Antares Pharma, Inc. Princeton South Corporate Center 100 Princeton South, Suite 300 Ewing, NJ NASDAQ : ATRS. Paul

Transcription

1 Antares Pharma, Inc. Princeton South Corporate Center 100 Princeton South, Suite 300 Ewing, NJ NASDAQ : ATRS Paul

2 Antares Mission: To develop and commercialize self-administered parenteral medicines that optimize clinical benefits with enhanced cost effective health outcomes 2

3 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 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. 3

4 Antares Background Antares is a growing Specialty Pharmaceutical Company with a diverse late stage 505(b)(2) pipeline of drug/device combination products Significant and proven clinical and regulatory expertise in proprietary drug/device combination products Comprehensive IP portfolio covering injection technology platform including auto injector, pen injector and needle-free injector systems 43 patents filed and 10 granted in the past 18 months Strong Partnership Experience with Leading Organizations including: Pfizer, Leo, Actavis, Ferring and Meda Pharma providing pipeline diversity and income stream Teva Partnership Covers five (5) products with nearly $3 billion in U.S. Sales 4

5 Recent Events OTREXUP NDA approved October 11, 2013 for the treatment of rheumatoid arthritis, psoriasis and poly-articular juvenile rheumatoid arthritis OTREXUP Entered into an exclusive U.S. promotion and marketing agreement with LEO Pharma for psoriasis VIBEX QS T Initiated P2 study evaluating testosterone administered weekly by subcutaneous injection using the Quick Shot technology Enrollment completed 11/12/13 OTREXUP Presented data from Otrexup clinical studies at the annual ACR meeting in October OTREXUP & VIBEX QS T U.S. patent issued entitled Prefilled Syringe Jet Injector designed to protect the use of medicament containing prefilled syringe based auto injectors Appointed Dr. Bruce Freundlich as Senior Vice President, Medical Appointed David H. Bergstrom, PhD as Senior Vice President, Pharmaceutical Development Appointed Robert P Roche Jr. to the Board of Directors 5

6 ATRS Technology Platform Built for Success Create Enhanced Products with Significant Sales Potential 505(b)(2) Pipeline Engineer Established Drugs for Clinical Advantage Needle-free Medi-Jet Multi-dose Pens Unique Technical Platform with IP Protection 6

7 Antares Pharma 505(b)(2) Business Model Novel route of administration Identify unmet patient need Combine technology with known molecules Novel Device Platform Enhanced Therapeutic Value Specialty Target Segment with Differentiated Products 7

8 Powerful Engine and Disciplined Process for Creating Novel Products ~200 Compounds Screened Preliminary Assessment Does candidate meet key evaluation criteria? Evaluation Criteria Clinical and Patient Benefits Health Economic Benefits Development Feasibility Commercial Attractiveness (e.g., concentrated market) >60 Feasible Candidates ~30 Interesting Market and Technical Input Assess market acceptance of product concept Determine specific requirements for development and approval OTREXUP QS T QS M Development Program Formalize the development & commercialization plan Additional Drug Products 8

9 Advanced Product Pipeline PARTNER PRODUCT PRECLINICAL CLINICAL FILED APPROVED MARKETED TEVA US Ferring EU JCR Japan TevTropin / Zomajet Marketed Products Meda (US) Elestrin Actavis (US) Daewoong (SK) ANTARES ANTARES (TRT) ANTARES (Neurology) TEVA US Gelnique 3% OTREXUP Vibex QS T Vibex QS M TevTropin 10mg Pipeline Products NDA NDA SNDA TEVA Vibex EPI ANDA TEVA Vibex Sumatriptan TEVA Pen 1 ANDA ANDA TEVA Pen 2 NDA Population Council Pfizer NestraGel Branded OTC Gel Product NDA NDA 9

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11 A Compelling Opportunity OTREXUP Overview First and only FDA approved SC MTX product for self administration Single use, once weekly disposable device Dosages: 10, 15, 20 and 25mg Oral MTX may not always provide an adequate response due to lack of efficacy or poor tolerability and has GI absorption limitations OTREXUP (SC MTX) delivers greater bioavailability than oral MTX systemic exposure of MTX from OTREXUP at all doses (10, 15, 20, and 25mg) was higher than that of oral MTX Convenience easy to use even for RA patients with moderate to severe hand impairment Safety avoid dosing errors and inadvertent exposure to cytotoxic agent through accidental needle sticks OTREXUP addresses a large and growing RA and Psoriasis market Switching to OTREXUP may extend the use of MTX as well as potentially reduce overall cost of the RA treatment continuum 11

12 Rheumatoid Arthritis Market Overview RA is an autoimmune disorder and a life-altering disease that progressively causes destruction of the joints affecting the daily activities of patients In 2014, there will be ~2.4 million cases of RA in the US, of which ~60% will be drug treated* Approximately 1.4 million of these patients will suffer from moderate to severe RA* RA is expected to grow at a steady rate of 1.7% annually, with population growth and aging* MTX is the foundation of RA treatment used alone or in combination with biologic agents (e.g., Humira, Enbrel) Rheumatoid Arthritis (Late stage) Often biologics are added to MTX treatment, a practice which has been validated by the guidelines Extensive European head to head literature citing role of MTX as first line DMARD in treatment of RA *Decision Resources Group Consulting 12

