This presentation provides an overview of Antares Pharma and its product pipeline. It summarizes that Antares has developed proprietary drug delivery systems, including auto-injectors and transdermal gels. It has several FDA-approved products and partnerships with major pharmaceutical companies. Its pipeline includes additional self-injection products in development, including products for rheumatoid arthritis and biosimilars, which represent large market opportunities.
PAREXEL Principal Consultant Angela McGillivary discusses commercial considerations, clinical development, regulatory requirements, submission and post approval strategies in emerging markets
Market Exclusivity Under the Waxman-Hatch ActMichael Swit
March 19, 2007 presentation to the San Diego County Bar Association IP Section, with a focus on:
•Orphan Drug Exclusivity (Seven Years)
•Five-Year Exclusivity
•Three-Year Exclusivity
•Pediatric Exclusivity (Six Months)
•180-Day Exclusivity
Hi
I am Rahul Ranjan Rai, perusing MBA from Jaypee Business School and I have completed this Project under the supervision of Pro. Evan Costle (france). I hope this presentation will help you to understand the emerging concepts in Generic Industry
Thank you
Regards
Rahul
Many emerging companies make the mistake of putting all of their resources into immediate needs, and often neglect longterm regulatory strategy concerns when it comes to submissions and approvals. Don’t neglect the strategy piece in your planning! This lunch will provide a deep-dive foundation of how to develop a regulatory strategy. Topics to be addressed include:
What are different types of regulatory submissions for devices?
What are current trends in regulatory agencies?
What regulations around devices affect your organization?
Attendees will have the opportunity to ask questions with their company’s needs in mind.
Join us and Halloran Consulting at M2D2 for this expert lunch. Food will be served.
PAREXEL Principal Consultant Angela McGillivary discusses commercial considerations, clinical development, regulatory requirements, submission and post approval strategies in emerging markets
Market Exclusivity Under the Waxman-Hatch ActMichael Swit
March 19, 2007 presentation to the San Diego County Bar Association IP Section, with a focus on:
•Orphan Drug Exclusivity (Seven Years)
•Five-Year Exclusivity
•Three-Year Exclusivity
•Pediatric Exclusivity (Six Months)
•180-Day Exclusivity
Hi
I am Rahul Ranjan Rai, perusing MBA from Jaypee Business School and I have completed this Project under the supervision of Pro. Evan Costle (france). I hope this presentation will help you to understand the emerging concepts in Generic Industry
Thank you
Regards
Rahul
Many emerging companies make the mistake of putting all of their resources into immediate needs, and often neglect longterm regulatory strategy concerns when it comes to submissions and approvals. Don’t neglect the strategy piece in your planning! This lunch will provide a deep-dive foundation of how to develop a regulatory strategy. Topics to be addressed include:
What are different types of regulatory submissions for devices?
What are current trends in regulatory agencies?
What regulations around devices affect your organization?
Attendees will have the opportunity to ask questions with their company’s needs in mind.
Join us and Halloran Consulting at M2D2 for this expert lunch. Food will be served.
Utilizing the powerful impact of real-time information on drug development an...Merlien Institute
Utilizing the powerful impact of real-time information on drug development and new product launch
Janet Kosloff - Co-Founder & CEO - InCrowd
Matt Grimley - Senior Market Research Manager - Vertex Pharmaceuticals
Determining the key challenges facing commercial organizations when launching a new drug. Evaluating the information needs related to pre-launch, activity product launch and immediate post launch. Utilizing innovative mobile technology for providing real-time access of valuable insights from target audience.
Similar to Investor presentation april_2012-1 (16)
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, 2011. 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
2
3. Antares Background
• Antares is a fast growing Pharmaceutical Company and the ONLY
US-based company offering auto-injector, pen and needle-free
technology platforms.
• 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 transdermal gel business has yielded two FDA approved
products and one in development.
• Our self-injection business has yielded one FDA approved product, a
deep pipeline with several products in development, some of which
we may elect to market ourselves.
• Our market research demonstrates our greatest opportunity and ROI
exists in the rapidly growing markets for self-injection products.
