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Paul K. Wotton, Ph.D.
President and Chief Executive Officer
July 2011
AMEX: AIS
2
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, 2010. 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
3
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 and royalties up 54% over 2009
• Broad multi-product partnership with Teva
• Proprietary VIBEX MTX in clinical trial, NDA targeted for 2012
• Anturol for overactive bladder: NDA Filed in 2010 and partnered with
Watson Pharmaceuticals
• Two LibiGel Phase 3 efficacy trials completed enrollment, safety trials
near completion
4
Advanced Product Portfolio based on Strong IP
Self Injector Products ATD Gel Products
Anturol®
5
INJECTABLE
PRODUCTS
INDICATION PRECLINICAL CLINICAL FILED MARKETED PARTNER
Tjet®/
Zomajet® HGH
TEVA -US
Ferring – EU
JCR - 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 Autoimmune
Diseases NDA
ANTARES
INDICATION PRE-
CLINICAL
PHASE 1 FILED MARKETED PARTNER
Elestrin® Menopause Azur (US)
Anturol® OAB Filed NDA Watson (US)
LibiGel® FSD
BioSante (US)
Antares
(ROW)
NestraGelTM Contraceptive Population
Council
wedDiverse and Advanced Product Pipeline
PHASE 2 PHASE 3GEL
PRODUCTS
6
VIBEX™
VIBEX™ MTX
Pens
Zomajet®
Injection Portfolio
7
• 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
8
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
9
• Strong, international marketing partner
– Top-seller of injectables with more than 125 products marketed worldwide
• Tev-Tropin® Tjet® (reusable) hGH
– Approved
– 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 programs
– One Generic and One Branded (505B2) product - ANDA filing anticipated in Q1 2012.
Branded program has completed PK work $1.5 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
10
US Market
• Total US hGH market ~$1.3B
• Tev-Tropin® originally launched in 2005
• Tev-Tropin® using Tjet® launched Q3 2009 and market share has
increased 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 Development
~200
Compounds
Screened
>60
Feasible
Candidates
~30
Interesting
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
11
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 considered
the 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
12
Rheumatoid
Arthritis
(Late stage)
13
• 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 efficacy 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
14
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
15
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
will complete in Q3 2011
• Anticipated NDA filing in H1 2012
• Projected launch in H1 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
16
Commercial/Advanced Transdermal Gel Portfolio
Anturol®
FDA Approved Delivery Technology
17
Anturol® : Overactive Bladder Market Overview (OAB)
• Affects an estimated 16% of
mature Western population –
90% of patients are women
• U.S. OAB market was $2.1
billion in 2010 and projected
to be greater than $2.3 billion
in 2014
• 18.4 MM TRX (Oxybutynin
37%)
• 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
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)
18
• 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
• Good compliance
• Well-Tolerated by most patients
• Phase 3 trial met endpoints in July 2010, open label extension safety
trial completed successfully
• PDUFA date –December 8, 2011
• Exclusive licensing agreement with Watson (US and Canada)
• Anticipated Launch in H1 2012
OAB Gel Partnership with Watson Pharmaceuticals
19
• 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 need and
market opportunity already exists
• BioSante reported favorable unblinded safety data on use of
testosterone in women for FSD – over 2800 patient years of data
• NDA filing planned for H1 2012
• Guidance from BioSante and Wall Street: $2B addressable market
• Mid single digit royalty + 25% of all milestones
• Antares owns international licensing rights in significant territories
LibiGel® Phase 3 Program Partnered with BioSante
20
Elestrin® : Convenient, Flexible Dosing, Effective
21
• 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*
• Looking for a partner for pivotal trials
NestraGel™: Partnered with the Population Council
**National Survey of Family Growth, CDC
22
Financial Overview
• Cash position
As of March 31st 2011, cash /cash equivalents of $13.1 million
Balance sheet strengthened in May 2011 with $23 million
financing
• 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)
Q1 2011 Revenues $3.6 million
• Reducing burn rate
Cash burn in 2010 was approximately $3.7 million
23
Potential Milestones for Next 12-18 Months
Teva Epinephrine project approved and launched
2nd Teva auto-injection project approved and launched
Other Teva programs advance including first Pen Program
Filing (ANDA)
Anturol approved, launched by Watson
LibiGel approved and launched
Methotrexate NDA filed in US, Canada and Europe
Methotrexate partnership in Europe
Company cash flow positive
Paul K. Wotton, Ph.D.
