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Forward-looking Statement
Except for the historical information contained herein, the matters set forth in this press release, including statements
regarding Avanir’s plans, potential opportunities, financial or other expectations, projections, goals, objectives,
milestones, strategies, market growth, timelines, legal matters, product pipeline, clinical studies, product development
and the potential benefits of its commercialized products and products under development are forward-looking
statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995.
These forward-looking statements are subject to risks and uncertainties that may cause actual results to differ
materially, including the risks and uncertainties associated with Avanir’s operating performance and financial position,
joint ventures, collaborations and partnerships with third parties, market size, market share, commercial viability,
market demand for and acceptance of Avanir’s products domestically and internationally, research, development and
commercialization of new products domestically and internationally, reliance upon the collaborative efforts of others,
competition domestically and internationally, the success of external business-development activities, intellectual
property rights, government regulation, obtaining and maintaining regulatory approvals domestically and internationally,
government investigations, litigation, including, but not limited to Avanir’s ability to obtain, maintain, and protect its
patents and other intellectual property both domestically and internationally, the occurrence of adverse safety events,
delay or failure to gain acceptance by the medical field domestically and internationally, dependence on third parties for
supply, manufacturing and distribution, delay or failure to adequately build or maintain the necessary sales, marketing,
supply chain management and reimbursement capabilities on our own or enter into arrangements with third parties to
perform these functions in a timely manner or on acceptable terms, and other risks detailed from time to time in the
Company's most recent Annual Report on Form 10-K and other documents subsequently filed with or furnished to the
Securities and Exchange Commission. These forward-looking statements are based on current information that may
change and you are cautioned not to place undue reliance on these forward-looking statements, which speak only as of
the date of this press release. All forward-looking statements are qualified in their entirety by this cautionary
statement, and the Company undertakes no obligation to revise or update any forward-looking statement to reflect
events or circumstances after the issuance of this press release.
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Avanir: A Leading CNS BioPharma
LONGEVITY OF FRANCHISE (exclusivity to 2030+ with AVP-786)
STUDIES IN 4 POTENTIAL NEW INDICATIONS (potential in the $ billions)
1 APPROVED PRODUCT + 1 FILED NDA (potential in the $100’s of millions)
GROWING REVENUES (net revenue run-rate ~$100 million)
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Avanir: A Leading CNS BioPharma
A Leading CNS Biopharma
Demonstrated commercial success
Broad development pipeline
Infrastructure to grow
Broad Pipeline Across 3 Assets
Pain: Migraine, DPN pain
Mood/Behavior: AD agitation, depression, autism
Movement Disorders: PD dyskinesia, spasticity
NUEDEXTA® in Pseudobulbar Affect
Large market with a high unmet medical need
First and only FDA & EMA approved Rx for PBA
Robust and growing revenues
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PBA: A Debilitating Condition Impacting Millions
Neurologic disorder causing involuntary & uncontrollable emotional outbursts
− Crying and or laughing episodes
− Incongruent or exaggerated to patient’s inner mood
− Usually occur several times per day
− Episodes last from seconds to minutes
Episodes can be severe and cause significant impairment
Occurs secondary to neurologic diseases or injuries
− Alzheimer’s disease, amyotrophic lateral sclerosis (ALS), multiple
sclerosis (MS), Parkinson’s disease, stroke, traumatic brain injury
Estimated 1.8 million with moderate-to-severe PBA1
1 Work SS. Adv Ther. 2011;28(7):586-601
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7
1% = $7 million
PBA Commercial Opportunity (U.S.)
Based on PRISM Registry data; Brooks et al. PLOS One, August 2013(8). www.plosone.org
18 million Patients with key neurological disorders
1.8 million with moderate-severe PBA
1% = $122 million
1.7 million Out-patient 100,000 Institutional
(NUEDEXTA <10% Today) (NUEDEXTA <1% Today)
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0
5
10
15
20
25
millions
($)
Net Revenues
Total
Retail
Institutional
Growing NUEDEXTA® Franchise
Monthly Capsule Count
Source: IMS Health Monthly NPA (National Prescription Audit); Avanir data on file
Robust Quarterly Growth
$24.4m
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PBA Awareness & Diagnosis
Continuing to Grow the PBA Opportunity…
• 152 Sales Representatives
− 80 Institutional
− 72 Retail
• PBA Education & Screening
• NUEDEXTA Clinical Sell
• Additional Clinical Data
• Contracting (75%+ Lives)
• Patient Assistance Programs
• PBA DTC Campaign
• Database Marketing
Strategy Key Tactics
Physician Adoption
Patient Access
Patient & Caregiver Activation
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NMDA
Receptor
Antagonist
Serotonin
Reuptake
Inhibitor
Norepinephrine
Reuptake
Inhibitor
Sigma-1
Receptor
Agonist
DM Binds to Key Receptors in the CNS
1. Netzer R, et al. Eur J Pharmacol. 1993;238(2-3):209-16; 2. Jaffe DB, et al. Neurosci Lett. 1989;105:227-32; 3. Zhou GZ, et al. Eur J Pharmacol.1991;206:261-9; 4.
