Intersect ENT Company Overview (XENT)

7/25/2019 Intersect ENT Company Overview (XENT)

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JUNE 2016

Company Presentation


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Forward-Looking Statements

1

Certain statements in this presentation constitute forward-looking statements withinthe meaning of the Securities Act of 1933, as amended (the Securities Act ), and

Securities Exchange Act of 1934, as amended ( Exchange Act ), including, without

limitation, statements regarding our outlook for financial performance, sales force growth,

clinical studies, approval of new products and indications and the receipt of reimbursement

coverage. We intend these forward-looking statements to be covered by the safe harbor

provisions for forward-looking statements contained in the Securities Act and the Exchange

Act and are making this statement for purposes of complying wi th those safe harbor

provisions. These forward-looking statements reflect our current views about our plans,intentions, expectations, strategies and prospects, which are based on the information

currently available to us and on assumptions we have made. Although we believe that our

plans, intentions, expectations, strategies and prospects as reflected in or suggested by those

forward-looking statements are reasonable, we can give no assurance that the plans,

intentions, expectations or strategies will be attained or achieved. Furthermore, actual results

may differ materially from those described in the forward-looking statements and will

be affected by a variety of risks and factors that are beyond our control, including those risksand uncertainties d iscussed under Risk Factors in our 10-K f iling dated February 25, 2016

and subsequent quarterly filings with the SEC. All information in this presentation is as of the

date of this presentation, and we undertake no duty to update this information unless required

by law.


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Our FocusChronic Sinusitis30M+ Patients

in US

Our SolutionsLocal, SustainedDrug Delivery via

Dissolvable Implants

Improving Quality of Life for Ear, Nose and Throat Patients

2


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Chronic Sinusit is

3

DEBILITATING, COSTLY CONDITION

There Is a Better Way

LIMITED TREATMENT

Source: DeConde et. al., Chronic Rhinosinusitis: Epidemiology and Burden of Disease, Am J of Rhinol Allergy 30. 134-139, 2016

$3,920

$5,266

$5,755

$7,261

$10,007

Diabetes

Heart Disease

Chronic Migrane

Severe Asthma

Refractory CRS

Annual Productivity Loss


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Challenges Across the Continuum of Careto Create and Maintain Sinus Patency and to Treat

Inflammation

CS Treatment Pathway

4

Oral Steroids ReduceInflammation but CanCause Side Effects

MEDICATIONTO TREAT

Surgery Opens Pathways butCan Result in Post-Operative

Scarring and Inflammation

SURGERYTO OPEN (FESS)

Within One Year, 64% haveSymptom Recurrence and

10% have Revision Surgery

MANAGEMENTTO MAINTAIN


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Mechanical Spacing and Local Drug DeliveryBioabsorbable Implant Technology

Portfolio Across Continuum of Care

5NOVA and RESOLVE are investigational and not currently available for sale in the United States.The implants are limited by federal (or United States) law to investigational use only.

PRIMARY CSOffice

RECURRENT CSOffice

FESSSurgery

NOVA RESOLVEPROPEL

Designed forNeeds of Disease

Progression


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Large US Market Opportunity

6

PATIENTS 800K 540K 635K

SIZE $1.1B $830M $1.3B

$3B+ in US

NOVA and RESOLVE are investigational and not currently available for sale in the United States.The implants are limited by federal (or United States) law to investigational use only.

PRIMARY CSOffice

RECURRENT CSOffice

FESSSurgery

NOVA RESOLVEPROPEL

Estimated Market Opportunity


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Intersect ENT Opportunity

7

LARGEMARKET $3B+ TAM in US

UNIQUEPRODUCTS1st and Only Drug ReleasingImplants in ENT

PRODUCTPIPELINE

In-Office Products toServe Continuum of Care

COMMERCIALGROWTH

REVENUE ($M)

2012 2013 2014 2015

$5.9

$17.9

$38.6

$61.6M

Track Record of Revenue &Gross Margin Growth


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Two Commercial Products

8

1st Drug Releasing Implants for Chronic Sinusitis Patients

Only PMA Approval

for CS Patients

>100,000 Patients

to Date

IMPROVINGSURGICAL OUTCOMES

Reduced Inflammation, Scarring and Needfor Additional Surgery and Oral Steroids


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PROPEL / PROPEL MINI

How It Works

9

Advanced intoSurgically Enlarged

Sinus Cavity

OPENS

Self-Expanding ImplantConforms to and

Holds Open Sinus

DELIVERS

Sustained, TargetedDelivery of Steroid

Over 30 Days

MAINTAINS

Opening by ReducingPost-Operative

Inflammation and Scarring

ETHMOID SINUS
http://../Propel%20Placement%20Video%20MP4%20format%2083111.mp4http://../Propel%20Placement%20Video%20MP4%20format%2083111.mp4http://../Propel%20Placement%20Video%20MP4%20format%2083111.mp4


