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): September 29, 2015

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.

Beginning on September 29, 2015, representatives of Zogenix, Inc. (“Zogenix”) will be attending meetings with investors and others in connection with Leerink Partners’ Fourth Annual Rare Disease Roundtable in New York City, New York. During these meetings, Zogenix 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 Item 7.01, 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.

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.

	ZOGENIX, INC.
Date: September 29, 2015	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

1

Company Overview

September 2015

NASDAQ:

Exhibit 99.1

2

Forward Looking Statements

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,"

"plans,"

"expects,"

"will,"

"potential"

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

timing

of

the

commencement

and

completion

of

clinical

trials

and

regulatory

submissions

for

ZX008

and

RELDAY;

the

Company's

cash

position

related

to

operating

expenses

and

planned

development

activities;

and

delivery

and

dosing

benefits

of

ZX008

and

RELDAY

and

the

potential

to

demonstrate

that

they

have

differentiated

product

profiles

amongst

currently

marketed

drug

products.

Actual

results

may

differ

from

those

set

forth

in

this

presentation

due

to

the

risk

and

uncertainties

inherent

in

Zogenix's

business,

including,

without

limitation:

difficulties

or

delays

relating

to

the

development,

testing,

manufacturing

and

marketing

of

any

of

Zogenix’s

product

candidates;

the

potential

that

earlier

clinical

trials

may

not

be

predictive

of

future

results;

Zogenix's

reliance

on

third

parties

to

conduct

its

clinical

trials,

enroll

patients,

manufacture

its

preclinical

and

clinical

drug

supplies

and

manufacture

commercial

supplies

of

its

drug

products,

if

approved;

Zogenix's

ability

to

fully

comply

with

numerous

federal,

state

and

local

laws

and

regulatory

requirements

that

apply

to

its

product

development

activities;

Zogenix

could

spend

its

available

financial

resources

faster

than

it

currently

expects

and

may

be

unable

to

raise

additional

capital

if

and

when

needed,

on

acceptable

terms

or

at

all;

and

other

risks

described

in

the

company's

filings

with

the

Securities

and

Exchange

Commission

(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

release

to

reflect

events

or

circumstances

after

the

date

hereof.

All

forward-looking

statements

are

qualified

in

their

entirety

by

this

cautionary

statement.

3

Developed, Commercialized

and Monetized

CHRONIC

PAIN

ACUTE

MIGRAINES

EPILEPSY

(DRAVET SYNDROME)

SCHIZOPHRENIA

ONCE-MONTHLY

ZX008

(low-dose fenfluramine)

Late Stage Development

Global Opportunities

Products for the Treatment of

CENTRAL NERVOUS SYSTEM (CNS) Disorders

4

The Zogenix Opportunity

PROMISING PIPELINE

of Differentiated CNS Compounds in Late-Stage Clinical Development

FULLY FUNDED

For Multiple Milestones Through 2017 for 2 Clinical Programs

EXPERIENCED TEAM

with Successful Track Record of Drug Development

HIGHLY EFFICIENT

Path to Commercialization and Profitability

ORPHAN DRUG STRATEGY

Focused on Solving Significant Treatment Gaps

5

•

Worldwide Rights

•

Orphan Drug Designation in U.S. and E.U.

•

Expect to Commercialize Directly in U.S. and E.U.

•

Asia-Pacific Partnering Opportunity

ZX008

Dravet Syndrome

PHASE 3 START

Q4 2015

6

Dravet Syndrome: A Catastrophic Illness

Intractable, Severe Epilepsy Which Begins In Infancy

•

Estimated 16,000 -

29,000 Patients in the

U.S. and E.U.

1

•

Approximately 75 Specialty Treatment

Centers in U.S. and similar in E.U.

•

Does not Effectively Respond to Traditional

Epilepsy Medications

•

Cognitive, Developmental,                                                

Behavioral, and Motor Impairment                                

Correlated with >5 Seizures/Month

2

•

Polypharmacy

is Standard of Care But No

Effective, Long-Term Treatment Exists

1.

Calculated

by

patient

incidence

rates

and

population

in

US

and

in

UK,

Germany,

Italy,

Spain,

France

Bayat

A

et

al;

Epilepsia.

2015:

56(4):e36-9

(ISSN:1528-1167)

The

incidence

of

SCN1A-related

Dravet

syndrome

in

Denmark

is

1:22,000:

A

population-based

study

from

2004

to

2009.

Brunklaus,

A.

et

al,

Brain,

2012:

135;

2329-2336.

Prognostic,

clinical

and

demographic

features

in

SCN1A

mutation-positive

Dravet

syndrome

Hurst,

Daniel;

Epilepsia.

31(4):397-400,

1990)

Epidemiology

of

Severe

Myoclonic

Epilepsy

of

Infancy

2.

Wolff

M.,

Dravet

C.

Epilepsia,

2006;

47

Suppl

2:45-8.

Severe

myoclonic

epilepsy

of

infants

(Dravet

syndrome):

natural

history

and

neuropsychological

findings.