President and Chief Executive Officer
July 2011
AMEX: AIS

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Investor presentation july_2011_final

  • 1. Paul K. Wotton, Ph.D. President and Chief Executive Officer July 2011 AMEX: AIS
  • 2. 2 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, 2010. 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
  • 3. 3 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 and royalties up 54% over 2009 • Broad multi-product partnership with Teva • Proprietary VIBEX MTX in clinical trial, NDA targeted for 2012 • Anturol for overactive bladder: NDA Filed in 2010 and partnered with Watson Pharmaceuticals • Two LibiGel Phase 3 efficacy trials completed enrollment, safety trials near completion
  • 4. 4 Advanced Product Portfolio based on Strong IP Self Injector Products ATD Gel Products Anturol®
  • 5. 5 INJECTABLE PRODUCTS INDICATION PRECLINICAL CLINICAL FILED MARKETED PARTNER Tjet®/ Zomajet® HGH TEVA -US Ferring – EU JCR - 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 Autoimmune Diseases NDA ANTARES INDICATION PRE- CLINICAL PHASE 1 FILED MARKETED PARTNER Elestrin® Menopause Azur (US) Anturol® OAB Filed NDA Watson (US) LibiGel® FSD BioSante (US) Antares (ROW) NestraGelTM Contraceptive Population Council wedDiverse and Advanced Product Pipeline PHASE 2 PHASE 3GEL PRODUCTS
  • 7. 7 • 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
  • 8. 8 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
  • 9. 9 • Strong, international marketing partner – Top-seller of injectables with more than 125 products marketed worldwide • Tev-Tropin® Tjet® (reusable) hGH – Approved – 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 programs – One Generic and One Branded (505B2) product - ANDA filing anticipated in Q1 2012. Branded program has completed PK work $1.5 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
  • 10. 10 US Market • Total US hGH market ~$1.3B • Tev-Tropin® originally launched in 2005 • Tev-Tropin® using Tjet® launched Q3 2009 and market share has increased 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
  • 11. New Injectable Products Engine for Internal Development ~200 Compounds Screened >60 Feasible Candidates ~30 Interesting 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 11
  • 12. 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 considered the 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 12 Rheumatoid Arthritis (Late stage)
  • 13. 13 • 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
  • 14. Braun, et al: Subcutaneous MTX provided better efficacy 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 14 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
  • 15. 15 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 will complete in Q3 2011 • Anticipated NDA filing in H1 2012 • Projected launch in H1 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
  • 16. 16 Commercial/Advanced Transdermal Gel Portfolio Anturol® FDA Approved Delivery Technology
  • 17. 17 Anturol® : Overactive Bladder Market Overview (OAB) • Affects an estimated 16% of mature Western population – 90% of patients are women • U.S. OAB market was $2.1 billion in 2010 and projected to be greater than $2.3 billion in 2014 • 18.4 MM TRX (Oxybutynin 37%) • 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 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)
  • 18. 18 • 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 • Good compliance • Well-Tolerated by most patients • Phase 3 trial met endpoints in July 2010, open label extension safety trial completed successfully • PDUFA date –December 8, 2011 • Exclusive licensing agreement with Watson (US and Canada) • Anticipated Launch in H1 2012 OAB Gel Partnership with Watson Pharmaceuticals
  • 19. 19 • 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 need and market opportunity already exists • BioSante reported favorable unblinded safety data on use of testosterone in women for FSD – over 2800 patient years of data • NDA filing planned for H1 2012 • Guidance from BioSante and Wall Street: $2B addressable market • Mid single digit royalty + 25% of all milestones • Antares owns international licensing rights in significant territories LibiGel® Phase 3 Program Partnered with BioSante
  • 20. 20 Elestrin® : Convenient, Flexible Dosing, Effective
  • 21. 21 • 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* • Looking for a partner for pivotal trials NestraGel™: Partnered with the Population Council **National Survey of Family Growth, CDC
  • 22. 22 Financial Overview • Cash position As of March 31st 2011, cash /cash equivalents of $13.1 million Balance sheet strengthened in May 2011 with $23 million financing • 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) Q1 2011 Revenues $3.6 million • Reducing burn rate Cash burn in 2010 was approximately $3.7 million
  • 23. 23 Potential Milestones for Next 12-18 Months Teva Epinephrine project approved and launched 2nd Teva auto-injection project approved and launched Other Teva programs advance including first Pen Program Filing (ANDA) Anturol approved, launched by Watson LibiGel approved and launched Methotrexate NDA filed in US, Canada and Europe Methotrexate partnership in Europe Company cash flow positive
  • 24. Paul K. Wotton, Ph.D. President and Chief Executive Officer July 2011 AMEX: AIS