In March 2010, healthcare reform legislation was enacted in the
United States, which contains several provisions that impact our
business. Although many provisions of the new legislation do not
take effect immediately, several provisions became effective in
the first quarter of 2010. These include:
Effective October 1, 2010, the new legislation re-defines
the Medicaid average manufacturer price, or AMP, such that the
AMP is calculated differently for our oral drugs and our
injected/infused drugs, and such that Medicaid rebates are
expected to increase for our oral drugs, Renagel, Renvela and
oral Hectorol, and our product Leukine, but be insignificantly
impacted for our other products.
Beginning in 2011, the new law requires that drug manufacturers
provide a 50% discount to Medicare beneficiaries whose
prescription drug costs cause them to be subject to the Medicare
Part D coverage gap, which is known as the donut
hole. Also beginning in 2011, we will be required to pay
our share of a new fee assessed on all branded prescription drug
manufacturers and importers. This fee will be calculated based
upon each organizations percentage share of total branded
prescription drug sales to U.S. government programs (such
as Medicare and Medicaid, the Department of Veterans Affairs, or
VA, the Department of Defense, or DOD, and the TriCare retail
pharmacy discount programs) made during the previous year. Sales
of orphan drugs, however, are not included in the fee
calculation.
Presently, uncertainty exists as many of the specific
determinations necessary to implement this new legislation have
yet to be decided and communicated to industry participants. We
are still assessing the full extent that the
U.S. healthcare reform legislation may have on our business.
Accounts
Receivable Related to Sales in Greece
Our consolidated balance sheets include accounts receivable, net
of reserves, held by our subsidiary in Greece related to sales
to government-owned or supported healthcare facilities in Greece
of approximately $65 million as of September 30, 2010
and approximately $57 million as of December 31, 2009.
Payment of these accounts is subject to significant delays due
to government funding and reimbursement practices. We believe
that this is an industry-wide issue for suppliers to these
facilities. In May 2010, the government of
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GENZYME
CORPORATION AND SUBSIDIARIES
Notes to
Unaudited, Consolidated Financial
Statements (Continued)
Greece announced a plan for repayment of its debt to
international pharmaceutical companies, which calls for
immediate payment of accounts receivable balances that were
established in 2005 and 2006. For accounts receivable
established between 2007 and 2009, the government of Greece will
issue non-interest bearing bonds, expected to be exchange
tradable, with maturities ranging from one to three years. We
recorded a charge of $7.2 million to bad debt expense, a
component of selling, general and administrative expenses, or
SG&A, in our consolidated statements of operations for the
second quarter of 2010, to write down the accounts receivable
balances held by our subsidiary in Greece to present value using
a 10% risk adjusted discount rate.
In conjunction with this plan, the government of Greece also
instituted price decreases of between 20% and 27% for all future
pharmaceutical product sales. The government of Greece has
recently required financial support from both the European Union
and the International Monetary Fund, or IMF, to avoid defaulting
on its sovereign debt. If significant additional changes occur
in the availability of government funding in Greece, we may not
be able to collect on amounts due from these customers.
All stock-based awards to non-employees are accounted for at
their fair value. We periodically grant awards, including time
vesting stock options, time vesting restricted stock units, or
RSUs, and performance vesting restricted stock units, or PSUs,
under our employee and director equity plans. Beginning in 2010,
our long-term incentive program for senior executives includes a
combination of:
Approximately half of each senior executives grant
consists of time vesting stock options with the remainder in
PSUs. Grants under our former long-term incentive program were
comprised of time vesting stock options and time vesting RSUs.
We record the estimated fair value of awards granted as
stock-based compensation expense in our consolidated statements
of operations over the requisite service period, which is
generally the vesting period. Where awards are made with
non-substantive vesting periods, such as where a portion of the
award vests upon retirement eligibility, we estimate and
recognize expense based on the period from the grant date to the
date on which the employee is retirement eligible.
The fair values of our:
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GENZYME
CORPORATION AND SUBSIDIARIES
Notes to
Unaudited, Consolidated Financial
Statements (Continued)
Recent
Accounting Pronouncements and Updates
Periodically, accounting pronouncements and related information
on the adoption, interpretation and application of
U.S. GAAP are issued or amended by the Financial Accounting
Standards Board, or FASB, or other standard setting bodies.
Changes to the FASB Accounting Standards
Codificationtm,
or ASC, are communicated through Accounting Standards Updates,
or ASUs. The following table shows FASB ASUs recently issued
that could affect our disclosures and our position for adoption:
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GENZYME
CORPORATION AND SUBSIDIARIES
Notes to
Unaudited, Consolidated Financial
Statements (Continued)
16
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GENZYME
CORPORATION AND SUBSIDIARIES
Notes to
Unaudited, Consolidated Financial
Statements (Continued)
As described in Note 2., Basis of Presentation and
Significant Accounting Policies Basis of
Presentation, to these consolidated financial
statements, for all periods presented, our consolidated balance
sheets have been recast to reflect the presentation of assets
held for sale and our consolidated statements of operations
17
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GENZYME
CORPORATION AND SUBSIDIARIES
Notes to
Unaudited, Consolidated Financial
Statements (Continued)
have been recast to reflect the presentation of discontinued
operations. The following table summarizes our income (loss)
from discontinued operations, net of tax (amounts in thousands):
The following table summarizes the assets held for sale and
liabilities associated with assets held for sale in our
consolidated balance sheets as of the dates indicated, which
include assets and liabilities of our genetic testing,
diagnostic products and pharmaceutical intermediates business
units and are reported under the caption Other
(amounts in thousands):
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GENZYME
CORPORATION AND SUBSIDIARIES
Notes to
Unaudited, Consolidated Financial
Statements (Continued)
A significant number of our assets and liabilities are carried
at fair value. These include:
Fair
Value Measurement Definition and
Hierarchy
Fair value is defined as the price that would be received to
sell an asset or paid to transfer a liability (i.e., the
exit price) in an orderly transaction between market
participants at the measurement date. In determining fair value,
we are permitted to use various valuation approaches, including
market, income and cost approaches. We are required to follow an
established fair value hierarchy for inputs used in measuring
fair value that maximizes the use of observable inputs and
minimizes the use of unobservable inputs by requiring that the
observable inputs be used when available.
