corporate presentation anthony mack, president & ceo william pedranti, coo © 2014 scilex...

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CORPORATE PRESENTATION ANTHONY MACK, PRESIDENT & CEO WILLIAM PEDRANTI, COO © 2014 SCILEX Pharmaceuticals, Inc. All Rights Reserved.

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Page 1: CORPORATE PRESENTATION ANTHONY MACK, PRESIDENT & CEO WILLIAM PEDRANTI, COO © 2014 SCILEX Pharmaceuticals, Inc. All Rights Reserved

CORPORATE PRESENTATION

ANTHONY MACK, PRESIDENT & CEO

WILLIAM PEDRANTI, COO© 2014 SCILEX Pharmaceuticals, Inc. All Rights Reserved.

Page 2: CORPORATE PRESENTATION ANTHONY MACK, PRESIDENT & CEO WILLIAM PEDRANTI, COO © 2014 SCILEX Pharmaceuticals, Inc. All Rights Reserved

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FORWARD LOOKING STATEMENTS

Certain statements contained herein may constitute "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements by the Company are based on current expectations, estimates and projections about the Company's product, management's beliefs and certain assumptions made by management. Readers are cautioned that any such forward-looking statements are not guarantees of future performance and are subject to certain risks, uncertainties and assumptions that are difficult to predict. Because such statements involve risks and uncertainties, the actual results and performance of the Company may differ materially from the results expressed or implied by such forward-looking statements. Given these uncertainties, readers are cautioned not to place undue reliance on such forward-looking statements. Unless otherwise required by law, the Company also disclaims any obligation to update its view of any such risks or uncertainties or to announce publicly the result of any revisions to the forward-looking statements made here.

THIS DOCUMENT CONTAINS PROPRIETARY INFORMATION THAT IS THE PROPERTY OF THE COMPANY. NEITHER THIS DOCUMENT, NOR THE PROPRIETARY INFORMATION CONTAINED HEREIN, SHALL BE PUBLISHED, REPRODUCED, COPIED, DISCLOSED OR USED FOR ANY OTHER PURPOSE, OTHER THAN THE REVIEW AND CONSIDERATION OF THIS DOCUMENT.

This presentation is intended solely for investors that are accredited investors under U.S. Securities and Exchange Commission rules.  This presentation is not an offer, nor the solicitation of an offer, to buy any securities.  An investment in Scilex’s securities involves a high degree of risk.  Before any potential investor invests in Scilex’s securities, the investor should review the private placement memorandum relating to this financing which contains more complete information about Scilex and this financing, including risks relating to any such investment.  The terms of any such investment will be governed by the definitive documentation evidencing such investment.

CONFIDENTIAL - DO NOT COPY OR DISTRIBUTE

Page 3: CORPORATE PRESENTATION ANTHONY MACK, PRESIDENT & CEO WILLIAM PEDRANTI, COO © 2014 SCILEX Pharmaceuticals, Inc. All Rights Reserved

Focus on the development and commercialization of late-stage products for the treatment of pain (100+ million Americans have chronic pain) Our First product Ztlido™ is being developed for the treatment of pain associated with post-herpetic neuralgia or PHN

Strong Management Team with experience marketing multiple pain products (Lidoderm®, OxyContin®)

ZTlido™ (lidocaine patch 1.8%), is a branded, fourth-generation transdermal lidocaine patch formulated for the treatment of the pain associated with PHN, a chronic, painful condition that may follow a shingles infection

The FDA concurred that a single powered bioequivalence study of ZTlido™ vs. Lidoderm® would be sufficient for submission of ZTlido™ under Section 505(b)(2)

ZTlido™ has potential superior qualities to Lidoderm-a product (branded and generic) that generated over a billion

dollars in U.S. sales in 2013*; targeted launch is Q1 2016

(TM) ZTlido IS A TRADEMARK OF SCILEX. All other trademarks are the property of their respective owners.* IMS 2014

SCILEX INVESTMENT HIGHLIGHTS

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Page 4: CORPORATE PRESENTATION ANTHONY MACK, PRESIDENT & CEO WILLIAM PEDRANTI, COO © 2014 SCILEX Pharmaceuticals, Inc. All Rights Reserved

