Download - Investor presentation april_2012-1
Paul Wotton Ph.D.President and Chief Executive Officer
April 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, 2011. 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
• Antares is a fast growing Pharmaceutical Company and the ONLY US-based company offering auto-injector, pen and needle-free technology platforms.
• 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 transdermal gel business has yielded two FDA approved products and one in development.
• Our self-injection business has yielded one FDA approved product, a deep pipeline with several products in development, some of which we may elect to market ourselves.
• Our market research demonstrates our greatest opportunity and ROI exists in the rapidly growing markets for self-injection products.
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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
• Recognized leader in fast-growing self-administered injection technology
• Proprietary VIBEX MTX successfully completed clinical trial
• Anturol Gel NDA approved and partnered with Watson Pharmaceuticals
• Broad multi-product partnership with Teva
• HGH Needle free product commercialized in Europe and US
• Growing intellectual property portfolio
• Multiple partnerships with leading companies – Pfizer, Teva, Watson and Ferring 4
Financial Overview
• Cash Position
� As of December 31st 2011 cash and investments of $34.4 million
� No debt
• Growing Revenue Base
� 2008 total revenues $4.6 million
� 2009 total revenues $8.3 million (47% over 2008)
� 2010 total revenues $12.8 million (54% over 2009)
� 2011 total revenues $16.5 million (28% over 2010)
� 2012 revenue expected to grow 30% – 50%
• Reducing Burn Rate
� Operating Cash burn in 2011 was approximately $1.9 million vs. $6.1 million in 2010
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Market Cap Progression
0
100
200
300
400
2008 2009 2010 2011 Current
$25
$93
$143
$228
>$300
Mar
ket C
ap in
Mill
ions
Year End Market Cap
Diverse and Advanced Product Pipeline
PRODUCT PRECLINICAL CLINICAL FILED MARKETEDPARTNER APPROVED
TEVA – US Ferring – EUJCR – Japan
Jazz (US)
Watson (US)Daewoong
(SK)
TEVA
TEVA
ANTARES
ANTARES
TEVA
TEVA
Population Council
Pfizer
TevTropin ®/Zomajet ®
Elestrin ®
Anturol ®
Vibex™ EPI
Vibex™ 2
Vibex™ MTX
Vibex™ QS1
Pen 1
Pen 2
NestraGel™
Undisclosed
NDA Approved
Filed ANDA
Filed ANDA
NDA
ANDA
NDA
NDA
NDA
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Advanced Injectable Products Portfolio
• Our VIBEX-MTX program is designed to enhance the performance of MTX for patients who need and depend on it for their health and well-being 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.
• 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
• Our Injectable Products mission is to develop, produce and commercialize high quality self-injectable medicines that are accessible to all patients who need and depend on them for their health and well-being while optimizing the cost of healthcare .
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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 InjectorsMulti-dose pensDesigned for new cartridgetechnology
Reusable Needle-Free InjectorsMultiple use Injectors forsubcutaneous delivery
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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 pr ograms– 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
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New Injectable Products Engine for Internal Develop ment
~200Compounds
Screened
>60Feasible
Candidates
MTX
~30Interesting
Product 2
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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• 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 apractical means for optimizing MTX performance prior to and in
combination with biologic drugs.
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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 – 4Q11 FDA meeting confirmed regulatory pathway for NDA filing
• MTX Rx’s exceed 5 million and growing
• 30% – 60% of patients do not tolerate oral MTX
• Independent market research with nearly 200 rheumatologists indicates VIBEX™ MTX will address a significant unmet need – prescribers would like more injectable MTX
• Novel and proprietary product with new IP
VIBEX™ MTX For Rheumatoid Arthritis
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Novel Self-Injection Technology Vital to Biological and Biosimilar Commercial Success
• Differentiation is critical to successful commercialization
• Commercial strategies must includedevice improvements, and patientsupport
• Antares’ self-injection technology offersphysicians and patients enhancedperformance, safety and reliability
• Enabling self-injection – patient empowerment is a key driver
• The New VIBEX QS is particularly well-suited for use with biosimilarproducts
– 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 Long-Term Growth Opportunities for Self-Injection Products
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Biosimilar Targets Exceeding $1 Billion Global Sale s
Brand Global Peak Sales>$1 Billions
Enbrel $ 8.0
Humira $ 7.3
Lantus $ 5.1
Epogen/Procrit $ 5.1
Neulasta $ 4.2
Novolog $ 3.8
Aranesp $ 3.2
Avonex $ 2.6
Novolin $ 2.5
Humalog $ 2.2
PEGasys $ 2.0
Rebif $ 1.7
Neupogen $ 1.3
Betaseron $ 1.2
Humulin $ 1.1
Source: FDA, Thompson, Zachs, Bernstein estimates and analysis. Peak sales from analyst models (SCB or consensus, as available). 17
Advanced Transdermal Gel Portfolio
Anturol®
FDA Approved and Commercialized Delivery Technology
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• Antares’ once-daily transdermal treatment for OAB (Anturol®)
• Gel dries quickly and clearly in less than 2 minutes, leaving no odor or residue feel
• NDA Approved – December 7, 2011
• U.S. OAB market was $2.1 billion in 2010 and projected to be greater than $2.3 billion in 2014
• Strategic acquisition for Watson – extends, protects, and expands their OAB product portfolio – with strong IP protection
• Watson will own the transdermal OAB segment
• Sales based milestones – Royalties on combined sales of Anturol® and Watson’s Gelnique® product
• Unmet market need for an efficacious product with low side effect profile
Oxybutynin Gel: Partnered with Watson Pharma in U.S.Approved by FDA – Launch in 2Q12
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Elestrin ®: Partnered with Jazz (Azur) Pharma
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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Potential Milestones for Next 12-18 Months
• Anturol® launched by Watson
• VIBEX EPI and VIBEX 2 auto-injector products approved
• 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
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Antares Pharma, Inc.Princeton Crossroads Corporate Center
250 Phillips Blvd., Suite 290Ewing, NJ 08618
Tel.: 609.359.3020Fax: 609.359.3015
Investor Relations: 609.359.3020 ext. 133