The fair value hierarchy is broken down into three levels based
on the reliability of inputs. We have categorized our fixed
income, equity securities, derivatives and contingent
consideration obligations within the hierarchy as follows:
Fair value is a market-based measure considered from the
perspective of a market participant who would buy the asset or
assume the liability rather than our own specific measure. All
of our fixed income securities are priced using a variety of
daily data sources, largely readily-available market data and
broker quotes. To validate these prices, we compare the fair
market values of our fixed income investments using market data
from observable and corroborated sources. We also perform the
fair value calculations for our derivatives and equity
securities using market data from observable and corroborated
sources. We determine the fair value of the contingent
consideration obligations based on a probability-weighted income
approach. The measurement is based on significant inputs not
observable in the market. In periods of market inactivity, the
observability of prices and inputs may be reduced for certain
instruments. This condition could cause an instrument to be
reclassified from Level 1 to Level 2 or from
Level 2 to Level 3. During the nine months ended
September 30, 2010, none of our instruments were
reclassified between Level 1, Level 2 or Level 3.
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GENZYME
CORPORATION AND SUBSIDIARIES
Notes to
Unaudited, Consolidated Financial
Statements (Continued)
The following tables set forth our assets and liabilities that
were accounted for at fair value on a recurring basis as of
September 30, 2010 and December 31, 2009 (amounts in
thousands):
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GENZYME
CORPORATION AND SUBSIDIARIES
Notes to
Unaudited, Consolidated Financial
Statements (Continued)
Changes in the fair value of our Level 3 contingent
consideration obligations during the nine months ended
September 30, 2010 were as follows (amounts in thousands):
Senior
Notes Payable
In June 2010, we issued $500.0 million aggregate principal
amount of our 3.625% senior notes due in June 2015, which
we refer to as our 2015 Notes, and $500.0 million aggregate
principal amount of our 5.000% senior notes due in June
2020, which we refer to as our 2020 Notes, and, together with
our 2015 Notes, as the Notes, as described in Note 12.,
Long-Term Debt, to these consolidated financial
statements. As of September 30, 2010, our:
The fair values of our 2015 Notes and 2010 Notes were determined
through a market-based approach using observable and
corroborated sources; within the hierarchy of fair value
measurements, these are classified as Level 2 fair values.
The carrying amounts reflected in our consolidated balance
sheets for cash, accounts receivable, other current assets,
accounts payable, accrued expenses, current portion of
contingent consideration obligations and current portion of
long-term debt and capital lease obligations approximate fair
value due to their short-term maturities.
As a result of our worldwide operations, we face exposure to
adverse movements in foreign currency exchange rates. Exposures
to currency fluctuations that result from sales of our products
in foreign markets are partially offset by the impact of
currency fluctuations on our international expenses. We may also
use derivatives, primarily foreign exchange forward contracts
for which we do not apply hedge accounting treatment, to further
reduce our exposure to changes in exchange rates, primarily to
offset the earnings effect from short-term foreign currency
assets and liabilities. We account for such derivatives at
market value with the resulting gains and losses reflected
within SG&A in our consolidated statements of operations.
We do not have any derivatives designated as hedging instruments
and we do not use derivative instruments for trading or
speculative purposes.
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GENZYME
CORPORATION AND SUBSIDIARIES
Notes to
Unaudited, Consolidated Financial
Statements (Continued)
Generally, we enter into foreign exchange forward contracts with
maturities of not more than 15 months. All foreign exchange
forward contracts in effect as of September 30, 2010 and
December 31, 2009 had maturities of 1 to 2 months. We
report these contracts on a net basis. Net asset derivatives are
included in other current assets and net liability derivatives
are included in accrued expenses in our consolidated balance
sheets.
The following table summarizes the balance sheet classification
of the fair value of these derivatives on both a gross and net
basis as of September 30, 2010 and December 31, 2009
(amounts in thousands):
Total foreign exchange (gains) and losses included in SG&A
in our consolidated statements of operations includes unrealized
and realized (gains) and losses related to both our foreign
exchange forward contracts and our foreign currency assets and
liabilities. The net impact of our overall unrealized and
realized foreign exchange (gains) and losses were as follows
(amounts in thousands):
The following table summarizes the effect of the unrealized and
realized net losses related to our foreign exchange forward
contracts on our consolidated statements of operations for the
three and nine months ended September 30, 2010 and 2009
(amounts in thousands):
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GENZYME
CORPORATION AND SUBSIDIARIES
Notes to
Unaudited, Consolidated Financial
Statements (Continued)
The following table sets forth our computation of basic and
diluted net income (loss) per common share (amounts in
thousands, except per share amounts):
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GENZYME
CORPORATION AND SUBSIDIARIES
Notes to
Unaudited, Consolidated Financial
Statements (Continued)
The components of comprehensive income (loss) for the periods
presented are as follows (amounts in thousands):
The following table sets forth the significant in-process
research and development, or IPR&D, projects for the
companies and assets we acquired between January 1, 2006
and September 30, 2010 (amounts in millions):
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GENZYME
CORPORATION AND SUBSIDIARIES
Notes to
Unaudited, Consolidated Financial
Statements (Continued)
Manufacturing-Related
Matters
In June 2009, we interrupted production of Cerezyme and
Fabrazyme at our Allston manufacturing facility after
identifying a virus in a bioreactor used for Cerezyme
production. We resumed Cerezyme shipments in the fourth quarter
of 2009. In February 2010, we began shipping Cerezyme at a rate
equal to 50% of estimated product demand in order to build a
small inventory buffer to help us better manage delivery of the
Cerezyme available. We continued shipping at 50% of estimated
product demand through the second quarter of 2010, due in part
to the impact of a second interruption in production in
March 2010 resulting from a municipal electrical power
failure that compounded issues with the facilitys water
system. We increased supply of Cerezyme in the third quarter of
2010 and Cerezyme patients in the United States were able to
begin to return to normal dosing levels in September. We expect
Cerezyme patients on a global basis to be able to return to
normal dosing during the fourth quarter of 2010.
Due to the June 2009 production interruption, low manufacturing
productivity upon re-start of production and efforts to build a
small inventory buffer, Fabrazyme shipments decreased in the
fourth quarter of 2009 and we began shipping Fabrazyme at a rate
equal to 30% of estimated product demand. We continued shipping
at 30% of estimated product demand through the third quarter of
2010. We continue to work to increase the productivity of the
Fabrazyme manufacturing process, which has performed at the low
end of the historical range since the re-start of production in
June 2009. We have developed a new working cell bank for
Fabrazyme that has been approved by the FDA and the European
Medicines Agency, or EMA. The new working cell bank has
completed five runs and has had 30% to 40% greater productivity
than the prior working cell bank. Fabrazyme patients are
beginning to be able to double their doses, starting in the
United States, and we expect Fabrazyme patients on a global
basis to be able to do so in the fourth quarter of 2010. We
expect to be able to fully supply global Fabrazyme demand during
the first half of 2011.
We recorded $5.6 million of charges during the three months
ended September 30, 2010 to costs of products sold in our
consolidated statements of operations for manufacturing-related
costs associated with various inventory write offs.
