1. Paul
OUR MISSION IS TO DEVELOP AND
COMMERCIALIZE SELF-ADMINISTERED
PARENTERAL MEDICINES THAT OPTIMIZE
CLINICAL BENEFITS WITH ENHANCED COST
EFFECTIVE HEALTH OUTCOMES
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, 2011, and on Form 10-Q for the quarter ended September 30, 2012.
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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3. Antares Background
Antares is a revenue generating state-of-the-art Specialty Pharmaceutical
Company with a late stage growing pipeline of drug/device combination
products based on VIBEX™, multi-dose pen and needle-free technologies
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
OTREXUP™ successfully completed multiple clinical trials for
Rheumatoid Arthritis patients, NDA submitted 12/14/12
VIBEX QS T entering the clinic in 2013 – New pipeline program VIBEX QS
M initiated
Strong Partnership Experience with Leading Organizations
Broad multi-product partnership with Teva
Partnership with Pfizer for an OTC product
Gelnique 3%™ marketed in the U.S. by Actavis and partnered with Daewoong in
South Korea
Zomajet® marketed by Ferring – Europe
Elestrin® marketed by Meda Pharma – U.S.
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4. Antares – Recent Track Record
• Our self-administration technology has yielded an FDA
approved product – Needle Free HGH – Marketed as
TevTropin® in U.S.
• HGH Needle Free product is approved as Zomajet™ in
Europe (Ferring) and as Twin-jector in Japan (JCR)
• Our transdermal gel technology has yielded two FDA
approved products – Elestrin® (HRT) and Gelnique 3%™
(OAB)
• We have an active and advanced internal development
pipeline
• NDA for our proprietary product OTREXUP™ submitted
ahead of schedule in Q412
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5. Diverse and Advanced Product Pipeline
PARTNER PRODUCT PRECLINICAL CLINICAL FILED APPROVED MARKETED
TEVA – US
TevTropin®/
Ferring – EU
Zomajet®
JCR – Japan
TevTropin®
TEVA – US SNDA
10mg
Meda (US) Elestrin®
Actavis (US)
Gelnique 3%™
Daewoong (SK)
TEVA Vibex™ EPI ANDA
Vibex™
TEVA ANDA
Sumatriptan
ANTARES
OTREXUP™ NDA
(RA/Psoriasis)
ANTARES
Vibex™ QS T NDA
(TRT)
ANTARES
Vibex™ QS M NDA
(Neurology)
TEVA Pen 1 ANDA
TEVA Pen 2 NDA
Population
NestraGel™ NDA
Council
Undisclosed
Pfizer NDA
OTC Product
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6. Advanced Injectable Products Portfolio
The only US based Company with proprietary Auto-Injector, Multi-dose Pen
and Needle Free Injection Technology Device Platforms, protected by strong
intellectual property
OTREXUP™ is designed to make self-administration of MTX easier for RA
patients with moderate to severe hand function impairment and was developed
with a goal to optimize the clinical benefit of MTX
VIBEX™-QS is designed to enhance the administration and performance of
complex and difficult to inject viscous medicines such as testosterone, biologics
or bio-similars
Through our partnership with Teva we are developing five uniquely different
injectable products in our leading edge design and engineering facility in
Minneapolis
Tjet® for Teva’s recombinant human growth hormone – TevTropin®
An alternative to the EpiPen®
Three additional high quality products for self-administered medicines
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7.
