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Paul K. Wotton, Ph.D. President and Chief Executive Officer July 2011 AMEX: AIS
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Page 1: Investor presentation july_2011_final

Paul K. Wotton, Ph.D.President and Chief Executive Officer

July 2011

AMEX: AIS

Page 2: Investor presentation july_2011_final

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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 inthese 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

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Investment Highlights

• Two programs approved, three on file with the FDA, and five in advanced

development

• Leader in fast growing self administered injection technology with one

product marketed (Tjet for Human Growth Hormone)

• Growing revenues from product sales and royalties u p 54% over 2009

• Broad multi-product partnership with Teva

• Proprietary VIBEX MTX in clinical trial, NDA target ed for 2012

• Anturol for overactive bladder: NDA Filed in 2010 a nd partnered with

Watson Pharmaceuticals

• Two LibiGel Phase 3 efficacy trials completed enrol lment, safety trials

near completion

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Advanced Product Portfolio based on Strong IP

Self Injector Products ATD Gel Products

Anturol ®

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INJECTABLE PRODUCTS

INDICATION PRECLINICAL CLINICAL FILED MARKETED PARTNER

Tjet®/Zomajet® HGH

TEVA -USFerring – EUJCR - Japan

Vibex TM 1 Epinephrine Filed ANDA TEVA

Vibex TM 2 Undisclosed Filed ANDA TEVA

Pen 1 Undisclosed ANDA TEVA

Pen 2 UndisclosedNDA

TEVA

Vibex TM MTX AutoimmuneDiseases NDA

ANTARES

INDICATION PRE-CLINICAL

PHASE 1 FILED MARKETED PARTNER

Elestrin® Menopause Azur (US)

Anturol® OAB Filed NDA Watson (US)

LibiGel® FSDBioSante (US)

Antares (ROW)

NestraGel TM Contraceptive Population Council

wedDiverse and Advanced Product Pipeline

PHASE 2 PHASE 3GEL PRODUCTS

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VIBEX™

VIBEX™ MTX

Pens

Zomajet®

Injection Portfolio

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• Significant market opportunity

– More than $25 Billion in products potentially compatible with our devices

• Our market research:

– 25/25 pharmaceutical and biotechnology companies surveyed expectgrowth in the area

• Future growth driven by several factors:

– Patent expirations of parenterals

� Opportunity for 505(b)2 product differentiation

� Life cycle management

– Move to self-injection – Patients – The Key Driver

– Growth of biologics market

� Follow-on biologics

� Bio Betters requiring delivery technology for patient acceptance

Growth Opportunities for Self Injection Products

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Key Advantages:• Ease of use• Rapid injection• Promotes compliance• Minimal sharps disposal

• High-quality subcutaneous injection

• Potential for multi-use• Excellent reliability

Antares Injectors Deliver Solutions

Disposable Auto Injectors (Vibex™)

Pen Injectors

Reusable Needle-Free Injectors

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• Strong, international marketing partner

– Top-seller of injectables with more than 125 products marketed worldwide

• Tev-Tropin ® Tjet® (reusable) hGH

– Approved

– U.S. rights, over $1 billion market, launched August 2009, device sales with strong margins, royalty on product sales - mid to high single digit %

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

– Filed with FDA

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

– $250+ million markets

– Device sales with strong margins, royalty on product sales – mid-to-high single digit %

• Two pen injectors (disposables) products – Global pr ograms

– One Generic and One Branded (505B2) product - ANDA filing anticipated in Q1 2012. Branded program has completed PK work $1.5 billion market for both products

– Transfer price plus margin on device sales, royalty on product sales - high single digit-to-mid teens percentage

Teva and Antares: Our Broad Collaboration

Multiple agreements for diverse products with nearl y $3 billion in U.S. sales

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US Market

• Total US hGH market ~$1.3B

• Tev-Tropin® originally launched in 2005

• Tev-Tropin® using Tjet® launched Q3 2009 and market share has increased to 5%

• Patient friendly needle free injection provides product differentiation

• Market share growing with new managed care wins in 2011

EU Market

• European hGH market is approximately $500M

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

• Ferring uses Antares’ needle free technology

Tev–Tropin ® Prescriptions Growing Post Tjet ® Launch

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New Injectable Products Engine for Internal Develop ment

~200Compounds

Screened

>60Feasible

Candidates

~30Interesting

Product 2

MTX

Product 4Product 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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Page 12: Investor presentation july_2011_final

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 consideredthe 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

• Concentrated prescribing base (3000 Prescribers)

• MTX Rx are growing

• Prescribers would like more injectable use

damage, prevent loss of function,and decrease pain.” (ACR)

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 higher dose titration

– 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

• Safety– Avoids dosing errors and inadvertent exposure to cytotoxic agent

– Locking needle shield reduces risk of accidental needle sticks

The VIBEX™ MTX Advantage

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Braun, et al: Subcutaneous MTX provided better effic acy than oral MTX without a higher rate of adverse events .

