Entellus Medical — Investor Presentation (May 2016)
28 slides from Entellus Medical's investor presentation, May 10, 2016
Slide 1: Investor Presentation
Exhibit 99.1 Investor Presentation May 2016 1
Slide 2: Forward Looking Statements
Forward Looking Statements This presentation may contain forward-looking statements concerning the company’s business, operations and financial performance and condition, as well as its plans, objectives and expectations for its business operations and financial performance and condition. These forw
Slide 3: Well Positioned in Chronic Sinusitis
Well Positioned in Chronic Sinusitis LARGE Potential Market Over 29 Million Adults and 6 Million Children with Chronic Sinusitis REDUCES Costs CLINICAL Efficacy Minimally Invasive Benefitting healthcare Randomized trial showing Treatment system & patient Entellus products as for Chronic & effective
Slide 4: Strong Financial Performance & Outlook
Strong Financial Performance & Outlook Annual Revenue Q1 Y/Y Revenue $18 $16.9M $70 $61.6M $16 $60 $13.5M $14 $48.8M $50 $12 $40 $10 $32.5M $8 $30 $6 $20 $17.6M $4 $10 $2 $0 $0 Q1 '15 Q1 '16 2012 2013 2014 2015 Gross Margin: 73% 76% 78% 77% 78% 76% Entellus Medical May 2016 4
Slide 5: Overview of Chronic Sinusitis
Overview of Chronic Sinusitis Common Symptoms U.S. Adult CS Statistics 1 Heavy Purulent Drainage Approximately 29 Million afflicted 2 Facial Pressure & Fullness 12.3M annual patient visits to MD 2 Nasal Congestion 23% of patient visits are to ENTs Fatigue 1.23M patients seen by ENTs annually Facial
Slide 6: Treatment of Chronic Sinusitis Patients
Treatment of Chronic Sinusitis Patients Annual Patients to ENT Entellus Market Opportunity in U.S. ~1,233,000 ~630,000 ~630,000 1,200,000 600,000 85% Well 160,000 Symptoms Relieved Suited for (25%) 1,000,000 493,000 (40%) by Medical BSD in Office Management (Rx) Office Market 800,000 464,000 400,000
Slide 7: Balloon Sinus Dilation Market Opportunity
Balloon Sinus Dilation Market Opportunity Office Market: + OR Market: = Total Market: $680M $275M $955M 464,000 Procedures 168,000 Procedures 630,000 Procedures Growth Drivers in the Trend Toward Office Sinus Procedures Strong clinical data from Entellus balloon sinus dilation Favorable economics fo
Slide 8: Full Line of Sinus Dilation Solutions
Full Line of Sinus Dilation Solutions Entellus Medical May 2016 8
Slide 9: XprESS Multi-Sinus Dilation System
XprESS Multi-Sinus Dilation System Product Family • Introduced 2011 • Introduced 2012 • Always sold with LED Light Fiber • Introduced 2015 • Always sold with LED Light Fiber Shapeable Tip Entellus Medical May 2016 9
Slide 10: XprESS Multi-Sinus Indications
XprESS Multi-Sinus Indications Indications for Use To access and treat the maxillary ostia/ethmoid infundibula in patients 2 years and older, and frontal ostia/recesses and sphenoid sinus ostia in patients 12 years and older using a trans-nasal approach. The bony sinus outflow tracts are remodeled b
Slide 11: Leading the Way to the Office
Leading the Way to the Office Xoran™ MiniCAT, Entellus Medical May 2016 11
Slide 12: Fiagon IGS Well Suited for Office Setting
Fiagon IGS Well Suited for Office Setting Entellus Medtronic Fiagon IGS Fusion IGS Open Platform Over 8X Over 8 times larger than Fiagon Minimal space ideally suited for Larger Requires separate cart making the office office use logistically challenging Simple set-up process Multiple complex steps C
Slide 13: Competitive Advantages
Competitive Advantages Entellus XprESS offers ENT physicians and staff: 1. Single integrated device 2. Sinus seeker-based design, familiar to sinus surgeons 3. Smaller device enables easier sinus access and procedure 4. Slideable balloon to enhance endoscopic visualization 5. Malleable, controllable
Slide 14: Competitive Advantages in Treating Maxillary & Frontal Sinuses
Competitive Advantages in Treating Maxillary & Frontal Sinuses MaxillaryAdvantage: FrontalAdvantage:5 Confirmation Methods • Controllable, angled device tip plus 1. Palpation and tactile feel transillumination enables accurate 2. Direct visualization cannulation of the maxillary sinus ostium 3. Dept
Slide 15: Comprehensive Intellectual Property
Comprehensive Intellectual Property Entellus & Acclarent license agreement - Feb 2011 – Entellus licensed entire portfolio of current and future Acclarent balloon sinus dilation patents – Entellus XprESS, FinESS, and PathAssist product lines are Covered Products under the non-exclusive license – Pay
