EX-99.1 2 d823044dex991.htm EX-99.1 EX-99.1
Company Update
November 2014
Exhibit 99.1
NASDAQ:


2
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 forward-looking statements include: the expected timing of the FDA review
and action date and potential approval of the sNDA and updated labels with abuse deterrent claims for Zohydro ER; the potential to develop an abuse
deterrent formulation of Zohydro ER with Altus and the timing of related studies; the potential timing of negotiating and carrying out a co-promotion
agreement for Zohydro ER; the timing of the commencement of Phase 3 clinical trials for Brabafen and a multi-dose clinical and safety study and Phase
3 clinical trials for Relday and the timing of the results; the potential timing of NDA submissions for each of the abuse deterrent formulation of
Zohydro ER with Altus, Brabafen and Relday and the expected timing of the FDA review and potential approval of the NDA submissions; the size of the
commercial opportunity for Zohydro ER and Relday; and the ability to secure debt financing based on the non-binding term sheet. Actual results may
differ from those set forth in this release due to the risks and uncertainties associated with regulatory review and approval of the sNDA, including the
risk that additional information or data requests from the FDA could significantly delay the FDA’s review period; risks and uncertainties associated with
the development and regulatory approval of an abuse deterrent formulation with Altus and Zogenix's reliance on Altus and its drug delivery platform
in such development efforts; unexpected adverse side effects or inadequate therapeutic efficacy of the abuse deterrent formulations that could limit
approval and/or commercialization; Zogenix’s dependence on the successful commercialization of Zohydro ER; Zogenix’s ability to achieve broad
market acceptance and generate revenues from sales of Zohydro ER; public concern regarding the safety of drug products such as Zohydro ER and the
impact of negative publicity and political influences relating to the regulation of the pain management market in general and opioids and Zohydro ER
in particular; competition from other pharmaceutical or biotechnology companies; risks associated with the acquisition of Brabant and integration of
Brabant's operations into Zogenix's business, including an increase in near and long-term expenditures, exposure to unknown liabilities and diversion
of Zogenix's management's time and attention; Zogenix’s dependence on its contract manufacturers and its ability to ensure an adequate and
continued supply of Zohydro ER to meet market demand; Zogenix’s dependence on third parties to develop an abuse deterrent formulation of
Zohydro ER, Relday and Brabafen; the potential that earlier clinical trials may not be predictive of future results; Zogenix’s ability to successfully
enforce its marketing exclusivities and intellectual property rights, and to defend the patents covering Zohydro ER, including the potential for
Paragraph IV litigation relating to the product; the potential product liability exposure associated with pharmaceutical products such as Zohydro ER
and other products Zogenix may in-license or acquire; difficulties in identifying, negotiating and carrying out a co-promotions agreement for Zohydro
ER; Zogenix’s ability to fully comply with numerous federal, state and local laws and regulatory requirements that apply to its commercial activities;
the risk that Zogenix will be unable to negotiate and enter into definitive agreements for a potential debt financing, on acceptable terms, or at all;
Zogenix's ability to raise additional funding that it may need to continue to pursue its commercial and business development plans; and other risks
detailed under “Risk Factors”and elsewhere in Zogenix’s periodic reports and other filings made with the Securities and Exchange Commission from
time to time. 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
CHRONIC PAIN
SCHIZOPHRENIA
$16B Market
Launch March 2014
Co-Promote Opportunity
ADF potential approvals 
2015 and 2016
Orphan Designation
US and EU
Phase 3  2Q2015
$29B+ Market
Worldwide Market Rights
Phase 1b  Jan 2015
Co-Development/
Commercialization
Opportunities
DRAVET SYNDROME
(low-dose fenfluramine)
Developing and Commercializing
High Value CNS Products
Dravet syndrome
Product Candidate With
Long-Term Data
Subcutaneous
Once-Monthly
Antipsychotic
Oral, 12-Hour
Extended Release
Hydrocodone without
Acetaminophen
CHRONIC PAIN
*
*12 months ended March 2014 Retail/Institutional Dollars
Symphony Health Systems (SHS) Source
®
April 2013 – March 2014. Pain -  Retail TRx Dollars. Antipsychotic -  Retail and Institution Dollars


CNS Pipeline –
Innovative Development and Regulatory Timelines
4


5
Oral, Extended Release
Hydrocodone
Acetaminophen
-Free
Hydrocodone Product
FDA Approved
October 2013
Launched
March 2014


6
Zohydro ER Commercial Update
15,134 Prescriptions in 3Q 2014, up 47% over 2Q 2014
31,000 Prescriptions and 4000 Prescribers from Launch
Through October 24, 2014
8 out of 10 Prescriptions Approved by Payers
Average NSP $240
>7000 Pharmacies Stocking Zohydro ER
METRICS
sNDA for modified formulation with abuse deterrent properties
filed September 30, 2014 –
target action date January 30, 2015
Hydrocodone Combination Products  Rescheduled from
Schedule III to Schedule II (October 2014)
Dr. Janet Woodcock, FDA, BioCentury TV, November 9, 2014:
ADT is  in “infancy”
stage and rather than forcing conventional
opioids off the market, FDA is focused on getting more abuse-
deterrent products approved
MARKET
DYNAMICS
Symphony Health Solutions, Source® PHAST Prescription Monthly, July – September 2014
Symphony Health Solutions, Source® PHAST Prescription Weekly, February  2014 - October 24, 2014


