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Investor presentation 20_december_2011
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Transcript of Investor presentation 20_december_2011
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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
Antares Background and Mission
• Antares is a US-based, fast growing Pharmaceutical
Company
• Our transdermal gel business has yielded two FDA
approved products, and one in late-stage
development.
• Our self-injection business has yielded one FDA
approved product, licensed to other firms, and
several products in development, some of which we
may elect to market ourselves.
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• We have demonstrated significant clinical and regulatory expertise in drug/device
combination products coupled with a comprehensive IP portfolio which gives us a
sustainable competitive advantage in this field
• Our market research demonstrates our greatest opportunity and ROI exists in the rapidly
growing markets for self-injection products. Our mission is:
• Developing, producing and commercializing high quality self-injectable
medicines that are accessible to all patients who need and depend on
them for their health and well-being
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Investment Highlights
• Antares is a revenue generating company with an
advanced product pipeline and multiple shots on goal
• Three products approved, two on file with the FDA, and
five in advanced development
• Leader in fast-growing self-administered injection
technology
• The ONLY US-based company offering auto-injector, pen
and needle-free technology platforms
• Broad multi-product partnership with Teva
• Proprietary VIBEX MTX successfully completed clinical trial
• Anturol Gel NDA approved and partnered with Watson Pharmaceuticals
• HGH Needle free product commercialized in Europe and US
• Growing intellectual property portfolio
Antares’ Progress in our Mission
• Through our partnership with Teva we are developing
five value added injectable products:
– Tjet for Teva’s recombinant human growth hormone -
TevTropin
– An alternative to the Epipen epinephrine auto-injector
– Three additional high quality products for self-injected
medicines
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• Our VIBEX-MTX program is designed to enhance the performance of MTX
for patients who need and depend on it for their health and wellbeing for the
treatment of rheumatoid arthritis
• Our VIBEX-QS program aims to enhance the injection performance of
biological and biosimilar products for patients who depend on them for
effectively treating complex diseases including rheumatoid arthritis and other
autoimmune disorders.
NestraGelTM Contraception Population
Council NDA
VibexTM EPI Allergic
Emergency Filed ANDA TEVA
VibexTM 2 Undisclosed
Filed ANDA TEVA
Pen 2 Undisclosed NDA TEVA
VibexTM MTX Rheumatoid
Arthritis NDA ANTARES
Pen 1 Undisclosed ANDA TEVA
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PRODUCT INDICATION PRECLINICAL CLINICAL FILED MARKETED PARTNER
Tjet®/
Zomajet®
HGH
Deficiency
TEVA –US
Ferring – EU
JCR –Japan
Elestrin® Menopause Jazz (US)
Diverse and Advanced Product Pipeline
Anturol® OAB NDA
Approved Watson (US)
Undisclosed Undisclosed Pfizer NDA
APPROVED
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Key Advantages:
• Easy to use at home
• High quality and rapid injection promotes compliance
• Minimal sharps disposal – safe for patients
• Excellent reliability means patients get reproducible doses time after time
• Manufactured in the US – high quality
Proprietary Self-Injection Technology Portfolio
High Quality – High Value Added – Easy to Use
Disposable Auto-Injectors
Vibex and Vibex™ QS
Single shot up to 1 ml
injection volume
including highly viscous
biologic products
Pen Injectors
Multidose pens
Designed for new cartridge
technology
Reusable Needle-Free Injectors
Multiple use Injectors for
subcutaneous delivery
Novel Self-Injection Technology Vital to
Biological and Biosimilar Commercial Success
• Differentiation is critical to successful
commercialization
• Commercial strategies must include
device improvements, and patient
support
• Antares’ self-injection technology offers
physicians and patients enhanced
performance, safety and reliability
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• Enabling self-injection – patient empowerment is a key driver
• The New VIBEX QS is particularly well-suited for use with biosimilar
products
– Novel spring mechanism - 1ml capacity
– Powerful and smooth expulsion—necessary for viscous biologic formulations
– Highly compact
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• Global sales of branded biologic products compatible
with our self-injection technologies exceed $50 billion
today
• Analysts agree that the high profile biosimilar/biobetter
market will be significant, between $2-3 billion by 2015.
Biosimilars: Significant Growth Opportunities for
Self-Injection Products
• Biosimilars and Biobetters growth driven by several factors:
– Patent expirations of parenteral biologics
– Rapidly growing demand of costly branded biologics
– Mounting pressure on healthcare budgets
– Patient access to and affordability of medicine
Biosimilar Targets exceeding $1 Billion Global Sales
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$0.2 $14.1
$97.3
$0
$20
$40
$60
$80
$100
$120
<$100M $100M -$1B
>$1B
Bil
lio
ns
Sales per Brand
Peak Global Sales
Source: FDA, Thompson, Zachs, Bernstein
estimates and analysis. Peak sales from
analyst models (SCB or consensus, as
available)
Brand
Global Peak Sales
> $1 Billion Avastin $9.2
Enbrel $8.0
Remicade $7.9
Humira $7.3
Rituxan $7.3
Herceptin $5.7
Lantus $5.1
Epogen/Procrit $5.1
Neulasta $4.2
Novolog $3.8
Erbitux $3.6
Aranesp $3.2
Recombinate $2.9
Lucentis $2.7
Avonex $2.6
Novolin $2.5
Humalog $2.2
PEGasys $2.0
Rebif $1.7
Cerezyme $1.5
NovoSeven $1.4
Tysabri $1.4
Neupogen $1.3
Synagis $1.3
Betaseron $1.2
Humulin $1.1
Kogenate FS $1.1
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• Teva is a strong, international marketing partner
• Tev-Tropin® Tjet® (reusable) hGH
– Growing franchise for Teva, Tjet launched August 2009
– Antares receives strong margins on device sales, and mid
to high single digit % royalty on overall product sales
Teva and Antares: Our Broad Collaboration
Multiple agreements for diverse products with
nearly $3 billion in U.S. sales
• Two Vibex™ (auto injector, single shot disposables) products
– Filed with FDA
– Epinephrine (N.A. rights) & an undisclosed product (U.S rights)
– $250+ million markets
– Antares receives margins on device sales, and mid to high single digit % royalty on overall
product sales
• Two pen injectors (disposables) products – Global programs
– One Generic (ANDA) and One Branded (505B2) product - $1.5 Billion in current sales
– ANDA filing anticipated WITHIN 12-18 months
– 505B2 program has completed PK work
– Antares receives transfer price + margin on device sales, single digit to-mid teens % royalty
on overall product sales
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US Market
• Total US hGH market ~$1.3B
• Tev-Tropin® needle and syringe originally launched in 2005
• Tjet® needle-free injector launched Q3 2009, Tev-Tropin® market share has grown
approximately threefold in two years
• Tjet® provides product differentiation—patient-friendly needle-free injection
• Teva reports Tjet® contributing to new managed care formulary additions in 2011
EU Market
• European hGH market is approximately $500M
• Ferring’s Zomajet hGH sold more than $60M in 2010 (12% market share)
• Zomajet uses Antares’ needle free technology
• Product continues to grow after six years
Tev–Tropin® Prescriptions Growing Post Tjet® Launch
HGH market is a good model for describing future biosimilar market
dynamics: Product differentiation is essential for capturing share.
New Injectable Products Engine for Internal Development
~200
Compounds
Screened
>60
Feasible
Candidates
~30
Interesting
Product 2
MTX
Product 4 Product 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 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 damage
prevent loss of function,
and decrease pain.‖ (ACR)
• Concentrated prescribing base (3000 Prescribers)
• MTX Rx are growing
• Prescribers would like more injectable use
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 titration to higher dose
– 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 – Entire Injection process complete within
three seconds
• Safety & Security
– Avoids dosing errors and inadvertent exposure to cytotoxic agent
– Locking needle shield reduces risk of accidental needle sticks
The VIBEX™ MTX Advantage:
First MTX auto-injector for use at home
VIBEX MTX provides physicians and RA patients a practical
means for optimizing MTX performance prior to & in combination
with biologic drugs.
