UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

 

SCHEDULE 14D-9

Solicitation/Recommendation Statement

Under Section 14(d)(4) of the Securities Exchange Act of 1934

 

 

AVANIR PHARMACEUTICALS, INC.

(Name of Subject Company)

 

 

AVANIR PHARMACEUTICALS, INC.

(Name of Person Filing Statement)

 

 

Common Stock, par value $0.0001 per share

(Title of Class of Securities)

05348P401

(CUSIP Number of Class of Securities)

Keith Katkin

President and Chief Executive Officer

Avanir Pharmaceuticals, Inc.

30 Enterprise, Suite 400,

Aliso Viejo, California 92656

(949) 389-6700

(Name, address and telephone number of person authorized to receive

notices and communications on behalf of the persons filing statement)

With copies to:

Charles K. Ruck

R. Scott Shean

David M. Wheeler

Latham & Watkins LLP

650 Town Center Drive, 20th Floor

Costa Mesa, CA 92626

(714) 540-1235

 

 

 

x Check the box if the filing relates solely to preliminary communications made before the commencement of a tender offer.

 

 

 


The New Global CNS
Company
December 2014


2
Creation of a Global Leader in CNS


3
Strategic Rationale
Increased resources
to continue our vision of
developing into a leading CNS specialty pharmaceutical
company
Remain an independent operating company -
Avanir
Pharmaceuticals -
with the benefit of tapping into the
resources of a large pharmaceutical company
(Johnson and Johnson operating model)
Confidential and Proprietary


4
Why Otsuka?
Maximize Share Value
Cultural
Alignment
Philosophical
Alignment
Business
Alignment
Confidential and Proprietary


Otsuka Desires to Build Capabilities
5
Otsuka’s people
have built world class capabilities to
develop and commercialize innovative
products for people
with psychiatric
conditions
Avanir’s people
have built world class capabilities to develop
and commercialize innovative
products for people with
neurologic
conditions
With
the added resources of Otsuka and the shared
expertise of our people, we will be able to accelerate the
development and commercialization of needed CNS drugs
and unlock additional value in Avanir’s business


Achieving Greatness
6


Otsuka Philosophy…
7
Creating our own unique and innovative products
Improving health and well being
Contributing to the lives of people worldwide
These words embody our dedication to:


"Always striving
to take the
road less traveled
For better health
worldwide
World-class
or
Not at All


Otsuka Overview
9
Parent:  Otsuka Holdings, Co., Ltd. (Tokyo, Japan)
Revenue/Net Income:  $14.1 Billion / $1.5 Billion (FY2013)
Core Business Segments:  Pharmaceuticals &
Nutraceuticals
Capabilities: Discovery Research, Preclinical and Clinical
Development, Manufacturing, Packaging, Distribution, and
Global Commercialization (U.S., Europe, and Asia Pacific)
Pharmaceutical Focus:  CNS, Oncology, and Cardiovascular


Hi-Z Tower
Otsuka Pharmaceutical Co., Ltd. 
Tokushima, Japan
Otsuka Pharmaceutical Co., Ltd
Established
August 10,1964
President
Taro Iwamoto
Employees
5,733
Sales (FY13)
US $7.5 Billion
+21.9%
Operating
income
US $2.0 Billion
+48.1%
Key U.S.
Companies
Otsuka America Pharmaceuticals Inc
Otsuka Pharmaceutical Development
& Commercialization, Inc.
Otsuka Maryland Medicinal
Laboratories, Inc.
Astex Pharmaceuticals
(as of March 31, 2014)
Otsuka Pharmaceuticals


