Apricus Biosciences - Jefferies 2011 Global Healthcare Conference Presentation
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Transcript of Apricus Biosciences - Jefferies 2011 Global Healthcare Conference Presentation
11 June‐8‐2011APRI‐
Corporate Jefferies Presentation1
Apricus Biosciences, Inc. Corporate presentationJefferies 2011 Global Healthcare Conference
June 8th, 2011
11 June‐8‐2011APRI‐
Corporate Jefferies Presentation2
Safe‐Harbor Statement
Statements under the Private Securities Litigation Reform Act, as amended: With
the
exception
of
the
historical
information
contained
in
this
presentation,
the
matters
described
herein
contain
forward‐looking
statements
that
involve
risks
and
uncertainties
that
may
individually,
mutually,
or
materially
impact
the
matters
herein
described,
including,
but
not
limited
to,
the
Company’s
ability
to
execute
its
business
plan,
obtain
regulatory
approval
for
products
under
development,
enter
into
partnering
agreements,
realize
revenue
and
pursue
growth
opportunities,
some
of which
are
outside
the
control
of
the
Company.
Attendees
are
cautioned
not
to
place
undue
reliance
on
these
forward‐looking
statements
as
actual
results
could
differ
materially
from
the
forward‐looking
statements
contained
herein.
Attendees
are
urged
to
read
the
risk
factors
set
forth
in
the
Company’s
most
recent
annual
report
on
Form
10‐K,
subsequent
quarterly
reports
filed
on
Form
10‐Q
and
its
most
recent
SEC
filings. Company
disclaims any intention to update this presentation.
11 June‐8‐2011APRI‐
Corporate Jefferies Presentation3
Financial Snapshot
•
NASDAQ:
APRI
•
Shares Outstanding
19.6M*•
Shares Fully‐diluted
22M*•
Shares in the float
16M*
•
Present Cash‐position
$10.2M*
•
Share‐price
$5.02**
•
Marketcap
~$99M**
•
Average Daily volume
~330k**
•
Revenues 2010
~$5M*As of March 31, 2011**As of June 2, 2011
11 June‐8‐2011APRI‐
Corporate Jefferies Presentation4
Company Highlights
•
Specialty Biopharmaceuticals company with proprietary platform technology
(NexACT®) to rapidly advance drug candidates through clinical development
•
Mid‐to‐late staged pipeline with multiple, significant near‐term value drivers
•
Multiple Partnerships in place with additional significant partnerships expected
near term
•
Experienced management team, proven to deliver on milestones and
objectives
•
Solid financial position: Current cash position through H2 2012 with goal to be
cashflow positive exiting 2011
11 June‐8‐2011APRI‐
Corporate Jefferies Presentation5
NexACT®: Multi‐Route Drug Delivery Technology
•
Patented:
NCE
patents
based
on
proprietary
permeation
enhancers
that
are
biodegradable, biocompatible, non‐toxic ingredients that mimic the composition of
human skin and tissues.
•
Effective: enables rapid absorption of high concentrations of drug directly to target
site or systemically into blood stream.
•
Safe: excellent pre‐clinical and clinical safety dossiers through thousands of patient
exposures
•
Versatile: effective with wide range of drugs classes and different routes •
Small molecules, peptides, proteins, SiRNA, anti‐sense, and antibodies•
Transdermal, Oral, Sub‐Q, Buccal, Rectal, Nasal, Ophthalmic
11 June‐8‐2011APRI‐
Corporate Jefferies Presentation6
NexACT®
(DDAIP) MOA‐Loosening Tight Junctions
11 June‐8‐2011APRI‐
Corporate Jefferies Presentation7
Apricus Bio Product Pipeline
11 June‐8‐2011APRI‐
Corporate Jefferies Presentation8
Vitaros®
(alprostadil/DDAIP) for the Treatment of Erectile Dysfunction
•PGE1, potent vasodilator, topical cream, high viscosity •Rapid onset (generally 10‐30 minutes) •Significant efficacy, including difficult to treat populations•Diabetics•Hypertensives•Patients with cardiac issues•Patients on nitrates and alpha blockers•Prostatectomy patients •Sildenafil (Viagra®) failures•Side effects are generally mild, transient and topically related.•Studied in over 3,300 patients
11 June‐8‐2011APRI‐
Corporate Jefferies Presentation9
Vitaros®
(alprostadil/DDAIP) for the Treatment of Erectile Dysfunction
11 June‐8‐2011APRI‐
Corporate Jefferies Presentation10
Femprox®
(alprostadil/DDAIP) for the Treatment of Female Sexual Arousal Disorder (FSAD)
Premeasured unit dose225 mg of cream containing
0.4 % alprostadil (900 µg), DDAIP 0.5%
11 June‐8‐2011APRI‐
Corporate Jefferies Presentation11
1st
Femprox®
Phase 3 Study
•
A Randomized, Placebo‐Controlled, Double‐Blind, Parallel Design Study of the
Efficacy and Safety of Alprostadil Cream in Patients with Female
Sexual Arousal
Disorder (FSAD)o
n= 400 patients placebo, 500, 700 or 900 mcg alprostadil
cream groups, Application sites:
clitoris and G‐spot
o
Five (5) month study
11 June‐8‐2011APRI‐
Corporate Jefferies Presentation12
MycoVa™
(Terbinafine/DDAIP) for the Treatment of Onychomycosis•Synthetic allylamine derivative which inhibits enzyme squalene epoxide in fungal
cell•DDAIP ‐
significant drug penetration through nail plate to bed and surrounding area•Formulations advantages