Maurice T, et al. Brain Res Brain Res Rev. 2001;37:116 –32; 5. Cobos EJ, et al. Curr Neuropharmacol. 2008;6:344-66; 6. Gillman PK, et al. Br J Anaesth.2005;95:434–41; 7.
Meoni P, et al. Br J Pharmacol. 1997;120(7):1255–62; 8. Codd EE, et al. JPET. 1995:274;1263-70; 9. Su TP, et al. Trends Pharmacol Sci.2010;31(12):557-66;10. Maurice T,
et al. Pharmacol Ther. 2009;124(2):195-206; 11. Carpenter CL, et al. Brain Res. 1988;439:372-5.
(Ki = 200 nM)3-5
Low affinity (Ki = 1500 nM)1,2
(Ki = 240 nM for inhibition of uptake; 13 µM for inhibition of binding)6-9
(Ki = 40 nM)
DEXTROMETHORPHAN
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Potential Therapeutic Applications of DM Pharmacology
Alzheimer’s Cognition
Parkinson’s
Depression
Pain
Memantine
Ketamine
Amantadine
NMDA
Receptor
Antagonist
Depression
Anxiety
PTSD
Impulse Control Disorder
Panic
OCD
Escitalopram
Sertraline
Fluoxetine
Serotonin
Reuptake
Inhibitor
Depression
Anxiety
Pain
ADHD
Duloxetine
Venlafaxine
Atomoxetine
Norepinephrine
Reuptake
Inhibitor
Depression
Cognition
Movement Disorder
Fluvoxamine
Donepezil
Sigma-1
Receptor
Agonist
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PRE-CLIN PHASE 1 PHASE 2 PHASE 3 FILED MARKET
Avanir Programs
NUEDEXTA
Pseudobulbar Affect
AVP-825
Migraine
AVP-923 / AVP-786
Alzheimer’s Disease (Agitation)
Parkinson’s Disease (Dyskinesia)
Treatment-Resistant Depression
Neuropathic Pain
Investigator Programs
AVP-923
Treatment-Resistant Depression
Behavior Symptoms (Autism)
Bulbar Function (ALS)
Pending
Broad Pipeline
Approved (U.S + Europe)
Data 2HCY14
Data 2HCY14
PDUFA 4QCY14
Study Begins 2HCY14
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Agitation in AD (Potential U.S. Opportunity)
Sources: 2012 Alzheimer’s Disease Facts & Figures (Alzheimer’s Assoc.); Alzheimer’s Dement. 2011 Jan; 7(1):80-93; USPSTF, Screening for Dementia in
Primary Care; Therapeutics Categories Outlook, Cowen & Co. October 2012; American Journal of Managed Care, 2011; Avanir Sep 2012; J. Rural Trop
Public Health 2010, Vol. 9, p. 82-94; J. Gerontol Nurs. 2008 December; 34(12):8-17; Patient numbers are approximate.
6 million with Dementia/AD
2.6 million diagnosed
1% = $115 million
1.6 million with Agitation*
* ~80% of nursing home residents with dementia have agitation
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Improving Agitation/Aggression in PBA Patients
-5
-4
-3
-2
-1
0
-1.31
-2.79*
-4.64* Change i
n N
PI A
git
ati
on/A
ggre
ssio
n
Fre
quency *
Severi
ty
(n=11) (n=14) (n=16)
* P≤0.05 for regression to evaluate dose-related trend
+ STAR Analysis done of patients with agitation/aggression occurring once a week or more frequently at baseline
The Neuropsychiatric Inventory (NPI) is a retrospective (to 1 month) caregiver–informant interview assessing the frequency and
severity of 12 neuropsychiatric symptom domains. Data on file. AVP-923 is not approved for the treatment of agitation.