7
Zohydro ER Fills an Important Medical Need
About 5% of patients on hydrocodone combination products are using it to
manage chronic pain
Unintentional acetaminophen overdose* is the leading cause of acute liver failure
No extended-release version of hydrocodone had been available
Zohydro ER is a more appropriate treatment                     
than IR-HC/APAP for severe chronic pain patients                       
requiring around-the-clock opioid therapy
No acetaminophen
Extended-release allows more consistent pain relief
12-hour dosing reduces total pills in 30-day prescription
Simple transition from IR-HC to ER-HC vs. switching to a different type of                  
extended-release molecule such morphine or oxycodone
*Blieden M, et.al. Expert Rev Clin Pharmacol. 2014


8
SaferLock ™
Locking Bottle
for safe storage
Zogenix Commitment to
Responsible Commercialization
Broad, Integrated Educational Resources for
Patients, Physicians and Pharmacists
EDUCATION
Commercial Activity Focused On Select Physicians –
High Decile ER/LA Opioid Prescribers (~60% of ER/LA opioid market)
MARKETING
Certification of Zogenix Territory Representatives
Incentive Compensation Based On Achieving Safe Use
Goals
SALES
Surveillance and Monitoring to Detect
Potential Misuse, Abuse and Diversion
MONITORING
Distribution of Safe Storage Mechanisms
STORAGE
Abuse Deterrent Formulations
ADF


9
Addition of Inert Beads That Form a Viscous Gel
When Crushed and Dissolved in Aqueous Solvents
Designed to be injection and insufflation resistant
Supplemental Application to Approved NDA
Formulation submission September 2014
Further submission with Abuse Liability Studies
(additional AD label claims) H1 2015
Hardened Tablet to Avoid Crushing and Chewing
Maintains Zohydro ER’s Unique Release Profile
Extraction Resistant
Insufflation and Injection Resistant
Separate NDA -
Referencing Current Approved
NDA for Safety and Efficacy
No Phase 3 Studies Required
Submission H2 2016
Extended IP Runway (>2030)
Abuse Deterrent (AD) Formulations                              
In Development
TWO
Simultaneous
APPROACHES
Modification of
Approved Capsule    
Formulation
Development
of Novel Tablet
Formulation
with Altus


10
Low-dose fenfluramine
for the treatment of Dravet syndrome,         
a rare and catastrophic form of intractable
epilepsy that begins in infancy
Phase 3 Candidate
Orphan drug designation in Europe and U.S.
BRABAFEN


11
Brabant Pharma Acquisition
Acquired October 27, 2014 for $20 million in cash and $15 million in stock
plus potential future milestone and royalty payments
Worldwide
development
and
commercialization
rights
to
Brabafen
TM
,
low-
dose fenfluramine, for the treatment of Dravet syndrome, a rare and
catastrophic form of intractable epilepsy that begins in infancy
Orphan drug designation in
Europe
and the U.S.
Phase 3 clinical studies of Brabafen planned for second quarter of 2015
Longest duration data (26 years) in treatment of Dravet syndrome
Signed a non-binding term sheet for a $20 million term loan plus            
an additional $4 million in a revolving line of credit
Potential financing expected to help fund R&D expenses for Brabafen


12
Dravet Syndrome –
Rare And Severe Condition
Orphan disease with incidence between 1:20,000 and 1:40,000 live
births
Genetic condition associated with mutations of the SCN1A gene
Severe, frequent seizures; drug-refractory
Cognitive decline; increasing motor problems
Children do not outgrow condition, require constant care and supervision
Significant mortality (approx. 15 -
20%), more frequent during childhood
Patients often suffer from Status Epilepticus (severe, continuous seizures) and
are at increased risk of Sudden Unexpected Death in Epilepsy (SUDEP)
Current treatments are limited and inadequate
No US product FDA-approved for Dravet syndrome
Stiripentol is the only drug specifically approved in EU for Dravet syndrome and
has limited and restricted use


13
Long Term Results of Brabafen In Dravet Syndrome
Showed Significant Reduction in Seizures (n=15)
Brabafen Responder Analysis
100%
80%
60%
40%
20%
0%
>50%
>70%
>90%
Seizure
Free
FDA Assessment of Primary Efficacy
In Dravet syndrome
93%
N=14
93%
N=14
87%
N=12
67%
N=10
Average length of treatment >12 years;                         
longest duration = 26 years
Mean age at last evaluation = 19 yr (3-35 yr)
Fenfluramine (5-10 mg BID) added on                                             
to existing antiepileptic drug therapy
Seizure diary follow-up twice a year;                                                
clinical & echocardiogram every year
Efficacy:
Evidence that seizures in some patients                        
ceased within days of starting treatment
On average patients were seizure free                          
for approximately 6 years (1-19 years)
Safety
Mild/transient
side
effects
loss
of
appetite,
fatigue,
somnolence
Evidence of clinically insignificant heart valve thickening in 3/15 patients (resolved in 1 patient)
Not
progressive
all
patients
remain
in
study
No pulmonary hypertension


