Investor presentation 20_december_2011

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Paul K. Wotton, Ph.D. President and Chief Executive Officer December 2011 AMEX: AIS

Transcript of Investor presentation 20_december_2011

Paul K. Wotton, Ph.D.

President and Chief Executive Officer

December 2011

AMEX: AIS

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This presentation may contain forward-looking statements which are made pursuant to the safe

harbor provisions of Section 21E of the Securities Exchange Act of 1934 and the Private Securities

Litigation Reform Act of 1995. Investors are cautioned that statements which are not strictly

historical statements, including, without limitation, statements regarding the plans, objectives and

future financial performance of Antares Pharma, constitute forward-looking statements which involve

risks and uncertainties. The Company’s actual results may differ materially from those anticipated in

these forward-looking statements based upon a number of factors, including anticipated operating

losses, uncertainties associated with research, development, testing and related regulatory

approvals, unproven markets, future capital needs and uncertainty of additional financing,

competition, uncertainties associated with intellectual property, complex manufacturing, high quality

requirements, dependence on third-party manufacturers, suppliers and collaborators, lack of sales

and marketing experience, loss of key personnel, uncertainties associated with market acceptance

and adequacy of reimbursement, technological change, and government regulation. For a more

detailed description of the risk factors associated with the Company, please refer to the Company’s

periodic reports filed with the U.S. Securities and Exchange Commission from time to time, including

its Annual Report on Form 10-K for the year ended December 31, 2010. Undue reliance should not

be placed on any forward-looking statements, which speak only as of the date of this presentation.

The Company undertakes no obligation to update any forward-looking information contained in this

presentation.

Safe Harbor Statement

Antares Background and Mission

• Antares is a US-based, fast growing Pharmaceutical

Company

• Our transdermal gel business has yielded two FDA

approved products, and one in late-stage

development.

• Our self-injection business has yielded one FDA

approved product, licensed to other firms, and

several products in development, some of which we

may elect to market ourselves.

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• We have demonstrated significant clinical and regulatory expertise in drug/device

combination products coupled with a comprehensive IP portfolio which gives us a

sustainable competitive advantage in this field

• Our market research demonstrates our greatest opportunity and ROI exists in the rapidly

growing markets for self-injection products. Our mission is:

• Developing, producing and commercializing high quality self-injectable

medicines that are accessible to all patients who need and depend on

them for their health and well-being

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Investment Highlights

• Antares is a revenue generating company with an

advanced product pipeline and multiple shots on goal

• Three products approved, two on file with the FDA, and

five in advanced development

• Leader in fast-growing self-administered injection

technology

• The ONLY US-based company offering auto-injector, pen

and needle-free technology platforms

• Broad multi-product partnership with Teva

• Proprietary VIBEX MTX successfully completed clinical trial

• Anturol Gel NDA approved and partnered with Watson Pharmaceuticals

• HGH Needle free product commercialized in Europe and US

• Growing intellectual property portfolio

Antares’ Progress in our Mission

• Through our partnership with Teva we are developing

five value added injectable products:

– Tjet for Teva’s recombinant human growth hormone -

TevTropin

– An alternative to the Epipen epinephrine auto-injector

– Three additional high quality products for self-injected

medicines

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• Our VIBEX-MTX program is designed to enhance the performance of MTX

for patients who need and depend on it for their health and wellbeing for the

treatment of rheumatoid arthritis

• Our VIBEX-QS program aims to enhance the injection performance of

biological and biosimilar products for patients who depend on them for

effectively treating complex diseases including rheumatoid arthritis and other

autoimmune disorders.

