Investor presentation new 2013 master

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Investor presentation new 2013 master

Investor presentation new 2013 master

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  • 1. Paul OUR MISSION IS TO DEVELOP AND COMMERCIALIZE SELF-ADMINISTERED PARENTERAL MEDICINES THAT OPTIMIZECLINICAL BENEFITS WITH ENHANCED COST EFFECTIVE HEALTH OUTCOMES
  • 2. Safe Harbor StatementThis presentation may contain forward-looking statements which are made pursuant to thesafe harbor provisions of Section 21E of the Securities Exchange Act of 1934 and the PrivateSecurities Litigation Reform Act of 1995. Investors are cautioned that statements which arenot strictly historical statements, including, without limitation, statements regarding theplans, objectives and future financial performance of Antares Pharma, constitute forward-looking statements which involve risks and uncertainties. The Company’s actual resultsmay differ materially from those anticipated in these forward-looking statements basedupon a number of factors, including anticipated operating losses, uncertainties associatedwith research, development, testing and related regulatory approvals, unproven markets,future capital needs and uncertainty of additional financing, competition, uncertaintiesassociated with intellectual property, complex manufacturing, high quality requirements,dependence on third-party manufacturers, suppliers and collaborators, lack of sales andmarketing experience, loss of key personnel, uncertainties associated with marketacceptance and adequacy of reimbursement, technological change, and governmentregulation. 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 ExchangeCommission from time to time, including its Annual Report on Form 10-K for the yearended 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 onlyas of the date of this presentation. The Company undertakes no obligation to update anyforward-looking information contained in this presentation. 2
  • 3. Antares BackgroundAntares is a revenue generating state-of-the-art Specialty PharmaceuticalCompany with a late stage growing pipeline of drug/device combinationproducts based on VIBEX™, multi-dose pen and needle-free technologiesWe have demonstrated significant clinical and regulatory expertise indrug/device combination products coupled with a comprehensive IPportfolio which gives us a sustainable competitive advantage in thisfieldOTREXUP™ successfully completed multiple clinical trials forRheumatoid Arthritis patients, NDA submitted 12/14/12VIBEX QS T entering the clinic in 2013 – New pipeline program VIBEX QSM initiatedStrong 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. 3
  • 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 4
  • 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 5
  • 6. Advanced Injectable Products PortfolioThe only US based Company with proprietary Auto-Injector, Multi-dose Penand Needle Free Injection Technology Device Platforms, protected by strongintellectual propertyOTREXUP™ is designed to make self-administration of MTX easier for RApatients with moderate to severe hand function impairment and was developedwith a goal to optimize the clinical benefit of MTXVIBEX™-QS is designed to enhance the administration and performance ofcomplex and difficult to inject viscous medicines such as testosterone, biologicsor bio-similarsThrough our partnership with Teva we are developing five uniquely differentinjectable products in our leading edge design and engineering facility inMinneapolis  Tjet® for Teva’s recombinant human growth hormone – TevTropin®  An alternative to the EpiPen®  Three additional high quality products for self-administered medicines 6
  • 7. OTREXUP™ OverviewA 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 8
  • 8. 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 9
  • 9. 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 10
  • 10. OTREXUP™ Systemic Availability Study: OralMTX Exposure Plateaus Above ~15mg/wk Dosing 3000 2500 Systemic Availability 2000 Oral MTX 1500 Otrexup 1000 500 10mg 15mg 20mg 25mg MTX Dose (mg) Relative Systemic Availability at 10mg, 15mg, 20mg and 25mg was 121%, 114%, 131% and 141%, respectively 11
  • 11. 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 12
  • 12. Recent Clinical and Pharmacoeconomic ResearchReinforces 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. 13
  • 13. 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 ofMTX and mortality in a large cohort of RA patients followed upprospectively for 25 years. These findings have implications for theuse of MTX in the treatment of RA. Our results support theongoing use of MTX as a cornerstone of RA treatment, with asurvival benefit independent of its effects on pain and functionallimitations. For patients in whom MTX monotherapy does notachieve complete control, add-on therapy may be more appropriatethan switching to other medications, as MTX may still carry asurvival benefit”. 14
  • 14. OTREXUP™ For Psoriasis Potential New IndicationPsoriasis is a common chronic skin disorder affecting men and women equallybeginning at any age between 20 and 30, or 50 and 60Both topical and systemic therapies are available for the treatment of psoriasisMild-to-moderate skin disease can often be managed with topical agents whilepatients with moderate-to-severe disease may need systemic therapy withmethotrexateThere is ample evidence of efficacy with newer systemic therapies such asbiologics; however, established therapies such as methotrexate andphototherapy continue to play a role in the management of moderate-to-severeplaque psoriasisMethotrexate has been used successfully in the treatment of psoriasis for over30 years and is usually administered in an intermittent regimen such as onceweekly – similar regimens are currently in use in patients with RAAccording to the National Psoriasis Foundation, as many as 7.5 millionAmericans have psoriasis – and up to 25% of them have moderate-to-severedisease 15
  • 15. 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 16
  • 16. 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 2016Sources: *Bloomberg **Global Industry Analysts 17
  • 17. 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 18
  • 18. Tjet® Needle Free Device HGH market is a good model for describing future biosimilar market dynamics: Product differentiation is essential for capturing shareUS 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 2013EU 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 19
  • 19. Financial OverviewCash Position As of September 30th 2012 cash and investments of $33.2 million No debt Recently raised $53 million in October 2012Growing 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 20
  • 20. Potential Timing of Product Launches 4.26.12 2017Gelnique 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 21
  • 21. 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 22
  • 22. Paul OUR MISSION IS TO DEVELOP AND COMMERCIALIZE SELF-ADMINISTERED PARENTERAL MEDICINES THAT OPTIMIZECLINICAL BENEFITS WITH ENHANCED COST EFFECTIVE HEALTH OUTCOMES