Flagship Products
11


Otsuka CNS Pipeline
Compound
Class
Indication (Formulation)
Region
Stage
OPC-14597
(Abilify™)
Aripiprazole
Dopamine
partial
agonist
Autism (Oral)
JP
Phase 3
Tourette disorder (Once-weekly tablet)
US
Filed
OPC-14597
(Abilify Maintena™)
Aripiprazole
Depot injection
Schizophrenia
JP
Filed
Bipolar
I disorder
JP, US,
& EU
Phase 3
levetiracetam
(Keppra™/E Keppra™)
(UCB partnership)
Anti-epileptic
drug
Epilepsy-generalized onset seizures (Oral)
JP
Phase 3
Epilepsy-partial
onset
seizures/mono
therapy
(Oral/injection)
JP
Filed
OPC-34712
Brexpiprazole
Serotonin-
Dopamine
Activity
Modulator
(SDAM)
Adjunctive therapy for major depressive disorder(Oral)
US
EU
Filed
Phase 3
Schizophrenia (Oral)
US
JP, EU
Filed
Phase 3
Agitation associated with Alzheimer's disease (Oral)
US, EU
Phase 3
Post-traumatic stress disorder
(Oral)
US, EU
Phase 3
Lu AE58054
(Lundbeck partnership)
5HT6
antagonist
Alzheimer’s disease (Oral)
US, EU,
JP
Phase3
AF 20513
-amyloid
vaccine
Alzheimer’s disease
US, EU
Phase 1
ASC-01
aripiprazole/sertraline
Dopamine
partial
agonist/ SSRI
Major depressive disorder(Oral)
JP, Asia
Phase3


13
Implications for Avanir
Business as usual
goal
is
not
to
change
how
we
operate
as
a
company!
No expected changes in headcount or cash compensation targets
The
benefits
of
being
a
small
biopharmaceutical
company
with
increased
resources and protection of a large company
Development and commercialization organization for Otsuka products focused
on
neurology
and
elderly…
more
products
to
sell
and
more
development
programs to pursue
Sativex (Phase III data in 1H2015)
Multiple Alzheimer’s Disease programs and brexpiprazole
Increased leverage
when dealing with business issues
Global
approach
to
the
business
US,
Europe
and
Asia
Confidential and Proprietary


14
Implications for the Commercial Team
Business as usual
with access to more resources
No expected changes in headcount or cash compensation targets
300+ psychiatry representatives contributing to the Nuedexta sales effort
More noise, more adoption, more patients being helped!
Increased leverage
with wholesalers, managed care organizations and
other customers
Commercialization arm for Otsuka products for neurology and elderly
patients
EU and ROW
commercialization infrastructure
Confidential and Proprietary


15
Implications for the R&D Team
Business as usual
with access to more resources
No expected changes in headcount or cash compensation targets
Continue development of all of our programs
Development arm for Otsuka neurology product candidates
Leverage
Otsuka
relationships
and
infrastructure
as
needed
Leverage
Otsuka
expertise
in
Psychiatry
drug
development
Global presence
to pursue worldwide development programs
Confidential and Proprietary


16
Financials
$17 per share; $3.5Bn offer value
Represents ~20x 2015 revenues; ~13.5x 2016 revenues
Significant take-out premium built into the pre-announcement stock price
Premiums
58% to the 90 trading day average trading price
47%
/
32%
premium
to
the
60
/
30
trading
day
average
trading
price,
respectively
55% premium over September financing
14% to Friday (11/28) close; 13% to 52wk high closing price
Confidential and Proprietary


17
Summary
Great
outcome
for
employees,
patients
and
shareholders
Business
as
usual
goal
is
not
to
change
how
we
operate!
No expected changes in headcount or cash compensation targets
The benefits of being a small biopharmaceutical company with increased
resources and protection of a large company
Opportunity to meet and interact with Taro Iwamoto, Ph.D. the President
of
Otsuka
this
afternoon
Send questions to Jesus Varela via e-mail for this afternoon
Confidential and Proprietary


Impact on Our Customers,
Researchers and Patients


19
Impact on Customers
Great outcome for customers
More resources to develop the PBA market by raising
awareness thereby increasing the number of patients to be
helped
Increased investment in the business
Worldwide presence
Increased investment in Avanir pipeline focused on bringing
innovative therapies to market for diseases with high unmet
needs
Confidential and Proprietary


20
Impact on Researchers
Great outcome for researchers
More resources to develop current and future Avanir
products
Increased investment in Avanir pipeline focused on bringing
innovative therapies to market for diseases with high unmet
needs
Increased investment in the business
Worldwide presence
Confidential and Proprietary


21
Impact on Patients
Great outcome for patients
More resources to develop the PBA market by raising
awareness thereby increasing the number of patients to be
helped
Increased investment in Avanir pipeline focused on bringing
innovative therapies to market for diseases with high unmet
needs
Worldwide presence
Confidential and Proprietary