NestraGelTM Contraception Population

Council NDA

VibexTM EPI Allergic

Emergency Filed ANDA TEVA

VibexTM 2 Undisclosed

Filed ANDA TEVA

Pen 2 Undisclosed NDA TEVA

VibexTM MTX Rheumatoid

Arthritis NDA ANTARES

Pen 1 Undisclosed ANDA TEVA

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PRODUCT INDICATION PRECLINICAL CLINICAL FILED MARKETED PARTNER

Tjet®/

Zomajet®

HGH

Deficiency

TEVA –US

Ferring – EU

JCR –Japan

Elestrin® Menopause Jazz (US)

Diverse and Advanced Product Pipeline

Anturol® OAB NDA

Approved Watson (US)

Undisclosed Undisclosed Pfizer NDA

APPROVED

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Key Advantages:

• Easy to use at home

• High quality and rapid injection promotes compliance

• Minimal sharps disposal – safe for patients

• Excellent reliability means patients get reproducible doses time after time

• Manufactured in the US – high quality

Proprietary Self-Injection Technology Portfolio

High Quality – High Value Added – Easy to Use

Disposable Auto-Injectors

Vibex and Vibex™ QS

Single shot up to 1 ml

injection volume

including highly viscous

biologic products

Pen Injectors

Multidose pens

Designed for new cartridge

technology

Reusable Needle-Free Injectors

Multiple use Injectors for

subcutaneous delivery

Novel Self-Injection Technology Vital to

Biological and Biosimilar Commercial Success

• Differentiation is critical to successful

commercialization

• Commercial strategies must include

device improvements, and patient

support

• Antares’ self-injection technology offers

physicians and patients enhanced

performance, safety and reliability

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• Enabling self-injection – patient empowerment is a key driver

• The New VIBEX QS is particularly well-suited for use with biosimilar

products

– Novel spring mechanism - 1ml capacity

– Powerful and smooth expulsion—necessary for viscous biologic formulations

– Highly compact

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• Global sales of branded biologic products compatible

with our self-injection technologies exceed $50 billion

today

• Analysts agree that the high profile biosimilar/biobetter

market will be significant, between $2-3 billion by 2015.

Biosimilars: Significant Growth Opportunities for

Self-Injection Products

• Biosimilars and Biobetters growth driven by several factors:

– Patent expirations of parenteral biologics

– Rapidly growing demand of costly branded biologics

– Mounting pressure on healthcare budgets

– Patient access to and affordability of medicine

Biosimilar Targets exceeding $1 Billion Global Sales

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$0.2 $14.1

$97.3

$0

$20

$40

$60

$80

$100

$120

<$100M $100M -$1B

>$1B

Bil

lio

ns

Sales per Brand

Peak Global Sales

Source: FDA, Thompson, Zachs, Bernstein

estimates and analysis. Peak sales from

analyst models (SCB or consensus, as

available)

Brand

Global Peak Sales

> $1 Billion Avastin $9.2

Enbrel $8.0

Remicade $7.9

Humira $7.3

Rituxan $7.3

Herceptin $5.7

Lantus $5.1

Epogen/Procrit $5.1

Neulasta $4.2

Novolog $3.8

Erbitux $3.6

Aranesp $3.2

Recombinate $2.9

Lucentis $2.7

Avonex $2.6

Novolin $2.5

Humalog $2.2

PEGasys $2.0

Rebif $1.7

Cerezyme $1.5

NovoSeven $1.4

Tysabri $1.4

Neupogen $1.3

Synagis $1.3

Betaseron $1.2

Humulin $1.1

Kogenate FS $1.1

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• Teva is a strong, international marketing partner

• Tev-Tropin® Tjet® (reusable) hGH

– Growing franchise for Teva, Tjet launched August 2009

– Antares receives strong margins on device sales, and mid

to high single digit % royalty on overall product sales

Teva and Antares: Our Broad Collaboration

Multiple agreements for diverse products with

nearly $3 billion in U.S. sales

• Two Vibex™ (auto injector, single shot disposables) products

– Filed with FDA

– Epinephrine (N.A. rights) & an undisclosed product (U.S rights)

– $250+ million markets

– Antares receives margins on device sales, and mid to high single digit % royalty on overall

product sales

• Two pen injectors (disposables) products – Global programs

– One Generic (ANDA) and One Branded (505B2) product - $1.5 Billion in current sales