NPI Agitation/Aggression in PBA Patients Treated with DM/Q
Placebo DMQ 20/10 DMQ 30/10
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Primary Endpoint
− Agitation/Aggression domain of Neuropsychiatric Inventory (NPI)
Secondary Endpoints
− MMSE
− ADCS-ADL
− ADCS-CGIC
− ADAS-Cog
− Quality of Life-AD
− Cornell Depression Scale
− Caregiver Strain Index
Additional Information
− Number of sites ~30 (US)
− Top-line data: H2 CY2014
Study AVR-131: Phase II Trial of AVP-923
Treatment of Symptoms of Agitation in Alzheimer’s Disease
Placebo
BID
AVP-923
20/10 mg BID
Escalating to
AVP-923
30/10 mg BID Randomize
N ≈ 200
AVP-923-20 is approved in the US as NUEDEXTA for the treatment of PBA; AVP-923-30 is not approved in the US; AVP – 923 is not approved for
the treatment of agitation in Alzheimer’s Disease
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Treatment-Resistant MDD (U.S. Opportunity)
Sources: http://nimh.nih.gov; CDC; J Affect Disord. 2012 Nov; Ronald M et al., Undiagnosed Depression, J Gen Intern Med. 2010; Treatment Resistant
Depression – Am Fam Physician. 2009; Arch Gen Psychiatry, 2010;67(12):1265-1273; Teresa BG et al., Cost Burden of Treatment Resistance in Patients
With Depression, Am J Manag Care 2010; STAR*D report, Am J Psychiatry 2006 * Refractory = non-responder or inadequate response; Patient numbers are
approximate.
15.7 million with Depression
7 million patients in treatment
4.6 million patients refractory* to 1st line
1% = $165 - 330 million
2.3 million patients refractory* to multiple lines
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Treatment-Resistant MDD Clinical Rationale
-10.00
-8.00
-6.00
-4.00
-2.00
0.00
-0.02
-1.10 -0.50
-1.59 P<0.05
-3.40 P<0.08
-8.60 P=0.03
Change i
n B
DI-
II S
core
Improved Depressive Symptoms in PBA Patients treated with DM/Q
Avanir STAR data on file. All P values vs placebo. Mild Depressive Symptoms: BDI>10≤19; Moderate or Greater Depressive Symptoms: BDI≥18
IMPRO
VEM
EN
T
(n=101) (n=97) (n=103) (n=48) (n=43) (n=38) (n=11) (n=12) (n=7)
-2.90 -3.30
-1.03
Overall Study Population
Post Hoc Subgroup Analysis
Patients with Moderate or Greater Depressive
Symptoms
Patients with Mild or Greater Depressive
Symptoms
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Next Steps for Treatment Resistant MDD
Initiate Phase II study H2 CY2014
Target population
− Patients with MDD that have insufficient response to conventional antidepressants
Randomized, placebo controlled
− AVP-786 or placebo adjunctive to other antidepressants
Standard efficacy and safety endpoints used in registration trials
Powered to demonstrate statistical and clinically meaningful differences
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Avanir’s Next NDA Filing
AVP-825 First and Only
Breath-Powered Powder
Formulation of Sumatriptan
AVP-825 is an investigational drug-device combination product utilizing a novel Breath Powered intranasal technology to
deliver a low-dose of sumatriptan powder.
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Transformational Nasal Technology
Breath Powered technology allows ideal intranasal targeting: Powder is delivered deep in nasal cavity where absorption is optimal without post-nasal drip or delivery to lungs.
Gamma-scintigraphy images from the same subject. Cumulative distribution during 32 minutes
White areas: 20% more of the max intensity; Orange Areas: 0-20% of the max intensity; Green Areas: no deposition
TRADITIONAL NASAL SPRAY AVP-825
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AVP-825: A Potential New Migraine Opportunity
Clinical profile may deliver on key unmet needs
Large well-established market but high dissatisfaction
− 1% share of the triptan market is worth $50-65 million
Peak revenue between $150-200 million
AVP-825 is an investigational drug-device combination product utilizing a novel Breath Powered intranasal technology to deliver a
low-dose of sumatriptan powder.
