Paul K. Wotton, Ph.D. President and Chief Executive Officer March 2011 AMEX: AIS
Aug 14, 2015
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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, 2009. 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
• Leader in fast growing self administered injection technology with one
product marketed (Tjet for Human Growth Hormone)
• Growing revenues from product sales and royalties up 54% over 2009
• Diverse portfolio of marketed and late-stage products
• Anturol for overactive bladder: NDA Filed in 2010 and fully owned
• Proprietary VIBEX MTX in clinical trial, expect rapid path forward with
NDA targeted for 2012
• Broad multi product partnership with Teva
• One of two Libigel Phase 3 efficacy trials completed enrollment
• Decreasing cash burn - More than one year’s cash on hand
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Advanced Product Portfolio based on Strong IP
Self Injector Products ATD Gel Products
Anturol®
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INJECTABLE PRODUCTS
INDICATION PRECLINICAL CLINICAL APPROVAL MARKETED PARTNER
Tjet®/Zomajet®
HGH TEVA -USFerring – EUJCR - Japan
VibexTM 1 Epinephrine Filed ANDA TEVA
VibexTM 2 Undisclosed Filed ANDA TEVA
Pen 1 Undisclosed ANDA TEVA
Pen 2 Undisclosed NDA TEVA
VibexTM MTX AutoimmuneDiseases
NDA ANTARES
GEL PRODUCTS
INDICATION PRECLINICAL CLINICAL APPROVAL MARKETED PARTNER
Elestrin® Menopause Azur (US)
Anturol® OAB Filed NDA TBD
LibiGel® FSD NDA BioSante (US)
NestraGelTM Contraceptive NDA Population Council
wedDiverse and Advanced Product Pipeline
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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 marketFollow-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– 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 – 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– Undisclosed products, NA, EU and Asia rights– $1.6 billion market for both products– 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 nearly $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
• Needle free injection provides differentiation
EU Market• European hGH market ~$500M
• Ferring’s hGH sold >$60M in 2010
• Ferring uses Antares’ technology
Tev–Tropin® Prescriptions Growing Post Tjet® Launch
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Mon
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XsTJet® approved
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VIBEX™ MTX StatusThe 1st MTX auto-injector for RA
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• Anticipated NDA filing in 2012• Independent market research
with nearly 200 rheumatologists indicates VIBEX™ MTX will address a significant unmet need
• Manufacturing partnership and license with Uman Pharma(Canada)
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VIBEX™ MTX: Rheumatoid Arthritis (RA) Market Overview
• 2.1 million RA patients in the U.S.
• Methotrexate (MTX) is standard of care, used in majority of RA patients
• 5.3 million RX for MTX in 2010, and growing
– 70% of RX are for RA
• 30% to 60% of patients don’t tolerate oral MTX & can do better on injection
• Concentrated prescriber base: 3000 Rheumatologists
70%
9%
20%
Arthritis
Psoriasis
Other Conditions
US Methotrexate Prescription Breakdown
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The VIBEX™ MTX Advantage
• 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
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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 2009 and projectedto be greater than $2.3 billionin 2014
• 18.3 MM TRX (Oxybutynin34%)
• 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.
$984
$452
$245
$197
$85
$51
$23
$13
$5
Detrol/LA
Vesicare
Enablex
Generic Oxybutynin
Sanctura/XR
Gelnique/Oxytrol
Toviaz
Ditropan/XL
Other
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• First & Only Titratable Once-Daily Transdermal Treatment for OAB• 2 pumps for 56mg dose or 3 pumps for 84mg dose
• Gel Dries Quickly and Clearly in less than 2 minutes, leaving no odor or residue feel
• Urge Incontinence Reduced by first week and sustained throughout 12-week study for both dosage strengths - 56 mg (p<0.028) and 84mg (p<0.033) vs placebo
• Efficacy comparable to market leader & newer oral OAB drugs
• Good compliance• 2.9% of patients on Anturol Gel discontinued due dermal side effects which were
mild and transient
• Well-Tolerated by most patients • Dry mouth in 11.5% of patients , less than 1% of patients on Anturol Gel
discontinued due to dry mouth• Constipation in 2.6% of patients vs. 1.5% with placebo• Low incidence of dizziness and fatigue comparable to placebo (<2%)
Anturol - Strong Product Profile
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• Physicians indicated that with Anturol transdermal oxybutynin would expand to over 20% of their OAB prescriptions after reading the Anturol product profile.
• Based on a survey of 200 MDs, Sep. 2010.
OAB Prescribers Like the Anturol Product Profile
96%
77%
4%
23%
Before Introduction to Anturol After Introduction to Anturol
Oral OAB Drugs
Transdermal OAB Drugs
Physicians Estimated RX Share
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• Phase 3 trial successfully met primary end point in July 2010
• NDA Filed December 2010
• Open Label extension safety trial completed successfully
• Awaiting FDA acceptance of application following NDA user
fee waiver receipt February 8, 2011
• Currently in talks with several potential partners
Anturol Update
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• Indication: hypoactive sexual desire disorder (HSDD)in menopausal women
• Currently in Phase 3 testing
• Enrollment completed in one of two efficacy studies
• Physician survey shows significant unmet medical need and market opportunity already exists
• BioSante reported favorable unblinded safety data on use of testosterone in women for FSD
• Antares owns international licensing rights in significant territories (e.g. EU) and all manufacturing
• NDA filing planned for 2011
• BioSante guidance: $2B addressable market
LibiGel® Phase 3 Program Partnered with BioSante
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New Promotion Restarted Elestrin® RX Growth
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Weekly TRX 4-Week Moving Average
Azur PharmaBegins Promotion
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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 events 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 contraceptive products − 31% of women discontinue oral contraceptives use after 6
months, and 44% within 12 months*
NestraGel™: Partnered with the Population Council
**National Survey of Family Growth, CDC
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Financial Overview
• Strong cash positionAs of December 31st 2010, cash /cash equivalents of $9.8 million
$1.50 Warrants/Options exercised - $5 Million in Q1 2011
• Growing revenue base2008 total revenues were $4.6 Million
2009 total revenues of $8.3M (47% over 2008)
2010 Revenues $12.8 Million (54% over 2009)
• Reducing burn rateCash burn in 2010 was approximately $3.7 million