Post on 07-Aug-2015
Antares Pharma, Inc. Princeton South Corporate Center
100 Princeton South, Suite 300 Ewing, NJ 08628 NASDAQ : ATRS
Paul
Our mission is to develop and commercialize self-administered parenteral medicines that optimize
clinical benefits with enhanced cost effective health outcomes
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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 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, 2012. 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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Antares Background
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Antares is a growing Specialty Pharmaceutical Company with a late stage 505(b)(2) pipeline of drug/device combination products
Significant clinical and regulatory expertise in proprietary drug/device combination products coupled with a comprehensive IP portfolio gives us a sustainable competitive advantage
Comprehensive IP portfolio covering injection technology platform including auto injector, pen injector and needle-free injector systems – 43 patents filed and 9 granted in the past 18 months
Internal wholly owned 505(b)(2) development programs include: OTREXUP™ – NDA submitted and accepted 02/26/13 – PDUFA 10/14/13 VIBEX QS T – entering the clinic in Q3 2013 New pipeline program – VIBEX QS M
Strong Partnership Experience with Leading Organizations Including: Pfizer, Actavis, Daewoong, Ferring and Meda Pharma providing pipeline diversity and income stream
Teva Partnership Covers 5 Products with nearly $3 billion in U.S. Sales
ATRS Technology Platform Built for Success Create Enhanced Products with Significant Sales Potential
Engineer Established Drugs for Clinical Advantage
Unique Technical Platform with IP Protection
Needle-free Multi-dose Pens Medi-Jet
505(b)(2) Pipeline
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Antares Pharma – 505(b)(2) Business Model
Novel route of administration
Enhanced Therapeutic
Value
Novel Device Platform
Identify unmet patient
need
Combine technology
with known
molecules
Specialty Target
Segment with Differentiated
Products
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Antares Therapeutic Product (ATP™) Strategy
Lower risk
Compressed development time – 2-3 years
Optimized clinical spend
Targeted commercial footprint
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Powerful Engine and Disciplined Process for Creating Novel Products
~200 Compounds
Screened
>60 Feasible
Candidates
OTREXUP™
~30 Interesting
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 QS T
QS M
Additional Drug Products
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Diverse and Advanced Product Pipeline PRODUCT PRECLINICAL CLINICAL FILED MARKETED PARTNER APPROVED
TEVA – US Ferring – EU JCR – Japan
TevTropin®/ Zomajet®
Meda (US) Elestrin®
Actavis (US) Daewoong (SK) Gelnique 3%™
TEVA Vibex™ EPI ANDA
TEVA Vibex™ Sumatriptan ANDA
TEVA Pen 1 ANDA
ANTARES (RA/Psoriasis) OTREXUP™ NDA
TEVA Pen 2 NDA Population
Council NestraGel™ NDA
Pfizer Undisclosed OTC Product NDA
ANTARES (TRT)
Vibex™ QS T NDA
TevTropin® 10mg TEVA – US SNDA
ANTARES (Neurology)
Vibex™ QS M NDA
Marketed Products
Pipeline Products
ATRS LONG TERM GOAL: LAUNCH AT
LEAST ONE PRODUCT PER YEAR
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A Compelling Opportunity First and only SC MTX product for self- administration Single use, once weekly disposable device Dosages: 10, 15, 20 and 25mg Convenience – easy to use even for RA patients with moderate to
severe hand impairment Virtually painless administration (dose volume always 400
microliters) Safety – avoid dosing errors and inadvertent exposure to cytotoxic
agent through accidental needle sticks OTREXUP™ addresses a large and growing RA and Psoriasis market 22% of patients discontinue oral treatment due to GI side effects
alone*
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OTREXUP™ Overview
*Decision Resources Group
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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)
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
Rheumatoid Arthritis (Late stage)
EULAR CONFERENCE – Madrid 2013
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Rheumatoid Arthritis: The Unmet Need
The Greatest Unmet Needs in Rheumatoid Arthritis Are :
Therapy with Better Efficacy
More Reasonably Priced Alternatives to Biologics
Subcutaneous Device for Methotrexate to provide Precise Dosing
Rheumatologists would consider using OTREXUP™ in patients needing ≥15 mg/week of oral MTX, likely because they recognize the benefit of using subcutaneous MTX at higher doses
“It is a safe device with easy administration. You don’t have to handle the needle, and getting the medication is easy too.” – US Rheumatologist speaking about OTREXUP™
Decision Resources Group Consulting
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Psoriasis
Psoriasis is a common chronic skin disorder affecting men and women equally beginning at any age between 20 and 30, or 50 and 60
Both topical and systemic therapies are available for the treatment of psoriasis
Mild-to-moderate skin disease can often be managed with topical agents while patients with severe disease potentially need systemic therapy with methotrexate
Methotrexate has been used successfully in the treatment of psoriasis for over 30 years and is usually administered in an intermittent regimen such as once weekly – similar regimens are currently in use in patients with RA – It is also highlighted as a therapeutic option after topical therapies and light therapy (where applicable)
According to the National Psoriasis Foundation, as many as 7.5 million Americans have psoriasis , and injectable MTX is recommended as part of treatment guidelines
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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
Alsufyani, et.al. – Journal of Rheumatology 2004 Jan;31(1):179-82 The role of subcutaneous administration of methotrexate in children with juvenile idiopathic arthritis who have failed oral methotrexate*
“Our results suggest that for patients failing oral MTX either because of inefficacy or toxicity, the use of SC MTX has a high likelihood of success with more than 70% of patients achieving clinically significant improvement, without clinically significant toxicity.”