We recorded $29.1 million of charges during the nine months
ended September 30, 2010 to costs of products sold in our
consolidated statements of operations, including:
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GENZYME
CORPORATION AND SUBSIDIARIES
Notes to
Unaudited, Consolidated Financial
Statements (Continued)
Inventory
Subject to Additional Evaluation and Release
At any particular time, in the course of manufacturing, we may
have certain inventory that requires further evaluation or
testing to ensure that it meets appropriate quality
specifications. As of September 30, 2010, we had
approximately $10 million of inventory that is being
evaluated or tested. If we determine that this inventory, or any
portion thereof, does not meet the necessary quality standards,
it may result in a write off of the inventory and a charge to
earnings.
Inventory
Capitalized Prior to Regulatory Approval
We capitalize inventory produced for commercial sale, which may
result in the capitalization of inventory prior to regulatory
approval of the product or the manufacturing facility where it
is produced. The determination for capitalization is based on
our judgment of probable future approval, commercial success and
realizable value. Such judgment incorporates our knowledge and
assessment of the regulatory review process for the product and
manufacturing process, our required investment in the product or
facility, market conditions, competing products and our economic
expectations for the product post-approval relative to the risk
of manufacturing the product prior to approval. In no event is
inventory capitalized prior to completion of a phase 3 clinical
trial and the completion of a series of successful validations
runs from the facility. At the completion of these events, the
product and the manufacturing process have reached technological
feasibility, upon which we believe the likelihood of obtaining
regulatory approval is high and probable future economic benefit
in the product exists. If a product is not approved for sale or
a manufacturing facility does not receive approval, it would
likely result in the write off of the inventory and a charge to
earnings.
Sevelamer
Hydrochloride and Sevelamer Carbonate
We manufacture the majority of our supply requirements for
sevelamer hydrochloride (the active ingredient in Renagel) and
sevelamer carbonate (the active ingredient in Renvela) at our
manufacturing facility in Haverhill, England. In December 2009,
equipment failure caused an explosion and fire at this facility,
which damaged some of the equipment used to produce these active
ingredients as well as the building in which the equipment was
located. As a result, we temporarily suspended production of
sevelamer hydrochloride and sevelamer carbonate at this facility
so the damaged equipment could be repaired. We resumed
production of sevelamer hydrochloride in May 2010 and production
of sevelamer carbonate in October 2010. We recorded
$9.1 million of expenses, for which there were no insurance
reimbursements, for the three months ended and
$22.8 million, net of $5.4 million of insurance
reimbursements, for the nine months ended September 30,
2010. The noted expenses were recorded to cost of products sold
in our consolidated statements of operations for Renagel and
Renvela related to the remediation cost of our Haverhill,
England manufacturing facility, including repairs and idle
capacity expenses. Remediation of this facility is substantially
complete and we anticipate that any remaining costs related to
the remediation will not be significant.
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GENZYME
CORPORATION AND SUBSIDIARIES
Notes to
Unaudited, Consolidated Financial
Statements (Continued)
The following table contains the change in our goodwill during
the nine months ended September 30, 2010 (amounts in
thousands):
We are required to perform impairment tests related to our
goodwill annually and whenever events or changes in
circumstances suggest that the carrying value of an intangible
asset may not be recoverable. We completed the required annual
impairment tests for our $1.36 billion of net goodwill in
the third quarter of 2010 and determined that no impairment
charges were required.
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CORPORATION AND SUBSIDIARIES
Notes to
Unaudited, Consolidated Financial
Statements (Continued)
The following table contains information about our other
intangible assets for the periods presented (amounts in
thousands):
All of our finite-lived other intangible assets are amortized
over their estimated useful lives.
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GENZYME
CORPORATION AND SUBSIDIARIES
Notes to
Unaudited, Consolidated Financial
Statements (Continued)
As of September 30, 2010, the estimated future amortization
expense for our finite-lived other intangible assets for the
remainder of fiscal year 2010, the four succeeding fiscal years
and thereafter is as follows (amounts in thousands):
We and BioMarin have entered into agreements to develop and
commercialize Aldurazyme, a recombinant form of the human enzyme
alpha-L-iduronidase, used to treat an LSD known as
mucopolysaccharidosis, or MPS, I. Under the relationship, an
entity we formed with BioMarin in 1998 called BioMarin/Genzyme
LLC has licensed all intellectual property related to Aldurazyme
and other collaboration products on a royalty-free basis to
BioMarin and us. BioMarin holds the manufacturing rights and we
hold the global marketing rights. We are required to pay
BioMarin a tiered royalty payment ranging from 39.5% to 50% of
worldwide net product sales of Aldurazyme.
Prior to January 1, 2010, we determined that we were the
primary beneficiary of BioMarin/Genzyme LLC and, as a result, we:
Effective January 1, 2010, in accordance with new guidance
we adopted for consolidating variable interest entities, we were
required to reassess our designation as primary beneficiary of
BioMarin/Genzyme LLC. Under the new guidance, the entity with
the power to direct the activities that most significantly
impact a variable interest entitys economic performance is
the primary beneficiary. We have concluded that BioMarin/Genzyme
LLC is a variable interest entity, but does not have a primary
beneficiary because the power to direct the activities of
BioMarin/Genzyme LLC that most significantly impact its
performance, is shared equally between us and BioMarin through
our commercialization rights and BioMarins manufacturing
rights. Effective January 1, 2010, we no longer consolidate
the results of BioMarin/Genzyme LLC and instead record our
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GENZYME
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Notes to
Unaudited, Consolidated Financial
Statements (Continued)
portion of the results of BioMarin/Genzyme LLC in equity in loss
of equity method investments in our consolidated statements of
operations. For the three and nine months ended
September 30, 2010, the results of BioMarin/Genzyme LLC and
our portion of the results of BioMarin/Genzyme LLC were not
significant.
We recorded the following gains (losses) on investments in
equity securities, net of charges for impairment of investments,
for the periods presented (amounts in thousands):
Gross gains (losses) on investments in equity securities
includes gains totaling $5.8 million for the three months
and $7.3 million for the nine months ended
September 30, 2010 resulting from the liquidation of our
entire investment in the common stock of EXACT Sciences
Corporation, or EXACT Sciences.
Charges for impairment of investments for all periods presented
includes the write down of our investments in certain venture
capital funds to fair value at the end of each period and for
the nine months ended September 30, 2010 also includes a
$32.3 million impairment charge recorded in June 2010 to
write down our investment in the common stock of Isis
Pharmaceuticals, Inc., or Isis, as described below.
At September 30, 2010, our stockholders equity
includes $10.9 million of unrealized gains and
$4.0 million of unrealized losses related to our strategic
investments in equity securities.
Investment
in Isis Common Stock
We review for potential impairment the carrying value of each of
our strategic investments in equity securities on a quarterly
basis. In June 2010, given the significance and duration of the
decline in value of our investment in Isis common stock as of
June 30, 2010, we considered the decline in value of this
investment to be other than temporary and we recorded a
$32.3 million impairment charge to gains (losses) on
investment in equity securities, net in our consolidated
statements of operations. As of September 30, 2010, our
investment in Isis common stock had a carrying value of
$47.9 million (or $9.57 per share) and a fair market value
of $42.0 million (or $8.40 per share). We considered all
available evidence in assessing the decline in value of our
investment in Isis common stock as of that date, including
investment analyst reports and Isiss expected results and
future outlook, none of which suggests that the decline would be
other than temporary. Currently, the average
12-month
price estimate for Isis common stock among analysts is
approximately $15 per share. Based on our analysis, we consider
the $5.9 million unrealized loss on our investment in Isis
common stock to be temporary. We will continue to review the
fair value of our investment in Isis common stock in comparison
to our historical cost and in the future, if the decline in
value has become other than temporary, we will write
down our investment in Isis common stock to its then current
market value and record an impairment charge to our consolidated
statements of operations.
2015
and 2020 Senior Notes
In June 2010, we sold $500.0 million aggregate principal
amount of our 2015 Notes and $500.0 million aggregate
principal amount of our 2020 Notes through institutional private
placements to fund the $1.0 billion payment under our
accelerated share repurchase agreement, as discussed in
Note 13., Stockholders Equity,
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Notes to
Unaudited, Consolidated Financial
Statements (Continued)
to these consolidated financial statements. We received net
proceeds from the sale of the Notes of approximately
$986.6 million, after deducting commissions and other
expenses related to the offerings. We recorded the net proceeds
in our consolidated balance sheets as of June 30, 2010 as:
Both the debt offering costs and debt discount will be amortized
to interest expense in our consolidated statements of
operations. The debt offering costs have been allocated
proportionately to our 2015 Notes and our 2020 Notes and are
being amortized based on the term of each such group of the
Notes. The debt discount for each group of the Notes will be
amortized using the effective interest method. The 2015 Notes
mature in June 2015 and the 2020 Notes mature in June 2020. The
2015 Notes have an annual interest rate of 3.625% and the 2020
Notes have an annual interest rate of 5.000% Interest accrues on
the Notes from June 17, 2010 and is payable semi-annually
in arrears on June 15 and December 15 of each year starting on
December 15, 2010.
The Notes are our senior unsecured obligations and rank equally
in right of payment with all of our other senior unsecured
indebtedness from time to time outstanding. The Notes are fully
and unconditionally guaranteed by one of our subsidiaries that
also guarantees our indebtedness under our 2006 revolving credit
facility. We may redeem the Notes in whole or in part at any
time at a redemption price equal to the greater of:
We may be required to offer to repurchase the Notes at a
purchase price equal to 101% of their principal amount if we are
subject to certain kinds of change of control as provided in the
indenture for the Notes.
In July 2006, we entered into a five-year $350.0 million
senior unsecured revolving credit facility with JPMorgan Chase
Bank, N.A., as administrative agent, Bank of America, N.A., as
syndication agent, ABN AMRO Bank N.V., Citizens Bank of
Massachusetts and Wachovia Bank, National Association, as
co-documentation agents, and a syndicate of lenders, which we
refer to as our 2006 revolving credit facility. The proceeds of
loans under our 2006 revolving credit facility can be used to
finance working capital needs and for general corporate
purposes. We may request that our 2006 revolving credit facility
be increased at any time by up to an additional
$350.0 million in the aggregate, subject to the agreement
of the lending banks, as long as no default or event of default
has occurred or is continuing and certain other customary
conditions are satisfied. Borrowings under our 2006 revolving
credit facility will bear interest at various rates depending on
the nature of the loan.
As of September 30, 2010, we had approximately
$9 million of outstanding standby letters of credit issued
against this facility and no borrowings, resulting in
approximately $341 million of available credit under our
2006 revolving credit facility, which matures July 14,
2011. The terms of this credit facility include various
covenants, including financial covenants that require us to meet
minimum interest coverage ratios and maximum leverage ratios. As
of September 30, 2010, we were in compliance with these
covenants.
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Notes to
Unaudited, Consolidated Financial
Statements (Continued)
Share
Repurchase Plan
In April 2010, our board of directors authorized a
$2.0 billion share repurchase plan consisting of the
near-term purchase of $1.0 billion of our common stock to
be financed with proceeds of newly issued debt, and the purchase
of an additional $1.0 billion of our common stock by June
2011. In June 2010, we entered into an accelerated share
repurchase agreement with Goldman Sachs under which we
repurchased $1.0 billion of our common stock at an
effective purchase price of $63.79 per share. Pursuant to the
agreement, in June 2010, we paid $1.0 billion to
Goldman Sachs and received 15.6 million shares, of which:
On October 18, 2010, upon final settlement under the
agreement, we received an additional 121,344 shares from
Goldman Sachs, which together with the shares received in June
equaled a total of 15.7 million shares repurchased. The
shares repurchased are authorized and no longer outstanding
shares.
Modification
of Certain Stock Options and RSUs
On May 26, 2010, in connection with our plan to approve
strategic alternatives for our genetic testing, diagnostic
products and pharmaceutical intermediates business units, the
compensation committee of our board of directors approved
certain modifications to the stock options and RSUs previously
granted to the employees of those business units, to be
effective as of the date of divestiture of each business unit.
The terms of these stock options were modified to extend the
post-termination exercise period from 90 days to one year.
We used Black-Scholes valuation models, based on the following
assumptions, to determine the valuation adjustment required for
the extension of the post-termination exercise period, and
recorded stock-based compensation expense using an expected term
of seven months:
Based on our analysis, we recorded an additional
$9.1 million of stock-based compensation expense in our
consolidated statements of operations for the three months ended
June 30, 2010, as these options were fully vested, for the
valuation adjustment related to the modification of these stock
options.