7

First Published Study of Fenfluramine Efficacy

in Dravet Syndrome

•

Long-term open-label study

of fenfluramine as an

adjunctive anticonvulsant

therapy

•

12 Dravet syndrome

patients, 11 with

confirmatory genetic

mutation

•

70% of patients seizure-free

at last assessment

•

Range of 1-19 years of

seizure freedom

Clinical data / IP                          

licensed by Zogenix

8

This analysis includes 10 patients from the original cohort (5 years of follow-

up) and 2 patients who began treatment  in 2011 (4 years of follow-up)

Patients age range of 9 months to 13 years

at treatment initiation

Recent Multi-Year Follow-Up Analysis Further

Supports Fenfluramine Efficacy in Dravet Syndrome

•

>80% of Patients Achieved 

>75% Reduction in Seizure

Frequency

•

29 of 58 Patient-Treatment

Years (50%) Were Seizure- Free

•

3 out of 12 Patients Were

Seizure-Free for All 5 Years

•

5 out of 12 Patients Were

Seizure-Free for 2-4 Years

•

No Clinically Significant Findings

Related to Cardiotoxicity

[Echocardiography]

•

Mild/Transient Side Effects:

Loss of Appetite, Fatigue,

Somnolence

Categorical Response to Low-Dose (10mg –

20mg Daily)

Fenfluramine

Ceulemans,

Berten,

et

al.

Five-Year

Follow-Up

of

Fenfluramine

as

Add-on

Treatment

in

Dravet

Syndrome.

11

th

European

Paediatric

Neurology

Society

Congress,

online

poster

presentation,

May

2015.

9

Pre-Clinical Evidence of Fenfluramine Activity in an

Established Model of Dravet Syndrome

Zhang,

Yifen,

et

al.

PLOS

May

12,

2015.

Pharmacological

Characterization

of

an

Antisense

Knockdown

Zebrafish

Model

of

Dravet

Syndrome:

Inhibition

of

Epileptic

Seizures

by

the

Serotonin

Agonist

Fenfluramine.

•

Zebrafish model of DS -

antisense

knockdown of scn1Lab

–

>80% of Dravet syndrome patients

test positive for SCN1A

gene

mutations

–

Mutant, in contrast to wild type,

zebrafish display hyperactivity,

convulsive seizure-like behavior, loss

of posture, repetitive jerking and a

myoclonic seizure-like pattern

•

Demonstrated  the ability of

fenfluramine to significantly reduce

locomotion and  to eliminate

epileptiform EEG activity

•

These data support the clinical results

obtained in the Belgium cohort of

patients

Wildtype

scn1Lab

Mutant

10

History of Therapeutic Use of Fenfluramine

•

Off-Label Combination Use with

Phentermine in 1980s/1990s, Often At

Higher than Approved Doses

•

Approved Dosage: 60-120mg Daily

–

Substantially

Higher than

ZX008 dose

in Dravet syndrome treatment

•

Fenfluramine Withdrawn Worldwide in

late 90’s/early 2000’s Due to Heart

Valve Problems in Obese Adults

•

>40 Studies Published Evaluating

Fenfluramine > 400 Children

•

Focus on Treating Autism, ADHD

•

No CV Side Effects Reported

Fenfluramine

Approved Use in

Adult Obesity

Approved Use in

Adult Obesity

Experimental Use in Pediatric

Neurobehavioral Conditions

Experimental Use in Pediatric

Neurobehavioral Conditions

11

Established Pathway to Phase 3 Development

and Regulatory Submissions

Summary of Correspondence with FDA and European

Agencies

•

Recognition That Benefit/Risk in Dravet Syndrome Is Different to Use of Fenfluramine

as an Appetite Suppressant

•

Confirmed Path to IND / CTA Submissions to Initiate Phase 3 Efficacy Trials

–

IND submitted at end of August 2015

–

CTA to be submitted through Voluntary Harmonization Procedure

–

FDA requires establishment of cardiovascular monitoring procedures prior to study

initiation

•

505(b)(2) Pathway in U.S. Confirmed

•

Encouraged to Seek Fast Track Designation in U.S. Once IND is Active

•

Orphan Drug Designation Granted

•

Post-Approval REMS / Risk Management Plan Will be Required

12

ZX008

Summary of Phase 3 Study Design

8 WEEKS

BASELINE

OBSERVATION

12 WEEKS

TREATMENT

Initial Screen

Placebo

Open Label

Safety Study

N = 105

Ages 2 –

18

ZX008

High dose

ZX008

Low dose

•

Two identical studies, one U.S. and one multinational (mainly Europe)

•

Q4 2015 initiation of U.S. study

•

Primary endpoint: change in convulsive seizures from baseline 

13

E.U.

57%

Market Research: ZX008 Could be Used as First or

Second Adjunct Therapy in Dravet Syndrome

% of Neuros

Who

Would Use ZX008

as a 1

st

or 2

nd

Adjunct Therapy

Source: BioStrategies Market Research, May 2015

U.S.

