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

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Presentation on theme: "CORPORATE PRESENTATION ANTHONY MACK, PRESIDENT & CEO WILLIAM PEDRANTI, COO © 2014 SCILEX Pharmaceuticals, Inc. All Rights Reserved."— 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 2

3  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 (TM) Ztlido IS A TRADEMARK OF SCILEX. All other trademarks are the property of their respective owners. SCILEX INVESTMENT HIGHLIGHTS 3 * ** IMS 2014

4 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 2014 September, 2013: -Pilot PK study demonstrates evidence of 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 Q1, 2014: -IND filing (Feb) Q1, 2015: -NDA Filing April, 2012: -FDA concurrence on 505(b)( 2 ) H2, 2015 Ztlido ™ Launch COMPANY MILESTONES Ztlido™ IS A TRADEMARK OF SCILEX Q2, Pivotal Study (May) 5 Q3, 2014: -Potential Initial Public Offering -Commenced dermal safety studies of its Ztlido™ April, 2013: -Acquired Latin American Rights to Ztlido™

6 THE TRANSDERMAL MARKET FOR PAIN 6

7 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 * 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 7

8 Ztlido™ is primed to capitalize on the Billion Dollar market created by Lidoderm® Introducing…. The Z ero H 2 O T ransdermal L idocaine Patch Potential Benefits: Superior Adhesiveness Better pliability & flexibility ZTL 1.8% (36 mg lidocaine) delivers equivalent analgesic intensity as Lidoderm 5% (700 mg lidocaine) 8

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 9

10 Projected timeline to approval R&D Budget and FDA ExpenseStatus/ Completion Initial formulation with stabilityCompleted Pilot PK studyCompleted Second Pilot PK StudyCompleted Pre IND meeting correspondenceCompleted (April 2012) Stability batchStarted Nov MiniPig Toxicity StudyCompleted Third Pilot PK StudyCompleted IND Submission (Clinipace)Completed Pivotal PK StudyCompleted Photoallergy/Phototoxicity StudiesCompleted Heat Overlay StudyCompleted Irritation/Sensitization StudyCompleted Final Audited Reports DueNovember 2014 NDA SubmissionExpected 1Q 2015 WITH A POTENTIAL 10 MONTH REVIEW PROCESS FOR 505(B)(2): ZTLIDO™ COULD BE APPROVED BY H2,

11 POTENTIAL LINE EXTENSIONS OFFER DOSING FLEXIBILITY 11 Product Lidocaine loading dose per patch vs. Ztlido™ potential loading dose Titration Lidoderm® (Lidocaine Patch 5%) Hydrogel Patch700 mgNo Ztlido™ 1.8%36 mgYes Ztlido `3.6%72 mgYes 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 12

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) 13 *

14 POTENTIAL FRANCHISE PIPELINE RegulatoryPilot PKPhase 1Phase 2Phase 3NDA 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 Q Ztlido 3.6%/5.4% (72/108 mg lidocaine) Pre-IND Discussion (H2, 2014) For the treatment of pain associated with PHN Myofascial syndrome (low back pain)Pre-IND Discussion (H1, 2015) 14

15  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 (TM) Ztlido IS A TRADEMARK OF SCILEX. All other trademarks are the property of their respective owners. SCILEX INVESTMENT HIGHLIGHTS 15 * ** 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 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 FOUNDATION OF SUCCESSFUL COLLABORATIONS 17

18 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 FOUNDATION OF SUCCESSFUL COLLABORATIONS 18


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