Investor presentation september_2011_
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Transcript of Investor presentation september_2011_
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This presentation may contain forward-looking statements which are made pursuant to the safeharbor provisions of Section 21E of the Securities Exchange Act of 1934 and the Private SecuritiesLitigation Reform Act of 1995. Investors are cautioned that statements which are not strictlyhistorical statements, including, without limitation, statements regarding the plans, objectives andfuture financial performance of Antares Pharma, constitute forward-looking statements which involverisks and uncertainties. The Company’s actual results may differ materially from those anticipated inthese forward-looking statements based upon a number of factors, including anticipated operatinglosses, uncertainties associated with research, development, testing and related regulatoryapprovals, unproven markets, future capital needs and uncertainty of additional financing,competition, uncertainties associated with intellectual property, complex manufacturing, high qualityrequirements, dependence on third-party manufacturers, suppliers and collaborators, lack of salesand marketing experience, loss of key personnel, uncertainties associated with market acceptanceand adequacy of reimbursement, technological change, and government regulation. For a moredetailed description of the risk factors associated with the Company, please refer to the Company’speriodic reports filed with the U.S. Securities and Exchange Commission from time to time, includingits Annual Report on Form 10-K for the year ended December 31, 2010. Undue reliance should notbe 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 thispresentation.
Safe Harbor Statement
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Investment Highlights
• Two programs approved, three on file with the FDA, and five in advanced
development
• Leader in fast growing self administered injection technology with one
product marketed (Tjet for Human Growth Hormone)
• Growing revenues from product sales
• Broad multi-product partnership with Teva
• Proprietary VIBEX MTX successfully completed clinic al trial, NDA
targeted for 2012
• Anturol for overactive bladder: NDA Filed in 2010 a nd partnered with
Watson Pharmaceuticals
• Two LibiGel Phase 3 efficacy trials completed enrol lment, safety trials
near completion
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INJECTABLE PRODUCTS
INDICATION PRECLINICAL CLINICAL FILED MARKETED PARTNER
Tjet®/Zomajet® HGH
TEVA -USFerring – EUJCR - Japan
Vibex TM 1 Epinephrine Filed ANDA TEVA
Vibex TM 2 Undisclosed Filed ANDA TEVA
Pen 1 Undisclosed ANDA TEVA
Pen 2 UndisclosedNDA
TEVA
Vibex TM MTX AutoimmuneDiseases NDA
ANTARES
INDICATION PRE-CLINICAL
PHASE 1 FILED MARKETED PARTNER
Elestrin® Menopause Azur (US)
Anturol® OAB Filed NDA Watson (US)
LibiGel® FSDBioSante (US)
Antares (ROW)
NestraGel TM Contraceptive Population Council
wedDiverse and Advanced Product Pipeline
PHASE 2 PHASE 3GEL PRODUCTS
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• Significant market opportunity
– More than $25 Billion in products potentially compatible with our devices
• Our market research:
– 25/25 pharmaceutical and biotechnology companies surveyed expect growth in the area
• Future growth driven by several factors:
– Patent expirations of parenterals
� Opportunity for 505(b)2 product differentiation
� Life cycle management
– Move to self-injection – Patients – The Key Driver
– Growth of biologics market
� Follow-on biologics
� Bio Betters requiring delivery technology for patient acceptance
Growth Opportunities for Self Injection Products
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Key Advantages:• Ease of use• Rapid injection• Promotes compliance• Minimal sharps disposal
• High-quality subcutaneous injection
• Potential for multi-use• Excellent reliability
Antares Injectors Deliver Solutions
Disposable Auto Injectors (Vibex™)
Pen Injectors
Reusable Needle-Free Injectors
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• Strong, international marketing partner
– Top-seller of injectables with more than 125 products marketed worldwide
• Tev-Tropin ® Tjet® (reusable) hGH
– Growing franchise for Teva
– U.S. rights, over $1 billion market, launched August 2009, device sales with strong margins, royalty on product sales - mid to high single digit %
• Two Vibex™ (auto injector, single shot disposables) products
– Filed with FDA
– Epinephrine (N.A. rights) & an undisclosed product (U.S rights)
– $250+ million markets
– Device sales with strong margins, royalty on product sales – mid-to-high single digit %
• Two pen injectors (disposables) products – Global pr ograms
– One Generic (ANDA) and One Branded (505B2) product - $1.5 Billion in sales today
– ANDA filing anticipated in 2012.
