Antares presentation -_january_2014
Transcript of Antares presentation -_january_2014
32nd Annual J.P. Morgan Healthcare Conference January 16, 2014
Paul K. Wotton, Ph.D.
President and Chief Executive Officer
NASDAQ:ATRS
Paul
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, 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.
Safe Harbor Statement
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Overview of Q313 and Recent Events
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RESEARCH AND DEVELOPMENT
• Received approval from the U.S. Food and Drug Administration (FDA) for OTREXUP™ for the treatment of RA,
Psoriasis and JRA.
• Initiated a clinical study evaluating testosterone enanthate administered weekly by subcutaneous injection and
dosed the first testosterone deficient adult males using the VIBEX® Quick Shot™ auto injector device. Enrolment
was completed 11/12/13, audited results due in late February.
BUSINESS DEVELOPMENT
• Entered into an exclusive U.S. collaboration agreement with LEO Pharma for OTREXUP™ in Dermatology.
CORPORATE
• Elected Robert P Roche Jr. to the Board of Directors. Mr. Roche brings to Antares extensive commercial and
product launch experience.
• Appointed Dr. Bruce Freundlich as Senior Vice President, Medical. Dr. Freundlich’s experience both in industry and
academia as a practicing and highly regarded rheumatologist will be valuable as we commercialize OTREXUP™.
• Appointed David H. Bergstrom Ph.D. Senior Vice President Pharmaceutical Development. Dr. Bergstrom has
worked on multiple FDA approved products including 505B2 drug/device combination programs.
• Finalizing OTREXUP™ launch plan – Supply Chain, Reimbursement, Sales Force Training, and Launch Meeting all
in place.
• Ended the quarter with $70.0 million in cash and investments and no debt.
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ANTARES PHARMA
DEVICE/GEL SALES
• Royalties
• Royalties from
partnered products
• Elestrin®
• Gelnique™
• TevTropin®
DEVICE BUSINESS
• Teva Partnership
• Pfizer Partnership
• Potential Future
Partners
PRODUCT BUSINESS
• OTREXUP™
• LEO Derm Partnership
PIPELINE ENGINE
• QS T 2016
• QS M 2017
• Others TBD
Antares Business Structure
Partnerships Antares Commercial Business
L E O
Antares Pharma – 505(b)(2) Growth Engine
Novel route of administration
Enhanced Therapeutic
Value
Novel Device Platform
Identify unmet patient
need
Combine technology with known molecules
Specialty Target Segment with Differentiated
Products
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Powerful Engine and Disciplined Process for Creating Novel Products
~200 Compounds
Screened
>60 Feasible
Candidates
OTREXUP™
~30 Interesting
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
QS T
QS M
Additional Drug Products
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ATRS Technology Platform Built for Success Create Enhanced Products with Significant Sales Potential
Engineer Established Drugs for Clinical Advantage
Unique Technical Platform with IP Protection
NEEDLE FREE
TevTropin®
TevTropin® 10 mg
MULTI-DOSE PENS
TEVA PEN 1
TEVA PEN 2
MEDI-JET
OTREXUP™ VIBEX® QS T
VIBEX® QS M VIBEX® Epi
VIBEX® Suma
505(b)(2) Pipeline
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Advanced Product Pipeline
PRODUCT PRECLINICAL CLINICAL FILED MARKETED PARTNER APPROVED
TEVA – US
Ferring – EU
JCR – Japan
TevTropin®/ Zomajet®
Meda (US) Elestrin®
Actavis (US)
Daewoong (SK) Gelnique 3%™
TEVA Vibex® EPI ANDA
TEVA Vibex®
Sumatriptan ANDA
TEVA Pen 1 ANDA
ANTARES OTREXUP™
TEVA Pen 2 NDA
Population Council
NestraGel™ NDA
Pfizer Branded OTC Gel
Product NDA
ANTARES (TRT)
Vibex® QS T NDA
TevTropin® 10mg TEVA – US SNDA
ANTARES (Neurology)
Vibex® QS M NDA
