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): November 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 November 18, 2014, Zogenix, Inc. (“Zogenix”) management will be attending the Stifel Nicolaus 2014 Healthcare Conference in New York City, New York, 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.

* * *

Zogenix cautions you that statements included in this report that are not a description of historical facts are forward-looking statements. Words such as “plans,” “believes,” “expects,” “anticipates,” and “will,” and similar expressions, are intended to identify forward-looking statements, and are based on Zogenix’s current beliefs and expectations. Such statements include, without limitation, statements regarding 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. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. Zogenix’s actual future results may differ materially from its current expectations due to the risks and uncertainties inherent in its business. These risks include, but are not limited to: 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. All forward-looking statements are qualified in their entirety by this cautionary statement, which is made under the safe harbor provisions of Section 21E of the Private Securities Litigation Reform Act of 1995, and Zogenix undertakes no obligation to revise or update this report to reflect events or circumstances after the date hereof.

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: November 18, 2014	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

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