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PROPEL and PROPEL mini

Clinically Proven Outcomes: Ethmoid Sinus

10

3 Prospective Trials, 200+ Patients

Only Device Used in Sinus SurgeryBacked by Level 1a Evidence

Reduction in Post-OperativeMedical and Surgical InterventionsMeta-Analysis of Two Prospective, Multicenter,Randomized, Controlled, Double-Blind Studies

POST-OPERATIVEINTERVENTION

p=0.0008

35%

INFLAMMATION(POLYPOSIS)

p


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PROPEL mini

Clinically Proven Outcomes: Frontal Sinus

11

FRONTAL SINUS

Approved March 2016 forPlacement in Frontal Sinus

25-30% of Sinus Surgeries

PROGRESS STUDY 80 Patient Prospective, Randomized, Blinded, Multi-Center Trial

Data on file at Company.

p=0.0070

38%

p=0.0002

54%

p=0.0015

56%

p=0.0225

75%

POST-OPERATIVEINTERVENTION

OCCLUSION/RESTENOSIS

NEED FOR ORALSTEROIDS

SURGICALINTERVENTION


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PROPEL

Physician Adoption

Key Drivers to ExpandPROPEL Usage

Sales Force SeasoningDeployment of Sales Consultants

Addition of Frontal Indication

12

OUR MARKETOUR MARKET BUILDING PENETRATION

~540,000Surgeries

OUR MARKET

7,500Target ENTs

1 in 3ENTs

1 in 4Accounts

1 in 10Procedures

Nationwide sales force of ~110includes ~70 TerritoryManagers and 20+ SalesConsultants


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PROPEL

Product Cost Offset by Clinical and Economic Value

1313

1Rudmik L and Smith TL. Economic Evaluation of a Steroid-Eluting Sinus Implant following Endoscopic Sinus Surgery for Chronic Rhinosinusitis.Otolaryngol Head Neck Surg. 2014 May 5;151(2):359-366.2Rudmik L, Mallow P, Swetha, P and Rizzo, J. Budget Impact Analysis of Bioabsorbable Drug Eluting Sinus Implants for Endoscopic Sinus Surgery;International Society of Pharmocoeconomics Outcomes and Research, 2015.

Focus on Higher Quality of Care with Lower Overall Cost

Cost Effectiveness Study

Placement of PROPEL following FESS is a cost-effective interventionfor preventing a postoperativeintervention within 60 daysafter surgery. 1

Budget Impact Model

Use of PROPEL is expected tosave the plan money via reducedHC utilization, despite the upfrontdevice cost2

RevisionSurgery

Polypectomy

Surgical

Adhesion Lysis

Repair ofTurbinate

Lateralization

Drugs

PROPEL


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Recent Supportive IFAR Guidelines

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Consensus guidelines released in the International Forum of Allergy & Rhinology1,highlighting Propels level of evidence, demonstrated benefits and an economicevaluation that PROPEL is cost-effective in decreasing postoperative intervention2

1. Orlandi, et al International Forum of Allergy & Rhinology. 2016. International Consensus Statement on Allergy and Rhinology: Rhinosinusitis. 2. Rudmik L,

Smith TL. Economic evaluation of a steroid-eluting sinus implant following endoscopic sinus surgery for chronic rhinosinusitis. Otolaryngol Head Neck Surg.2014;151:359366.


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In-Office Solutions

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FESSSurgeryPRIMARY CSOffice

NOVA

RECURRENT CSOffice

RESOLVEPROPEL

MEDICATIONTO TREAT

MANAGEMENTTO MAINTAIN

SURGERYTO OPEN



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NOVA

How It Works

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Primary (Including Post Dilation) or Revision Patients

Hourglass Shape to Maximize Tissue Apposition and Support

Regulatory Pathway: PMA-s

IN-OFFICE or SURGICAL SOLUTION

FRONTALANDMAXILLARY SINUSES

Frontal Placement

80 Patient Prospective, Randomized, Blinded, Multi-Center Trial

Shared Preliminary Data May, 2016

Demonstrated Efficacy and Safety in Frontal Sinus

65% reduction in need forpost-operative interventions

(p=0.0023)

Data on file at Company.

