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



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.



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



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



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



NexACT®

(DDAIP) MOA‐Loosening Tight Junctions



Apricus Bio Product Pipeline



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



Vitaros®

(alprostadil/DDAIP) for the Treatment of Erectile Dysfunction



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%



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



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™



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)




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)



MycoVa™Primary Efficacy Results




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)



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)



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



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



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™



Commercial Partners for Vitaros®

USA

Middle East & Gulf

Israel

Italy

http://www.wcrx.com/



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



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



Contact

Edward CoxVP, Corporate Development & IR

858‐848‐4249

www.apricusbio.com

http://www.apricusbio.com/






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Health & Medicine

Apricus Biosciences - Jefferies 2011 Global Healthcare Conference Presentation