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WE KNOW PAIN & TRANSDERMALS

SENIOR MANAGAGEMENT

Anthony Mack Chief Executive Officer

• Experienced pharmaceutical executive who has driven the successful commercialization of leading pain products (OxyContin, Lidoderm Opana ER))

• Held management positions with Purdue Pharma, Endo Pharmaceuticals, Novartis and EKR Therapeutics

• President and Founder of ProSolus Pharmaceuticals

• M.B.A. in Pharmaceutical and Healthcare Marketing and B.S. in Business Management

• More than 20 years of industry experience

William Pedranti Chief Operating Officer

• Helped raise over $200 MM through capital transactions for Spectrum Pharmaceuticals

• Over a decade of experience as legal counsel and senior executive for pharmaceutical and biotech

• Past Vice-President and General Counsel for Spectrum Pharmaceuticals. Provided corporate, transactional, regulatory and M&A advice to companies at Latham and Watkins, LLP

INDEPENDENT DIRECTORS

Eric Floyd, PhD

• VP, Global Regulatory Affairs • H. Lundbeck AS (current)• PhD, Neurophysiology

Jerrold Sendrow

• CFO & Director, 800 Travel Systems (past)• VP-Finance, Columbia Travel Group (past)

SCIENTIFIC ADVISORY BOARD

Jeffrey Gudin, MDAnesthesiologist, Pain Specialist

Charles Argoff, MD Neurologist, Pain Specialist

Srinivas Nalamachu, MD

Internal Medicine, Pain Specialist

Kip Vought Regulatory and Strategic Development Consultant

Page 5: CORPORATE PRESENTATION ANTHONY MACK, PRESIDENT & CEO WILLIAM PEDRANTI, COO © 2014 SCILEX Pharmaceuticals, Inc. All Rights Reserved

2012

2016September 2013:-Pilot PK study demonstrates potential of establishing bioequivalence to Lidoderm®

SCILEX™ Pharmaceuticals Launched

July 2012:-SCILEX held its first of three strategic meetings with its Japanese Partner

February 2013: -Commercial rights to Lidocaine transdermal tape (ZTlido™) for US and Canada

February 2014:-IND filing

Q1 2015: -Targeted NDA Filing

April 2012:

-FDA concurrence on 505(b)(2)

ZTlido™ Targete

d Launch

Q1 2016

COMPANY MILESTONES

ZTlido™ IS A TRADEMARK OF SCILEX

May 2014:-Initiated Pivotal Study

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Q3 2014: -Completed dermal safety studies -Completed all clinical studies

April 2013:-Acquired Latin American Commercial Rights to ZTlido™

Page 6: CORPORATE PRESENTATION ANTHONY MACK, PRESIDENT & CEO WILLIAM PEDRANTI, COO © 2014 SCILEX Pharmaceuticals, Inc. All Rights Reserved

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THE TRANSDERMAL MARKET FOR PAIN

Page 7: CORPORATE PRESENTATION ANTHONY MACK, PRESIDENT & CEO WILLIAM PEDRANTI, COO © 2014 SCILEX Pharmaceuticals, Inc. All Rights Reserved

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Source: Medtrack, September 2013, Copyright Informa UK; company websites

The transdermal drug delivery market is set to grow from $21 Billion in 2010 to $32 Billion by 2015. *

Pain is the largest segment in the pipeline of transdermal drugs under development.

High barriers to entry make this market attractive for branded drugs with novel delivery systems despite generics.

TRANSDERMAL MARKET OUTLOOK

Page 8: CORPORATE PRESENTATION ANTHONY MACK, PRESIDENT & CEO WILLIAM PEDRANTI, COO © 2014 SCILEX Pharmaceuticals, Inc. All Rights Reserved

ZTlido™ will seek to capitalize on the Billion Dollar market created by Lidoderm®

ZTlido 1.8%LIDOCAINE (36 MG) TRANSDERMAL TAPE

The Zero H2O Transdermal Lidocaine Tape (ZTL)

8CONFIDENTIAL - DO NOT COPY OR DISTRIBUTE

Page 9: CORPORATE PRESENTATION ANTHONY MACK, PRESIDENT & CEO WILLIAM PEDRANTI, COO © 2014 SCILEX Pharmaceuticals, Inc. All Rights Reserved