– ANDA filing anticipated WITHIN 12-18 months

– 505B2 program has completed PK work

– Antares receives transfer price + margin on device sales, single digit to-mid teens % royalty

on overall product sales

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US Market

• Total US hGH market ~$1.3B

• Tev-Tropin® needle and syringe originally launched in 2005

• Tjet® needle-free injector launched Q3 2009, Tev-Tropin® market share has grown

approximately threefold in two years

• Tjet® provides product differentiation—patient-friendly needle-free injection

• Teva reports Tjet® contributing to new managed care formulary additions in 2011

EU Market

• European hGH market is approximately $500M

• Ferring’s Zomajet hGH sold more than $60M in 2010 (12% market share)

• Zomajet uses Antares’ needle free technology

• Product continues to grow after six years

Tev–Tropin® Prescriptions Growing Post Tjet® Launch

HGH market is a good model for describing future biosimilar market

dynamics: Product differentiation is essential for capturing share.

New Injectable Products Engine for Internal Development

~200

Compounds

Screened

>60

Feasible

Candidates

~30

Interesting

Product 2

MTX

Product 4 Product 3

Evaluation Criteria • Clinical and Patient Benefits

• Health Economic Benefits

• Development Feasibility

• Commercial Attractiveness

(e.g., concentrated market)

Preliminary

Assessment • Does candidate meet

key evaluation criteria?

Market and

Technical Input • Assess market acceptance of

product concept

• Determine specific

requirements for development

and approval

Development Program • Formalize the development &

commercialization plan

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Rheumatoid Arthritis – Market Overview

• RA is an autoimmune disorder that primarily affects the joints and occurs in

middle-aged women 3-5 times more frequently than in men

• RA affects about 2.1 million in US (1% of adult population) and 30-60% do not

tolerate oral methotrexate (MTX) which also shows variable absorption

• Most patients experience a chronic, fluctuating course of disease that, despite

therapy, may result in progressive joint damage, deformity, and disability

• MTX is widely considered

the foundation of RA

treatment—used alone or in

combination with biologic agents

(e.g., Humira, Enbrel)

• ―The ultimate goals in managing

RA are to prevent or control joint damage

prevent loss of function,

and decrease pain.‖ (ACR)

• Concentrated prescribing base (3000 Prescribers)

• MTX Rx are growing

• Prescribers would like more injectable use

ACR: American College of Rheumatology

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Rheumatoid

Arthritis

(Late stage)

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• Clinical benefits

– Removes variable absorption of oral MTX

– Enables titration to higher dose

– Better efficacy vs. oral MTX

– Better tolerability vs. oral MTX

• Convenience

– 3-easy steps — easy to teach patients

– Hidden needle reduces patient apprehension, supports compliance

– Fast, complete and comfortable – Entire Injection process complete within

three seconds

• Safety & Security

– Avoids dosing errors and inadvertent exposure to cytotoxic agent

– Locking needle shield reduces risk of accidental needle sticks

The VIBEX™ MTX Advantage:

First MTX auto-injector for use at home

VIBEX MTX provides physicians and RA patients a practical

means for optimizing MTX performance prior to & in combination

with biologic drugs.

Recent clinical and pharmacoeconomic research

reinforces the role of MTX as first line DMARD

• Braun, et al (2008): Subcutaneous MTX (15 mg/wk) provided better efficacy than

oral MTX without a higher rate of adverse events. (N=375)

• Kremer, et al (2009): Switching from oral to SC MTX resulted in clinical

improvement explained by accumulation of long chain polyglutamated MTX

• Bakker, et al (2011): Switching from oral to SC MTX resulted in tight control of RA

in an additional 10% to 15% of patients, avoiding the use of a biologic in those

patients (N= 236)

• O’Dell, et al (2011): One-third of patients started on MTX alone had an "excellent"

response that persisted out to two years. Furthermore, patients who started on

MTX had radiographic evidence of disease control similar to those starting on MTX

plus a biologic agent. N=766)

• Schipper, et al (2011): Pharmacoeconomic evaluation of costs and efficacy of

starting patients on MTX-alone vs. MTX plus anti-TNF in early RA results in similar

remission rates, favoring an MTX-alone approach.