On May 26, 2010, the compensation committee of our board of
directors also approved the following modifications to certain
RSUs granted to the employees of these three business units, to
be effective as of the date of divestiture for each business
unit:
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Notes to
Unaudited, Consolidated Financial
Statements (Continued)
Prior to these modifications, the RSUs granted in May 2008 had a
grant date fair value of $68.48 per share and the RSUs granted
in May 2009 had a grant date fair value of $58.66 per share
based on the closing price of our common stock at the date of
each grant. The modifications triggered a new measurement date
for these RSUs and, as a result, we revalued these RSUs based on
a new grant date fair value of $50.00 per share, the closing
price of our common stock on the date of modification. We
recorded additional stock-based compensation for these RSUs of
$5.0 million in our consolidated statements of operations
for the nine months ended September 30, 2010, to adjust the
cumulative stock-based compensation expense recorded for these
RSUs for the modifications, including:
We expect to record approximately $5 million of additional
stock-based compensation expense for these RSUs during the
fourth quarter of 2010 as a result of these modifications.
Long-Term
Incentive Program for Senior Executives
From 2007 through 2009, our long-term incentive program for
senior executives was comprised of equity awards in the form of
time vesting stock options and time vesting RSUs. Beginning with
2010, the equity vehicles for our long-term incentive program
for senior executives includes a combination of:
Approximately half of each senior executives grant
consists of time vesting stock options with the remainder in
PSUs.
For the 2010 through 2012 performance period, the performance
metrics are:
Each metric is weighted equally. For both metrics, performance
between the threshold level and the target level will be awarded
in PSUs. The PSUs will be paid out in shares of our stock at the
end of the three-year period if performance between the
threshold level and target level is achieved. If performance
above the target level is achieved, the portion of the award
above the target level will be paid out in cash up to a
predetermined maximum cash award. Since it is possible that the
PSUs may not pay out at all, it is completely at
risk compensation.
In January 2010, the compensation committee of our board of
directors approved a range for the three-year cash flow return
on invested capital metric of 85% to 115%. For performance
between 85% and 100% of the cash flow return on invested capital
target, the payout range is 50% to 100% of the senior
executives target PSU award associated with this
performance measure. Performance between 101% and 115% of the
cash flow return on invested capital target will result in a
cash payment that will be awarded based on performance achieved
between target and maximum levels, up to a predetermined maximum.
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Notes to
Unaudited, Consolidated Financial
Statements (Continued)
The committee also approved the following performance levels for
R-TSR:
For performance between the R-TSR threshold and target levels,
the payout range is 35% to 100% of the senior executives
target PSU award associated with this performance measure. R-TSR
performance between the target and maximum levels will result in
a cash payment that will be awarded based on performance
achieved between target and maximum levels, up to a
predetermined maximum.
If a participating senior executives employment is
terminated before the end of the performance period because of
death, disability or retirement, payment of the PSU will be
pro-rated to the date of termination based upon the
companys actual achievement of performance levels at the
end of the performance period. Upon a change in control, payment
of a PSU will be paid out at the target performance level and
pro-rated to the date of the change of control.
PSUs
During the nine months ended September 30, 2010, we granted
a total of 223,066 PSUs with a weighted average grant date fair
value of $49.86 per share to senior executives under our 2004
Equity Plan. The PSUs are subject to the attainment of certain
performance criteria established at the beginning of the
performance period, as described above, and cliff vest at the
end of the performance period, which ends December 31,
2012. Compensation expense associated with our PSUs is initially
based upon the number of shares expected to vest after assessing
the probability that certain performance criteria will be met
and the associated targeted payout level that is forecasted will
be achieved, net of estimated forfeitures. Compensation expense
for our PSUs is recognized over the applicable performance
period, adjusted for the effect of estimated forfeitures.
The fair value of PSUs subject to the cash flow return on
investment performance metric, which includes both performance
and service conditions, is estimated based on the market value
of our stock on the date of grant. We use a lattice model with a
Monte Carlo simulation to determine the fair value of PSUs
subject to the R-TSR performance metric, which includes both
market and service conditions. The lattice model requires
various highly judgmental assumptions to determine the fair
value of the awards. This model samples paths of our stock price
and the stock prices of a group of peer companies in the
S&P 500 Health Care Index, which we refer to as the Peer
Group, and calculates the resulting change in cash flow multiple
at the end of the forecasted performance period. This model
iterates these randomly forecasted results until the
distribution of results converge on a mean or estimated fair
value.
We used the following assumptions to determine the fair value of
these awards:
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CORPORATION AND SUBSIDIARIES
Notes to
Unaudited, Consolidated Financial
Statements (Continued)
We allocated pre-tax stock-based compensation expense, net of
estimated forfeitures, based on the functional cost center of
each employee as follows (amounts in thousands):
We amortize stock-based compensation expense capitalized to
inventory based on inventory turns.
At September 30, 2010, there was $232.7 million of
pre-tax stock-based compensation expense, net of estimated
forfeitures, related to unvested awards not yet recognized which
is expected to be recognized over a weighted average period of
2.1 years.
FDA
Consent Decree
On May 24, 2010, we entered into a consent decree with the
FDA relating to our Allston facility. Under the terms of the
consent decree, we will pay an upfront disgorgement of past
profits of $175.0 million. Conditioned upon our compliance
with the terms of the consent decree, we may continue to ship
Cerezyme and Fabrazyme, which are manufactured, filled and
finished at the facility, as well as Thyrogen, which is filled
and finished at the facility. In the United States, Thyrogen
that is filled and finished at the facility will only be
distributed based on medical necessity, in accordance with FDA
criteria. The consent decree requires us to move our fill-finish
operations out of the Allston facility for Thyrogen sold within
the United States by November 22, 2010 and for Fabrazyme
sold within the United States by November 24, 2010. We must
move our fill-finish operations for all products sold outside of
the United States by August 31, 2011. If we are not able to
meet these deadlines, the FDA can require us to disgorge 18.5%
of the revenue from the sale of any products that are filled and
finished at the Allston facility after the applicable deadlines.
The consent decree also requires us to implement a plan to bring
the Allston facility operations into compliance with applicable
laws and regulations. The plan must address any deficiencies
previously reported to us or identified as part of a
comprehensive inspection conducted by a third-party expert, who
we are required to retain, and who will monitor and oversee our
implementation of the plan. In 2009, we began implementing a
comprehensive remediation plan, prepared with assistance from
our compliance consultant, The Quantic Group, Ltd., or Quantic,
to improve quality and compliance at the Allston facility. We
intend to revise that plan to include any additional remediation
efforts required in connection with the consent decree as
identified by Quantic, who we have retained to be the
third-party expert under the consent decree. The plan, as
revised, which will be subject to FDA approval, is expected to
take approximately three to four years to complete and will
include a timetable of specified compliance milestones. If the
milestones are not met in
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Notes to
Unaudited, Consolidated Financial
Statements (Continued)
accordance with the timetable, the FDA can require us to pay
$15,000 per day, per affected drug, until these compliance
milestones are met. Upon satisfying the compliance requirements
in accordance with the terms of the consent decree, we will be
required to retain an auditor to monitor and oversee ongoing
compliance at the Allston facility for an additional five years.
