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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 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 2

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

4 4 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, 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 2016 September 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 ™ Targeted Launch Q COMPANY MILESTONES ZTlido™ IS A TRADEMARK OF SCILEX May 2014: -Initiated Pivotal Study 5 Q3 2014: -Completed dermal safety studies -Completed all clinical studies April 2013: -Acquired Latin American Commercial 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 ™ will seek to capitalize on the Billion Dollar market created by Lidoderm® The Z ero H 2 O T ransdermal Lido caine T ape (ZTL) 8 CONFIDENTIAL - DO NOT COPY OR DISTRIBUTE

9 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 9

10 Clinical Development Regulatory Status 10

11 Projected timeline to approval R&D Milestone Status/ Completion Initial formulation with stabilityCompleted Small scale batchCompleted Pilot PK studyCompleted Second Pilot PK StudyCompleted Pre IND meeting correspondenceCompleted (April 2012) Stability batchStarted Nov MiniPig Toxicity StudyCompleted Third round Pilot PK StudyCompleted IND Submission (Clinipace)Completed Pivotal PK StudyCompleted Photoallergy/Phototoxicity StudiesCompleted Heat Overlay StudyCompleted Irritation/Sensitization StudyCompleted Final Clinical Study ReportsDecember 31 NDA SubmissionTargeted 1Q 2015 WITH A POTENTIAL 6 TO 10 MONTH REVIEW PROCESS FOR 505(B)(2): ZTLIDO COULD BE APPROVED AND LAUNCHED BY Q1,

12 Potential Future Targeted Indications* ZTlido™ LIFE CYCLE MANAGEMENT 12 *Will require FDA approval

13 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) 13

14 POTENTIAL ZTLIDO PRODUCT PIPELINE RegulatoryPilot PKPhase 1Phase 2Phase 3NDA ZTlido 1.8% (36 mg lidocaine) 505(b)(2) Bio-equivalence to Lidoderm 5% For the relief of pain associated with PHN All studies completed* Targeting Q 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) 14 *Final clinical study reports are expected by December 31, 2014

15 Potential Line Extensions Offer Dosing Flexibility 15 Product Lidocaine loading dose per patchPotential Titration Lidoderm® (5% Hydrogel Patch)700 mgNo ZTlido 1.8%36 mgYes ZTlido ~3.6%~72 mgYes 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

16 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 Advisors Past 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 16

17 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 17

18  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 Q *IMS 2014 (TM) ZTlido IS A TRADEMARK OF SCILEX. All other trademarks are the property of their respective owners. SCILEX INVESTMENT HIGHLIGHTS 18

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


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