AVP-825:
Rapid Absorption
Fast Pain
Relief
Low Dose
Low Systemic
AEs
Easy and
Convenient
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0
10
20
30
40
50
60
70
80
0 10 20 30 40 50 60 70 80 90 100 110 120
% O
F S
UBJECTS W
ITH
HEAD
ACH
E R
ELIE
F *
TIME TO RELIEF IN MINUTES
AVP-82516mg (n=108)
Placebo (n=104)
* P<.0.05
* Defined as reduction from moderate (Grade 2) or severe (Grade 3) pain to none (Grade 0) or mild (Grade1) pain
* *
* * *
AVP-825: Meaningful Efficacy and Onset of Action
Source: TARGET Phase III data; AVP-825 is an investigational drug-device combination product utilizing
a novel Breath Powered intranasal technology to deliver a low-dose of sumatriptan powder.
Headache relief begins to separate at 15 minutes, significant by 30 minutes: Large effect size achieved despite modest sample size
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Key Financial Metrics
NUEDEXTA NET
REVENUES:
$24.4 million
TOTAL CASH
BALANCE:
$56.5 million
3-months ending March 31, 2014 (Fiscal 2Q 2014)
TOTAL NET
REVENUES:
$26.9 million
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Multiple Catalysts over Next the 12 Months
NDA Filing (AVP-825)
ANDA Litigation Decision
PBA Phase IV Interim Data (“PRISM II”)
H1 CY2014 H2 CY2014
LID Parkinson’s Phase II Data
Agitation in Alzheimer’s Phase II Data
IND Filing for AVP-786
Initiate TR-MDD Phase II (AVP-786)
PDUFA Date (AVP-825)
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Important Information
About NUEDEXTA
NUEDEXTA is an innovative combination of two well-characterized components; dextromethorphan hydrobromide (20 mg), the ingredient active in the
central nervous system, and quinidine sulfate (10 mg), a metabolic inhibitor enabling therapeutic dextromethorphan concentrations. NUEDEXTA acts on
sigma-1 and NMDA receptors in the brain, although the mechanism by which NUEDEXTA exerts therapeutic effects in patients with PBA is unknown.
NUEDEXTA Important Safety Information
NUEDEXTA is indicated for the treatment of pseudobulbar affect (PBA). PBA occurs secondary to a variety of otherwise unrelated neurological conditions,
and is characterized by involuntary, sudden, and frequent episodes of laughing and/or crying. PBA episodes typically occur out of proportion or
incongruent to the underlying emotional state. Studies to support the effectiveness of NUEDEXTA were performed in patients with amyotrophic lateral
sclerosis (ALS) and multiple sclerosis (MS). NUEDEXTA has not been shown to be safe and effective in other types of emotional lability that can commonly
occur, for example, in Alzheimer’s disease and other dementias. NUEDEXTA and certain other medicines can interact, causing serious side effects. If you
take certain drugs or have certain heart problems, NUEDEXTA may not be right for you. NUEDEXTA causes dose-dependent QTc prolongation. When
initiating NUEDEXTA in patients at risk for QT prolongation and torsades de pointes, electrocardiographic (ECG) evaluation should be conducted at
baseline and 3-4 hours after the first dose. The most common adverse reactions are diarrhea, dizziness, cough, vomiting, asthenia, peripheral edema,
urinary tract infection, influenza, increased gamma-glutamyltransferase, and flatulence. NUEDEXTA may cause dizziness. These are not all the risks from
use of NUEDEXTA. Please refer to full Prescribing Information at www.NUEDEXTA.com.
AVP-923 is an investigational product and not FDA approved.
AVP-825 is an investigational product and not FDA approved.
AVP-786 is an investigational product and not FDA approved.
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COMPANY CONTACT:
Ian Clements, PhD
IR & Corporate Communications
• www.avanir.com
• www.nuedexta.com
• www.pbafacts.com
©2014 Avanir Pharmaceuticals, Inc. All rights reserved. Avanir® and NUEDEXTA® are trademarks or registered trademarks of Avanir Pharmaceuticals, Inc. in the United States and other countries. All other trademarks are the property of their respective owners. The information herein is for informational purposes only and represents the current view of Avanir Pharmaceuticals, Inc. as of the date of this presentation. Avanir cannot guarantee the accuracy of any information provided after the date of this presentation. Avanir makes no warranties, express, implied or statutory, as to the information in this presentation.