EX-99.1 2 d746038dex991.htm EX-99.1 EX-99.1
Overview
June 2014
Exhibit 99.1


2
Forward Looking Statement
Forward Looking Statement
Zogenix
cautions
you
that
statements
included
in
this
presentation
that
are
not
a
description
of
historical
facts
are
forward-looking
statements.
Words
such
as
"believes,"
"anticipates,"
"plans,"
"expects,"
"indicates,"
"will,"
"intends,"
"potential,"
"suggests,"
"assuming,"
"designed"
and
similar
expressions
are
intended
to
identify
forward-looking
statements.
These
statements
are
based
on
the
company's
current
beliefs
and
expectations.
These
forward-looking
statements
include
statements
regarding:
the
market
potential
for
Zogenix’s
products
and
product
candidates,
and
its
ability
to
compete
within
those
markets;
the
expected
timing
of
various
activities
for
Zogenix’s
product
pipeline;
the
potential
to
develop
abuse
deterrent
formulations
of
Zohydro
ER
and
extend
its
intellectual
property
protection;
and
financial
guidance
for
2014.
The
inclusion
of
forward-looking
statements
should
not
be
regarded
as
a
representation
by
Zogenix
that
any
of
its
plans
will
be
achieved.
Actual
results
may
differ
from
those
set
forth
in
this
presentation
due
to
the
risks
and
uncertainties
inherent
in
Zogenix's
business,
including,
without
limitation:
Zogenix's
ability
to
achieve
broad
market
acceptance
and
generate
revenues
from
sales
of
Zohydro
ER;
Zogenix’s
ability
to
successfully
execute
its
sales
and
marketing
strategy
for
Zohydro
ER;
inadequate
therapeutic
efficacy
or
unexpected
adverse
side
effects
relating
to
Zohydro
ER
that
could
prevent
its
ongoing
commercialization,
or
that
could
result
in
recalls
or
product
liability
claims;
risks
and
uncertainties
associated
with
the
development
and
regulatory
approval
of
an
abuse
deterrent
formulation
of
Zohydro
ER
and
Zogenix’s
reliance
on
its
collaborators
in
such
development
efforts;
the
ability
of
Zogenix
and
its
licensors
to
obtain,
maintain
and
successfully
enforce
adequate
patent
and
other
intellectual
property
protection
of
its
products
and
product
candidates
and
the
ability
to
operate
its
business
without
infringing
the
intellectual
property
rights
of
others;
difficulties
in
identifying,
negotiating
and
carrying
out
strategic
transactions
relating
to
Zohydro
ER,
DosePro
Needle-Free
Delivery
Platform
and
Relday;
the
inherent
risks
of
clinical
development
of
Relday,
including
potential
delays
in
enrollment
and
completion
of
clinical
trials;
Zogenix's
dependence
on
its
existing
collaboration
with
DURECT
Corporation
and
potential
new
partners
to
develop
Relday;
the
market
potential
for
Zogenix’s
product
candidates,
and
its
ability
to
compete
within
those
markets;
and
other
risks
described
in
Zogenix's
filings
with
the
SEC.
You
are
cautioned
not
to
place
undue
reliance
on
these
forward-looking
statements,
which
speak
only
as
of
the
date
hereof,
and
Zogenix
undertakes
no
obligation
to
revise
or
update
this
presentation
to
reflect
events
or
circumstances
after
the
date
hereof,
except
as
required
by
law.
All
forward-looking
statements
are
qualified
in
their
entirety
by
this
cautionary
statement.
This
caution
is
made
under
the
safe
harbor
provisions
of
the
Private
Securities
Litigation
Reform
Act
of
1995.


3
The Zogenix Opportunity
The Zogenix Opportunity
UNIQUE MODEL
Combining Medicine and Technology to Provide
Differentiated Products That Meet Medical Needs
PROVEN EXECUTION
2 FDA Approvals, Successful Commercial Product,
Validated DosePro Platform, Strong Pipeline
SIGNIFICANT MARKET OPPORTUNITY
1st to Market in Large Opportunities with Innovative
Medicine and Technology
INFRASTRUCTURE for COMMERCIALIZATION
Key Hires and Expanded Sales Team In Place to Continue Leadership
COMMITMENT to RESPONSIBILITY
Executing on Responsible Commercialization and Development
of Abuse Deterrent (AD) Formulations


4
Oral, 12-Hour
Extended Release
Once Monthly
Subcutaneous Injection
DosePro®
Needle-Free
Delivery Platform
Unique Model:
Unique Model:
Combining Medicine and Technology
Combining Medicine and Technology
CHRONIC PAIN
ANTIPSYCHOTIC
INTERNAL/EXTERNAL
Hydrocodone
Without
Acetaminophen
Risperidone
Development
Opportunities
Medicine
Medicine
Medicine
Technology
Technology
COMMERCIALIZING
and
DEVELOPING
Innovative
Products


