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

Transcription

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

2 Safe Harbor Statement 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 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, Undue reliance should not be placed on any forwardlooking 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. 2

3 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. 3

4 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 Gelnique 3% NDA approved and partnered with Watson Pharmaceuticals Launched April 26, 2012 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

5 Financial Overview Cash Position As of March 31 st 2012 cash and investments of $33.2 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) Q112 total revenues $6.9 million 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

6 Market Cap Progression 6

7 Diverse and Advanced Product Pipeline PARTNER TEVA US Ferring EU JCR Japan PRODUCT PRECLINICAL CLINICAL FILED APPROVED MARKETED TevTropin / Zomajet Jazz (US) Watson (US) Daewoong (SK) Elestrin Gelnique 3% TEVA Vibex EPI Filed ANDA TEVA Vibex 2 Filed ANDA ANTARES Vibex MTX NDA ANTARES Vibex QS T NDA TEVA Pen 1 ANDA TEVA Population Council Pfizer Pen 2 NestraGel Undisclosed NDA NDA NDA 7

8 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. 8

9 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 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 Reusable Needle-Free Injectors Multiple use Injectors for subcutaneous delivery 9

10 Teva and Antares: Our Broad Collaboration Multiple agreements for diverse products with nearly $3 billion in U.S. sales 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 litigation settled launch June 2015 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 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 10

11 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 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 11

12 New Injectable Products Engine for Internal Development Evaluation Criteria Clinical and Patient Benefits Health Economic Benefits Development Feasibility Commercial Attractiveness (e.g., concentrated market) Product 3 ~200 Compounds Screened >60 Feasible Candidates ~30 Interesting Testosterone Product 4 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 MTX 12

13 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 and in combination with biologic drugs. 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 13

14 VIBEX MTX For Rheumatoid Arthritis Highly reproducible PK data and injection site tolerability in preclinical study Clinical trial completed in Q 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 have said they would like more injectable MTX Novel and proprietary product with new IP The First MTX Auto-Injector for RA 14

15 The VIBEX QS T for Testosterone Replacement Therapy (TRT) Potentially the first self-injectable testosterone product for men suffering from symptomatic testosterone deficiency (Low T) Rx s for current treatment options equal two-thirds topical gel testosterone and one third intramuscular injections, and according to recent reports, U.S. sales of testosterone replacement therapies exceeded $1.6 billion* in million Rx s Studies have shown that gel patients do not achieve adequate absorption or therapeutic response, injection patients bear the cost and inconvenience of in-office injections every 2 to 4 weeks Physicians surveyed believe self-injection will improve patient compliance and deliver sufficient serum testosterone levels The New VIBEX QS is particularly well-suited for use with highly viscous drugs such as testosterone Novel spring mechanism up to a 1 ml capacity highly compact device This combination drug/device product is in pre-clinical development, expected to go to market in 2016 * Bloomberg 15

16 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 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 16

17 Biosimilars: Significant Long-Term Growth Opportunities for Self-Injection Products 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 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 17

18 Biosimilar Targets Exceeding $1 Billion Global Sales 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). 18

19 Advanced Transdermal Gel Portfolio FDA Approved and Commercialized Delivery Technology 19

20 Gelnique 3% : Partnered with Watson Pharma in N.A. Approved by FDA Launched April 26, 2012 Antares once-daily transdermal treatment for OAB Gelnique 3% Gel dries quickly and clearly in less than 2 minutes, leaving no odor or residue feel 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 Gelnique 3% and Watson s current Gelnique product Unmet market need for an efficacious product with a low side effect profile 20

21 Elestrin : Partnered with Jazz Pharma 21

22 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 22

23 Potential Milestones for Next Months Gelnique 3% launched by Watson in April first royalty payment from the Gelnique franchise due in Q3 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 Testosterone Advance partnership discussions for NestraGel Confirm two additional pipeline products for development 23

24 Antares Pharma, Inc. Princeton South Corporate Center 100 Charles Ewing Boulevard, Suite 300 Ewing, NJ Tel.: Investor Relations: