Cowen and Company 35 Annual...Cowen and Company 35th Annual Healthcare Conference March 2, 2015...
Transcript of Cowen and Company 35 Annual...Cowen and Company 35th Annual Healthcare Conference March 2, 2015...
Eamonn P. Hobbs President and Chief Executive Officer
Cowen and Company 35th Annual Healthcare Conference March 2, 2015
NASDAQ: ATRS
NASDAQ: ATRS
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 sales growth of Otrexup,
timing of regulatory approval of products in development and the clinical benefits of those products, actions of third-party
partners and regulatory actions related to their products, anticipated operating losses, uncertainties associated with
research, development, testing and related regulatory approvals, outcomes of clinical trials and timing of release of data
therefrom; unproven markets, future capital needs and uncertainty of additional financing, competition, uncertainties
associated with intellectual property, complex manufacturing, quality requirements, dependence on third-party
manufacturers, suppliers and collaborators, outcomes of litigation, lack of sales and marketing experience, the impact of
moving from a contract sales force to hiring field-based sales representatives, 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, 2013. 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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NASDAQ: ATRS
Antares Pharma – Our Strategic Roadmap
Antares Pharma is a unique U.S.-based, specialty
pharmaceutical company
Our formula for success combines optimized drug formulations
with unique delivery devices to create high performance
combination products
Our Business Model consists of “Three Strategic Legs on the
Stool” with programs in each Leg proceeding in parallel.
NASDAQ: ATRS
Leveraging Technology For Growth
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PROPRIETARY PRODUCTS ALLIANCE PRODUCTS
OTREXUP™
QuickShot® Testosterone
QuickShot® M (CNS)
Elestrin®
Gelnique 3%™
Epinephrine Pen
Exenatide Pen
Teva “Pen 1”
Pfizer OTC Gel
Undisclosed Life Cycle Management
TevTropin®/Zomajet®
COMPLEX GENERICS
VIBEX® Sumatriptan
Antares Business Strategy
NASDAQ: ATRS
Proven Device Technology Platform
» VIBEX and Needle-Free devices approved for
marketing various products in U.S., E.U. & Japan
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VIBEX ® Auto Injector 01
QuickShot ® Auto Injector 02
Needle Free 03
Multi-Dose Pens 04
NASDAQ: ATRS
2015 Potential Catalysts
QuickShot® Testosterone – Released top-line pharmacokinetic
results from Phase 3 study – February 25, 2015
OTREXUP™ prescription growth
VIBEX® Epinephrine Pen (Teva)
Shipment of auto injector launch quantities to begin in Q1
Approval and Therapeutic Equivalence decision by FDA
VIBEX® Sumatriptan approval (Antares)
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Proprietary
Products
QuickShot®
Testosterone
QuickShot®
M (CNS)
OTREXUP™
Legacy/Royalty Products
NASDAQ: ATRS
Antares Proprietary Products
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Approved in U.S. and launched by Antares Q1 2014 for the
treatment of rheumatoid arthritis (“RA”); LEO Pharma Inc. is
promoting the psoriasis indication.
Phase 3 pharmacokinetic (“PK”) study enrollment complete
and top-line data reported February 25, 2015; working with
FDA to determine next steps toward registration based on
recommendations received on January 9, 2015.
Undisclosed neurology product currently in
preclinical development.
Elestrin® is marketed in the U.S. by Meda
Pharma, and Gelnique 3%™ is market by
Actavis PLC in the U.S.
OTREXUP™
QuickShot® Testosterone
Legacy / Royalty Products
QuickShot® M
NASDAQ: ATRS
NASDAQ: ATRS OTREXUP™ (methotrexate) Injection for Subcutaneous (SC) Use
< First approved methotrexate for SC injection in the U.S. >
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Single-use, disposable & easy to use
Collar activated, no push button, easy to grip and virtually painless
Needle guard prevents accidental sticks
Audible click followed by red indicator to confirm injection is complete
Approved in 7.5, 10, 15, 20 & 25 mg color-coded doses. 10 mg device shown
OTREXUP’s UNIQUE DESIGN & FUNCTION
OTREXUPTM (methotrexate) injection [prescribing information]. Ewing, NJ: Antares Pharma, Inc; 2013
NASDAQ: ATRS Published Literature Would Suggest that MTX is the Cornerstone of RA Therapy
Most rheumatologists use oral MTX as first-line therapy for RA
o Many patients will have a good to excellent response to MTX monotherapy
Reasons for discontinuation of oral MTX are usually lack of efficacy or poor tolerability
Patients who have inadequate response to oral MTX for reasons of tolerability or efficacy may continue to derive benefit from MTX via optimization with SC administration.