Slide 16: Substantial Body of Clinical Evidence
Substantial Body of Clinical Evidence Studies Subjects Treated REMODEL Randomized Trial of Entellus Office Balloon Sinus Dilation vs. FESS 135 XprESS Multi-Sinus Office 81 Treatment XprESS Pediatric Study 50 5 Other Clinical Studies of Entellus Products 473 2 Cadaver Studies: Accuracy of Maxillary S
Slide 17: Just Published! REMODEL Larger Cohort With Long-term Outcomes
Just Published! REMODEL Larger Cohort With Long-term Outcomes and Meta-Analysis of Standalone Balloon Dilation Studies Rakesh K. Chandra, MD; Robert C. Kern, MD; Jeffrey L. Cutler, MD; Kevin C. Welch, MD; Paul T. Russell, MD The Laryngoscope. January, 2016. [printed version] – REMODEL data on larger
Slide 18: REMODEL Randomized Trial of Office Balloon Sinus Dilation vs. FESS
REMODEL Randomized Trial of Office Balloon Sinus Dilation vs. FESS Prospective, multicenter randomized controlled trial at 14 centers – 135 Adult patients treated with Entellus balloon sinus dilation performed in an ENT physician office or traditional sinus surgery (FESS) – All patients exhibited ma
Slide 19: REMODEL Randomized Trial of Office Balloon Sinus Dilation vs. FESS
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 Entellus B
Slide 20: REMODEL Trial - Additional Key Findings
REMODEL Trial –Additional Key Findings Entellus balloon products used in the ENT physician office as a standalone therapy demonstrated the following: Bleeding after Discharge Duration (days) of Prescription Pain Rx 100% 4 p = 0.009 p < 0.0001 2.8 75% 3 56% 50% 2 32% 1.0 25% 1 0% 0 Balloon FESS Ballo
Slide 21: Clinical Studies to Broaden Indications
Clinical Studies to Broaden Indications Pediatric IDE Study – Multicenter study to support 510(k) clearance – Treatment of 50 sinuses in 25 to 50 patients; 3-month follow-up – Study completed; FDA 510(k) clearance received Patient Age 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 Acclarent Max
Slide 22: BSD Significantly Reduces Health Care Utilization and Activity Impairment
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 7.0 – Sinusitis episodes p <0.0001 6.8 – Sinus infections 6.0 p <0.0001 – Antibiotic use 5.0 5.4 p <0.0001 – Physician v
Slide 23: Broad Reimbursement
Broad Reimbursement Acceptance by many insurers has led to broad insurance coverage for balloon sinus dilation Balloon Dilation During FESS Stand-alone Balloon Dilation 12% 21% 79% 88% Covered Investigational Covered Investigational 5/816 5/8/16 Major payors for standalone balloon sinus dilation inc
Slide 24: Cost of FESS vs. Office Balloon Sinus Dilation
Cost of FESS vs. Office Balloon Sinus Dilation Office BSD is less costly to patients and the healthcare system than FESS in the OR, irrespective of the number of sinuses treated Sinus Disease 2016 National Average Cost to Medicare % FESS costs BSD FESS in FESS more than BSD: in Office Hospital in AS
Slide 25: Focused on Market Development
Focused on Market Development 140 Direct U.S. sales organization as of March 31, 2016 Sales Rep Training 400+ * Peer training events 15,000+ * 20,000+ * Views of Live Case Average visits per month to Videos Patient Market Physician SinusSurgeryOptions.com Education Development Training 8,000+ * Pati
Slide 26: International Commercialization Underway
International Commercialization Underway Worldwide regulatory approvals received Recently established direct sales team in the UK Indirect distribution efforts underway in Europe and Canada Initial cases commenced in June 2015 Entellus Medical May 2016 26
Slide 27: Revenue and Cash Snapshot
Revenue and Cash Snapshot Quarterly Revenue YOY & Guidance * 2015 vs 2014 2016 vs 2015 $20 $18.1M $17.8M – $18.8M $18 $16.9M $16 $15.2M $14.8M $15.2M Growing Revenue Base $14.6M $13.5M $14 $12.5M – 2015: 26% growth $11.7M $12 – 2016E: 19 – 25% growth $10 Expanding Account Base $8 $6 Cash position of
Slide 28: Positioned For Growth
Positioned For Growth Penetrate U.S. Market Broaden Indications and Acceptance Grow Direct Sales Force Pediatric indication Educate ENTs on clinical and Eustachian tube indication economic value of office BSD Mini-FESS Increase Payor Coverage Increase Patient Awareness Peer-to-peer initiatives New P