CORPORATE PRESENTATION - SCILEX Pharmaceuticals

Download Report

Transcript CORPORATE PRESENTATION - SCILEX Pharmaceuticals

CORPORATE PRESENTATION

ANTHONY MACK, PRESIDENT & CEO WILLIAM PEDRANTI, COO

© 2014 SCILEX Pharmaceuticals, Inc. All Rights Reserved.

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 2

SCILEX INVESTMENT HIGHLIGHTS

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

* IMS 2014

WE KNOW PAIN & TRANSDERMALS

Anthony Mack

Chief Executive Officer

William Pedranti SENIOR MANAGAGEMENT

Chief Operating 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

Eric Floyd, PhD INDEPENDENT DIRECTORS

• • • 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 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

Charles Argoff, MD Srinivas Nalamachu, MD Kip Vought

Neurologist, Pain Specialist Internal Medicine, Pain Specialist Regulatory and Strategic Development Consultant 4

COMPANY MILESTONES

September 2013

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

April 2013:

-Acquired Latin American Commercial Rights to

ZTlido

February 2013

: -Commercial rights to Lidocaine transdermal tape (

ZTlido

™) for US and Canada

July 2012

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

April 2012

: -FDA concurrence on 505(b)( 2 )

2012

2016 ZTlido

Targeted Launch Q1 2016

Q1 2015:

-Targeted NDA Filing

Q3 2014:

-Completed dermal safety studies -Completed all clinical studies

May 2014:

-Initiated Pivotal Study

February 2014

: -IND filing

SCILEX™ Pharmaceuticals Launched

ZTlido™ IS A TRADEMARK OF SCILEX 5

THE TRANSDERMAL MARKET FOR PAIN

6

TRANSDERMAL MARKET OUTLOOK

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.

7

The

Z

ero H 2 O

T

ransdermal

Lido

caine Tape

(ZTL)

ZTlido

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

CONFIDENTIAL - DO NOT COPY OR DISTRIBUTE 8

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

Clinical Development Regulatory Status

10

Projected timeline to approval

WITH A POTENTIAL 6 TO 10 MONTH REVIEW PROCESS FOR 505(B)(2): ZTLIDO COULD BE APPROVED AND LAUNCHED BY Q1, 2016 R&D Milestone

Initial formulation with stability Small scale batch Pilot PK study Second Pilot PK Study Pre IND meeting correspondence Stability batch MiniPig Toxicity Study Third round Pilot PK Study IND Submission (Clinipace) Pivotal PK Study Photoallergy/Phototoxicity Studies Heat Overlay Study Irritation/Sensitization Study Final Clinical Study Reports NDA Submission

Status/ Completion

Completed Completed Completed Completed Completed (April 2012) Started Nov. 2012 Completed Completed Completed Completed Completed Completed Completed December 31 Targeted 1Q 2015 11

Potential Future Targeted Indications*

ZTlido™ LIFE CYCLE MANAGEMENT

*Will require FDA approval 12

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

POTENTIAL ZTLIDO PRODUCT PIPELINE

ZTlido1.8%

(36 mg lidocaine)

ZTlido 3.6%/5.4%

(72/108 mg lidocaine) Myofascial syndrome (low back pain)

Regulatory Pilot PK Phase 1

505(b)(2) Bio-equivalence to Lidoderm 5% For the relief of pain associated with PHN Pre-IND Discussion (1H, 2015) For the relief of pain associated with PHN

Phase 2 Phase 3

All studies completed*

NDA

Targeting Q1 2015 Pre-IND Discussion (1H, 2015) 14 *Final clinical study reports are expected by December 31, 2014

Potential Line Extensions Offer Dosing Flexibility

Product Lidoderm® (5% Hydrogel Patch) ZTlido 1.8% ZTlido ~3.6% ZTlido ~5.4% Lidocaine loading dose per patch 700 mg 36 mg ~72 mg ~108 mg Potential Titration No Yes Yes ZTlido line extension patches can be developed for indications beyond shingles. Line extensions allow clinicians to individualize therapy.

CONFIDENTIAL - DO NOT COPY OR DISTRIBUTE 15

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

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 16

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

InVentiv Health

Commercial Sales and Marketing Optimization Strategist 17

SCILEX INVESTMENT HIGHLIGHTS

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

*IMS 2014

Contact Information

For additional information please contact: William Pedranti SCILEX Pharmaceuticals, Inc.

101 Lindenwood Drive, Suite 225 Malvern, PA 19355 Cell: 949-413-2672 Office: 484-875-3032

19