The consent decree is subject to, and effective upon, approval
by the U.S. District Court for the District of
Massachusetts. The consent decree was filed with the
U.S. District Court on May 24, 2010 and we are
awaiting the courts approval.
Legal
Proceedings
In July 2009 and August 2009, two purported securities class
action lawsuits were filed in the U.S. District Court for
the District of Massachusetts against us and our President and
Chief Executive Officer. The lawsuits were filed on behalf of
those who purchased our common stock during the period from
June 26, 2008 through July 21, 2009 and allege
violations of Section 10(b) and 20(a) of the Securities
Exchange Act of 1934 and
Rule 10b-5
promulgated thereunder. Each of the lawsuits is premised upon
allegations that, among other things, we made materially false
and misleading statements and omissions by failing to disclose
instances of viral contamination at two of our manufacturing
facilities and our receipt of a list of inspection observations
from the FDA related to one of the facilities, which detailed
observations of practices that the FDA considered to be
deviations from good manufacturing practice, or GMP. The
plaintiffs seek unspecified damages and reimbursement of costs,
including attorneys and experts fees. In November
2009, the lawsuits were consolidated in In Re Genzyme Corp.
Securities Litigation and a lead plaintiff was appointed. In
March 2010, the plaintiffs filed a consolidated amended
complaint that extended the class period from October 24,
2007 through November 13, 2009 and named additional
individuals as defendants. In June 2010, we filed a motion to
dismiss the class action. The plaintiffs filed an opposition to
our motion to dismiss in August 2010 and we filed a reply in
support of our motion to dismiss in September 2010. A hearing on
the motion to dismiss is scheduled to be held in January 2011.
On August 11, 2010, Jerry L. & Mena M. Morelos
Revocable Trust filed a lawsuit allegedly on behalf of a
putative class of shareholders in the U.S. District Court
for the District of Massachusetts against us, our board of
directors, certain executive officers, and Sanofi (the
Morelos Action). The suit alleges that our directors
breached their fiduciary duties by attempting to sell Genzyme
without regard to the effect of a potential transaction on
shareholders, adopting processes and procedures that will not
benefit shareholders and engaging in self-dealing in order to
obtain personal benefits not shared equally by all shareholders
in connection with a purported proposed merger. The suit alleges
that certain of our directors are beholden to activist
shareholders. The suit also alleges that we and Sanofi aided and
abetted the purported breaches of fiduciary duties. The suit
seeks, among other relief, (i) class action status,
(ii) an order enjoining the defendants from consummating a
transaction, unless and until we adopt procedures designed to
obtain the best value for our shareholders, (iii) an order
directing the defendants to exercise their fiduciary duties and
commence a sales process that is in the best interest of
shareholders, (iv) an order rescinding, to the extent
already implemented, any transaction agreement, (v) an
order imposing a constructive trust in favor of the plaintiff
and the putative class upon any benefits improperly received by
the defendants as a result of any transaction, and (vi) an
award to plaintiffs of the costs of the action, including
reasonable attorneys and experts fees and expenses.
On September 8, 2010, Bernard Malina filed a lawsuit
allegedly on behalf of a putative class of shareholders in the
U.S. District Court for the District of Massachusetts
against us and our board of directors (the Malina
Action). The suit alleges that our directors breached
their fiduciary duties by attempting to sell Genzyme without
regard to the effect of a potential transaction on shareholders
and engaging in a plan and scheme to obtain personal benefits at
the expense of shareholders in connection with a purported
proposed merger. The suit seeks, among other relief,
(i) class action status, (ii) an order directing the
defendants to
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Notes to
Unaudited, Consolidated Financial
Statements (Continued)
exercise their fiduciary duties and commence a sales process
that is in the best interest of shareholders,
(iii) compensatory damages, and (iv) an award to
plaintiffs of the costs of the action, including reasonable
attorneys, accountants and experts fees and
expenses.
On September 9, 2010, Emanuel Resendes filed a lawsuit
allegedly on behalf of a putative class of shareholders in the
U.S. District Court for the District of Massachusetts
against our board of directors and certain executive officers
(the Resendes Action). The suit alleges that our
directors breached their fiduciary duties by attempting to sell
Genzyme without regard to the effect of a potential transaction
on shareholders and engaging in self-dealing in order to obtain
personal benefits not shared equally by all shareholders in
connection with a purported proposed merger. The suit seeks,
among other relief, (i) class action status, (ii) an
order enjoining the defendants from entering into any contract
which harms the class or could prohibit the defendants from
maximizing shareholder value, (iii) an order enjoining the
defendants from initiating any defensive measures that would
make the consummation of a transaction more difficult or costly
for a potential acquiror, (iv) an order directing the
defendants to exercise their fiduciary duties and refrain from
advancing their own interests at the expense of the class and
their fiduciary duties, and (v) an award to plaintiffs of
the costs of the action, including reasonable attorneys
and experts fees and expenses.
On September 14, 2010, William S. Field, Trustee u/a dated
October 12, 1991, by William S. Field Jr., filed a lawsuit
allegedly on behalf of a putative class of shareholders in the
U.S. District Court for the District of Massachusetts
against us, our board of directors and certain executive
officers (the Field Action). The suit alleges that
our directors breached their fiduciary duties by failing to
pursue a transaction that would provide the highest value
reasonably available for shareholders and by not providing full
and fair disclosure to shareholders. The suit seeks, among other
relief, (i) class action status, (ii) an order
appointing an independent special committee with authority to
evaluate, negotiate and, if in the best interests of
shareholders, accept the offer from Sanofi or other offers,
(iii) an award to plaintiffs of the costs of the action,
including reasonable attorneys, accountants and
experts fees and expenses and (iv) such other relief
as the court deems proper.
On October 18, 2010, Warren Pinchuck filed a lawsuit
allegedly on behalf of a putative class of shareholders in the
U.S. District Court for the District of Massachusetts
against us, our board of directors and certain executive
officers (the Pinchuck Action). The suit alleges
that the defendants violated Section 14(e) of the Exchange
Act by issuing a false and misleading
Schedule 14D-9 statement
and breached their fiduciary duties by, among other things,
refusing to negotiate in good faith with Sanofi and by failing
to allow due diligence to be performed to facilitate a higher
offer being made by Sanofi or others. The suit seeks, among
other relief (i) class action status, (ii) a
declaration that the defendants have violated Section 14(e)
of the Exchange Act, (iii) a declaration that the
defendants have breached their fiduciary duties, (iv) an
order enjoining the defendants from breaching their fiduciary
duties by refusing to consider and respond to the proposed
transaction in good faith, (v) an order enjoining the
defendants from initiating any anti-takeover devices that would
inhibit the defendants ability to maximize value for their
shareholders, (vi) compensatory damages, to the extent
injunctive relief is not granted, and (vii) an award to
plaintiffs of the costs of the action, including reasonable
attorneys and experts fees and expenses.