Marketed Products
Pipeline Products
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A Compelling Opportunity
First and only FDA approved SC MTX product for
self administration now available to patients
Single use, once weekly disposable device
Dosages: 10, 15, 20 and 25mg
Oral MTX may not always provide an adequate response due to lack of efficacy or poor tolerability and has GI absorption limitations
OTREXUP™ (SC MTX) delivers greater bioavailability than oral MTX – systemic exposure of MTX from OTREXUP™ at all doses (10, 15, 20, and 25mg) was higher than that of oral MTX
Convenience – easy to use even for RA patients with moderate to severe hand impairment
Safety – avoid dosing errors and inadvertent exposure to cytotoxic agent through accidental needle sticks
OTREXUP™ addresses a large and growing RA and Psoriasis market
Switching to OTREXUP™ may extend the use of MTX as well as potentially reduce overall cost of the RA treatment continuum
Seven Orange Book listed patents with coverage ranging from 2019 - 2030
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OTREXUP™ Overview
RA Market Overview
Approximately 3,000 RHU specialists in USA Decile 4-10 RHU: ~2,500
Estimated 1.5 million people with RA in USA
RA Market continues to grow at similar rates (July 2012 MAT) $17B in Sales, up 14% vs. year ago 15.7m TRxs, up 3% vs. year ago
Biologics continue to dominate share of sales Humira – 25% Enbrel – 24% Remicade – 22% Rituxan – 18%
Methotrexate and hydroxychloroquine (Plaquenil) continue to lead TRx share Methotrexate – 36% Hydroxychloroquine – 28%
25%
24% 22%
18%
4%
2% 2% 1% 0% 1%
RA Market – Product $ Share
HUMIRA
ENBREL
REMICADE
RITUXAN
ORENCIA
CIMZIA
SIMPONI
ACTEMRA
METHOTREXATE
Other
36%
28%
10%
10%
6%
5% 1%
1% 1% 0% 0% 1%
RA Market – Product TRx Share
METHOTREXATE
HYDROXYCHLOROQUINE
HUMIRA
ENBREL
SULFASALAZINE
LEFLUNOMIDE
NEORAL
CIMZIA
SIMPONI
REMICADE
ORENCIA
Other
11 Note: Data do not reflect co-Rx of DMARD with Biologics
First-line Therapy Second-line Therapy Third-line Therapy Diagnosis
Key Findings for Newly Diagnosed Patients
Lines of Therapy in Rheumatoid Arthritis
43.8
% o
f dia
gnosed p
atients
movin
g to f
irst-
line in f
irst year
155 A
vg d
ays f
rom
Dx to 1
st R
x
46.4
% o
f firs
t-lin
e m
ovin
g to s
econd
-lin
e in f
irst ye
ar
27
2 A
vg d
ays o
n 1
st-
line b
efo
re 2
nd-l
ine
70.8
% o
f second
-lin
e m
ovin
g to third lin
e in f
irst year
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0 A
vera
ge d
ays o
n 2
nd-l
ine b
efo
re 3
rd-l
ine
Methotrexate 48.4%
Hydroxychloroquine/chloroquine 34.0%
Sulfasalazine 6.7%
Leflunomide 3.8%
Enbrel 3.2%
Humira 3.1%
Other conventional DMARDs 1.5%
Remicade 1.4%
Rituxan 0.8%
Orencia IV 0.6%
Simponi 0.2%
Cimzia 0.1%
Actemra 0.1%
Grand Total 103.9%
Methotrexate 57.0%
Hydroxychloroquine/chloroquine 32.1%
Enbrel 14.0%
Humira 13.1%
Leflunomide 12.6%
Sulfasalazine 12.1%
Remicade 5.4%
Other conventional DMARDs 2.4%
Simponi 2.4%
Orencia IV 1.7%
Cimzia 1.4%
Rituxan 0.7%
Actemra 0.2%
Grand Total 155.0%
Methotrexate 57.5%
Hydroxychloroquine/chloroquine 32.2%
Enbrel 16.9%
Humira 13.0%
Leflunomide 11.7%
Sulfasalazine 8.2%
Remicade 6.2%
Orencia IV 3.1%
Simponi 2.3%
Other conventional DMARDs 2.0%
Rituxan 1.7%
Cimzia 1.3%
Actemra 0.2%
Grand Total 156.3%
Nearly half of newly diagnosed, drug-treated RA patients received methotrexate as a first-line therapy
Note: Drugs with no measurable patient share are not shown. Percentages reflect distribution of patient share. Data represent patients newly diagnosed between January 1, 2009,
and June 30, 2009; the treatment progression of these patients was followed for 1095 days. Total percent of patients may exceed 100% due to combination therapy.