– Branded program has completed PK work
– Transfer price plus margin on device sales, royalty on product sales - high single digit-to-mid teens percentage
Teva and Antares: Our Broad Collaboration
Multiple agreements for diverse products with nearl y $3 billion in U.S. sales
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US Market
• Total US hGH market ~$1.3B
• Tev-Tropin® originally launched in 2005
• Tev-Tropin® using Tjet® launched Q3 2009 and resultant market share has grown form 2% to 5%
• Patient friendly needle free injection provides product differentiation
• Market share growing with new managed care wins in 2011
EU Market
• European hGH market is approximately $500M
• Ferring’s Zomajet hGH sold more than $60M in 2010 (12% market share)
• Ferring uses Antares’ needle free technology
Tev–Tropin ® Prescriptions Growing Post Tjet ® Launch
New Injectable Products Engine for Internal Develop ment
~200Compounds
Screened
>60Feasible
Candidates
~30Interesting
Product 2
MTX
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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Rheumatoid Arthritis – Market Overview
• RA is an autoimmune disorder that primarily affects the joints and occurs in middle-aged women 3-5 times more frequently than in men
• RA affects about 2.1 million in US (1% of adult population) and 30-60% do not tolerate oral Methotrexate (MTX) which also shows variable absorption
• Most patients experience a chronic, fluctuating course of disease that, despite therapy, may result in progressive joint damage, deformity, and disability
• MTX is widely consideredthe foundation of RA
treatment—used alone or in combination with biologic agents (e.g., Humira, Enbrel)
• “The ultimate goals in managing RA are to prevent or control joint
• Concentrated prescribing base (3000 Prescribers)
• MTX Rx are growing
• Prescribers would like more injectable use
damage, prevent loss of function,and decrease pain.” (ACR)
ACR: American College of Rheumatology
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Rheumatoid
Arthritis(Late stage)
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• Clinical benefits– Removes variable absorption of oral MTX
– Enables higher dose titration
– 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
• Safety– Avoids dosing errors and inadvertent exposure to cytotoxic agent
– Locking needle shield reduces risk of accidental needle sticks
The VIBEX™ MTX Advantage
Braun, et al: Subcutaneous MTX provided better effic acy than oral MTX without a higher rate of adverse events .
• A large (N=375) 6-month, randomized, double-blind, controlled trial examining clinical efficacy and safety following oral and SC MTX (15 mg/wk) administration
• Significantly more patients administered SC MTX versus oral MTX, at the same dose, achieved greater ACR20 and ACR70 responses at Week 24
• The percentages of patients reporting adverse events and SAEs were similar
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Source: Braun J, et al, Comparison of the Clinical Efficacy and Safety of Subcutaneous Versus Oral Administration of Methotrexate in Patients With Active Rheumatoid Arthritis, Arthritis and Rheumatism, Vol. 58, No. 1, January 2008, pp 73–81
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The 1st MTX auto-injector for RA
• Demonstrated highly reproducible PK data and injection site tolerability in preclinical study
• Clinical trial initiated in Jan. 2011 and completed in Q3 2011 with positive results
• Anticipated NDA filing in 2012
• Projected launch in 2013
• Independent market research with nearly 200 rheumatologists indicates VIBEX™ MTX will address a significant unmet need
• Manufacturing partnership and license with Uman Pharma (Canada)
VIBEX™ MTX Status: First MTX auto-injector for RA for at home subcutaneous use
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Anturol ® : Overactive Bladder Market Overview (OAB)
• Affects an estimated 16% ofmature Western population –90% of patients are women
• U.S. OAB market was $2.1billion in 2010 and projectedto be greater than $2.3 billionin 2014
• 18.4 MM TRX (Oxybutynin37%)
• Major AEs for OAB drugsinclude dry mouth andconstipation resulting in poorcompliance
• Unmet market need for anefficacious product with lowside effects profile
Sources: IMS Heath National Sales Perspective, Cowen & Co. Therapeutic Categories Report, March 2010.