16 *Division of Rheumatology, Department of Pediatrics, University of British Columbia, Vancouver, BC, Canada
MTX – Teaching an Established Drug New Tricks MTX Use Associated with a 70% Reduction in Mortality in RA Patients
Wasko, et.al. – Arthritis & Rheumatism Vol. 65, No. 2, February 2013 – pp 334-342
A study was conducted of 5,626 RA patients prospectively for 25 years to determine the risk of death associated with Methotrexate use
“In summary, we report the protective relationship between use of MTX and mortality in a large cohort of RA patients followed up prospectively for 25 years. These findings have implications for the use of MTX in the treatment of RA. Our results support the ongoing use of MTX as a cornerstone of RA treatment, with a survival benefit independent of its effects on pain and functional limitations. For patients in whom MTX monotherapy does not achieve complete control, add-on therapy may be more appropriate than switching to other medications, as MTX may still carry a survival benefit.”
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OTREXUP™ Commercial Team – Broad Healthcare and Rheumatology Experience
>100 Years of Combined Commercial Experience
Senior Vice President, Sales and Marketing LeRoux Jooste – Cephalon, Wyeth, Lilly – Launched Enbrel
26 years
Executive Director, Managed Markets (Wyeth) 40 years
Director of Marketing (UCB, BMS) 20 years
Director of Sales (Wyeth) 31 years
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Vibex QST – Optimizing TRT
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Explosive Annual Growth in Testosterone Prescriptions
0
1
2
3
4
5
6
2008 2009 2010 2011 2012
0.5 0.7
1.0
1.5
2.1
2.7 3.1
3.4
3.9
5.1
Pres
crip
tion
s in
Mil
lion
s
Year
Injectable Testosterone
Topical Testosterone
Source: Bloomberg/Wolters Kluwer Prescription Data
2.1
5.1
2012
In Millions
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VIBEX QS T – Testosterone Replacement Therapy (TRT) U.S. sales of testosterone replacement therapies exceeded $2.5 billion* in 2012 –
7.2 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 – clinical path forward agreed upon with agency
Expected to go to market in 2016
21 Sources: *Bloomberg **Global Industry Analysts
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
US with growing awareness Three-year development program to
NDA – Projected launch in 2016
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Powerful Engine and Disciplined Process for Creating Novel Products
~200 Compounds
Screened
>60 Feasible
Candidates
OTREXUP™
~30 Interesting
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 QS T
QS M
Additional Drug Products
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Potential Drug Product Combination/ Four Examples With a Combined Range of $250 - $500 Million in Revenues Glucagon for Hypoglycemic Rescue
Hypoglycemia can be an emergency situation where the time to receiving treatment is critical and the available care provider has limited or no formal training. The patient may or may not be able to self-administer a precise dose with currently available options. An auto-injector device that is easy to use increases speed and access to effective treatment. Any institution involved in caring for diabetic patients should make certain that all individuals (including family members) are trained and have ready access to a VIBEX-Glucagon device in the event of encountering a hypoglycemic emergency
Diazepam for Epileptic Seizures Cluster seizure, if not promptly resolved can result in status epilepticus and death. Effective treatment typically requires administration of diazepam or similar drug by injection or rectal gel – both for prompt onset and because the patient is unable to self-administer. A study comparing IV vs. IM administration by first responders favored IM primarily as a result of reducing the time to injecting. VIBEX Diazepam shortens the time to injection vs. IV or conventional needle and syringe dosed from vials. VIBEX Diazepam also enables minimally trained persons, e.g., parents or teachers, to administer rescue medicine to the patient prior to arrival of first responders
Currently available options are not quick
& easy to use
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Lovenox For Post Surgical Care Administered via Sub-Q injections to inpatient for prophylaxis of thromboembolic complications in patients undergoing surgical procedures, for treatment of DVT, and post-MI. Currently available in vials and PFS, an auto injector offers a precise, faster and more convenient administration option with potential for outpatient use.
Ketorolac for Short Term Moderate to Severe Pain NSAID Indicated for short term use (5 days) for moderate to severe pain that would otherwise require narcotic analgesia. Commonly used in institutional setting for post-surgical pain management. Demonstrated opioid-sparing effect. Can be administered via IM injections, IV, intranasally or orally.
Luitpold is marketing a ketorolac nasal spray to emergency departments as a non-narcotic alternative for pain management. An IM auto injector offers a fast and easy alternative, with precise dosing, to nasal spray or conventional injections from vials.
Currently available options are not quick
& easy to use
Potential Drug Product Combination/ Four Examples With a Combined Range of $250 - $500 Million in Revenues
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Financial Overview
Cash Position
As of June 30th 2013 cash and investments of $75 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)
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Priority Goals for Next 12-18 Months
• OTREXUP™ approval and launch
• VIBEX™ QS T (testosterone) to complete clinical studies
• VIBEX™ QS M to begin clinical studies
• Teva programs advance including both multi-dose pen products filed
• TevTropin® 10 mg approval and launch
• International OTREXUP™ partnership
• OTREXUP™ partnership - Psoriasis
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Antares Pharma, Inc. Princeton South Corporate Center
100 Princeton South, Suite 300 Ewing, NJ 08628 NASDAQ: ATRS
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