3
4. 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
• Recognized leader in fast-growing self-administered injection
technology
• Proprietary VIBEX MTX successfully completed clinical trial
• Anturol Gel NDA approved and partnered with Watson
Pharmaceuticals
• Broad multi-product partnership with Teva
• HGH Needle free product commercialized in Europe and US
• Growing intellectual property portfolio
• Multiple partnerships with leading companies – Pfizer, Teva, Watson
and Ferring 4
5. Financial Overview
• Cash Position
As of December 31st 2011 cash and investments of $34.4 million
No debt
• Growing Revenue Base
2008 total revenues $4.6 million
2009 total revenues $8.3 million (47% over 2008)
2010 total revenues $12.8 million (54% over 2009)
2011 total revenues $16.5 million (28% over 2010)
2012 revenue expected to grow 30% – 50%
• Reducing Burn Rate
Operating Cash burn in 2011 was approximately $1.9 million vs. $6.1
million in 2010
5
7. Diverse and Advanced Product Pipeline
PRODUCT PRECLINICAL CLINICAL FILED MARKETEDPARTNER APPROVED
TEVA – US
Ferring – EU
JCR – Japan
Jazz (US)
Watson (US)
Daewoong
(SK)
TEVA
TEVA
ANTARES
ANTARES
TEVA
TEVA
Population
Council
Pfizer
TevTropin®/
Zomajet®
Elestrin®
Anturol®
Vibex™ EPI
Vibex™ 2
Vibex™ MTX
Vibex™ QS1
Pen 1
Pen 2
NestraGel™
Undisclosed
NDA
Approved
Filed ANDA
Filed ANDA
NDA
ANDA
NDA
NDA
NDA
7
8. Advanced Injectable Products Portfolio
• Our VIBEX-MTX program is designed to enhance the performance of MTX for patients
who need and depend on it for their health and well-being 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.
• 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
• Our Injectable Products mission is to develop, produce and commercialize high quality
self-injectable medicines that are accessible to all patients who need and depend on
them for their health and well-being while optimizing the cost of healthcare.
8
9. 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
Multi-dose pens
Designed for new cartridge
technology
Reusable Needle-Free Injectors
Multiple use Injectors for
subcutaneous delivery
9
10. • 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
• 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
Teva and Antares: Our Broad Collaboration
Multiple agreements for diverse products with nearly
$3 billion in U.S. sales
10
11. 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
11
12. New Injectable Products Engine for Internal Development
~200
Compounds
Screened
>60
Feasible
Candidates
MTX
~30
Interesting
Product 2
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
12
13. • 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 and in
combination with biologic drugs.
13
14. 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 – 4Q11 FDA meeting
confirmed regulatory pathway for NDA
filing
• MTX Rx’s exceed 5 million and growing
• 30% – 60% of patients do not tolerate
oral MTX
• Independent market research with
nearly 200 rheumatologists indicates
VIBEX™ MTX will address a significant
unmet need – prescribers would like
more injectable MTX
• Novel and proprietary product with new
IP
VIBEX™ MTX For Rheumatoid Arthritis
14
15. 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
• 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
15
16. • 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 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
Biosimilars: Significant Long-Term Growth
Opportunities for Self-Injection Products
16
18. Advanced Transdermal Gel Portfolio
Anturol®
FDA Approved and Commercialized Delivery
Technology
18
19. • Antares’ once-daily transdermal treatment for OAB (Anturol®)
• Gel dries quickly and clearly in less than 2 minutes, leaving no odor or
residue feel
• NDA Approved – December 7, 2011
• U.S. OAB market was $2.1 billion in 2010 and projected to be greater than
$2.3 billion in 2014
• Strategic acquisition for Watson – extends, protects, and expands their OAB
product portfolio – with strong IP protection
• Watson will own the transdermal OAB segment
• Sales based milestones – Royalties on combined sales of Anturol® and
Watson’s Gelnique® product
• Unmet market need for an efficacious product with low side effect profile
Oxybutynin Gel: Partnered with Watson Pharma in U.S.
Approved by FDA – Launch in 2Q12
19
21. 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 and commercialization partner
21
22. Potential Milestones for Next 12-18 Months
• Anturol® launched by Watson
• VIBEX EPI and VIBEX 2 auto-injector products approved
• 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
22
23. Antares Pharma, Inc.
Princeton Crossroads Corporate Center
250 Phillips Blvd., Suite 290
Ewing, NJ 08618
Tel.: 609.359.3020
Fax: 609.359.3015
Investor Relations: 609.359.3020 ext. 133