PROGRESS STUDY



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RESOLVE

How It Works

17

Patients Who Have Had Prior Surgery

Dilates Obstructed Cavity

Delivers~4x Steroid (vs. PROPEL) Over 90 Days

Regulatory Path: NDA

IN-OFFICE TREATMENT FOR RECURRENT CRS/POLYPS

Ethmoid SinusPre-implant

ImmediatelyPost-implant

6 WeeksPost-implant

ETHMOID SINUS



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RESOLVE

Promising Results

18

Change from Baseline in Endoscopic and Symptom Scores vs. Sham Procedure.

Format modified from Han JK, Forwith KD, Smith TL, et al. RESOLVE: a randomized, controlled, blinded study of bioabsorbable steroid releasing sinus implants for

in-office treatment of recurrent sinonasal polyposis. Int Forum Allergy Rhinol. 2014;4:861-870.

THREE TRIALS COMPLETE

Pilot (12), PK Study (5), RESOLVE (100)

RESOLVE: Enrolled Patients Indicatedfor Revision Surgery

At Six Months, Control Patients 3.6xHigher Risk of Remaining Indicated forRevision Surgery than Treated Pts

Reduction in Polyp Burden andPatient SymptomsProspective, Multicenter, Randomized, Controlled,Blinded 100 Patient Study

-1

-0.8

-0.6

-0.4

-0.2

0

CHANGE INBILATERAL POLYP GRADE

Treatment

Control

p Grade 2 polyps (n=74)

CHANGE IN OBSTRUCTION/CONGESTION SCORE

p


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Industry Landscape

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We Are a Unique Solution Complementary to Other Technologies

STEROIDS SURGICAL TOOLS / SUPPLIES


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Multiple Barriers to Entry

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REGULATORY Only Drug Releasing Implants in ENT

Three PMA Approvals

RESOLVE: NDA Pathway

R&D / MANUFACTURING

50,000 ft

2

Facility in Menlo Park, CA Specialized Capabilities in

Bioabsorbable DES

Robust Quality System

INTELLECTUAL PROPERTY

59 Issued Patents 37 Pending Patents

Covers Sinus Delivery ofDrug Releasing Implants

CLINICAL Level 1a Evidence

Award Winning Clinical Science

15 Peer-Reviewed Publications


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Outlook: Clinical Milestones

21

NOVA

RESOLVE

PROPEL

2016 2017 2018

PROPELmini

FrontalApproval

PMA-sApproval(Frontal)

NDAApproval

RESOLVE IIEnrollment

PROGRESS

NovaEnrollment

RESOLVE IIToplineData

PROGRESS

NovaToplineData


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Emerging Opportunity Outside the US

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~540K FESS / Year

~450K FESS / Year

~250K FESS / Year

ATTRACTIVE MARKET OPPORTUNITIES Initial Targets Germany And Japan

PROPEL Has CE Mark Approval

DEVELOPING MARKETCOMMERCIALIZATION PLANS Regulatory Pathways

KOL Support

Reimbursement Activities

Market Entry Strategy


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Experienced Leadership

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MANAGEMENT TEAMLISA EARNHARDTPresident & CEO

RICH KAUFMANCOO, SVP R&D & Operations

JERI HILLEMANCFO

DAVID LEHMANGeneral Counsel

JAMES STAMBAUGHVP Clinical Affairs

AMY WOLBECKVP Regulatory Affairs & Quality

CHAS McKHANNChief Commercial Officer

EXPERIENCE INCLUDES


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Intersect ENT Opportunity

24

LARGEMARKET $3B+ TAM in US

UNIQUEPRODUCTS 1st

and Only Drug ReleasingImplants in ENT

PRODUCTPIPELINE

In-Office Products toServe Continuum of Care

COMMERCIALGROWTH

Track Record of Revenue &Gross Margin Growth

REVENUE ($M)

2012 2013 2014 2015

$5.9

$17.9

$38.6

$61.6M


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$3B+ US Market

1st and ONLY Drug Releasing Implants in ENT

PORTFOLIO to Treat Continuum of Care

TRACK RECORD of Revenue & Gross MarginGrowth


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NASDAQ: XENT

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Intersect ENT Company Overview (XENT)

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