8. OTREXUP™ Overview
A Compelling Opportunity in RA
First and only SC MTX product for self-administration
Single use, once weekly disposable device
Dosages: 10, 15, 20 and 25mg
Convenience
3-easy steps – easy to teach patients
Hidden needle reduces patient apprehension, supports compliance
Easy to use even for RA patients with moderate to severe hand impairment
Fast, complete and comfortable
Virtually painless administration
Safety
Avoids dosing errors and inadvertent exposure to cytotoxic agent
Locking needle shield reduces risk of accidental needle sticks
OTREXUP™ addresses a large and growing RA market opportunity
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9. Rheumatoid Arthritis – Market Overview
RA is a systemic autoimmune disorder that primarily affects the joints and occurs in middle-
aged women about 2 times more frequently than in men
RA affects about 1.5 million in US (approximately 1% of adult population) and 30-60% do not
tolerate oral MTX which also shows variable absorption
MTX is widely considered the foundation of RA treatment –
used alone or in combination with biologic agents Rheumatoid
(e.g., Humira, Enbrel) Arthritis
(Late stage)
“The ultimate goals in managing RA are to prevent or
control joint damage, prevent loss of function, and
decrease pain.” (ACR*)
RA market continues to grow - $17b in sales, 15.7m TRx’s
MTX Rx’s exceed 5 million and growing
Prescribers would like more injectable use
*ACR = American College of Rheumatology
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10. OTREXUP™ Study Results
Human Factors Usability Study for OTREXUP™ showed that
OTREXUP™ is safe and effective for RA patients with moderate to
severe hand function impairment
The results of the Actual Human Use study show that self-
administration of methotrexate using OTREXUP™ is safe and well
tolerated
98% of patients found OTREXUP™ easy to use and 100% of patients
found the instructions and training to be clear and easy to follow
Patients experienced minimal or no pain at the site of administration
(mean value = 3.6mm on a 100mm VAS scale)
No treatment-emergent serious adverse events related to the drug
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12. Summary Opportunity:
OTREXUP™ For RA
• All Clinical trials completed by 3Q12
with positive results – 4Q12 FDA
meeting reconfirmed regulatory
pathway for December 2012 filing
• Market research with more than 200
rheumatologists confirms that
OTREXUP™ will address a significant
unmet need
• Concentrated prescribing base of
approximately 3000 rheumatologists
allows for a focused and efficient sales
force of approximately 30 sales
representatives
• 2H13 begin to implement support
infrastructure
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13. 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.”
Liakos, et al (Eular Conference 2012): Subcutaneous methotrexate is more efficacious
and better tolerated than oral methotrexate: The experience of a large group of patients in
the rheumatology department of a district general hospital.
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14. MTX - Teaching An Established Drug New Tricks
MTX Use Associated With A 70% Reduction In Mortality In RA Patients
• Wasko, et al – Arthritis & Rheumatism Vol. 65, No. 2, February 2013 – pp 334-
342
• A study was conducted of 5,626 RA patients prospectively for 25 years to
determine the risk of death associated with Methotrexate use
“In summary, we report the protective relationship between use of
MTX and mortality in a large cohort of RA patients followed up
prospectively for 25 years. These findings have implications for the
use of MTX in the treatment of RA. Our results support the
ongoing use of MTX as a cornerstone of RA treatment, with a
survival benefit independent of its effects on pain and functional
limitations. For patients in whom MTX monotherapy does not
achieve complete control, add-on therapy may be more appropriate
than switching to other medications, as MTX may still carry a
survival benefit”.
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15. OTREXUP™ For Psoriasis
Potential New Indication
Psoriasis is a common chronic skin disorder affecting men and women equally
beginning at any age between 20 and 30, or 50 and 60
Both topical and systemic therapies are available for the treatment of psoriasis
Mild-to-moderate skin disease can often be managed with topical agents while
patients with moderate-to-severe disease may need systemic therapy with
methotrexate
There is ample evidence of efficacy with newer systemic therapies such as
biologics; however, established therapies such as methotrexate and
phototherapy continue to play a role in the management of moderate-to-severe
plaque psoriasis
Methotrexate has been used successfully in the treatment of psoriasis for over
30 years and is usually administered in an intermittent regimen such as once
weekly – similar regimens are currently in use in patients with RA
According to the National Psoriasis Foundation, as many as 7.5 million
