Investor presentation -_february_2012

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Paul K. Wotton, Ph.D. President and Chief Executive Officer February 2012 AMEX: AIS

Transcript of Investor presentation -_february_2012

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

February 2012

AMEX: AIS

This presentation may contain forward-looking statements which are made pursuant to the safe harborprovisions of Section 21E of the Securities Exchange Act of 1934 and the Private Securities LitigationReform Act of 1995. Investors are cautioned that statements which are not strictly historicalstatements, including, without limitation, statements regarding the plans, objectives and future financialperformance of Antares Pharma, constitute forward-looking statements which involve risks anduncertainties. The Company’s actual results may differ materially from those anticipated in theseforward-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 marketingexperience, loss of key personnel, uncertainties associated with market acceptance and adequacy ofreimbursement, technological change, and government regulation. For a more detailed description ofthe risk factors associated with the Company, please refer to the Company’s periodic reports filed withthe U.S. Securities and Exchange Commission from time to time, including its Annual Report on Form10-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 noobligation to update any forward-looking information contained in this presentation.

Safe Harbor Statement

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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 advancedproduct pipeline and multiple shots on goal

• Three products approved, two on file with the FDA, andfive in advanced development

• Leader in fast-growing self-administered injectiontechnology

• 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.

NestraGel TM Contraception Population Council

NDA

Vibex TM EPI AllergicEmergency

Filed ANDA TEVA

Vibex TM 2 Undisclosed Filed ANDA TEVA

Pen 2 Undisclosed NDA TEVA

Vibex TM MTXRheumatoid

ArthritisNDA ANTARES

Pen 1 Undisclosed ANDA TEVA

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PRODUCT INDICATION PRECLINICAL CLINICAL FILED MARKETED PARTNER

Tjet®/Zomajet®

HGH Deficiency

TEVA –US Ferring – EUJCR –Japan

Elestrin® Menopause Jazz (US)

Diverse and Advanced Product Pipeline

Oxybutynin 3% Gel (Anturol®)

OABNDAApproved

Watson (US)Daewoong (SK)

Undisclosed Undisclosed PfizerNDA

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 PortfolioHigh 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 biologicproducts

Pen InjectorsMultidose pensDesigned for new cartridgetechnology

Reusable Needle-Free InjectorsMultiple use Injectors forsubcutaneous 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/biobettermarket will be significant, between $2-3 billion by 2015

• 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

Biosimilars: Significant Growth Opportunities for Self-Injection Products

Biosimilar Targets Exceeding $1 Billion Global Sale s

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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

• 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 % royaltyon overall product sales

Teva and Antares: Our Broad Collaboration

Multiple agreements for diverse products with nearly $3 billion in U.S. 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 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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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 ofRA 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 decreasepain.” (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

• Exclusive licensing agreements with Watson (US and Canada) and Daewoong (South Korea)

• 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

Oxybutynin Gel: Partnered with Watson Pharma in U.S .Approved by FDA – Launch in 2012

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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 and commercialization partner

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Financial Overview

• Cash Position

� As of September 30th 2011 cash andcash 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

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 firstpen product filed (ANDA)

• VIBEX MTX NDA filed

• VIBEX MTX partnership in Europe

• New VIBEX QS pipeline product development program initiated

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

February 2012

AMEX: AIS