o Improved bioavailability
o Improved efficacy
o Improved tolerability
Braun, et al (2008) – Kremer, et al (2009) – Bakker, et al (2011) – O’Dell et al (2011) – Schipper, et al (2011) – Fitzpatrick, et al (2011)
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OTREXUP™: Oral MTX Exposure Plateaus ≥15 mg/week
3000
0
MTX Dose (mg)
Mea
n A
UC
(n
gh
/mL)
Oral MTX (n=47)
Otrexup SC MTX
Auto Injector(n=47)
2600
2200
1800
1400
1000
10 15 20 25
• Oral MTX has GI absorption
limitations
• Bioavailability following oral
dosing showed a plateau effect
at doses of 15mg and greater1
• The systemic exposure of MTX
from Otrexup™ at doses of 10,
15, 20, and 25mg was higher
than that of oral MTX by 17, 13,
31, and 36%, respectively1
1. OtrexupTM [prescribing information], 2013. 2. Schiff MH, et al. Arthritis Rheum. 2013; 65 (10 suppl): S337-338/Phase 2 data
The OTREXUP™ Value Proposition = Increased Bioavailability
NASDAQ: ATRS
OTREXUP™ vs. Other Recent In-Category Launches
4 7 22 50 65 76 92
136 164 155 138
163 199
227 218 204 249 267
293 321 339
303 358
322
390 381 369 416
464 472 430 435
464
523 548
411
475
573 530
463
524 559
479 529 520 515
484 468 462
525 532 515
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Source: Symphony Health Solutions Weekly Phast, Time aligned per product launch
OTREXUP
Rayos
Xeljanz
Orencia
Benlysta Rasuvo
NASDAQ: ATRS
OTREXUP™ TRx Per Rep vs. Xeljanz, Rayos and Rasuvo
0.2 0.3 0.9
2.0 2.6
3.0 3.7
5.4
6.6 6.2
5.5
6.5
8.0
9.1 8.7
8.2
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12.8 13.6
12.1
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12.9
15.6 15.2
14.8
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18.6 18.9
17.2 17.4
18.6
20.9
21.9
16.4
19.0
22.9
21.2
18.5
21.0
22.4
19.2
21.2 20.8 20.6
19.4 18.7 18.5
21.0 21.3 20.6
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20.0
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TRx per territory Xeljanz: 160 reps (80 territories) Rayos: 40 reps (40 territories)
Otrexup: 25 reps (25 territories) Rasuvo: 27 reps (27 territories)
Source: Symphony Health Solutions Weekly Phast, Time aligned per product launch
OTREXUP
Rayos (Horizon)
Xeljanz (Pfizer)
Rasuvo (Medac)
NASDAQ: ATRS
OTREXUP™ Month-Over-Month TRx Growth 2014 - 2015
2 91
403
677
1027
1298
1613
1832
2033
2299 2144
2295 2140
0
500
1000
1500
2000
2500
Jan Feb Mar Apr May Jun Jul Aug Sep Oct Nov Dec Jan
Otrexup TRx=17,854
Source: Symphony Health Solutions
NASDAQ: ATRS
Plans to Grow OTREXUP™ Scripts in 2015
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Convert contract sales reps and build an Antares
sales force
Increase the number of sales territories
Replace under-performing reps
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Improve hub services to assist physicians with
reimbursement process
Launch new patient starter kits for use during the hub
reimbursement process
Contract with Managed Care Organizations on fiscally
responsible basis
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Proprietary
Products
Pipeline
QuickShot® Testosterone
QuickShot® M (CNS)
NASDAQ: ATRS
QuickShot® Testosterone
Potentially the first at-home auto injector for subcutaneous treatment of low testosterone (Low T)
Single use, disposable QuickShot® device engineered to deliver high viscosity products through fine (27 gauge) needle with 1 ml capacity
Designed to be quick, easy and painless – approximately 5 seconds to self-inject
Once a week injection potentially optimizes blood levels – Peak/Trough ratio reduced versus once or twice a month IM administration
Designed to eliminate transference issue associated with gels
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NASDAQ: ATRS
Status of Testosterone Replacement Therapy (TRT)
September 2014 FDA Advisory Committee presentations show no adverse
event data to support claims of increased cardiovascular risk and indicate
more diligent screening for low T diagnosis is necessary. FDA stated that
more data is needed to support age-related Low T indication.