~50% of patients add or switch
to a biologic in < 36 months
OTREXUP™ In Dermatology – LEO Pharma
Exclusive U.S. collaboration agreement with LEO Pharma for OTREXUP™ in dermatology
LEO is a global leader in dermatology and topical treatments for psoriasis
Antares to receive up to $20 million in milestone payments including an upfront payment of $5 million
Antares will record all dermatology related product revenues
LEO will be responsible for promotion and marketing activities in dermatology supported by a sales force of 75 representatives
LEO has proven capabilities within life-cycle management focusing on innovative patient solutions in dermatology
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OTREXUP™Polyarticular Juvenile Arthritis
Polyarticular Juvenile Arthritis refers to a form of juvenile arthritis that causes joint inflammation and stiffness for more than six weeks in children under 16
About 30% of all children with juvenile arthritis have polyarticular disease and girls are two times more likely to have the disease than boys
Children with polyarticular juvenile arthritis are unlikely to outgrow the disease, therefore initial drug therapy should be aggressive in order to control the inflammatory process and relieve symptoms as quickly as possible
It is rare for NSAIDS alone to control the inflammatory process of polyarticular disease – methotrexate has been recognized as the standard therapy for children with this form of juvenile arthritis
OTREXUP™ label includes Juvenile Indication – 80% of prescriptions in this area written by same physicians as for Adult RA
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OTREXUP™ Launch Plan
OTREXUP™ NDA approved October 14 – launched!
OTREXUP™ Commercial Team – Broad Rheumatology expertise with over
100 years of combined commercial experience
DMs, Sales Representatives and NAMs possess extensive experience in
marketing rheumatoid arthritis drugs and will be Quintiles employees
dedicated solely to the marketing of OTREXUP™
Six MSL’s providing value proposition to Key Opinion Leaders in RA
Feedback from AMCP validates pricing strategy – $548 per Rx (4 weeks)
Discussions with pharmacy and medical directors suggest initial tier 3
access with several plans already mentioning the possibility of tier 2 access
Leo will launch to dermatologists in February with 75 Representatives
bringing total number of OTREXUP™ sales personnel to over 100
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OTREXUP™ Launch Success Factors
Enthusiasm by Rheumatologists and Dermatologists
Market Access Through Managed Care
Understanding the value proposition of OTREXUP™
ATRS Managed Markets Group working since June
Initial Tier 3 coverage with potential for Tier 2
coverage
Risk Mitigation With LEO Partnership
“First Impressions” Program educating Physicians,
Nurses and Patients
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VIBEX QS Testosterone
First testosterone jet-injector for treatment of Low T
Single use, disposable VIBEX™ QS device engineered to deliver high viscosity products through fine (27 gauge) needle with 1 ml capacity
Quick, easy and painless – less than 5 seconds to inject
Once a week injection optimizes blood levels
Peak: Trough ratio reduced compared to once or twice a month administration
Many untreated Low-T patients in the U.S. with growing awareness
Three-year development program to NDA – Projected launch in 2016
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QS T Competing in Changing TRT Market
0
1
2
3
4
5
6
2008 2009 2010 2011 2012 2013
0.5 0.7
1.0
1.5
2.1 2.4
2.7
3.1 3.4
3.9
5.1 4.9
Pre
scri
pti
on
s in
Mill
ion
s
Year Injectable Testosterone
Topical Testosterone
Source: Bloomberg/Wolters Kluwer Prescription Data
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TRT Market Overview
• Injectables continue to
show strong growth
• Antares well positioned to
take advantage of the
injectables growth
segment with QuickShot™
Testosterone
• Gel market growth is
slowing in 2013 due in
large part to: – Switching of patients from
gels to injectables
– Side effect (transference)
issues
VIBEX QS T – Testosterone Replacement Therapy (TRT)
U.S. sales of testosterone replacement therapies exceeded $2.7 billion* in 2013 – 7.3 million Rx’s, growing at ~18% 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)
Pre-IND meeting held with FDA on 12/5/12 – clinical path forward agreed upon with agency
First patients dosed 9/16/13 – 2015 NDA filing on track
Expected to go to market in 2016
19 Sources: *Bloomberg **Global Industry Analysts
Financial Overview
Cash Position
As of September 30th 2013 cash and investments of $70 million
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 total revenues $22.6 million (37% over 2011)
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Priority Goals for Next 12-18 Months
OTREXUP™ partnership – Completed
OTREXUP™ launched in Q1 2014 for RA and Psoriasis (LEO)
• VIBEX™ QS T (testosterone) will complete clinical studies
• VIBEX™ QS M to begin clinical studies
• Teva programs – two multi-dose pen products filed
• TevTropin® 10 mg approval and launch
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