Americans have psoriasis – and up to 25% of them have moderate-to-severe
disease
15
16. Current Dermatologist Prescribing Trends
• Psoriasis is treated by dermatologists who prescribe topical
(corticosteroids), conventional (MTX, cyclosporine) and
biologics (Enbrel, Humira, Stelara)
• Almost 50% of dermatologists prescribe MTX as the first
systemic drug for the treatment of moderate to severe
psoriasis
• Approximately 13% of currently treated psoriasis patients in
dermatology offices are prescribed MTX
• Managed care requires prior authorization and step therapy
prior to reimbursing biologics
• About one-third of eligible patients do not receive a biologic
due to reimbursement restrictions
• About one-third of patients are approved to receive biologics
Source: Decision Resources Report, November 2012, U.S. Payer and Prescribers Attitudes Novel Oral, Topical, and Biologic Emerging Agents in
the Psoriasis Market: Implications for Market Access
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17. VIBEX QS T for Testosterone Replacement
Therapy (TRT)
Potentially the first self administered auto injectable testosterone product for men
suffering from symptomatic testosterone deficiency (Low T)
Rx’s for current treatment options equal two-thirds topical gel testosterone and one third
intramuscular injections
U.S. sales of testosterone replacement therapies exceeded $1.6 billion* in 2011 – 5.6
million Rx’s, growing at 20% annually and projected to exceed $5 Billion in 2017**
Studies have shown that gel patients do not achieve adequate absorption or therapeutic
response, injection patients bear the cost and inconvenience of in-office deep
intramuscular injections every 2 to 4 weeks
Physicians surveyed believe weekly self-injection will improve patient compliance and
deliver optimized serum testosterone levels
Self contained Auto-injector avoids the transference issues seen with Gels (Black Box)
The New VIBEX QS is designed for use with highly viscous injections such as
testosterone
Novel spring mechanism – up to 1 ml capacity – highly compact device
Pre-IND meeting held with FDA on 12/5 – clinical path forward agreed upon with agency
Expected to go to market in 2016
Sources: *Bloomberg **Global Industry Analysts
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18. Teva and Antares: Our Broad Collaboration
Multiple agreements for diverse products with nearly
$3 billion in U.S. sales
Teva is a strong, international marketing partner
Tev-Tropin® Tjet® (reusable) hGH
Growing franchise for Teva, Tjet launched August 2009 – 10 mg due to launch in 2013
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
Vibex Epi filed with FDA – litigation settled – launch June 2015 pending FDA approval - Antares
receives margins on device sales, and mid to high single digit % royalty on overall product sales
Vibex Sumatriptan with U.S. rights – ANDA on file with FDA – upfront cash payment
received, milestone payment due on launch – 50/50 split of net profit margins
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 – Pen 1
505B2 program has completed PK work – Pen 2
Antares receives transfer price + margin on device sales, single digit to-mid teens % royalty
on overall product sales
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19. Tjet® Needle Free Device
HGH market is a good model for describing future biosimilar market
dynamics: Product differentiation is essential for capturing share
US Market
• Total U.S. 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
• sNDA for 10 mg filed Q312 – anticipate
approval and launch in 2013
EU Market
• European hGH market is approximately $500M
• Ferring’s Zomajet hGH sold more than $75M in 2011 (12% share including 10 mg)
• Zomajet uses Antares’ needle free technology
• Product continues to grow after six years
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20. Financial Overview
Cash Position
As of September 30th 2012 cash and investments of $33.2 million
No debt
Recently raised $53 million in October 2012
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% – On track
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21. Potential Timing of Product Launches
4.26.12
2017
Gelnique VIBEX QS M
3%
2016
VIBEX QS T
TEVA Pen 1
Pfizer OTC
2015
VIBEX EPI
TEVA Pen 2
(Europe)
2014
OTREXUP™
VIBEX Sumatriptan
ATRS LONG TERM GROWTH DRIVER:
2013 LAUNCH AT LEAST ONE PRODUCT PER
TevTropin YEAR FROM PIPELINE
10 mg
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22. Priority Goals for Next 12-18 Months
• VIBEX™ QS T (testosterone) to begin clinical studies
• VIBEX™ QS M to begin clinical studies
• Other Teva programs advance including first multi-dose
pen product filed (ANDA)
• International OTREXUP™ partnership
• TevTropin® 10 mg approval and launch
• Implement OTREXUP™ support infrastructure
• OTREXUP™ approval and launch – our transformational
event
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23. Paul
OUR MISSION IS TO DEVELOP AND
COMMERCIALIZE SELF-ADMINISTERED
PARENTERAL MEDICINES THAT OPTIMIZE
CLINICAL BENEFITS WITH ENHANCED COST
EFFECTIVE HEALTH OUTCOMES