We believe that with proper screening, our QuickShot® Testosterone product:
o Will eliminate transference issues
o May eliminate painful intramuscular injections and the peaks and troughs
associated with bi-weekly administration
o May improve compliance
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NASDAQ: ATRS
Phase 2 (QS T-13-002) Results Overview
QS T dosed at 50 mg and 100 mg
6 weekly doses
Standard PK endpoints
o 29 adult males with low T were randomized into two groups – one
group receiving 50 mg testosterone and the other 100 mg
testosterone
The study demonstrated rapid restoration and consistent
maintenance of steady testosterone blood levels
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NASDAQ: ATRS
Pivotal Phase 3 (QS T-13-003) Overview
150 adult men enrolled
o Documented diagnosis of hypogonadism or testosterone deficiency defined as having repeated testosterone levels below 300 ng/dL
Patients meeting eligibility criteria were assigned a starting dose of 75 mg QS T once weekly for six weeks
Blinded adjustments to dose are made at week 7 based upon the week 6 pre-dose blood level
Efficacy of QS T and dose adjustment to regulate testosterone levels evaluated after 12 weeks of treatment
Patients then followed for additional 40 weeks
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NASDAQ: ATRS
QST-13-003 Pharmacokinetic Results
Population/Analysis Cavg Lower limit of the 95% 2-
sided C. I.
C avg % in Range 300 – 1100 ng/dL
n (%)
Cmax <1500 ng/dL n (%)
Cmax >1800 ng/dL n (%)
Primary analysis* N=150 87.3% 139 (92.7%) 137 (91.3%)** 0%
Completers N=137 94.8% 135 (98.5%) 137 (100%) 0%
Protocol-Required Outcomes ≥65% 75% ≥85% ≤5%
* All patients with 1 or more doses, Cavg 0-168 hours post week 12 injection or last measured concentration carried forward
**Patients without a Cmax determination at week 12 are assigned above 1500 ng/dL
NASDAQ: ATRS
Updates to QS T Program
Received written recommendations from FDA on January 9, 2015.
Antares believes that many of the recommendations cited in the advice letter are already included in the protocols of the ongoing phase 3 study as a result of guidance provided by FDA at the May 2014 Type C meeting.
Antares Pharma is assessing the FDA’s comments in the advice letter and their impact on the timing of the filing of a New Drug Application for QS T with FDA.
o FDA has recommended a larger safety database, including approximately 350 subjects exposed to QS T with 200 subjects exposed for six months and 100 subjects exposed for a year.
o May need approximately 70 additional subjects exposed to QS T for six months based on number of subjects in previous studies and in current phase 3 study
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Complex
Generic
Products
VIBEX® Sumatriptan
NASDAQ: ATRS
VIBEX® Sumatriptan
ANDA amendments filed with the FDA in the first half of 2014
Antares will hold marketing authorization
Teva will be distribution partner
o Antares to receive undisclosed milestone upon launch
o Net profit split 50/50 between parties
Complete Response Letter received January 2015 provided labeling revisions and cited minor deficiencies
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Alliance
Products
VIBEX® Epinephrine
Exenatide – “Pen 2”
“Pen 1”
OTC Gel Product
Life Cycle
Management
NASDAQ: ATRS High Quality Partners Validate Device Expertise & Provide Financial Benefits Over Life Cycle
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PROJECT PHASE FINANCIAL BENEFITS
Signing Upfront payments - Amortized over contract term.
Development All costs incurred (expense & capital) are covered plus a reasonable margin.
May involve milestone payments for success.
Commercialization Supply agreement for manufacture of devices plus a royalty on net sales.
NASDAQ: ATRS Broad Device Collaboration with Teva Pharmaceutical Industries, Ltd.
VIBEX®
Epinephrine o Teva filed final amendment with FDA December 2014
o Antares receives margins on device sales, and high single-digit royalty on overall product sales
o Antares to manufacture and ship substantial device quantities beginning early 2015
o Teva has projected 2015 launch pending FDA approval and AB rating decision
Exenatide – “Pen 2” o Teva filed ANDA with FDA in October 2014
o AstraZeneca and Amylin filed Paragraph IV certification in December 2014
o Antares receives margin on supply agreement and single digit to mid-teens royalty on overall product sales
“Pen 1” o 505 (b) 2 program has completed PK work in Europe
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NASDAQ: ATRS
Additional Partnership Products in Place
Pfizer – Undisclosed Branded OTC Gel Product
o Currently in Phase 3 clinical development
o Pfizer assumes full cost and responsibility for clinical development, manufacturing and commercialization
o Antares receives development and sales based milestones and royalties on net sales for 3 years post launch
Undisclosed Partnership
o Life cycle management (LCM) project announced in Q3 2014 – currently in clinical development
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NASDAQ: ATRS
Antares Pharma – A Compelling Investment Opportunity
• QuickShot® Testosterone – Released top-line pharmacokinetic results from
Phase 3 study – February 25, 2015
• OTREXUP™ prescription growth
• VIBEX® Epinephrine Pen (Teva)
Shipment of auto injector launch quantities to begin in Q1
Approval and Therapeutic Equivalence decision by FDA
• Sumatriptan Pen approval
2015 Potential Catalysts
Eamonn P. Hobbs President and Chief Executive Officer
Cowen and Company 35th Annual Healthcare Conference March 2, 2015
NASDAQ: ATRS