Recent clinical and pharmacoeconomic research
reinforces the role of MTX as first line DMARD
• Braun, et al (2008): Subcutaneous MTX (15 mg/wk) provided better efficacy than
oral MTX without a higher rate of adverse events. (N=375)
• Kremer, et al (2009): Switching from oral to SC MTX resulted in clinical
improvement explained by accumulation of long chain polyglutamated MTX
• Bakker, et al (2011): Switching from oral to SC MTX resulted in tight control of RA
in an additional 10% to 15% of patients, avoiding the use of a biologic in those
patients (N= 236)
• O’Dell, et al (2011): One-third of patients started on MTX alone had an "excellent"
response that persisted out to two years. Furthermore, patients who started on
MTX had radiographic evidence of disease control similar to those starting on MTX
plus a biologic agent. N=766)
• Schipper, et al (2011): Pharmacoeconomic evaluation of costs and efficacy of
starting patients on MTX-alone vs. MTX plus anti-TNF in early RA results in similar
remission rates, favoring an MTX-alone approach.
• Fitzpatrick, et al (2011): In a study of resource utilization in RA management, the
authors conclude, “…there is clear evidence that SC MTX, certainly from a cost
perspective, is definitely worthwhile because it reduces cost of treatment without
compromising patient care.”
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The First MTX auto-injector
for RA
• Highly reproducible PK data and
injection site tolerability in preclinical
study
• Clinical trial completed in Q3 2011
with positive results
• Meeting with FDA in 4Q confirmed
and clarified regulatory pathway for
NDA filing
• Independent market research with
nearly 200 rheumatologists indicates
VIBEX™ MTX will address a
significant unmet need
• Novel and proprietary product with
new IP
VIBEX™ MTX For Rheumatoid Arthritis
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Overactive Bladder Market Overview (OAB)
Affects an estimated
16% of mature
Western population –
90% of patients are
women.
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)
• 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
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• Antares’ once-daily transdermal treatment for OAB
• Gel dries quickly and clearly in less than 2 minutes, leaving
no odor or residue feel
• NDA Approved –December 7, 2011
Oxybutynin Gel: Partnered with Watson Pharmaceuticals
Approved by FDA – Launch in 2012
• Exclusive licensing agreement with Watson (US and
Canada)
• Anticipated launch in H1 2012
• Strategic acquisition for Watson—extends, protects, and
expands their OAB product portfolio—with strong IP
protection
• Watson will own the transdermal OAB segment
22
Nestragel™ Development Program
• Indication: contraception
• Successful Phase 2 Trial:
• suppressed ovulation (given for 21 days)
• well tolerated with no serious adverse events reported and no skin irritation
• Nestorone® has no androgenic effects but is not orally active–ideally
suited to gel administration
• Formulation and active drugs are designed to reduce adverse events
− 31% of women discontinue oral contraceptives use after 6 months, and 44%
within 12 months*
• Seeking a development & commercialization partner
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Financial Overview
• Cash position
As of September 30th 2011 cash and
cash equivalents of $32.2 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)
2011 YTD revenues $11.0 million (41% increase over 2010 YTD)
• Reducing burn rate
Cash burn in 2010 was approximately $3.7 million
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Potential Milestones for next 12-18 months
• Anturol launched by Watson
• Teva epinephrine product commercialized
• 2nd Teva auto-injector product approved
and launched
• Other Teva programs advance including first
pen product filed (ANDA)
• VIBEX MTX NDA filed
• VIBEX MTX partnership in Europe
• New VIBEX QS pipeline product development program initiated