Transcript Completion - 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 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
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 Q1 2016
(TM) ZTlido IS A TRADEMARK OF SCILEX. All other trademarks are the property of their respective
owners.
* http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2995530/
** IMS 2014
3
WE KNOW PAIN & TRANSDERMALS
SENIOR MANAGAGEMENT
•
•
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
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
•
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
Charles Argoff, MD
Srinivas Nalamachu, MD
Kip Vought
Anesthesiologist, Pain Specialist
Neurologist, Pain Specialist
Internal Medicine, Pain Specialist
Regulatory and Strategic
Development Consultant
4
COMPANY MILESTONES
September, 2013:
-Pilot PK study demonstrates evidence of
bioequivalence to Lidoderm®
H1, 2016
ZTlido™
Launch
2016
April, 2013:
-Acquired Latin American 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
Q1, 2015:
-NDA Filing
Q3, 2014:
-Completed dermal safety
studies
-Completed all clinical studies
May, 2014:
-Initiated Pivotal Study
February, 2014:
-IND filing
SCILEX™ Pharmaceuticals
Launched
5
ZTlido™ IS A TRADEMARK OF SCILEX
THE TRANSDERMAL MARKET FOR PAIN
6
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.
TRANSDERMAL MARKET OUTLOOK
High barriers to entry make this
market attractive for branded
drugs with novel delivery
systems despite generics.
Source: Medtrack, September 2013, Copyright Informa UK; company websites
7
The Zero H2O Transdermal
Lidocaine Tape (ZTL)
ZTlido™ is primed to capitalize on the Billion Dollar
market created by Lidoderm®
CONFIDENTIAL - DO NOT COPY OR DISTRIBUTE
8
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
Clinical Development
Regulatory Status
10
Projected
timeline to
approval
R&D Milestone
Initial formulation with stability
Completed
Small scale batch
Completed
Pilot PK study
Completed
Second Pilot PK Study
Completed
Pre IND meeting correspondence
Stability batch
WITH A POTENTIAL 10
MONTH REVIEW PROCESS
FOR 505(B)(2):
ZTLIDO COULD BE
APPROVED BY Q1, 2016
Status/ Completion
Completed (April 2012)
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
NDA Submission
Expected 1Q 2015
11
MYOFASCIAL SYNDROME
(LOW BACK PAIN)
Potential Indications
ZTlido™ LIFE CYCLE MANAGEMENT
12
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, antidepressants
 Opioids
 Neural stimulation
 Nerve blocking agents (local anesthetics,
steroids, anti-inflammatory, etc)
 Surgery (vertebroplasty, kyphoplasty)
13
* http://www.ninds.nih.gov/disorders/backpain/detail_backpain.htm
POTENTIAL FRANCHISE PIPELINE
Regulatory
Pilot PK
Phase 1
Phase 2
Phase 3
NDA
All studies
completed
Q1
2015
ZTlido1.8%
(36 mg lidocaine)
505(b)(2) Bio-equivalence to Lidoderm 5%
For the treatment of pain associated with
PHN
ZTlido 3.6%/5.4%
(72/108 mg lidocaine)
Pre-IND Discussion (Q1, 2015)
For the treatment of pain associated with PHN
Myofascial syndrome
(low back pain)
Pre-IND Discussion (H1, 2015)
14
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 Q1 2016
(TM) ZTlido IS A TRADEMARK OF SCILEX. All other trademarks are the property of their respective owners.
* http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2995530/
** IMS 2014
15
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
16
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
17
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
18