Cowen and Company 35 Annual...Cowen and Company 35th Annual Healthcare Conference March 2, 2015...

31
Eamonn P. Hobbs President and Chief Executive Officer Cowen and Company 35 th Annual Healthcare Conference March 2, 2015 NASDAQ: ATRS

Transcript of Cowen and Company 35 Annual...Cowen and Company 35th Annual Healthcare Conference March 2, 2015...

Page 1: Cowen and Company 35 Annual...Cowen and Company 35th Annual Healthcare Conference March 2, 2015 NASDAQ: ATRS NASDAQ: ATRS Safe Harbor Statement This presentation may contain forward-looking

Eamonn P. Hobbs President and Chief Executive Officer

Cowen and Company 35th Annual Healthcare Conference March 2, 2015

NASDAQ: ATRS

Page 2: Cowen and Company 35 Annual...Cowen and Company 35th Annual Healthcare Conference March 2, 2015 NASDAQ: ATRS NASDAQ: ATRS Safe Harbor Statement This presentation may contain forward-looking

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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Page 3: Cowen and Company 35 Annual...Cowen and Company 35th Annual Healthcare Conference March 2, 2015 NASDAQ: ATRS NASDAQ: ATRS Safe Harbor Statement This presentation may contain forward-looking

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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.

Page 4: Cowen and Company 35 Annual...Cowen and Company 35th Annual Healthcare Conference March 2, 2015 NASDAQ: ATRS NASDAQ: ATRS Safe Harbor Statement This presentation may contain forward-looking

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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

Page 5: Cowen and Company 35 Annual...Cowen and Company 35th Annual Healthcare Conference March 2, 2015 NASDAQ: ATRS NASDAQ: ATRS Safe Harbor Statement This presentation may contain forward-looking

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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

Page 6: Cowen and Company 35 Annual...Cowen and Company 35th Annual Healthcare Conference March 2, 2015 NASDAQ: ATRS NASDAQ: ATRS Safe Harbor Statement This presentation may contain forward-looking

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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)

Page 7: Cowen and Company 35 Annual...Cowen and Company 35th Annual Healthcare Conference March 2, 2015 NASDAQ: ATRS NASDAQ: ATRS Safe Harbor Statement This presentation may contain forward-looking

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Proprietary

Products

QuickShot®

Testosterone

QuickShot®

M (CNS)

OTREXUP™

Legacy/Royalty Products

Page 8: Cowen and Company 35 Annual...Cowen and Company 35th Annual Healthcare Conference March 2, 2015 NASDAQ: ATRS NASDAQ: ATRS Safe Harbor Statement This presentation may contain forward-looking

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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

Page 9: Cowen and Company 35 Annual...Cowen and Company 35th Annual Healthcare Conference March 2, 2015 NASDAQ: ATRS NASDAQ: ATRS Safe Harbor Statement This presentation may contain forward-looking

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Page 10: Cowen and Company 35 Annual...Cowen and Company 35th Annual Healthcare Conference March 2, 2015 NASDAQ: ATRS NASDAQ: ATRS Safe Harbor Statement This presentation may contain forward-looking

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

Page 11: Cowen and Company 35 Annual...Cowen and Company 35th Annual Healthcare Conference March 2, 2015 NASDAQ: ATRS NASDAQ: ATRS Safe Harbor Statement This presentation may contain forward-looking

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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Page 12: Cowen and Company 35 Annual...Cowen and Company 35th Annual Healthcare Conference March 2, 2015 NASDAQ: ATRS NASDAQ: ATRS Safe Harbor Statement This presentation may contain forward-looking

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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

Page 13: Cowen and Company 35 Annual...Cowen and Company 35th Annual Healthcare Conference March 2, 2015 NASDAQ: ATRS NASDAQ: ATRS Safe Harbor Statement This presentation may contain forward-looking

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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

0

200

400

600

800

1000

1200

1400

1600

1800

2000

we

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46

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48

wee

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50

wee

k 5

1w

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52

Source: Symphony Health Solutions Weekly Phast, Time aligned per product launch

OTREXUP

Rayos

Xeljanz

Orencia

Benlysta Rasuvo

Page 14: Cowen and Company 35 Annual...Cowen and Company 35th Annual Healthcare Conference March 2, 2015 NASDAQ: ATRS NASDAQ: ATRS Safe Harbor Statement This presentation may contain forward-looking

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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

10.0 10.7

11.7

12.8 13.6

12.1

14.3

12.9

15.6 15.2

14.8

16.6

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

0.0

5.0

10.0

15.0

20.0

25.0

wee

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2

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)