• Fitzpatrick, et al (2011): In a study of resource utilization in RA management, the

authors conclude, “…there is clear evidence that SC MTX, certainly from a cost

perspective, is definitely worthwhile because it reduces cost of treatment without

compromising patient care.”

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The First MTX auto-injector

for RA

• Highly reproducible PK data and

injection site tolerability in preclinical

study

• Clinical trial completed in Q3 2011

with positive results

• Meeting with FDA in 4Q confirmed

and clarified regulatory pathway for

NDA filing

• Independent market research with

nearly 200 rheumatologists indicates

VIBEX™ MTX will address a

significant unmet need

• Novel and proprietary product with

new IP

VIBEX™ MTX For Rheumatoid Arthritis

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Advanced Transdermal Gel Portfolio

Anturol®

FDA Approved and Commercialized Delivery

Technology

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Overactive Bladder Market Overview (OAB)

Affects an estimated

16% of mature

Western population –

90% of patients are

women.

Sources: IMS Heath National Sales Perspective, Cowen & Co. Therapeutic Categories Report, March 2010.

$5.3

$8.3

$51.8

$72.1

$83.4

$191.7

$268.3

$523.1

$856.2

Generic Trospium

Ditropan / XL

Gelnique/Oxytrol

Toviaz

Sanctura /XR

Generic Oxybutynin

Enablex

Vesicare

Detrol /LA

2010 U.S. OAB Market

($ millions)

• U.S. OAB market was $2.1

billion in 2010 and projected to

be greater than $2.3 billion in

2014

• 18.4 MM TRX (oxybutynin 37%)

• Major AEs for OAB drugs

include dry mouth and

constipation resulting in poor

compliance

• Unmet market need for an

efficacious product with low side

effects profile

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• Antares’ once-daily transdermal treatment for OAB

• Gel dries quickly and clearly in less than 2 minutes, leaving

no odor or residue feel

• NDA Approved –December 7, 2011

Oxybutynin Gel: Partnered with Watson Pharmaceuticals

Approved by FDA – Launch in 2012

• Exclusive licensing agreement with Watson (US and

Canada)

• Anticipated launch in H1 2012

• Strategic acquisition for Watson—extends, protects, and

expands their OAB product portfolio—with strong IP

protection

• Watson will own the transdermal OAB segment

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Elestrin®: Partnered with Jazz (Azur) Pharma

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Nestragel™ Development Program

• Indication: contraception

• Successful Phase 2 Trial:

• suppressed ovulation (given for 21 days)

• well tolerated with no serious adverse events reported and no skin irritation

• Nestorone® has no androgenic effects but is not orally active–ideally

suited to gel administration

• Formulation and active drugs are designed to reduce adverse events

− 31% of women discontinue oral contraceptives use after 6 months, and 44%

within 12 months*

• Seeking a development & commercialization partner

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Financial Overview

• Cash position

As of September 30th 2011 cash and

cash equivalents of $32.2 million

No debt

• Growing revenue base

2008 total revenues were $4.6 million

2009 total revenues of $8.3 million (47% over 2008)

2010 Revenues $12.8 million (54% over 2009)

2011 YTD revenues $11.0 million (41% increase over 2010 YTD)

• Reducing burn rate

Cash burn in 2010 was approximately $3.7 million

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Potential Milestones for next 12-18 months

• Anturol launched by Watson

• Teva epinephrine product commercialized

• 2nd Teva auto-injector product approved

and launched

• Other Teva programs advance including first

pen product filed (ANDA)

• VIBEX MTX NDA filed

• VIBEX MTX partnership in Europe

• New VIBEX QS pipeline product development program initiated

Paul K. Wotton, Ph.D.

President and Chief Executive Officer

December 2011

AMEX: AIS