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AIS Investor presentation december2010
1. Paul K. Wotton, Ph.D.
President and Chief Executive Officer
December 2010
AMEX: AIS
2. Page 2
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 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, 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.
3. Page 3
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 Filing 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
4. Page 4
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®
6. Page 6
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 market
Follow-on biologics
Bio Betters requiring delivery technology for patient acceptance
8. Page 8
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
9. Page 9
Tev–Tropin® Prescriptions - Growing with Tjet®
‐
200
400
600
800
1,000
1,200
1,400
Monthly 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
10. Page 10
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
• 5.1 million RX for MTX in 2009, 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 Methotrexate
Prescription Breakdown
11. Page 11
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
• 2+ year, low cost, low risk development
program to NDA
• In market research, physicians expressed
strong interest in the product concept
11
14. Page 14
Elestrin® RX Growth Indicates Strong Market Response
to New Promotion
0
500
1000
1500
2000
2500
3000
MonthlyTRX's
Azur Pharma
Initiates Promotion
Source: IMS National Prescription Audit
15. Page 15
Anturol® : Overactive Bladder Market Overview (OAB)
Detrol/Detrol
LA
$984
Ditropan/
Ditropan XL
$13
Generic
Oxybutynin
$197
Vesicare
$452
Enablex
$245
Sanctura/
Sanctura XR
$85
Toviaz
$23
Gelnique/
Oxytrol
$51
Other
$5
OAB Sales
U.S. Market
2009
($ 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.
15
16. Page 16
Anturol ® : Strong Product Profile
First & Only Titratable Once-Daily Transdermal Treatment for OAB
Provides Robust Efficacy with Less Interference from Side Effects
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%)
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
17. Page 17
OAB Prescribers Like the Anturol Product Profile
First & 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 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, fielded Sep.
2010.
18. Page 18
Anturol® Effective Transdermal Gel with Flexible Dosing in
Convenient Metered-Dose Dispenser
18
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 to
individual 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 Filing Planned for Q4 2010
19. Page 19
LibiGel® Phase 3 Program Partnered with BioSante
• Indication: hypoactive sexual desire disorder (HSDD) in
menopausal women
• Currently in Phase 3 testing
• Physician survey shows significant unmet medical need and
market opportunity 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
20. Page 20
Nestorone® Gel: Partnered with the Population Council
• Indication: contraception
• Featured Extensively in Media - October 2010
• Successfully completed Phase 2 Trial (three separate doses given
for 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
21. Page 21
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
22. Paul K. Wotton, Ph.D.
President and Chief Executive Officer
December 2010
AMEX: AIS