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July
27, 2007
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Mr.
Peter Lankau
Chief
Executive Officer
Endo
Pharmaceuticals Holdings, Inc.
100
Endo Boulevard
Chadds
Ford, PA 19317
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Dear
Mr. Lankau:
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As
you are aware D. E. Shaw Composite Portfolios L.L.C. and certain
of its
affiliates (collectively “we” or the “D. E. Shaw group”) beneficially own
approximately 5.6% of the outstanding shares of Endo Pharmaceuticals
Holdings Inc. (“ENDP” or the “Company”).
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Over
the past several months we have had a constructive dialogue
with you and
your management team on the Company’s current prospects and longer-term
strategic vision. We continue to believe that ENDP’s current
portfolio consists of highly valuable products (including Lidoderm,
Opana
IR and ER, and Frova) that provide the Company with the commercial
presence in pain management that is required to be considered
“world-class.” In addition, the Company’s cash balance remains
a widely misunderstood and undervalued asset. We believe the
true fair value of ENDP is being discounted due to 1) inefficient
capital structure, 2) publicly stated intention to diversify away
from pain management, and 3) the perceived risk of Lidoderm
genericization.
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Over
the last 12 months, ENDP has underperformed relative to the
DJIA, NASDAQ,
and S&P 500. These indices have appreciated 26.7%, 31.8%,
22.8% respectively versus 11.5% for ENDP. ENDP currently has
approximately 3 times the net cash per share of the Company’s peer
group1 and applying valuation
metrics that appropriately account for cash and debt (i.e.,
P/E
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As
mentioned above, we believe that three issues contribute to this
valuation
gap: 1) inefficient capital structure, 2) publicly
stated intention to diversify away from pain management, and
3) the
perceived risk of Lidoderm genericization. Each of these topics
is worth further discussion:
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Inefficient
capital structure. As of the end of Q1 2007, ENDP had
a net cash position of
$731
million, or 16% of the Company’s market capitalization. In
addition, ENDP is generating greater than $200 million of cash
per year
and growing. The conscious decision to hold all of this cash on
the Company’s balance sheet while management continues to assess the
strategic landscape is destroying value as the market gives ENDP
no credit
for this cash. While the Company’s cash leaves it the
flexibility to consider and make acquisitions, ENDP has been
guiding to
complete a near-term transaction for the last 10 months and the
present
value of the cash asset continues to decline. By more
effectively deploying this cash in the near-term, ENDP can substantially
improve its present and future valuation with no risk of impairing
the
ability to pursue a future transaction.
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The
Company’s large cash position could be used to fund highly accretive
share
buybacks that would likely create value far in excess of your
expected
interest income. One option is: a $1.5 billion
levered buyback at $35 per share funded using $500 million in
available
cash and $1 billion in a hybrid debt structure at 5% (2.2 times
net debt
to CY07 consensus EBITDA1
leverage) would increase earnings per share by more than
20%. In this scenario we believe the Company would retain
sufficient financial flexibility to execute appropriate strategic
transactions as they arise.
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Publicly
stated intention to diversify away from pain management decreases
attractiveness to strategic acquirers. We believe the
Company’s world-class commercial presence in pain management, large and
growing product portfolio, and significant cash flow are of obvious
value
to a wide spectrum of strategic and financial acquirers. Our
conversations with investors, advisers, and executives in the
healthcare
space have supported this view, and we strongly believe that
ENDP is an
attractive acquisition target. However, we are concerned that
the Company’s public intention to diversify away from pain management via
a major transaction would meaningfully dilute the value of these
assets
while also increasing the risk profile of the business. While
we are typically very supportive of the Company’s capital being allocated
to new opportunities at attractive prices, we are not convinced
that such
a deal is out there. In fact, the inability to consummate an
attractively priced deal over the last 9 to 12 months supports
this
concern. In these scenarios, we are perfectly happy to benefit
from the strong cash flow via an optimized balance sheet.
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Even
if a strategic transaction is being considered, we believe it
is
imperative that management and the Board of Directors thoroughly
evaluate
all strategic alternatives prior to embarking on a major diversification
initiative to ensure the highest value to shareholders. As a
strategic acquisition candidate, ENDP provides a portfolio of
growing pain
products already generating revenue in excess of $1 billion per
year, a
pipeline of pain opportunities, and reliable cash flow of over
$200
million per year—all highly valuable assets in the pharmaceutical
market. The current market dynamic, which is characterized by
near-term revenue gaps, sparse pipelines, and limited new growth
opportunities, only bolsters this value. Additionally, there is
a myriad of potential synergies in a strategic transaction, including
opportunities to commercialize select ENDP drugs outside the
United States
and to reduce redundant commercial and administrative infrastructure,
clinical spend, and overhead.
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Lidoderm
genericization risk. While the market appears to
discount the Company’s valuation based on perceived risks of Lidoderm
genericization, we believe the risk to the Lidoderm business
is
overstated. Specifically:
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The
Lidoderm IP estate is broad and sound—the product currently has five
Orange Book listed patents covering formulation and method
of use that
must be challenged successfully prior to generic
approval.
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▪
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The
Lidoderm IP estate is broad and sound—the product currently has five
Orange Book listed patents covering formulation and method
of use that
must be challenged successfully prior to generic
approval.
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▪
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The
Office of Generic Drugs (“OGD”) recommendation on an abbreviated generic
pathway for Lidoderm is onerous, particularly in its requirement
that the
size of patch and level of lidocaine in the patch pre- and
post-treatment
be identical to the branded comparator, decreasing the possibility
of
“inventing around” the existing Lidoderm formulation
patents. Additionally, the recommendation has not yet accounted
for the fact that the Lidoderm label clearly states that the
product acts
locally rather than systemically and Lidoderm does not cause
complete
sensory block of the treated area. We expect that OGD and FDA
will need to address both of these issues, and possibly the
issue of
“skinny labeling” before approving a Lidoderm generic.