5
1st to Develop/Market
1st to Develop/Market
Oral, 12-Hour
Extended Release
Hydrocodone without
Acetaminophen
1
st
$16B Market
US Market Unpartnered
Launch March 2014
Subcutaneous
Once-Monthly
Antipsychotic
1
st
$29B+ Market*
Worldwide Market Rights
Phase 1
*12
months
ended
March
2014
Retail/Institutional
$
Symphony
Health
Systems
(SHS)
Source®
April
2013
March
2014.
Pain
-
Retail
TRx
Dollars.
Antipsychotic
-
Retail
and
Institution
Dollars
DosePro Needle Free
Product For Acute
Migraines And Cluster
Headaches
1
st
$105M Transaction
Sold to Endo
Closed Q2 2014


6
SUMAVEL DosePro®
SUMAVEL DosePro®
Transaction
Transaction
Better Call Point Fit
Significant Resources for Education   
and Marketing
Transfer of New Drug Application
Worldwide Product Rights
Purchase of Finished Goods Inventory
Strengthens Balance Sheet: $85M* in
Cash, $20M in Milestone Payments
Ownership of DosePro®
Needle-Free
Delivery System Technology
All Manufacturing Assets Upon Which
DosePro®
Is Based
Responsibility for Entire DosePro®
Manufacturing Supply Chain
Well Positioned to Optimize
Our Commercial Focus
on Pain Management
*
$8.5
million
of
which
in
escrow
for
12
months
for
potential
indemnification
claims


7
Strong Pipeline
Strong Pipeline
PRODUCT/ PROGRAM
Pre-Clinical
Phase 1
Phase 2
Phase 3
NDA
Commercial
Status
ZOHYDRO®
ER
ER Hydrocodone Capsules
For Chronic Pain
2 AD Formulations
RELDAY
TM
Monthly SQ Risperidone
for Schizophrenia
Undisclosed DosePro CNS Product Candidate(s)
Undisclosed
N/A
N/A
Approved October 25
2013
Launched March 3rd
2014
Targeting Late 2016
MD PK Study in 2H
2014
Pre-IND Mtg Nov.
2013


8
Oral, Extended Release
Hydrocodone
Acetaminophen-Free
Hydrocodone Product
FDA Approved
October 2013
Launched
March 2014
1
st
1
st


9
ZOHYDRO ER Progress
ZOHYDRO ER Progress
1,141 Prescriptions in First Quarter 2014
8,935 Prescriptions from Launch Through June 13, 2014
(1)
>85% of Prescriptions for ZOHYDRO ER are for the 30 mg
Strength or Less, as Anticipated
MOMENTUM
MOMENTUM
EDUCATION/
EDUCATION/
LEGAL
LEGAL
Engaging Local, State and National Officials to Educate on
Medical Need for ZOHYDRO ER
U.S. District Court in Massachusetts Prevents
Implementation of MA’s Ban of ZOHYDRO ER on
Constitutional Grounds (April 15)
FDA Issues Supportive Documents (Blog Posting, Fact Sheet)
(1)   8,032 prescriptions from launch through June 6, 2014
Source Healthcare Analytics, Source® PHAST Prescription Monthly, January – March 2014
Source Healthcare Analytics, Source® PHAST Prescription Weekly, weeks ending January 3, 2014 – June 6, 2014


10
Multiple
Strengths
(10-50
mg)
DEA
Schedule
II
Product
with
Class-Wide
REMS
Voluntary
Initiatives
to
Support
Appropriate
Use
2
Orange
Book
Patents
with
Expiry
in
Nov
2019
Orange
Book
NP
Exclusivity
Through
Oct
2016
Abuse
Deterrent
(AD)
Formulations
in
Development
that
May
Also
Extend
Patent
Runway
CLINICIANS
Prescribe
the
RIGHT
Dose
of
Hydrocodone
Simplifies
Conversion
from
Immediate
Release
(IR)
to
Extended
Release
(ER)
New
Option
for
Opioid
Rotation
PATIENTS
Consistent
12-Hour
Delivery
Less
Frequent
Dosing
Reduced
Risk
of
Acetaminophen
Toxicity
Hydrocodone:
Established
Tolerability
ZOHYDRO ER
ZOHYDRO ER


