8-K

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, DC 20549

FORM 8-K

CURRENT REPORT

Pursuant to Section 13 or 15(d)

of the Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): June 18, 2014

ZOGENIX, INC.

(Exact Name of Registrant as Specified in its Charter)

Delaware	001-34962	20-5300780
(State or Other Jurisdiction of Incorporation)	(Commission File Number)	(IRS Employer Identification No.)
12400 High Bluff Drive, Suite 650, San Diego, CA		92130
(Address of Principal Executive Offices)		(Zip Code)

Registrant’s telephone number, including area code: (858) 259-1165

(Former Name or Former Address, if Changed Since Last Report.)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):

¨ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

¨ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

¨ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

¨ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Item 7.01. Regulation FD Disclosure.

On June 18, 2014, Ann Rhoads, Chief Financial Officer of Zogenix, Inc. (“Zogenix”), will be attending the Wells Fargo 2014 Healthcare Conference in Boston, Massachusetts, and will present the slides attached as Exhibit 99.1 to this Current Report on Form 8-K, which is incorporated herein by reference.

The information in this report, including Exhibit 99.1, is being furnished pursuant to Item 7.01 and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or the Exchange Act, or otherwise subject to the liabilities of that section, and it shall not be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or under the Exchange Act, whether made before or after the date hereof, except as expressly set forth by specific reference in such filing to this item of this report.

* * *

By filing this Current Report on Form 8-K and furnishing this information, Zogenix makes no admission as to the materiality of any information in this report. The information contained in this Current Report on Form 8-K is intended to be considered in the context of Zogenix’s filings with the SEC and other public announcements that Zogenix makes, by press release or otherwise, from time to time. Zogenix undertakes no duty or obligation to publicly update or revise the information contained in this report, although it may do so from time to time as its management believes is appropriate. Any such updating may be made through the filing of other reports or documents with the SEC, through press releases or through other public disclosure.

Zogenix cautions you that statements included in this Current Report on Form 8-K and the attached exhibit 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 Zogenix’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 report and the attached exhibit due to the risk 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. All forward-looking statements are qualified in their entirety by this cautionary statement and Zogenix undertakes no obligation to revise or update this report to reflect events or circumstances after the date hereof. This caution is made under the safe harbor provisions of Section 21E of the Exchange Act.

Item 9.01 Financial Statements and Exhibits.

(d) Exhibits.

Exhibit No.	Description
99.1	Slide Presentation

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

Date: June 18, 2014	ZOGENIX, INC.
	By:	/s/ Ann D. Rhoads
	Name: Ann D. Rhoads
	Title: Executive Vice President, Chief Financial Officer, Treasurer and Secretary

EXHIBIT INDEX

Exhibit No.	Description
99.1	Slide Presentation

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

•

7,564 Prescriptions from Launch Through June 6, 2014

•

>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)

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

(6-16-14   ~139,539,151 Shares)

$241M

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

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