Page 15: Cowen and Company 35 Annual...Cowen and Company 35th Annual Healthcare Conference March 2, 2015 NASDAQ: ATRS NASDAQ: ATRS Safe Harbor Statement This presentation may contain forward-looking

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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

Page 16: Cowen and Company 35 Annual...Cowen and Company 35th Annual Healthcare Conference March 2, 2015 NASDAQ: ATRS NASDAQ: ATRS Safe Harbor Statement This presentation may contain forward-looking

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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

1

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

2

3

Page 17: Cowen and Company 35 Annual...Cowen and Company 35th Annual Healthcare Conference March 2, 2015 NASDAQ: ATRS NASDAQ: ATRS Safe Harbor Statement This presentation may contain forward-looking

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Proprietary

Products

Pipeline

QuickShot® Testosterone

QuickShot® M (CNS)

Page 18: Cowen and Company 35 Annual...Cowen and Company 35th Annual Healthcare Conference March 2, 2015 NASDAQ: ATRS NASDAQ: ATRS Safe Harbor Statement This presentation may contain forward-looking

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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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Page 19: Cowen and Company 35 Annual...Cowen and Company 35th Annual Healthcare Conference March 2, 2015 NASDAQ: ATRS NASDAQ: ATRS Safe Harbor Statement This presentation may contain forward-looking

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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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Page 20: Cowen and Company 35 Annual...Cowen and Company 35th Annual Healthcare Conference March 2, 2015 NASDAQ: ATRS NASDAQ: ATRS Safe Harbor Statement This presentation may contain forward-looking

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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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Page 21: Cowen and Company 35 Annual...Cowen and Company 35th Annual Healthcare Conference March 2, 2015 NASDAQ: ATRS NASDAQ: ATRS Safe Harbor Statement This presentation may contain forward-looking

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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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Page 22: Cowen and Company 35 Annual...Cowen and Company 35th Annual Healthcare Conference March 2, 2015 NASDAQ: ATRS NASDAQ: ATRS Safe Harbor Statement This presentation may contain forward-looking

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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

Page 23: Cowen and Company 35 Annual...Cowen and Company 35th Annual Healthcare Conference March 2, 2015 NASDAQ: ATRS NASDAQ: ATRS Safe Harbor Statement This presentation may contain forward-looking

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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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Page 24: Cowen and Company 35 Annual...Cowen and Company 35th Annual Healthcare Conference March 2, 2015 NASDAQ: ATRS NASDAQ: ATRS Safe Harbor Statement This presentation may contain forward-looking

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Complex

Generic

Products

VIBEX® Sumatriptan

Page 25: Cowen and Company 35 Annual...Cowen and Company 35th Annual Healthcare Conference March 2, 2015 NASDAQ: ATRS NASDAQ: ATRS Safe Harbor Statement This presentation may contain forward-looking

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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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Page 26: Cowen and Company 35 Annual...Cowen and Company 35th Annual Healthcare Conference March 2, 2015 NASDAQ: ATRS NASDAQ: ATRS Safe Harbor Statement This presentation may contain forward-looking

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Alliance

Products

VIBEX® Epinephrine

Exenatide – “Pen 2”

“Pen 1”

OTC Gel Product

Life Cycle

Management

Page 27: Cowen and Company 35 Annual...Cowen and Company 35th Annual Healthcare Conference March 2, 2015 NASDAQ: ATRS NASDAQ: ATRS Safe Harbor Statement This presentation may contain forward-looking

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.

Page 28: Cowen and Company 35 Annual...Cowen and Company 35th Annual Healthcare Conference March 2, 2015 NASDAQ: ATRS NASDAQ: ATRS Safe Harbor Statement This presentation may contain forward-looking

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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Page 29: Cowen and Company 35 Annual...Cowen and Company 35th Annual Healthcare Conference March 2, 2015 NASDAQ: ATRS NASDAQ: ATRS Safe Harbor Statement This presentation may contain forward-looking

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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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Page 30: Cowen and Company 35 Annual...Cowen and Company 35th Annual Healthcare Conference March 2, 2015 NASDAQ: ATRS NASDAQ: ATRS Safe Harbor Statement This presentation may contain forward-looking

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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

Page 31: Cowen and Company 35 Annual...Cowen and Company 35th Annual Healthcare Conference March 2, 2015 NASDAQ: ATRS NASDAQ: ATRS Safe Harbor Statement This presentation may contain forward-looking

Eamonn P. Hobbs President and Chief Executive Officer

Cowen and Company 35th Annual Healthcare Conference March 2, 2015

NASDAQ: ATRS