$5.3
$8.3
$51.8
$72.1
$83.4
$191.7
$268.3
$523.1
$856.2
Generic Trospium
Ditropan / XL
Gelnique/Oxytrol
Toviaz
Sanctura /XR
Generic Oxybutynin
Enablex
Vesicare
Detrol /LA
2010 U.S. OAB Market
($ millions)
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• First & Only Titratable Once-Daily Transdermal Trea tment for OAB• 2 pumps for 56mg dose or 3 pumps for 84mg dose
• Gel Dries Quickly and Clearly in less than 2 minute s, leaving no odor or residue feel
• Urge Incontinence Reduced by first week and sustain ed throughout 12-week study for both dosage strengths
• Good compliance
• Well-Tolerated by most patients
• Phase 3 trial met endpoints in July 2010, open labe l extension safety trial completed successfully
• PDUFA date –December 8, 2011
• Exclusive licensing agreement with Watson (US and C anada)
• Anticipated Launch in H1 2012
OAB Gel Partnership with Watson Pharmaceuticals
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• Indication: hypoactive sexual desire disorder (HSDD )in menopausal women
• Currently in Phase 3 testing
• Enrollment completed in two efficacy studies
• Physician survey shows significant unmet medical ne ed and market opportunity already exists
• BioSante reported favorable unblinded safety data on use of testosterone in women for FSD – over 2800 patient ye ars of data
• NDA filing planned for 2012
• Guidance from BioSante and Wall Street: $2B addres sable market
• Mid single digit royalty + 25% of all milestones
• Antares owns international licensing rights in sign ificant territories
LibiGel ® Phase 3 Program Partnered with BioSante
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• Indication: contraception
• Featured Extensively in Media - October 2010
• Successfully completed Phase 2 Trial (three separate doses givenfor 21 days) induced ovulation suppression
• Product well tolerated with no serious adverse even ts reported and no instances of skin irritation
• Nestorone ® has no androgenic effects but is not orally active – ideally suited to gel administration
• Potentially attractive contraceptive option as both the formulation and active drugs are designed to reduce adverse events which can lead to discontinuation with other forms of reversible cont raceptive products
− 31% of women discontinue oral contraceptives use af ter 6 months, and 44% within 12 months*
• Looking for a partner for pivotal trials
NestraGel™: Partnered with the Population Council
**National Survey of Family Growth, CDC
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Financial Overview
• Cash position
� As of June 30th 2011, cash /cash equivalents of $33.3 million
� No debt
• Growing revenue base
� 2008 total revenues were $4.6 million
� 2009 total revenues of $8.3 million (47% over 2008)
� 2010 Revenues $12.8 million (54% over 2009)
� Q2 YTD 2011 Revenues $7.1million (Product revenues up 46%)
• Reducing burn rate
� Cash burn in 2010 was approximately $3.7 million
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Potential Milestones for Next 12-18 Months
� Anturol approved, launched by Watson
� Teva Epinephrine project approved and launched
� 2nd Teva auto-injection project approved and launched
� Other Teva programs advance including first Pen Pro gram Filing (ANDA)
� LibiGel approved and launched
� Methotrexate NDA filed in US, Canada and Europe
� Methotrexate partnership in Europe
� Company cash flow positive