•
Drug availability•
Not trapped in lacquer matrix•
Easily treat adjacent skin and folds•
Patient convenience•
Ease of application, quick drying•
Wash off, no lacquer removal•Clinical Studies in ~900 patients
•
2 Phase 3 trials completed in US, EU and Canada•
1 EU comparator trial vs. Loceryl®
(amorolfine)
MycoVa™
11 June‐8‐2011APRI‐
Corporate Jefferies Presentation13
MycoVa™Primary Efficacy Results
Treatment nProportion
(%)Difference(95% CI) P value
Statistical significance
Terbinafine 48 w(N=507) 6 1.18 0.22 (-1.01, 1.44)1 0.73023 NoAmorolfine 48 w (N=522) 5 0.96 0.23 (-1.03, 1.48)2
Complete cure rates at the end of study (ITT Population, LOCF)
Treatment nProportion
(%)Difference(95% CI) P value
Statistical significance
Terbinafine 48 w(N=507) 23 4.54 0.75 (-1.50, 3.00)1 0.53272 No
Amorolfine 48 w (N=522) 20 3.83
Source: MycoVa™ Clinical Study Report
Clinical effectiveness rates at end of study (ITT population, LOCF)
11 June‐8‐2011APRI‐
Corporate Jefferies Presentation14
MycoVa™Primary Efficacy Results
Treatment nProportion
(%)Difference(95% CI) P value
Statistical significance
Terbinafine 48 w(N=507) 82 16.17 0.86 (-3.15, 4.87)1 0.68432 No
Amorolfine 48 w (N=522) 82 15.71
Mycological cure rates at end of study (ITT population, LOCF)
11 June‐8‐2011APRI‐
Corporate Jefferies Presentation15
Market Opportunity
•
Multifunctional NexACT®
Small Molecule Platform Targets Over $10 Billion in approved and
Late‐Stage Product Opportunities
•
Vitaros®
For erectile dysfunction. Approved in Canada. NDA filed in US and Europe.
Worldwide market over $4 Billion
•
Femprox®
For FSAD. One successful Phase III. Awaiting guidance for filing
in Europe
and Canada. Preparing for US Phase III for NDA filing. Worldwide market
estimated to be up to $4 Billion
•
MycoVa™
For Onychomycosis. Europe Comparator Phase III trial competed. Awaiting
guidance for filing in Europe and Canada. Worldwide market over
$1 Billion
•
PrevOnco™
For liver cancer (HCC). In Phase II and heading to Phase III. Worldwide
market over $1 Billion
(Partial Pipeline)
11 June‐8‐2011APRI‐
Corporate Jefferies Presentation16
Milestones Achieved
Had first drug Vitaros® for erectile dysfunction approved by Health Canada
Strengthened financial foundation of the company Cash into H2 2012
Completed first partnerships for Vitaros®Bracco‐Vitaros® partnership (Italy)Elis‐Vitaros® partnership (Middle East)Neopharm‐Vitaros® partnership (Israel)
Unqualified audit opinion (Going Concern removed for the 1st time in 9 years)
Filed for European Approval for Vitaros® in Q2 2011
Last Financing October 2010 ~$9M at $1.83
Returned on shareholder valueUp over 40% YTD
11 June‐8‐2011APRI‐
Corporate Jefferies Presentation17
Near Term Upcoming Milestones
Announce additional ex‐US commercial partnerships for Vitaros®: CanadaEuropeAfricaLatin America
Goal to be cash‐flow positive by the end of 2011through upfront payments from partnership agreements
Commence sales of Vitaros® in Canada
11 June‐8‐2011APRI‐
Corporate Jefferies Presentation18
Upcoming Milestones
Announce first NexACT® technology licensing deal
File for marketing approval in Canada and Europe depending on regulatory guidance feedback for
MycoVa™Femprox®
Out‐license other late‐stage clinical productsFemprox®MyCova™PrevOnco™
11 June‐8‐2011APRI‐
Corporate Jefferies Presentation19
Commercial Partners for Vitaros®
USA
Middle East & Gulf
Israel
Italy
11 June‐8‐2011APRI‐
Corporate Jefferies Presentation20
Proven & Experienced Management Team
•
President & CEO‐
Dr. Bassam Damaj •
Pfizer,
Genentech
(now
Roche),
Pharmacopeia
(now
Ligand),
Tanabe
Seiyaku
(now
Mitsubishi‐Tanabe), Bio‐Quant, Celltek, R&D Healthcare
•
Strong Finance, Operations, and Legal Team•
Steve Martin‐
Gen‐Probe, Stratagene
(now Agilent)•
Edward Cox‐
Bio‐Quant, NexMed•
Randy Berholtz‐
Nanogen, ACON Labs
•
Proven Senior Business Development Team •
Mark Wilson‐
Pfizer, Halozyme (Technology)•
Linda Smibert‐
BMS, AstraZeneca, Santarus (Products)
•
Experienced Research & Development and Regulatory Team•
Dr. Mohamed Hachicha‐
Forest Labs, Purdue Pharma•
Dr. Richard Martin‐
Exelixis, Tanabe Seiyaku (now Mitsubishi‐Tanabe)•
Daniel Frank‐
Wyeth, Pfizer•
Dr. Joachim Schupp‐
Novartis
11 June‐8‐2011APRI‐
Corporate Jefferies Presentation21
In Summary
•
Approved
drug
(Vitaros®)
and
clinically
validated
drug
delivery
technology
•
Commercial partnerships in place and expanding
•
Unique,
patented
and
versatile
technology
that
can
be
partnered
multiple
times
to
multiple
partners
&
used
to
develop
multiple
drugs
•
Revenue‐generating with current cash reserves into H2 2012
11 June‐8‐2011APRI‐
Corporate Jefferies Presentation22
Contact
Edward CoxVP, Corporate Development & IR
858‐848‐4249
www.apricusbio.com
11 June‐8‐2011APRI‐
Corporate Jefferies Presentation23
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•
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