11
Ideal Profile for Chronic Pain Treatment
Ideal Profile for Chronic Pain Treatment
ZOHYDRO ER vs. Vicodin
CONSISTENT
12 Hour Profile to Prevent
Breakthrough Pain
LOWER
Maximum
Concentration
LESS
Peak to Trough
Variation
Vicodin 10 mg T0 + T6
Zohydro ER  20 mg T0
Mean Plasma
Concentration
ng/ml
Time (Hours)


12
ZOHYDRO
ER
is
an
Opioid
Agonist,
Extended-Release
Oral
Formulation
of
Hydrocodone
Without
Acetaminophen,
for
the
Management
of
Pain
Severe
Enough
to
Require
Daily,
Around-the-Clock,
Long-Term
Opioid
Treatment
and
for
Which
Alternative
Treatment
Options
Are
Inadequate
Responder Graph and Indication Details
Responder Graph and Indication Details
%
Responding
Subjects
Responders


13
Lower Liver Toxicity
Lower Liver Toxicity
1.
Larson
AM
et
al.
Acetaminophen-Induced
Acute
Liver
Failure:
Results
a
United
States
Multicenter,
Prospective
Study.
HEPATOLOGY
2005;42:1364-1372
2.
Michna,
E,
Duh,
MS,
Korves,
C,
Dahl,
JL.
Removal
of
opioid/acetaminophen
comvination
prescription
pain
medications:
assessing
the
evidence
for
hepatotoxicity
and
consequences
of
removal
of
these
medications.
Pain
Medicine.
2010;
11:
369-378.
Acetaminophen Is the
Leading Cause of Severe
Liver Failure in This
Country, Leading to
Liver Transplants or
Even Death
1
63
Percent
of
Unintentional
Acetaminophen
Overdoses
Are Attributed to the
Use of Hydrocodone-
Acetaminophen
Combination Products
2
Acetaminophen Overdose
Also
Is
a
Leading
Cause
of
Acute
Liver
Failure
in
the
United States²
FACT
ZOHYDRO ER Is the First and Only
Extended-Release Hydrocodone
Pain Product without Acetaminophen


14
13 Million
ER Opioid TRx Annually
The Market Need
The Market Need
for Extended Release (ER) Hydrocodone
for Extended Release (ER) Hydrocodone
5.0M
6.6M
1.0M
0.2M
ER
Products
OxyContin
Avinza, Kadian,
Embeda, MS
Contin+
Generic ERs
Opana ER
(Including
Generics)
Exalgo
ER Sales
$2.6B
$1.4B
$528M
$238M
1st
ER
Hydrocodone
Source:
SHS
Source®
TRx
and
retail
dollars
(April
2013-March
2014).
Market
comprised
of
product
classes
listed


15
The Medical Need
The Medical Need
47 Million
*
Patients Take
IR HC/APAP
Meeting the Need in
Opioid Rotation
*
FDA
analysis
of
IMS
Health
Total
Patient
Tracker
data
for
2011
(presented
at
Zohydro
ER
Advisory
Committee,
December
2012)
1
Proportion
of
chronic
use
patients
based
upon
Ingenix
Employer
Solutions
claims
database,
2006
2009
(Rice
JB
et
al,
AAPM
Meeting,
Palm
Springs,
2012)
2.4 Million
Patients
5%
Take It for
Chronic Pain
>90 Days
> 20mg HC/d
1


16
2.4 Million Patients
5%
Penetration
(120,000
Patients)
WAC
Price
per
Day
of
Therapy:
$8.30
Days
per
Month
of
Therapy:
30
#
of
TRx
per
Year:
8
ZOHYDROo ER
ZOHYDROo ER
Illustrative 5% Market Opportunity
Illustrative 5% Market Opportunity
Approximately
$240 Million Gross Revenue


17
Systematic Approach
Systematic Approach
to Responsible Commercialization
to Responsible Commercialization
Broad,
Integrated
Educational
Resources
for
Patients,
Physicians
and
Pharmacists
EDUCATION
EDUCATION
Commercial
Activity
Focused
On
Selected
Physicians
MARKETING
MARKETING
Certification
of
Zogenix
Territory
Representatives
Incentive
Compensation
Based
Exclusively
On
Achieving
Safe
Use
Goals
SALES
SALES
Surveillance
and
Monitoring
to
Detect
Potential
Misuse,
Abuse
and
Diversion
MONITORING
MONITORING
Distribution
of
Safe
Storage
Mechanisms
STORAGE
STORAGE


18
Multiple Educational Resources
Multiple Educational Resources
for Patients, Prescribers, and Pharmacists
for Patients, Prescribers, and Pharmacists
HCP Kit
Patient Toolkit
Education and Safe
Storage Offers
Conversion
Guide
Healthcare
and Provider
Websites


