Professional Documents
Culture Documents
May 2017
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Forward Looking Statements
This presentation may contain forward-looking statements within the meaning of the Private Securities Litigation Reform
Act of 1995. Forward-looking statements generally can be identified by the use of works such as expect, anticipate,
could, may, intend, will, continue, outlook, guidance, future, look forward, other words of similar meaning and
the use of future dates. Forward-looking statements in this presentation include statements about our total addressable
market, financial guidance and future financial performance, product performance and benefits, ability to implement our
business model and strategic plan, ability to manage and grow our business, ability to establish and maintain intellectual
property protection for our products or avoid claims of infringement, ability to hire and retain key personnel, and
expectations about market trends, along with third-party payor reimbursement and coverage decisions. These forward-
looking statements are base on the current expectations of our management and involve known and unknown risks and
uncertainties that may cause our actual results, performance or achievements expressed or implied by the forward-looking
statements. Such risks and uncertainties include, among others, the dependence of our net sales on our XprESS family of
products, future market acceptance and adoption of such products and adequate levels of coverage or reimbursement for
procedures using such products; our ability to successfully develop and commercialize new ENT products; competition;
ability to expand, manage and maintain our direct sales organization and market and sell our products in the United Sates
and internationally; risks and uncertainties involved in our international operations; the compliance of our products and
activates with the laws and regulations of the countries in which they are marketed; failure or delay in obtaining FDA or
other regulatory approvals or the effect of FDA or other regulatory actions; out ability to manage our anticipated growth;
risk of product recalls, product liability claims and litigation and inadequate insurance coverage relating thereto; intellectual
property disputes; loss of key suppliers; inadequate of capital resources and inability to raise additional financing when
needed and on favorable terms. Other factors that may cause actual results to differ materially from current expectations
include, among other things, those described in the section entitled Risk Factors and elsewhere in greater detail in our
Annual Report on Form 10-K for the year ended December 31, 2016 filed with the Securities and Exchange Commission
on February 22, 2017 and other filings with the SEC including our Quarterly Report on Form 10-Q for the quarter ended
March 31, 2017. We undertake no obligation to update or revise any forward-looking statements, even if subsequent
events cause our views to change. This presentation contains statistical data that we obtained from industry publications
and reports generated by third parties. Although we believe that the publications and reports are reliable, we have not
independently verified this statistical data.
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Well Positioned in Chronic Sinusitis & ETD
LARGE Potential Market
Over 29 Million Adults and 6 Million Children with Chronic Sinusitis
Over 2.4 Million Adults with Eustachian Tube Dysfunction
CLINICAL Efficacy
Randomized trial shows Minimally Invasive
Treatment REDUCES Costs
Entellus balloon dilation as
effective as sinus surgery for Chronic & Benefitting healthcare
system & patient
Recurrent Sinusitis
Randomized trial shows (CRS) & Persistent
superior symptom relief
compared to medical Eustachian Tube
management for ETD Dysfunction (ETD)
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Strong Financial Performance
$20 $19.1M
$80 $75.2M
$18 $16.9M
$70
$61.6M $16
$60 $14
$48.8M
$50 $12
(in millions)
$10
$40
$32.5M
$8
$30
$6
$20 $17.6M
$4
$10 $2
$0
$0
Q1 '16 Q1 '17
2012 2013 2014 2015 2016
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Overview of Chronic Sinusitis
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Treatment of Chronic Sinusitis Patients
400,000 200,000
Surgery
552,000 OR
(FESS) 30% Well 168,000
200,000 (45%) Market
Suited for (27%)
168,000
Hybrid BSD
(27%)
in OR
0 0
All numbers are company estimates for 2015. Excludes Pediatric and Eustachian tube patients.
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Balloon Sinus Dilation US Market Opportunity
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Adjunctive Procedures Expand Market Potential
Total Ethmoidectomy
Concha Bullosa
Polypectomy
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XprESS ENT Dilation System
Product Family
Introduced 2011
Introduced 2012
Always sold with LED
Light Fiber
Introduced 2015
Always sold with LED
Light Fiber
Shapeable Tip
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XprESS Indications
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Total ENT Solutions
Xoran MiniCAT (partner) FocESS Sinuscopes
FocESS HD Wireless Camera
MiniFESS Seekers
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Competitive Advantages
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Latest Product Launches
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Latest Product Launches
XprESS Entellus Medical
ENT Dilation System Reinforced Anesthesia Needle
The most versatile balloon dilation Deliver maximum patient comfort
device on the market with optimal control
Cleared for balloon dilation of the The unique reinforced sleeve and
Eustachian tubes in patients 18+. positive stop features give you
optimal control, consistency, and
Timing: confidence in your injections.