Forward-Looking Statements
The statements included in this communication that are not a description of historical facts are forward-looking statements. Words or phrases
such as “believe,”
“may,”
“could,”
“will,”
“estimate,”
“continue,”
“anticipate,”
“intend,”
“seek,”
“plan,”
“expect,”
“should,”
“would”
or similar
expressions are intended to identify forward-looking statements. These forward-looking statements include without limitation statements
regarding the benefits and planned completion of the transactions contemplated by the Agreement and Plan of Merger dated as of
December 2,
2014
(the
“Merger
Agreement”)
by
and
among
Avanir
Pharmaceuticals,
Inc.
(the
“Company”),
Otsuka
Pharmaceutical
Co.,
Ltd.
(“Parent”) and Bigarade Corporation, a wholly-owned subsidiary of Parent (“Acquisition Sub”). Risks and uncertainties that could cause results
to differ from expectations include: uncertainties as to the timing of the tender offer and the merger; uncertainties as to the percentage of
Company
stockholders
tendering
their
shares
in
the
tender
offer;
the
possibility
that
competing
offers
will
be
made;
the
possibility
that
various
closing
conditions
for
the
tender
offer
or
the
merger
may
not
be
satisfied
or
waived,
including
that
a
governmental
entity
may
prohibit,
delay
or
refuse
to
grant
approval
for
the
consummation
of
the
merger;
the
effects
of
disruption
caused
by
the
transaction
making
it
more
difficult
to
maintain relationships with employees, collaborators, vendors and other business partners; the risk that stockholder litigation in connection with
the tender offer or the merger may result in significant costs of defense, indemnification and liability; and risks and uncertainties pertaining to the
business of the Company, including the risks and uncertainties detailed in the Company’s public periodic filings with the United States Securities
and Exchange Commission  (the “SEC), as well as the tender offer materials to be filed by Parent and Acquisition Sub and the
Solicitation/Recommendation
Statement
to
be
filed
by
the
Company
in
connection
with
the
tender
offer.
You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. All forward-looking
statements are qualified in their entirety by this cautionary statement and the Company undertakes no obligation to revise or update this report
to
reflect
events
or
circumstances
after
the
date
hereof,
except
as
required
by
law.
This
caution
is
made
under
the
safe
harbor
provisions
of
Section 21E of the Private Securities Litigation Reform Act of 1995.
Additional Information
The
tender
offer
described
above
has
not
yet
commenced.
This
communication
is
not
an
offer
to
buy
nor
a
solicitation
of
an
offer
to
sell
any
securities
of
the
Company.
The
solicitation
and
the
offer
to
buy
shares
of
the
Company’s
common
stock
will
only
be
made
pursuant
to
a
tender
offer statement on Schedule TO, including an offer to purchase, a letter of transmittal and other related materials that Parent and Acquisition
Sub intend to file with the SEC. In addition, the Company will file with the SEC a Solicitation/Recommendation Statement on Schedule 14D-9
with respect to the tender offer. Once filed, investors will be able to obtain the tender offer statement on Schedule TO, the offer to purchase, the
Solicitation/Recommendation
Statement
of
the
Company
on
Schedule
14D-9
and
related
materials
with
respect
to
the
tender
offer
and
the
merger,
free
of
charge
at
the
website
of
the
SEC
at
www.sec.gov,
and
from
the
information
agent
named
in
the
tender
offer
materials.
Investors
may
also
obtain,
at
no
charge,
any
such
documents
filed
with
or
furnished
to
the
SEC
by
the
Company
under
the
“Investors”
section
of
the
Company’s website at www.avanir.com. INVESTORS AND SECURITY HOLDERS ARE ADVISED TO READ THESE DOCUMENTS WHEN
THEY
BECOME
AVAILABLE,
INCLUDING
THE
SOLICITATION/RECOMMENDATION
STATEMENT
OF
THE
COMPANY
AND
ANY
AMENDMENTS
THERETO,
AS
WELL
AS
ANY
OTHER
DOCUMENTS
RELATING
TO
THE
TENDER
OFFER
AND
THE
MERGER
THAT
ARE
FILED WITH THE SEC, CAREFULLY AND IN THEIR ENTIRETY PRIOR TO MAKING ANY DECISIONS WITH RESPECT TO WHETHER TO
TENDER THEIR SHARES INTO THE TENDER OFFER BECAUSE THEY CONTAIN IMPORTANT INFORMATION, INCLUDING THE TERMS
AND CONDITIONS OF THE TENDER OFFER.
22