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▪
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In
the event of a paragraph iv filing, Lidoderm will still have
31.5 months
of protection under the Hatch Waxman statute after a paragraph
iv generic
filing (45 days to file suit from notification, automatic 30
month stay of
action).
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▪
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The
Company has filed a thorough and scientifically valid Citizen’s Petition
that must be addressed by FDA before final action is taken
on any
application. At a minimum, the Citizen’s Petition should force
FDA and OGD to agree on how to treat the questions of local
versus
systemic efficacy and skin irritation/sensitization when assessing
a
generic filing.
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▪
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Branded
transdermal products historically retain significant revenue
after
genericization due to the limited number of generic companies
with
approvable patch capability and the traditional difficulty
in
manufacturing patches on a commercial scale (e.g., Duragesic,
Climara).
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While
the risk of Lidoderm genericization is out of management’s direct control,
we believe management has taken appropriate steps to protect
the product
by filing a well-reasoned Citizen’s Petition and publicly expressing
continued confidence in the current Lidoderm patent
estate. However, we believe management is being overly
conservative on both the balance sheet and the need to diversify
versus
the actual risk to Lidoderm.
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Despite
management’s extremely conservative view of the franchise, we continue
to
believe ENDP has an outstanding fundamental business in pain
management. However, we believe the ongoing valuation gap
relative to peers can be addressed by making the Company’s capital
structure more efficient. Additionally, we believe the Board of
Directors must first consider all strategic alternatives prior
to pursuing
a transaction to diversify away from pain management. In the
absence of taking initiatives to address these issues, we have
little
confidence that ENDP shares will appreciate to fair value in
a timely
manner. On the other hand, by pursuing these initiatives, we
believe ENDP’s management and Board of Directors will unlock significant
value for the Company’s shareholders.
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We
are happy to meet with management and/or the Board of Directors
at their
convenience to discuss our views. Thank you for your
consideration and we look forward to continuing our constructive
dialogue.
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NOTHING
IN THIS LETTER CONSTITUTES TAX, LEGAL (INCLUDING WITHOUT LIMITATION
INTELLECTUAL PROPERTY), INVESTMENT, OR TAX ADVICE. THE COMPANY,
ITS MANAGEMENT, AND ITS BOARD OF DIRECTORS SHOULD CONSULT ITS
OWN ADVISERS
FOR ADVICE CONCERNING THE VARIOUS CONSIDERATIONS RELATING TO
THE MATTERS
OUTLINED OR REFERRED TO IN THIS LETTER. NONE OF
D. E. SHAW COMPOSITE PORTFOLIOS, L.L.C., D. E. SHAW
& CO., L.P. (ITS INVESTMENT ADVISER), D. E. SHAW & CO.,
L.L.C. (ITS MANAGING MEMBER), AND ANY OTHER ENTITY IN THE
D. E. SHAW GROUP; NOR THEIR AFFILIATES; NOR ANY SHAREHOLDERS,
PARTNERS, MEMBERS, MANAGERS, DIRECTORS, PRINCIPALS, PERSONNEL,
TRUSTEES,
OR AGENTS OF ANY OF THE FOREGOING IS RESPONSIBLE FOR GIVING,
OR IS LIABLE
FOR, ANY LEGAL, INVESTMENT, OR TAX ADVICE WITH RESPECT TO THE
COMPANY NOR
SHALL BE LIABLE FOR ANY ERRORS (AS A RESULT OF NEGLIGENCE OR
OTHERWISE TO
THE FULLEST EXTENT PERMITTED BY LAW IN THE ABSENCE OF FRAUD)
IN THE
INFORMATION, BELIEFS, AND/OR OPINIONS INCLUDED IN THIS LETTER,
OR FOR THE
CONSEQUENCES OF RELYING ON SUCH INFORMATION, BELIEFS, OR
OPINIONS. ANY INFORMATION, BELIEFS, AND/OR OPINIONS PROVIDED IN
THIS LETTER CONSTITUTE THE UNDERSTANDING OF THE ENTITY PROVIDING
SUCH
INFORMATION, BELIEFS, AND/OR OPINIONS AS OF THE DATE OF THIS
LETTER, ARE
SUBJECT TO CHANGE WITHOUT NOTICE, AND MAY NOT REFLECT THE CRITERIA
EMPLOYED BY THE ENTITIES IN THE D. E. SHAW GROUP TO EVALUATE
INVESTMENTS. NO REPRESENTATION IS MADE THAT THE STATISTICS AND
OTHER INFORMATION DESCRIBED IN THIS LETTER ARE COMPLETE OR ADEQUATE
OR
THAT THEY WOULD BE USEFUL IN SUCCESSFULLY EVALUATING THE COMPANY’S
BUSINESS OR STRATEGIC DECISIONS. CERTAIN INFORMATION AND
OPINIONS INCLUDED IN THIS LETTER HAVE BEEN OBTAINED FROM THIRD-PARTY
SOURCES BELIEVED TO BE APPROPRIATE FOR CONSIDERATION. SOURCES
FOR SUCH INFORMATION AND OPINIONS MAY HAVE SELF-INTERESTED REASONS
FOR
PROVIDING INCORRECT INFORMATION. MOREOVER, NO ASSURANCE CAN BE
GIVEN THAT SUCH INFORMATION OR OPINIONS ARE RELIABLE, AND THEY
SHOULD NOT
BE TAKEN AS SUCH.
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