81%

Neurologists…

•

Were Overwhelmingly Positive Regarding the Safety and Efficacy Profile

of ZX008

•

Consider 78%

of Dravet

Syndrome Patients to be Clinically Appropriate for

ZX008 Treatment

Polypharmacy

is Standard of Care for

Management of Epilepsy

14

Established Product Protection

ORPHAN DRUG STATUS

May Provide 10 Years of Market Exclusivity in E.U. and 7 Years in U.S.

When Obtained in Japan, ODS Will Provide 10 Years Exclusivity

PATENTS PENDING

(1)

Use of Fenfluramine in Dravet Syndrome and

Elements

of a Future REMS Program

Ongoing Preclinical & Development Work Providing Additional IP Opportunities

PRODUCT SPECIFIC REMS

Will Include Patient Registry and Cardiac Monitoring

Difficult to Circumvent and Expensive to Replicate

(1)

Method For the Treatment of Dravet Syndrome –

(13/887,014), (EP 2014/058954), (14/447/253), (14/447/303), (14/447,369)

15

Proprietary  Subcutaneous

Once-Monthly Antipsychotic

•

Highly Differentiated Profile

•

Worldwide Rights

•

Co-Development/Commercialization Opportunity

Schizophrenia

PHASE 3 READY

Q1 2016

16

Market Overview of LAIs for Treatment of

Schizophrenia

•

2.4 Million Diagnosed Patients

in the U.S.

•

Treatment Compliance Can Be

Challenging

•

Treatment Paradigm Evolving

Towards Earlier Use of LAIs

LAIs for

Schizophrenia

LAIs for

Schizophrenia

PATIENTS

PHYSICIANS

Large, Growing

$4 –

5B WW Market

•

Highly Concentrated U.S. Market

•

11,000 Psychiatrists Prescribing LAI

Antipsychotics

Source: Credit Suisse Securities Research, Dec. 9, 2014

17

RELDAY Has a Differentiated LAI Profile

•

Designed to overcome complexities associated

with other long acting injections

–

No oral supplementation / complicated loading dose

regimens

–

Initiation dose identical to maintenance dose

•

Once-monthly

dosing interval

•

Subcutaneous administration

–

Potential for improved safety and tolerability

•

Stable formulation without the need for

reconstitution prior to use

18

Strong Physician Endorsement of Product

Attributes Relative to Marketed LAIs

Highest on Clinical

and Product Merits

Very Positive/Positive

On Initial Reaction

Source: BioStrategies Group, 2013, N=150 U.S. Physicians, 173 E.U. Physicians

U.S.

E.U.

69%

61%

RELDAY

INVEGA®

SUSTENNA®

Risperdal®

CONSTA®

Abilify

Maintena™

Zyprexa®

Relprevv™

7 POINT SCALE

1 = “Worst”     |     7 = “Best”

Average (U.S. and E.U.)

5.1

4.4

4.2

3.9

3.4

19

Development Progress to Date

•

Single-Dose Study Successfully Completed

•

Multi-Dose Study Initiated: Top-Line Results

Q3 2015

•

Issued and Pending Patents Through

at Least 2034

•

Formulation Technology also Amenable to

Three-Monthly Dosing Interval for Future

Development and Life-Cycle Management

A Proven, Effective

and Safe Molecule

for the Treatment

of Schizophrenia

20

2015

Q1

Q2

Q3

Q4

Focused on Execution in Late-Stage

Development

ZX008

Submit

IND / CTAs

Initiate U.S.

Phase 3

Initiate EU Phase 3 (Q1 2016)

Targeting Phase 3 Results

Prepare for NDA/MAA

Submission

End of Phase 2 FDA Meeting

Initiate Phase 3 with Partner

Phase 1B

Results

Expected

AES scientific

presentations

2016

Initiated

Phase 1B

Trial

Initiate

Partnering

Discussions

21

Financial Highlights

Cash

( balance at 6-30-15 plus follow-on offering net proceeds)

$169.4 M        

Debt

(1)

(as of 6-30-15)

$20.0

M

Guidance

for 2H-2015

R&D expenses

G&A expenses

$19 M –

$22 M

$14 M –

$16 M

Common Shares Outstanding

(2)

24.6 million

Fully Diluted Shares

(3)

29.0 million

(1)

Excludes $7.0 million working capital advance from Endo International

(2)

Common shares outstanding include 5.5 million shares issues in August 2015 follow-on offering

(3)

Fully diluted shares include options to purchase 2.4 million shares and warrants to purchase 2.0 million shares with weighted average exercise prices of

$18.96 and $21.47, respectively

22

NASDAQ:

PROMISING PIPELINE

FULLY FUNDED CLINICAL PROGRAMS

EXPERIENCED, SUCCESSFUL  TEAM

SIGNIFICANT NEAR-TERM MILESTONES

HIGHLY EFFICIENT

PATH TO COMMERCIALIZATION