13 OTREXUP In Dermatology LEO Pharma Exclusive U.S. promotion and marketing agreement with LEO Pharma for OTREXUP in dermatology LEO is a global leader in dermatology and topical treatments for psoriasis Antares to receive up to $20 million in milestone payments including an upfront payment of $5 million Antares will record all dermatology related product revenues LEO will be responsible for promotion and marketing activities in dermatology supported by a sales force of 75 representatives LEO has proven capabilities within life-cycle management focusing on innovative patient solutions in dermatology 13

14 OTREXUP Polyarticular Juvenile Arthritis Polyarticular Juvenile Arthritis refers to a form of juvenile arthritis that causes joint inflammation and stiffness for more than six weeks in children under 16 About 30% of all children with juvenile arthritis have polyarticular disease and girls are two times more likely to have the disease than boys Children with polyarticular juvenile arthritis are unlikely to outgrow the disease, therefore initial drug therapy should be aggressive in order to control the inflammatory process and relieve symptoms as quickly as possible It is rare for NSAIDS alone to control the inflammatory process of polyarticular disease methotrexate has been recognized as the standard therapy for children with this form of juvenile arthritis Otrexup label includes Juvenile Indication 80% of prescriptions in this area written by same physicians as for Adult RA 14

15 OTREXUP Launch Plan OTREXUP NDA approved October 2013 launch late January OTREXUP Commercial Team Broad Rheumatology expertise with over 100 years of combined commercial experience DMs, Sales Representatives and NAMs possess extensive experience in marketing rheumatoid arthritis drugs and will be Quintiles employees dedicated solely to the marketing of OTREXUP Six MSL s providing value proposition to Key Opinion Leaders in RA Feedback from AMCP validates pricing strategy $548 per Rx (4 weeks) Discussions with pharmacy and medical directors suggest initial tier 3 access with several plans already mentioning the possibility of tier 2 access Leo will launch to dermatologists with 75 Representatives bringing total number of OTREXUP sales personnel to over

16 Powerful Engine and Disciplined Process for Creating Novel Products ~200 Compounds Screened Preliminary Assessment Does candidate meet key evaluation criteria? Evaluation Criteria Clinical and Patient Benefits Health Economic Benefits Development Feasibility Commercial Attractiveness (e.g., concentrated market) >60 Feasible Candidates ~30 Interesting Market and Technical Input Assess market acceptance of product concept Determine specific requirements for development and approval OTREXUP QS T QS M Development Program Formalize the development & commercialization plan Additional Drug Products 16

17 VIBEX QS Testosterone First testosterone jet-injector for treatment of Low T Single use, disposable VIBEX QS device engineered to deliver high viscosity products through fine (27 gauge) needle with 1 ml capacity Quick, easy and painless less than 5 seconds to inject Once a week injection optimizes blood levels Peak: Trough ratio reduced compared to once or twice a month administration Many untreated Low-T patients in the U.S. with growing awareness Three-year development program to NDA Projected launch in

18 Explosive Annual Growth in Testosterone Prescriptions Prescriptions in Millions In Millions Injectable Testosterone Topical Testosterone Year Source: Bloomberg/Wolters Kluwer Prescription Data 18

19 VIBEX QS T Testosterone Replacement Therapy (TRT) U.S. sales of testosterone replacement therapies exceeded $2.5 billion* in million Rx s, growing at 20% annually and projected to exceed $5 Billion in 2017** Studies have shown that gel patients do not achieve adequate absorption or therapeutic response, injection patients bear the cost and inconvenience of in-office deep intramuscular injections every 2 to 4 weeks Physicians surveyed believe weekly self-injection will improve patient compliance and deliver optimized serum testosterone levels Self contained Auto-injector avoids the transference issues seen with Gels (Black Box) Pre-IND meeting held with FDA on 12/5/12 clinical path forward agreed upon with agency First patients dosed 9/16/ NDA filing on track Expected to go to market in 2016 Sources: *Bloomberg **Global Industry Analysts 19

20 Cash Position Financial Overview As of September 30 th 2013 cash and investments of $70 million 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 total revenues $22.6 million (37% over 2011) 20

21 Priority Goals for Next Months OTREXUP partnership Completed OTREXUP launch in Q for RA and Psoriasis (LEO) VIBEX QS T (testosterone) will complete clinical studies VIBEX QS M to begin clinical studies Teva programs two multi-dose pen products filed TevTropin 10 mg approval and launch 21

22 Antares Pharma, Inc. Princeton South Corporate Center 100 Princeton South, Suite 300 Ewing, NJ NASDAQ: ATRS 22