The plaintiffs and the defendants in the Morelos Action, Malina
Action, Resendes Action, Field Action and Pinchuck Action have
filed a joint stipulation with the federal court seeking
consolidation of the cases.
State
Securities Litigation
On August 16, 2010, plaintiff Chester County
Employees Retirement Fund filed a lawsuit allegedly on
behalf of a putative class of shareholders in Massachusetts
Superior Court (Middlesex County) against us and our board of
directors (the Chester Action). An amended complaint
was filed in the Chester Action on September 2, 2010. The
amended complaint alleges that the defendants breached their
fiduciary duties by failing to adequately inform themselves
regarding the potential offer by Sanofi or any offer by any
other party and failing to pursue the best available transaction
for shareholders. The suit seeks, among other relief,
(i) class
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Notes to
Unaudited, Consolidated Financial
Statements (Continued)
action status, (ii) an order enjoining the defendants from
initiating any defensive measures designed to prevent
shareholders from receiving and accepting a value-maximizing
offer, (iii) an order directing the defendants to exercise
their fiduciary duties to obtain a transaction in
shareholders best interests, (iv) compensatory
damages and (v) an award to plaintiffs of the costs of the
action, including reasonable attorneys and experts
fees and expenses. On September 23, 2010, by joint motion
of the parties, the Chester Action was transferred to the
Business Litigation Session of Suffolk County Superior Court in
Boston, Massachusetts.
On August 17, 2010, Alan R. Kahn filed a lawsuit allegedly
on behalf of a putative class of shareholders in the
Massachusetts Superior Court (Middlesex County) against us, our
board of directors, certain executive officers, and Sanofi (the
Kahn Action). The suit alleges that the defendants
breached their fiduciary duties in approving a proposed
transaction and failing to negotiate in good faith with Sanofi.
The suit seeks, among other relief, (i) class action
status, (ii) an order enjoining the defendants from
initiating any defensive measures that would inhibit the
defendants ability to maximize shareholder value,
(iii) compensatory damages and (iv) an award to
plaintiffs of the costs of the action, including reasonable
attorneys and experts fees and expenses.
On September 1, 2010, David Shade filed a lawsuit allegedly
on behalf of a putative class of shareholders in the
Massachusetts Superior Court (Middlesex County) against us and
our board of directors (the Shade Action). The suit
alleges that the defendants breached their fiduciary duties in
rejecting all offers and approaches by Sanofi and refusing to
engage in any negotiations with Sanofi. The suit seeks, among
other relief, (i) class action status, (ii) a
declaration that the defendants breached their fiduciary duties,
(iii) compensatory damages and (iv) an award to
plaintiffs of the costs of the action, including reasonable
attorneys fees and expenses and experts fees.
On September 2, 2010, the Louisiana Municipal Police
Employees Retirement System filed a lawsuit allegedly on
behalf of a putative class of shareholders in the Massachusetts
Superior Court (Middlesex County) against us and our board of
directors (the Louisiana Action). The suit alleges
that the defendants breached their fiduciary duties in rejecting
all offers and approaches by Sanofi and refusing to engage in
any negotiations with Sanofi. The suit seeks, among other
relief, (i) class action status, (ii) a declaration
that the defendants breached their fiduciary duties,
(iii) compensatory damages and (iv) an award to
plaintiffs of the costs of the action, including reasonable
attorneys fees and expenses and experts fees.
On October 5, 2010, plaintiffs and the defendants in the
Chester Action, Kahn Action, Shade Action and Louisiana Action
filed a joint stipulation with the Business Litigation Session
of Suffolk County Superior Court in the Chester Action seeking
consolidation of the state cases. On the same day, the Court
signed an order approving the consolidation of these cases in
In Re Genzyme Corp. Shareholder Litigation. On
October 18, 2010, plaintiffs filed a consolidated amended
complaint allegedly on behalf of a putative class of
shareholders against us and our board of directors (the
Consolidated State Action). The consolidated
complaint alleges that the defendants breached their fiduciary
duty by failing to properly inform themselves of Sanofis
offer, by refusing to negotiate in good faith with Sanofi, and
by attempting to thwart Sanofis proposed tender offer. The
suit seeks, among other relief (i) class action status,
(ii) a declaration that the defendants have breached their
fiduciary duties, (iii) an order requiring the defendants
to fully disclose all material information regarding the
Schedule 14D-9
filed by us, (iv) compensatory damages and (v) an
award to plaintiffs of the costs of the action, including
reasonable attorneys and experts fees and expenses.
Since August 2009, we have received ten letters from
shareholders demanding that our board of directors take action
on our behalf to remedy alleged breaches of fiduciary duty by
our directors and certain executive officers. The demand letters
are primarily premised on allegations regarding our disclosures
to shareholders with respect to manufacturing issues and
compliance with GMP and our processes and decisions related to
manufacturing at our Allston facility. Several of the letters
also assert that certain of our executive officers and
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GENZYME
CORPORATION AND SUBSIDIARIES
Notes to
Unaudited, Consolidated Financial
Statements (Continued)
directors took advantage of their knowledge of material
non-public information about Genzyme to illegally sell stock
they personally held in Genzyme. Our board of directors has
designated a special committee of three independent directors to
oversee the investigation of the allegations made in the demand
letters and to recommend to the independent directors of our
board whether any action should be instituted on our behalf
against any officer or director. The committee has retained
independent legal counsel. If the independent members of our
board of directors were to make a determination that it was in
our best interest to institute an action against any officers or
directors, any monetary recovery would be to our benefit. The
special committees investigation is ongoing.
In December 2009, two actions were filed by shareholders
derivatively for our benefit in the U.S. District Court for
the District of Massachusetts against our board of directors and
certain of our executive officers after a ninety day period
following their respective demand letters had elapsed (the
District Court Actions). In January 2010, a
derivative action was filed in Massachusetts Superior Court
(Middlesex County) by a shareholder who has not issued a demand
letter and in February and March 2010, two additional derivative
actions were filed in Massachusetts Superior Court (Suffolk
County and Middlesex County, respectively) by two separate
shareholders after the lapse of a ninety day period following
the shareholders respective demand letters (collectively,
the State Court Actions).
The derivative actions in general are based on allegations that
our board of directors and certain executive officers breached
their fiduciary duties by causing us to make purportedly false
and misleading or inadequate disclosures of information
regarding manufacturing issues, compliance with GMP, ability to
meet product demand, expected revenue growth, and approval of
Lumizyme. The actions also allege that certain of our directors
and executive officers took advantage of their knowledge of
material non-public information about us to illegally sell stock
they personally held in us. The plaintiffs generally seek, among
other things, judgment in favor of us for the amount of damages
sustained by us as a result of the alleged breaches of fiduciary
duty, disgorgement to us of proceeds that certain of our
directors and executive officers received from sales of our
stock and all proceeds derived from their service as our
directors or executives, and reimbursement of plaintiffs
costs, including attorneys and experts fees. The
District Court Actions have been consolidated in In Re
Genzyme Derivative Litigation and the plaintiffs have agreed
to a joint stipulation staying these cases until our board of
directors has had sufficient time to exercise its duties and
complete an appropriate investigation, which is ongoing. On
July 9, 2010, one of the State Court Actions was dismissed
without prejudice for plaintiffs failure to serve process
on the defendants. The Middlesex Court also ordered transfer and
consolidation of the remaining two State Court Actions in the
Suffolk Superior Court Business Litigation Session. The court
has indicated that discovery in that action also will be stayed
for some period pending our board of directors completion
of its ongoing investigation in response to the shareholders
demand.
In October 2009, Shelbyzyme LLC filed a complaint against us in
the U.S. District Court for the District of Delaware
alleging infringement of U.S. patent 7,011,831 by
making, using, selling and promoting a method for the
treatment of Fabry disease. The 831 patent, which is
directed to a method for treating Fabry disease, was issued in
March 2006 and expired in March 2009. The plaintiffs seek
damages for past infringement, including treble damages for
alleged willful infringement and reimbursement of costs,
including attorneys fees.
We are party to a legal action brought by Kayat Trading Ltd., or
Kayat, pending before the District Court in Nicosia, Cyprus.
Kayat alleges that we breached a 1996 distribution agreement
under which we granted
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GENZYME
CORPORATION AND SUBSIDIARIES
Notes to
Unaudited, Consolidated Financial
Statements (Continued)
Kayat the right to distribute melatonin tablets in the Ukraine,
primarily by not providing products or by providing
non-conforming products. Kayat further claims that due to the
alleged breach, it suffered lost profits that Kayat claims it
would have received under agreements it alleges it had entered
into with subdistributors. Kayat also alleges common law fraud
and violations of Mass. Gen. L. c. 93A and the Racketeer
Influenced and Corrupt Organizations Act. Kayat filed its suit
on August 8, 2002 and a trial began in Cyprus in December
2009. Kayat seeks damages for its legal claims and for expenses
it claims it has incurred, including legal fees and advertising,
promotion and other
out-of-pocket
expenses.
We are not able to predict the outcome of the lawsuits and
matters described above or estimate the amount or range of any
possible loss we might incur if we do not prevail in final,
non-appealable determination of these matters. Therefore, we
have not accrued any amounts in connection with the lawsuits and
matters described above.
We also are subject to other legal proceedings and claims
arising in connection with our business. Although we cannot
predict the outcome of these other proceedings and claims, we do
not believe the ultimate resolution of any of these other
existing matters would have a material adverse effect on our
consolidated financial position or results of operations.
Our effective tax rate for all periods presented varies from the
U.S. statutory tax rate as a result of:
In addition, our tax benefit for both the three and nine months
ended September 30, 2010 includes tax benefits due to the
realization, for U.S. income tax purposes, of prior
periods foreign income tax paid in the amount of
$9.5 million for the three months ended September 30,
2010 and $19.5 million for the nine months ended
September 30, 2010.
Our benefits from tax provisions for the nine months ended
September 30, 2010 also includes tax benefits in the amount
of $15.2 million as a result of the resolution of tax
examinations in major tax jurisdictions and tax expenses in the
amount of $20.6 million resulting from the remeasurement of
the deferred tax assets related to our acquisition of certain
assets from Bayer in 2009.
We are currently under audit by various states and foreign
jurisdictions for various years. We believe that we have
provided sufficiently for all audit exposures. Settlement of
these audits or the expiration of the statute of limitations on
the assessment of income taxes for any tax year will likely
result in a reduction of future tax provisions. Any such benefit
would be recorded upon final resolution of the audit or
expiration of the applicable statute of limitations.
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GENZYME
CORPORATION AND SUBSIDIARIES
Notes to
Unaudited, Consolidated Financial
Statements (Continued)
We present segment information in a manner consistent with the
method we use to report this information to our management.
Effective January 1, 2010, based on changes in how we
review our business, we re-allocated certain of our business
units amongst our segments and adopted new names for certain of
our reporting segments. Under the new reporting structure, we
are organized into five reporting segments as described above in
Note 1., Description of Business, to these
consolidated financial statements. We have revised our 2009
segment disclosures to conform to our 2010 presentation.
We have provided information concerning the operations of these
reportable segments in the following tables (amounts in
thousands):
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GENZYME
CORPORATION AND SUBSIDIARIES
Notes to
Unaudited, Consolidated Financial
Statements (Continued)
Income (loss) before income taxes for our Hematology and
Oncology and Multiple Sclerosis reporting segments includes the
following contingent consideration expenses (amounts in
thousands):
We provide information concerning the assets of our reportable
segments in the following table (amounts in thousands):
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GENZYME
CORPORATION AND SUBSIDIARIES
Notes to
Unaudited, Consolidated Financial
Statements (Continued)
Our payment obligations under our 2015 and 2020 Senior Notes
(see Note 12., Long-Term Debt to these
consolidated financial statements) are guaranteed by our
wholly-owned subsidiary, Genzyme Therapeutic Products Limited
Partnership, which we refer to as our Guarantor Subsidiary. Such
guarantees are full, unconditional and joint and several. The
following supplemental financial information sets forth, on a
combined basis, balance sheets, statements of operations and
statements of cash flows for Genzyme Corporation (Parent), our
Guarantor Subsidiary (which is 100% owned by the Parent) and our
Non-Guarantor Subsidiaries.
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GENZYME
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Notes to
Unaudited, Consolidated Financial
Statements (Continued)
Consolidating
Statements of Operations for the Three Months Ended
September 30, 2010
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GENZYME
CORPORATION AND SUBSIDIARIES
Notes to
Unaudited, Consolidated Financial
Statements (Continued)
Consolidating
Statements of Operations for the Three Months Ended
September 30, 2009
(Unaudited, amounts in thousands)
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GENZYME
CORPORATION AND SUBSIDIARIES
Notes to
Unaudited, Consolidated Financial
Statements (Continued)
Consolidating
Statements of Operations for the Nine Months Ended
September 30, 2010
(Unaudited, amounts in thousands)
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