Professional Documents
Culture Documents
JUNE 2016
Forward-Looking Statements
Certain statements in this presentation constitute forward-looking statements within
the 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 with 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 risks
and uncertainties discussed under Risk Factors in our 10-K filing 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.
Our Focus
Our Solutions
Chronic Sinusitis
30M+ Patients
in US
Local, Sustained
Drug Delivery via
Dissolvable Implants
Chronic Sinusitis
DEBILITATING, COSTLY CONDITION
LIMITED TREATMENT
$10,007
Severe Asthma
$7,261
Chronic Migrane
Heart Disease
Diabetes
$5,755
$5,266
$3,920
Source: DeConde et. al., Chronic Rhinosinusitis: Epidemiology and Burden of Disease, Am J of Rhinol Allergy 30. 134-139, 2016
CS Treatment Pathway
MEDICATION
TO TREAT
SURGERY
TO OPEN (FESS)
MANAGEMENT
TO MAINTAIN
FESS
RECURRENT CS
Office
Surgery
Office
NOVA
PROPEL
RESOLVE
Designed for
Needs of Disease
Progression
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.
FESS
RECURRENT CS
Office
Surgery
Office
NOVA
PROPEL
RESOLVE
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.
$3B+ TAM in US
$61.6M
$38.6
In-Office Products to
Serve Continuum of Care
$17.9
$5.9
COMMERCIAL
GROWTH
2012
2013
2014
2015
IMPROVING
SURGICAL OUTCOMES
>100,000 Patients
to Date
How It Works
ETHMOID SINUS
Advanced into
Surgically Enlarged
Sinus Cavity
OPENS
DELIVERS
MAINTAINS
Self-Expanding Implant
Conforms to and
Holds Open Sinus
Sustained, Targeted
Delivery of Steroid
Over 30 Days
Opening by Reducing
Post-Operative
Inflammation and Scarring
POST-OPERATIVE
INTERVENTION
INFLAMMATION
(POLYPOSIS)
NEED FOR
ORAL STEROIDS
SCARRING
(ADHESIONS)
35%
46%
40%
70%
p=0.0008
p<0.0001
p=0.0023
p=0.0013
Meta-analysis: Han JK, Marple BF, Smith TL et al. Int Forum Allergy Rhinol, Vol. 2, No. 4, July/August 2012
10
PROPEL mini
FRONTAL SINUS
PROGRESS STUDY
POST-OPERATIVE
INTERVENTION
OCCLUSION/
RESTENOSIS
SURGICAL
INTERVENTION
38%
54%
56%
75%
p=0.0070
p=0.0002
p=0.0015
p=0.0225
11
PROPEL
Physician Adoption
OURMARKET
MARKET
OUR
7,500
Target ENTs
~540,000
Surgeries
BUILDING PENETRATION
OUR MARKET
1 in 3
ENTs
1 in 4
Accounts
1 in 10
Procedures
PROPEL
Repair of
Turbinate
Lateralization
Surgical
Adhesion Lysis
PROPEL
Polypectomy
Revision
Surgery
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.
13
13
14
In-Office Solutions
MEDICATION
TO TREAT
SURGERY
TO OPEN
MANAGEMENT
TO MAINTAIN
PRIMARY CS
FESS
RECURRENT CS
Office
Surgery
Office
NOVA
PROPEL
RESOLVE
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.
15
NOVA
How It Works
IN-OFFICE or SURGICAL SOLUTION
FRONTAL AND
MAXILLARY SINUSES
Frontal Placement
16
RESOLVE
How It Works
IN-OFFICE TREATMENT FOR RECURRENT CRS/POLYPS
ETHMOID SINUS
Ethmoid Sinus
Pre-implant
Immediately
Post-implant
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.
6 Weeks
Post-implant
17
RESOLVE
Promising Results
THREE TRIALS COMPLETE
CHANGE IN
BILATERAL POLYP GRADE
0
p = ns
p<0.05
0.0
-0.2
-0.2
Treatment
Control
-0.4
-0.6
-0.4
-0.6
-0.8
-1.0
-0.8
-1.2
-1
-1.4
p<0.05
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.
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.18
Industry Landscape
STEROIDS
19
REGULATORY
Level 1a Evidence
15 Peer-Reviewed Publications
INTELLECTUAL PROPERTY
R&D / MANUFACTURING
59 Issued Patents
37 Pending Patents
Specialized Capabilities in
Bioabsorbable DES
20
2016
PROPEL
mini
Frontal
Approval
PROPEL
RESOLVE II
RESOLVE II
RESOLVE
Nova
Enrollment
NDA
Approval
Topline
Data
Enrollment
PROGRESS
NOVA
2018
PROGRESS
Nova
Topline
Data
PMA-s
Approval
(Frontal)
21
DEVELOPING MARKET
COMMERCIALIZATION PLANS
Regulatory Pathways
KOL Support
Reimbursement Activities
Market Entry Strategy
22
Experienced Leadership
MANAGEMENT TEAM
LISA EARNHARDT
JERI HILLEMAN
CFO
CHAS McKHANN
RICH KAUFMAN
DAVID LEHMAN
JAMES STAMBAUGH
General Counsel
VP Clinical Affairs
AMY WOLBECK
VP Regulatory Affairs & Quality
EXPERIENCE INCLUDES
23
$3B+ TAM in US
$61.6M
$38.6
In-Office Products to
Serve Continuum of Care
$17.9
$5.9
COMMERCIAL
GROWTH
2012
2013
2014
2015
24
$3B+ US Market
1st and ONLY Drug Releasing Implants in ENT
PORTFOLIO to Treat Continuum of Care
TRACK RECORD of Revenue & Gross Margin
Growth
25
NASDAQ: XENT