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ZTlido’s ATTRIBUTES MAKE IT POTENTIAL BEST IN CLASS FOR THE TREATMENT OF PAIN ASSOCIATED WITH PHN

36 mg lidocaine vs. 700 mg lidocaine for Lidoderm®

Less active ingredient perceived to be safer by physician

FDA concerned with disposal of used Lidoderm patches

Approximately half the manufacturing cost due to no water content

Potential to load ZTlido™ with higher lidocaine doses for maximum performance

Superior adhesiveness

Better compliance (concerns about Lidoderm® patches falling off)

Potential for indication expansion e.g. low-back pain

Superior adhesion and pliability has potential to expand market

Top prescriber survey suggests potential uses in active joints such as wrists, knees, ankles and neck

Generics (Hydrogels -Lidoderm®) cannot compete

Page 10: CORPORATE PRESENTATION ANTHONY MACK, PRESIDENT & CEO WILLIAM PEDRANTI, COO © 2014 SCILEX Pharmaceuticals, Inc. All Rights Reserved

Clinical Development Regulatory Status

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Page 11: CORPORATE PRESENTATION ANTHONY MACK, PRESIDENT & CEO WILLIAM PEDRANTI, COO © 2014 SCILEX Pharmaceuticals, Inc. All Rights Reserved

Projected timeline to approval

R&D Milestone Status/ Completion

Initial formulation with stability Completed

Small scale batch Completed

Pilot PK study Completed

Second Pilot PK Study Completed

Pre IND meeting correspondence Completed (April 2012)

Stability batch Started Nov. 2012

MiniPig Toxicity Study Completed

Third round Pilot PK Study Completed

IND Submission (Clinipace) Completed

Pivotal PK Study Completed

Photoallergy/Phototoxicity Studies Completed

Heat Overlay Study Completed

Irritation/Sensitization Study Completed

Final Clinical Study Reports December 31

NDA Submission Targeted 1Q 2015

WITH A POTENTIAL 6 TO 10 MONTH REVIEW PROCESS FOR 505(B)(2):

ZTLIDO COULD BE APPROVED AND LAUNCHED BY Q1, 2016

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Page 12: CORPORATE PRESENTATION ANTHONY MACK, PRESIDENT & CEO WILLIAM PEDRANTI, COO © 2014 SCILEX Pharmaceuticals, Inc. All Rights Reserved

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Potential Future Targeted Indications*

ZTlido™ LIFE CYCLE MANAGEMENT

*Will require FDA approval

Page 13: CORPORATE PRESENTATION ANTHONY MACK, PRESIDENT & CEO WILLIAM PEDRANTI, COO © 2014 SCILEX Pharmaceuticals, Inc. All Rights Reserved

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Targeted Indication for Lifecycle Management Low Back Pain

Over 31 MM cases per year

>$50 Billion annual spent*

No. 1 cause of disability

Mostly mechanical in nature

Various treatment options: OTC medications, anti-convulsants, anti-depressants

Opioids

Neural stimulation

Nerve blocking agents (local anesthetics, steroids, anti-inflammatory, etc)

Surgery (vertebroplasty, kyphoplasty)

Page 14: CORPORATE PRESENTATION ANTHONY MACK, PRESIDENT & CEO WILLIAM PEDRANTI, COO © 2014 SCILEX Pharmaceuticals, Inc. All Rights Reserved

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POTENTIAL ZTLIDO PRODUCT PIPELINE

Regulatory Pilot PK

Phase 1

Phase 2

Phase 3 NDA

ZTlido1.8% (36 mg lidocaine)

505(b)(2) Bio-equivalence to Lidoderm 5%For the relief of pain associated with PHN

All studies completed*

Targeting Q1

2015

ZTlido 3.6%/5.4% (72/108 mg lidocaine)

Pre-IND Discussion (1H, 2015)For the relief of pain associated with PHN

Myofascial syndrome (low back pain) Pre-IND Discussion (1H, 2015)

*Final clinical study reports are expected by December 31, 2014

Page 15: CORPORATE PRESENTATION ANTHONY MACK, PRESIDENT & CEO WILLIAM PEDRANTI, COO © 2014 SCILEX Pharmaceuticals, Inc. All Rights Reserved

Potential Line Extensions Offer Dosing Flexibility

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Product Lidocaine loading

dose per patch Potential Titration

Lidoderm® (5% Hydrogel Patch) 700 mg No

ZTlido 1.8% 36 mg Yes

ZTlido ~3.6% ~72 mg Yes

ZTlido ~5.4% ~108 mg

ZTlido line extension patches can be developed for indications beyond shingles.