14
Remaining Development Plan for Brabafen
Agreed  upon pre-clinical and clinical requirements from FDA and EMA
Phase 3 pivotal clinical study protocol
Two placebo controlled studies (United States and Europe)
40-60 patients each
Add-on therapy
12-week evaluation period
Evaluating number of seizures compared to baseline
Phase 3 initiation planned for second quarter 2015
Phase 3 data in early 2016
U.S. potential approval in late 2016
European potential approval in 2017


15
Once-Monthly Risperidone
Phase 1b –
Jan 2015
Proof of Concept Established
Schizophrenia
With A Unique PK Profile,
Available as a Subcutaneous
Injection for Treatment of


16
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):
A Highly Attractive Market
Source:  Credit Suisse, May 2014
Note: Includes 2013 WAC $ from SHS JNJ reported ex-U.S. sales.
U.S. LAI Sales (Schizophrenia)
$ Millions
$400M
$1.2B
2007
2013
20%
CAGR
Further Clinical Evidence of Earlier LAI Usage
Will Likely Drive Additional Upside


17
RELDAY Product Profile vs.
Current LAI Atypical Antipsychotics (AA)
KEY ATTRIBUTES
FROM  PHYSICIAN
RESEARCH
RISPERDAL
CONSTA
(RISPERIDONE)
INVEGA
SUSTENNA
(PALIPERIDONE)
ZYPREXA
RELPREVV
(OLANZAPINE)
ABILIFY
MAINTENA
(ARIPIPRAZOLE)
RELDAY
(RISPERIDONE)
Therapeutic Levels
on Day 1
No Loading Dose/
Oral Supplementation
1X Monthly
Subcutaneous
No Reconstitution
Substantial Market Research Supports Key Features Physicians Want
17


18
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
REGULATORY
STRATEGY
PROOF OF
CONCEPT
Confirmed 505(b)(2) NDA in US
Abridged Hybrid MAA likely in EU


19
RELDAY Clinical Study Design
Starts in January 2015, Top-Line Results Q3 2015
ROW Partnering With Data (H2 2015)
End of Phase II Meeting (Q3/Q4 2015)
Begin Phase III Trial (H1 2016)
OVERVIEW
INJECTIONS
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 (n=40)
Patients Randomized
into One of Four
Cohorts:
Cohort 1: Relday, 60mg Once-Monthly SQ Depot Injection
Cohort 2: Relday, 90mg Once-Monthly SQ Depot Injection
Cohort 3: Relday, 120mg Once-Monthly SQ Depot Injection
Cohort 4: Risperdal
®
Consta
®
-
25 mg IM Bi-Weekly Depot Injection


20
Financial Highlights
Q3 2014 Total Revenue
(Zohydro ER revenue of $4.1M)
$8.8M
Market Capitalization
(8-6-14   ~139,539,151 Shares)
$190M
Q3 2014 Cash Balance
(1)
$50.5M
and $8.5M
(escrow)
$0M
Common Stock Outstanding
153,040,066
Fully Diluted Shares
(3)
185,657,387
Employees
220
(1)
Excludes $24m in debt facility secured with Brabant acquisition and $13.5m related to the Purdue waiver exchange and Teva right of reference agreement
(2)
Excludes $7m working capital advance from Endo International and pending $24m in debt facility 
(3)
Fully diluted shares as of 10/17/14 include options to purchase 16,893,600  shares and warrants to purchase 15,723,721 shares with weighted average exercise prices
of $2.67 and $2.73 respectively
Debt
(2)


21
Experienced Management Team
INDUSTRY EXPERIENCE
Roger Hawley
Chief Executive Officer
Co-Founder
27
Glaxo, GSK, Elan, InterMune
Stephen Farr, Ph.D.
President
Co-Founder
21
Aradigm, Cardiff University
Ann Rhoads
Chief Financial Officer
20
Premier, Sprout, DLJ, Bain & Co, Merrill Lynch
Bradley Galer, M.D.
Chief Medical Officer
19
Nuvo Research, Endo
MANUFACTURING
DEVELOPMENT
COMMERCIALIZATION
History of Successful Execution


22
Significant Cadence of Potential                         
Value Creating Milestones Through 2018
2015
Relday Multi-Dose Clinical Trial Begins
Abuse Liability Studies Zohydro ER AD capsules Begins
Potential Zohydro ER Co-Promotion
Brabafen Phase 3 Clinical Trial Begins
Relday Multi-Dose Trial Data Results
NDA for Altus ADF Zohydro ER
Brabafen Phase 3 Data
Relday Phase 3 Clinical Trial
Brabafen EU Approval
& Altus ADF Zohydro ER
2016
2017
2018
sNDA Potential Approval
Zohydro ER (AD capsules)
Updated Zohydro ER label with AD claims
NDA Potential Approval
Zohydro ER (AD tablets)
NDA Potential Approval
Brabafen
Relday Target NDA
Brabafen Target NDA