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CORPORATE PRESENTATION

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Presentation on theme: "CORPORATE PRESENTATION"— Presentation transcript:

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

2 Forward Looking Statements
Certain statements contained herein may constitute "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 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 IS NOT AN OFFER, NOR THE SOLICITATION OF AN OFFER TO BUY ANY SECURITIES. SUCH AN OFFER, IF MADE, WILL BE MADE ONLY THROUGH A PROSPECTUS OR OTHER SUCH DOCUMENT ISSUED IN ACCORDANCE WITH THE UNITED STATES SECURITIES ACT, AND OTHER APPLICABLE LAWS, RULES AND REGULATIONS. CONFIDENTIAL - DO NOT COPY OR DISTRIBUTE

3 SCILEX INVESTMENT HIGHLIGHTS
Focus on the development and commercialization of late-stage products for the treatment of pain (100+ million Americans have chronic pain) Particular focus on high barrier to entry products such as transdermals ($32 Billion U.S. Market in 2015)* 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 post-herpetic neuralgia, or 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 $1.45 billion in U.S. sales in 2013**; potential launch is 2H 2015 ** IMS (TM) Ztlido IS A TRADEMARK OF SCILEX. All other trademarks are the property of their respective owners. * ** IMS 2014

4 We Know Pain & Transdermals
MANAGEMENT TEAM Anthony Mack Chief Executive Officer Experienced pharmaceutical executive who has driven the successful commercialization of leading pain products 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 financial transactions 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 Richard Cohen Chief Financial Officer Past President and Member of the Board of CorMedix Inc. Former Member of the Board of Dune Energy Inc.   Past Director and Chairman of the Audit Committee of Rodman and Renshaw BOARD OF 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, MD Anesthesiologist, Pain Specialist Charles Argoff, MD Neurologist, Pain Specialist Srinivas Nalamachu, MD Internal Medicine, Pain Specialist Kip Vought Regulatory and Strategic Development Consultant

5 SCILEX™ Pharmaceuticals Launched
Company Milestones H2, 2015 Ztlido™ Launch September, 2013: -Pilot PK study demonstrates evidence of bioequivalence to Lidoderm® 2014 April, 2013: -Acquired Latin American Rights to Ztlido™ Q1, 2015: -NDA Filing February, 2013: -Commercial rights to Lidocaine transdermal tape (Ztlido™) for US and Canada Q3, 2014: -Potential Initial Public Offering -Commenced dermal safety studies of its Ztlido™ July, 2012: -SCILEX held its first of three strategic meetings with its Japanese Partner Q2, 2014 -Pivotal Study (May) April, 2012: -FDA concurrence on 505(b)(2) Q1, 2014: -IND filing (Feb) 2012 SCILEX™ Pharmaceuticals Launched Ztlido™ IS A TRADEMARK OF SCILEX

6 The transdermal market for pain

7 Transdermal Market Outlook
The transdermal drug delivery market is set to grow from $21 Billion in 2010 to $32 Billion by * 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 * Source: Medtrack, September 2013, Copyright Informa UK; company websites

8 Ztlido™ 1.8% LIDOCAINE (36 MG) TRANSDERMAL PATCH
Potential Benefits: Superior Adhesiveness Better pliability & flexibility ZTL 1.8% (36 mg lidocaine) delivers equivalent analgesic intensity as Lidoderm 5% (700 mg lidocaine) Ztlido™ 1.8% The Zero H2O Transdermal Lidocaine Patch Introducing…. LIDOCAINE (36 MG) TRANSDERMAL PATCH Ztlido™ is primed to capitalize on the Billion Dollar market created by Lidoderm®

9 ZTLIDO’s POTENTIAL ATTRIBUTES MAKE IT 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

10 Projected timeline to approval
R&D Budget and FDA Expense Status/ Completion Initial formulation with stability Completed Pilot PK study Second Pilot PK Study Pre IND meeting correspondence Completed (April 2012) Stability batch Started Nov. 2012 MiniPig Toxicity Study Third Pilot PK Study IND Submission (Clinipace) Pivotal PK Study Photoallergy/Phototoxicity Studies Heat Overlay Study Irritation/Sensitization Study Final Audited Reports Due November 2014 NDA Submission Expected 1Q 2015 with a POTENTIAL 10 month review PROCESS for 505(b)(2): Ztlido™ could be approved BY H2, 2015

11 POTENTIAL Line Extensions Offer Dosing Flexibility
Product Lidocaine loading dose per patch vs. Ztlido™ potential loading dose Titration Lidoderm® (Lidocaine Patch 5%) Hydrogel Patch 700 mg No Ztlido™ 1.8% 36 mg Yes Ztlido `3.6% 72 mg Ztlido `5.4% 108 mg Ztlido™ has the potential to gain regulatory approval for applications for the treatment of pain associated with PHN. Multiple strengths would enable clinicians to adjust the dosage, hence, the patient’s therapy may be individualized.

12 MYOFASCIAL SYNDROME (LOW BACK PAIN) Potential Indications
Ztlido™ LIFE CYCLE MANAGEMENT

13 Low Back pain- A significant unmet medical need
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) *

14 Potential Franchise Pipeline
Regulatory Pilot PK Phase 1 Phase 2 Phase 3 NDA Ztlido™1.8% (36 mg lidocaine) 505(b)(2) Bio-equivalence to Lidoderm 5% For the treatment of pain associated with PHN Pivotal BE Study Started May, 2014 Q1 2015 Ztlido 3.6%/5.4% (72/108 mg lidocaine) Pre-IND Discussion (H2, 2014) Myofascial syndrome (low back pain) Pre-IND Discussion (H1, 2015)

15 SCILEX INVESTMENT HIGHLIGHTS
Focus on the development and commercialization of late-stage products for the treatment of pain (100+ million Americans have chronic pain) Particular focus on high barrier to entry products such as transdermals ($32 Billion U.S. Market in 2015)* 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 post-herpetic neuralgia, or 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 $1.45 billion in U.S. sales in 2013**; potential launch is 2H 2015 ** IMS (TM) Ztlido IS A TRADEMARK OF SCILEX. All other trademarks are the property of their respective owners. * ** IMS 2014

16 Contact Information For additional information please contact: William Pedranti SCILEX Pharmaceuticals, Inc. 101 Lindenwood Drive, Suite 225 Malvern, PA Cell: Office:

17 Foundation of Successful Collaborations
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

18 Foundation of Successful Collaborations
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


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