19
Successful Execution: ZOHYDRO ER
Successful Execution: ZOHYDRO ER
Targeting a Significant Footprint
20,000
High Decile ER/LA
Opioid Prescribers
(Top 6 Deciles)
60%
Commercial Organization of 190 Employees
FOCUS
COMMITMENT
COMPLIANCE
CONTROL
Responsibly Building Adoption for Long-Term Success
of
ER
Opioid
Market


20
Modification of
Existing SODAS
Formulation
with Alkermes
First Step in AD ZOHYDRO ER
Addition of Inert Beads That Form a Viscous Gel
When Crushed and Dissolved in Aqueous Solvents
Insufflation and Injection Resistant
Development
of Novel Tablet
Formulation
with Altus
Final Step in AD ZOHYDRO ER
Hardened Tablet to Avoid Crushing and Chewing
Maintains ZOHYDRO ER’s Unique Release Profile
Extraction Resistant
Insufflation and Injection Resistant
Potential extended IP Runway (>2030)
Committed to Developing
Committed to Developing
Abuse Deterrent (AD) Formulations
Abuse Deterrent (AD) Formulations
TWO
Simultaneous
APPROACHES


21
Once-Monthly Risperidone
With A Unique PK Profile,
Available as a Subcutaneous
Injection for Treatment of
Schizophrenia
1
st
Phase 1
Proof of Concept Established


22
Highly Concentrated U.S. Market with
11,000 Psychiatrists Prescribing Long-
Acting Injectable Antipsychotics
Growing U.S. and EU Market for LAI
Products
Risperdal Consta, 100mg/Month
>$1,200 in U.S.
$2.8 Billion Market
in U.S.+ Europe in 2013
Long Acting Injections (LAIs):
Long Acting Injections (LAIs):
A Highly Attractive Market
A Highly Attractive Market
Source:  Credit Suisse, May 2014
Further Clinical Evidence of Earlier LAI Usage
Will Likely Drive Additional Upside
Note: Includes 2013 WAC $ from SHS JNJ reported ex-U.S. sales.
U.S. LAI Sales (Schizophrenia)
$ Millions
$400M
$1.2B


23
RELDAY Surpasses Current LAI Atypical
RELDAY Surpasses Current LAI Atypical
Antipsychotics (AA) on Multiple Attributes
Antipsychotics (AA) on Multiple Attributes
KEY ATTRIBUTES
KEY ATTRIBUTES
FROM PHYSICIAN
FROM PHYSICIAN
RESEARCH
RESEARCH
RISPERDAL
RISPERDAL
CONSTA
CONSTA
(RISPERIDONE)
(RISPERIDONE)
INVEGA
INVEGA
SUSTENNA
SUSTENNA
(PALIPERIDONE)
(PALIPERIDONE)
ZYPREXA
ZYPREXA
RELPREVV
RELPREVV
(OLANZAPINE)
(OLANZAPINE)
ABILIFY
ABILIFY
MAINTENA
MAINTENA
(ARIPIPRAZOLE)
(ARIPIPRAZOLE)
RELDAY
RELDAY
(RISPERIDONE)
(RISPERIDONE)
Therapeutic Levels
on Day 1
×
×
×
×
No Loading Dose/
Oral Supplementation
×
×
×
×
1X Monthly
×
Subcutaneous
×
×
×
×
No Reconstitution
×
×
×
Relday Profile Delivers on Key Features Physicians Want


24
RELDAY: A Differentiated Product Profile
RELDAY: A Differentiated Product Profile
vs. Available LAIs
vs. Available LAIs
Positive Physician Reaction
Positive Physician Reaction
Higher Relative Rating
Higher Relative Rating
7 POINT SCALE: 1 = “WORST”
AND 7 = “BEST”
Relative Rating of Clinical
and Product Merit
PARTICIPANT RATING OF RELDAY PROFILE
Initial Reaction to Relday
RELDAY
4.5
5.7
5.1
Risperdal®
CONSTA®
3.9
4.6
4.2
INVEGA®
SUSTENNA®
3.9
5.0
4.4
Abilify Maintena™
3.9
n/a
3.9
Zyprexa®
Relprevv™
3.6
3.2
3.4
Average
Source: BioStrategies Group, 2013, N=150 US Physicians, 173 EU Physicians


