Paul K. Wotton, Ph.D. President and Chief Executive Officer February 2011 AMEX: AIS
Aug 14, 2015
Paul K. Wotton, Ph.D.President and Chief Executive Officer
February 2011
AMEX: AIS
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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 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 inthese 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, 2009. 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.
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Antares - Delivering Strong Results
• Growing Revenues – Solid Business Base• Deep and advanced product pipeline
• Balanced portfolio - Multiple shots on goal• Tjet: Driving TevTropin growth
• Anturol: Successful Phase III Clinical Results, NDA Filed in 2010
• VIBEX MTX: Development program moving forward
• Teva – All programs continue progress
• Significant news flow resulting from accomplishments in our proprietary and partnered programs
• Growing revenues from product sales with decreasing cash burn and more than one year’s cash on hand
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Advanced Product Pipeline based on Patented Technologies
Parenteral Injectors ATD Gel Products Portfolio
Anturol®
Antares currently receives a royalty from sales of Elestrin® and Tev-Tropin® and potential future royalties on LibiGel®
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Substantial Late Stage Product Pipeline
INJECTABLE PRODUCTS
INDICATION DESIGN / PRECLINICAL CLINICAL APPROVAL LAUNCH PARTNER
Tjet®/Zomajet®
HGH TEVA/Ferring
VibexTM 1 Epinephrine Filed TEVA
VibexTM 2 Undisclosed Filed TEVA
Pen 1 Undisclosed TEVA
Pen 2 Undisclosed TEVA
VibexTM MTX AutoimmuneDiseases
GEL PRODUCTS
PRECLINICAL PHASE 1 PHASE 2 PHASE 3 LAUNCH PARTNER
Elestrin® Menopause Azur (US)
Anturol® OAB Filed
LibiGel® FSD BioSante (US)
NestraGelTM Contraceptive Population Council
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Parenteral Medicines – Key Opportunities
• 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
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Convenient Injections– Antares Multiple Solutions
Key Advantages:• Ease of use• Rapid injection• Promotes compliance• Minimal sharps disposal• High-quality
subcutaneous injection• Potential for multi-use• Excellent reliability
Disposable Auto Injectors (Vibex™)
Pen Injectors
Reusable Needle-Free Injectors
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Teva and Antares – Our Broad Collaboration
Multiple agreements for diverse products with nearly $3 billion in U.S. sales
• Strong, international marketing partner– Top-seller of injectables worldwide– More than 125 products marketed– Branded and generic opportunities
• 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 & an undisclosed product, N.A. & U.S rights respectively,
+$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, over $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
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Tev–Tropin® Prescriptions - Growing with Tjet®
0
200
400
600
800
1000
1200
1400
Mon
thly Total RXs
TJet® approved
US Market
• Total US hGH market ~$1.3B
• Tev-Tropin® originally launched in 2005
• Tev-Tropin® using Tjet® launched 8/2009
• Needle free injection provides differentiation
EU Market Example
• European hGH market ~$500M
• Ferring uses Antares’ technology
• Ferring’s hGH sold $60M in 2009
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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
• VIBEX MTX is easy to use, safe, convenient, raises standard of care
• Concentrated prescriber base: 3000 Rheumatologists
US MethotrexatePrescription Breakdown
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Product Profile: VIBEX™ MTX
• 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 1st MTX auto-injector for RA
• Collaboration with Uman Pharma to jointly develop and commercialize VIBEX™ MTX
• 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
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Advanced Transdermal Gel PortfolioFDA Approved Delivery Technology
Anturol®
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Elestrin® : Convenient, Flexible Dosing, Effective
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Elestrin® RX Growth Indicates Strong Market Response to New Promotion
0
500
1000
1500
2000
2500
3000
Mon
thly
TR
X's
Azur PharmaInitiates Promotion
Source: IMS National Prescription Audit
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Anturol® : Overactive Bladder Market Overview (OAB)
Detrol/DetrolLA$984
Ditropan/Ditropan XL
$13
Generic Oxybutynin
$197
Vesicare$452
Enablex$245
Sanctura/Sanctura XR
$85
Toviaz$23
Gelnique/Oxytrol$51
Other$5
OAB SalesU.S. Market
2009 ($ millions)
• U.S. OAB market was $2.1 billion in 2009 (18.3 MM TRX, Oxybutynin 34%) and projected to be greater than $2.3 billion in 2014
• Affects an estimated 16% of mature Western population – 90% of patients are women
• Major AEs for OAB drugs include dry mouth and constipation resulting in poor compliance
• Unmet market need for an efficacious product with low side effects profile
• Anturol has demonstrated similar efficacy but better safety than newer oral OAB drugs
Sources: IMS Heath National Sales Perspective, Cowen & Co. Therapeutic Categories Report, March 2010.
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Anturol® : Strong Product ProfileFirst & Only Titratable Once-Daily Transdermal Treatment for OAB
Provides Robust Efficacy with Less Interference from Side Effects
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
Adjustable Dosages to meet individual patient needs for efficacy and tolerability• 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
Good compliance—only 2.9% of patients on Anturol Gel discontinued due dermal side effects which were transient and mild
Avoids First-Pass Hepatic Metabolism for lower level of desethyloxybutynin (DEO)• DEO is an active metabolite with greater effect on salivary glands and associated with dry mouth• Transdermal administration significantly reduces DEO level vs. that following oral administration
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%)
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OAB Prescribers Like the Anturol Product ProfileFirst & Only Titratable Once-Daily Transdermal Treatment for OAB
96%
77%
4%
23%
0%
10%
20%
30%
40%
50%
60%
70%
80%
90%
100%
Pre‐exposure Post‐Exposure
Physicians' Estimated RX Share for Oral and Transdermal OAB Medications
Transdermal OAB Drugs
Oral OAB Drugs
• Physicians indicated that with Anturoltransdermal oxybutyninwould expand to over 20% of their OAB prescriptions after reading the Anturolproduct profile.
• Based on a survey of 200 MDs, fielded Sep. 2010.
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Anturol® Effective Transdermal Gel with Flexible Dosing in Convenient Metered-Dose Dispenser
• Over $2 Billion US OAB Treatment Market
• Current products have high AEs creating unmet need
• Phase 3 trial successfully met primary end point – July 2010
• Efficacy comparable to Market Leader & Newer Oral OAB drugs
• Rapid onset of action within first week
• Better Tolerability vs. Market Leader & Newer Oral OAB drugs
• Lower rates of dry mouth and constipation
• Two dose strengths in metered dose dispenser allows tailoring toindividual patient needs
• Market research (200 Physicians) confirmed Dose Titration is key for a transdermal product to compete against newer oral agents e.g. Enablex
• NDA Filed December 2010
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• Indication: hypoactive sexual desire disorder (HSDD)in menopausal women
• Currently in Phase 3 testing
• Physician survey shows significant unmet medical need and marketopportunity already exists
− Two million off label prescriptions for FSD in 2007 according to IMS
• BioSante recently 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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NestraGel™: Partnered with the Population Council
• 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*
*urvey *National S of Family Growth, CDC
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Financial Overview
• Strong cash position– As of September 30th 2010, cash and cash equivalents of $10.2
million
• Growing revenue base– 2008 total revenues were $4.6 Million
– 2009 total revenues of $8.3M (up 46.8% over 2008)
– Q3 YTD 2010 Revenues $9.5 Million
• Reducing burn rate– Cash burn in Q3 was approximately $1.2M;YTD burn $3.3M
– Annual burn rate expected to continue to decline from 2009 rate
Paul K. Wotton, Ph.D.President and Chief Executive Officer
February 2011
AMEX: AIS