- Q2 17
Timing:
- Q2 17
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Competitive Advantages in Treating
Maxillary & Frontal Sinuses
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Substantial Body of Clinical Evidence
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REMODEL Study Published Jan 2016
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REMODEL Randomized Trial of Office Balloon Sinus Dilation vs. FESS
3 1.2
1.0
Balloon dilation non-inferior
to FESS, p <0.001 p < 0.0001
2 0.8
Similar Debridement
Symptom 1 Rate Superior to
0.4
Reduction 0.2 FESS
0
Pre-Tx 6M 12M 18M 24M 0
SNOT-20 Symptom Score Avg. Debridements per Patient
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REMODEL Trial Additional Key Findings
Entellus balloon products used in the ENT physician office as a
standalone therapy demonstrated the following:
0%
Balloon FESS
Entellus XprESS products are the only devices proven to be as effective as FESS in a
sufficiently powered prospective, multicenter, randomized, controlled trial.
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BSD Significantly Reduces Health Care
Utilization and Activity Impairment
Rhinosinusitis Symptom Inventory (RSI)
Healthcare Use (Meta-analysis)
8.0
Reduces N = 167 N = 165 N = 172
Sinusitis episodes 7.0
6.8
p <0.0001
Sinus infections 6.0
p <0.0001
Antibiotic use 5.0 5.4
p <0.0001
Physician visits 4.0 4.5
working 0.0
Acute Antibiotic Physician/nurse
infections courses visits
12 Months before Tx 12 Months after Tx
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XprESS Pediatric Study Published Nov 2016
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XprESS Pediatric Clinical Study
Prospective, multicenter, single-arm study of balloon sinus dilation in 50 pediatric CRS patients
(ages 2 to 21 years) with 6-month follow-up
Mean Change from Baseline in SN-5
100% technical success Overall and Subscale Scores
(157/157 sinuses)
0 complications
92% of patients
improved by the minimal
clinically important
difference of 1.0 or more
on the overall SN-5
score at 6 months
0 Revisions
Soler ZM, et al. Int Forum Allergy Rhinol. 2016;DOI: 10.1002/alr.21889.
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Broad Reimbursement
Broad insurance coverage for balloon sinus dilation
Balloon Dilation During FESS Stand-alone Balloon Dilation
12% 20%
80%
88%
Effective May 1st, Massachusetts BCBS and Nebraska BCBS initiated coverage for
stand alone balloon sinus dilation adding 3.5M covered lives
Major payors for standalone balloon sinus dilation include Medicare, Medicaid in 35
states, United Healthcare, Aetna, Cigna, Humana, Kaiser, TRICARE, Health Net,
BCBS in 20 states
Non-covering insurers include Anthem/WellPoint and certain other BCBS plans
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Cost of FESS vs. Standalone Office Balloon Dilation
Office BSD is less costly to patients and the healthcare system than
FESS in the OR, irrespective of the number of sinuses treated
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Focused on Market Development
149
Average U.S. Sales organization
as of March 31, 2017
25,000+* Sales
Rep
Training
400+*
Average visits per month to
SinusSurgeryOptions.com Peer training events
8,000+* 30,000+*
Patients using Find-a- Views of Live Case Videos
Doctor tool each month on Patient Market Physician
average Education Development Training
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International Commercialization Underway
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Quarterly Revenue Snapshot
$20 $18.7
$18.1
$19.1 $18.7 Growing Revenue Base
$17.9
$16.9
2016: 22% growth
(in millions)
$15.2 $14.8
$15 2017E: 14 18% growth
Cash and equivalents
$10 position of $68M as of
March 31, 2017
$5
$0
Q2'15 Q2'16 Q3'15 Q3'16 Q4'15 Q4'16 Q1'16 Q1'17 Q2'16 Q2'17 E
* Guidance communicated on 5/3/17. The fact that the company includes these projections in this presentation should not be taken to mean
that these comments continue to be the companys projections as of any subsequent date.
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Significant Accomplishments
Introduced Created a robust portfolio of ENT products for in-office use
Significant Introduced over 20 office-based products for ENTs
# of New Products Increased U.S. patent portfolio to 34 issued and 20 pending
Expanded number of covered lives to 80% and 88% for standalone BSD and BSD with
FESS, respectively
Expanded
Reimbursement Received Eustachian 510k clearance and CE Mark approval for Eustachian tube
Coverage and dysfunction in the U.S. and Europe
Market Opportunity Grew our addressable market opportunity in excess of 60,000 patients with the FDA
approval of our pediatric indication*
Broadened Extended footprint by adding new sales reps and increasing the number of ENT
Sales Rep Coverage accounts we service
Continued to develop a broad clinical dataset and enable industry leading publications
Continued Focus on
to drive increased BSD reimbursement (e.g. META Analysis, 24 month data from
Clinical Evidence
REMODEL Trial, Pediatric Study)
International Made significant progress internationally, with regulatory approval for and a commercial
Expansion presence in more than 10 countries
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