25
RELDAY Clinical Program Status
RELDAY Clinical Program Status
Established in the First IND Study
Subjects with Schizophrenia (n=40)
Pharmacokinetics (PK)
Therapeutic Levels within 8 hours of Dosing
First Day Levels Consistent with Comparable Oral Dose
Duration Consistent with Once-monthly Dosing
Dose-Proportionality Across the Entire Therapeutic Range
Safety /Tolerability
No Unique Safety or Tolerability Issues with SC Dosing
Injection Site Reactions Were Mild and Spontaneously Resolved
US PATHWAY
STRATEGY
PROOF OF
PROOF OF
CONCEPT
CONCEPT
505(b)(2) NDA Pathway Strategy in USA


26
RELDAY Clinical Study Design
RELDAY Clinical Study Design
Starts in Q4 2014, ends Q3 2015
Initiate Multiple-Dose PK and Safety Study (H2 2014)
ROW Partnering With Data (H2 2015)
End of Phase II Meeting (Q3/Q4 2015)
Begin Phase III Trial (H1 2016)
OVERVIEW
OVERVIEW
INJECTIONS
INJECTIONS
TIMING
TIMING
NEXT STEPS
(Target Dates)
Relday Patients Will Receive 4 Injections Over 16 Weeks
Consta Patients Will Receive 5 Injections (Required to
Reach Steady-State)
Open-Label, PK and Safety, in Patients with Chronic, Stable
Schizophrenia or Schizoaffective Disorder
Patients Randomized
into One of Four
Cohorts:
Cohort 1: 60 mg Relday (0.5 mL SQ depot injection)
Cohort 2: 90 mg Relday (0.75 mL SQ depot injection)
Cohort 3: 120 mg Relday (1.0 mL SQ depot injection)
Cohort 4: Risperdal
®
Consta
®
(25 mg IM Bi-Weekly Depot Injection)


27
Financial Highlights
Financial Highlights
Q1 2014 Net Product Revenue
(Unaudited Sumavel DosePro/service revenue~$7.4m,
Zohydro $286k)
$7.7M
Market Capitalization
(6-20-14   ~139,539,151 Shares)
$271M
Cash Balance
(1)
(Q1 2014 proforma for sale of Sumavel DosePro to Endo)
~$100M
Debt/Royalty
(5-16-2014)
$0M
Common Stock Outstanding
139,539,151
Fully Diluted Shares
(2)
174,449,634
Employees
250
(1)
3/31/14 cash of $51m plus proceeds from sale of Sumavel DosePro minus repayment of royalty obligation
(2)
Fully diluted shares as of 3/31/14 include restricted stock units to purchase 1,325,500 shares, options to purchase 17,861,262 shares and warrants to purchase 15,723,721
shares with weighted average exercise prices of $2.71 and $2.73 respectively.


28
2014 Financial Guidance
2014 Financial Guidance
ZOHYDRO ER Revenue
No Guidance in Launch Year
Revenue for Manufacturing
and Supply of Sumavel
DosePro for Endo
Low Single Digit Markup to Costs Which Will Be
Recorded as a Component of Cost of Goods Sold
ZOHYDRO ER Gross Margin*
Approximately 85% of Net ZOHYDRO ER Revenue
(Manufacturing fees to ALKS at 15% NSP per unit)
Royalty Expense*
6% of Net ZOHYDRO ER Revenue
Expenses
Includes Research and
Development, Selling, General
and Administrative Expenses
$110 -
$120M
* Manufacturing fees of 15% of net selling price per unit and royalties of 6% of net revenue to third-party manufacturer


29
Experienced Management Team
Experienced Management Team
INDUSTRY EXPERIENCE
INDUSTRY EXPERIENCE
Roger Hawley*
Chief Executive Officer
27
Glaxo, GSK, Elan, InterMune
Stephen Farr, Ph.D.*
President
21
Aradigm, Cardiff University
Ann Rhoads
Chief Financial Officer
20
Premier, Sprout, DLJ, Bain & Co, Merrill Lynch
R. Scott Shively
Chief Commercial Officer
32
Pfizer, Alpharma, Altana, Endo, Sanofi-Aventis
Bradley Galer, M.D.
Chief Medical Officer
19
Nuvo Research, Endo
*Co-Founders
MANUFACTURING
DEVELOPMENT
COMMERCIALIZATION
History of Successful Execution


30
Zogenix: Where Medicine Meets Technology
Zogenix: Where Medicine Meets Technology
DEVELOPING
and
COMMERCIALIZING
Innovative
Products
PROVEN
EXECUTION
RESPONSIBLE
COMMERCIALIZATION
UNIQUE
MODEL
INFRASTRUCTURE
IN PLACE
SIGNIFICANT
MARKETS
CHRONIC PAIN
1
st
INTERNAL/EXTERNAL
1
st
DosePro®
Needle-Free
Delivery Platform
ANTIPSYCHOTIC
1
st