• A large (N=375) 6-month, randomized, double-blind, controlled trial examining clinical efficacy and safety following oral and SC MTX (15 mg/wk) administration

• Significantly more patients administered SC MTX versus oral MTX, at the same dose, achieved greater ACR20 and ACR70 responses at Week 24

• The percentages of patients reporting adverse events and SAEs were similar

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Source: Braun J, et al, Comparison of the Clinical Efficacy and Safety of Subcutaneous Versus Oral Administration of Methotrexate in Patients With Active Rheumatoid Arthritis, Arthritis and Rheumatism, Vol. 58, No. 1, January 2008, pp 73–81

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The 1st MTX auto-injector for RA

• Demonstrated highly reproducible PK data and injection site tolerability in preclinical study

• Clinical trial initiated in Jan. 2011 and will complete in Q3 2011

• Anticipated NDA filing in H1 2012

• Projected launch in H1 2013

• Independent market research with nearly 200 rheumatologists indicates VIBEX™ MTX will address a significant unmet need

• Manufacturing partnership and license with Uman Pharma (Canada)

VIBEX™ MTX Status: First MTX auto-injector for RA for at home subcutaneous use

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Commercial/Advanced Transdermal Gel Portfolio

Anturol ®

FDA Approved Delivery Technology

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Anturol ® : Overactive Bladder Market Overview (OAB)

• Affects an estimated 16% of mature Western population –90% of patients are women

• 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

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)

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• First & Only Titratable Once-Daily Transdermal Trea tment for OAB• 2 pumps for 56mg dose or 3 pumps for 84mg dose

• Gel Dries Quickly and Clearly in less than 2 minute s, leaving no odor or residue feel

• Urge Incontinence Reduced by first week and sustain ed throughout 12-week study for both dosage strengths

• Good compliance

• Well-Tolerated by most patients

• Phase 3 trial met endpoints in July 2010, open labe l extension safety trial completed successfully

• PDUFA date –December 8, 2011

• Exclusive licensing agreement with Watson (US and C anada)

• Anticipated Launch in H1 2012

OAB Gel Partnership with Watson Pharmaceuticals

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• Indication: hypoactive sexual desire disorder (HSDD )in menopausal women

• Currently in Phase 3 testing

• Enrollment completed in two efficacy studies

• Physician survey shows significant unmet medical ne ed and market opportunity already exists

• BioSante reported favorable unblinded safety data on use of testosterone in women for FSD – over 2800 patient ye ars of data

• NDA filing planned for H1 2012

• Guidance from BioSante and Wall Street: $2B addres sable market

• Mid single digit royalty + 25% of all milestones

• Antares owns international licensing rights in sign ificant territories

LibiGel ® Phase 3 Program Partnered with BioSante

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Elestrin® : Convenient, Flexible Dosing, Effective

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• Indication: contraception

• Featured Extensively in Media - October 2010

• Successfully completed Phase 2 Trial (three separate doses givenfor 21 days) induced ovulation suppression

• Product well tolerated with no serious adverse even ts reported and no instances of skin irritation

• Nestorone ® has no androgenic effects but is not orally active – ideally suited to gel administration

• Potentially attractive contraceptive option as both the formulation and active drugs are designed to reduce adverse events which can lead to discontinuation with other forms of reversible cont raceptive products

− 31% of women discontinue oral contraceptives use af ter 6 months,and 44% within 12 months*

• Looking for a partner for pivotal trials

NestraGel™: Partnered with the Population Council

**National Survey of Family Growth, CDC

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Financial Overview

• Cash position

� As of March 31st 2011, cash /cash equivalents of $13.1 million

� Balance sheet strengthened in May 2011 with $23 million financing

• 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)

� Q1 2011 Revenues $3.6 million

• Reducing burn rate

� Cash burn in 2010 was approximately $3.7 million

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Potential Milestones for Next 12-18 Months

� Teva Epinephrine project approved and launched

� 2nd Teva auto-injection project approved and launched

� Other Teva programs advance including first Pen Pro gram Filing (ANDA)

� Anturol approved, launched by Watson

� LibiGel approved and launched

� Methotrexate NDA filed in US, Canada and Europe

� Methotrexate partnership in Europe

� Company cash flow positive

Page 24: Investor presentation july_2011_final

Paul K. Wotton, Ph.D.President and Chief Executive Officer

July 2011

AMEX: AIS