Line extensions allow clinicians to individualize therapy.

CONFIDENTIAL - DO NOT COPY OR DISTRIBUTE

Page 16: CORPORATE PRESENTATION ANTHONY MACK, PRESIDENT & CEO WILLIAM PEDRANTI, COO © 2014 SCILEX Pharmaceuticals, Inc. All Rights Reserved

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SCILEX™ has relationships with leading companies in their respective fields:

Japanese Research Development and Manufacturing Partner Founded in 1907

Japanese pharmaceutical research, development and manufacturing partners

Transdermal manufacturer sells to large pharma

David Rosen, Partner at Foley & Lardner LLP

Handled the pre-IND meeting correspondence with FDA

Previously worked at FDA over 10 years

Chaired 505(b)(2) initiative

Dr. Jeff Gudin, Pain Consultant

Director, Pain Management and Palliative Care, Englewood Hospital and Medical Center

President, Medical Education Consultants

Yale University School of Medicine, Fellow, Pain Management, 1996 – 1997

Richard Cohen, Chord Financial AdvisorsPast President and Member of the Board of CorMedix Inc.

Past Director and Chairman of the Audit Committee of Rodman and Renshaw

FOUNDATION OF SUCCESSFUL COLLABORATIONS

Page 17: CORPORATE PRESENTATION ANTHONY MACK, PRESIDENT & CEO WILLIAM PEDRANTI, COO © 2014 SCILEX Pharmaceuticals, Inc. All Rights Reserved

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SCILEX™ has relationships with leading companies in their respective fields:

Ken Smith, Ph.D. (IP Counsel)

Previously, Chief IP Counsel for Alpharma

VP of Intellectual Property for Sanofi-Aventis

Beckloff Associates/Cardinal Health (Manufacturing Audit)

Conducted Manufacturing Audit of Japanese Partner

cGMP Audit and Consulting

Clinipace Worldwide (CRO)

Regulatory, Pre-Clinical and Clinical

Preparing the IND; CRO chosen for ZTlido™

BDO USA LLP

Auditor

InVentiv Health Commercial Sales and Marketing Optimization Strategist

FOUNDATION OF SUCCESSFUL COLLABORATIONS

Page 18: CORPORATE PRESENTATION ANTHONY MACK, PRESIDENT & CEO WILLIAM PEDRANTI, COO © 2014 SCILEX Pharmaceuticals, Inc. All Rights Reserved

Focus on the development and commercialization of late-stage products for the treatment of pain (100+ million Americans have chronic pain). Our First product ZTlido™ will focus on the treatment of pain associated with PHN.

Strong Management Team with experience marketing multiple pain products (Lidoderm®, OxyContin®)

ZTlido™ (lidocaine patch 1.8%), is a branded, fourth-generation transdermal lidocaine patch formulated for the treatment of the pain associated with PHN, a chronic, painful condition that may follow a shingles infection

The FDA concurred that a single powered bioequivalence study of ZTlido™ vs. Lidoderm® would be sufficient for submission of ZTlido™ under Section 505(b)(2)

ZTlido™ has potential superior qualities to Lidoderm-a product (branded and generic) that generated over a billion dollars in U.S. sales in 2013*; targeted launch is Q1 2016

*IMS 2014

(TM) ZTlido IS A TRADEMARK OF SCILEX. All other trademarks are the property of their respective owners.

SCILEX INVESTMENT HIGHLIGHTS

18

Page 19: CORPORATE PRESENTATION ANTHONY MACK, PRESIDENT & CEO WILLIAM PEDRANTI, COO © 2014 SCILEX Pharmaceuticals, Inc. All Rights Reserved

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Contact Information

For additional information please contact:

William PedrantiSCILEX Pharmaceuticals, Inc.

101 Lindenwood Drive, Suite 225Malvern, PA 19355Cell: 949-413-2672

Office: 484-875-3032