Antares presentation -_september_2013

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Antares Pharma, Inc. Princeton South Corporate Center 100 Princeton South, Suite 300 Ewing, NJ 08628 NASDAQ : ATRS Paul

Transcript of Antares presentation -_september_2013

Page 1: Antares presentation -_september_2013

Antares Pharma, Inc. Princeton South Corporate Center

100 Princeton South, Suite 300 Ewing, NJ 08628 NASDAQ : ATRS

Paul

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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

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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)

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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

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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

19 Confidential

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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

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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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