MAY 2015 Company Presentation Exhibit 99.1 |
Forward-Looking Statements 1 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. 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 Form 10-K filing dated March 11, 2015 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. |
2 ADVANCING CLINICALLY-PROVEN THERAPIES for Ear, Nose and Throat (ENT) Physicians and Patients Focus on Chronic Sinusitis (CS) 29M Patients in US IMPROVING QUALITY OF LIFE from Surgery to Office Care |
Chronic Sinusitis: Significant Unmet Need 3 DEBILITATING INFLAMMATORY CONDITION 1 in 8 Adults 3.5M Managed by ENT 500,000+ Surgeries / Year Top 10 Most Costly Condition for US Employers |
1st Two Commercial Products 4 1 st Drug Releasing Implants for Chronic Sinusitis Patients Only PMA Approval for CS Patients 60,000+ Patients to Date IMPROVING SURGICAL OUTCOMES Reduced Inflammation, Scarring and Need for Additional Surgery and Oral Steroids |
Intersect ENT Opportunity 5 LARGE MARKET $4.8B TAM in US UNIQUE PRODUCTS 1 st and Only Drug Releasing Implants in ENT PRODUCT PIPELINE In-Office Products to Serve Continuum of Care TRACK RECORD Strong Revenue Growth and Gross Margins (70+%) ANNUAL REVENUE ($M) $6 $18 $39 2012 2013 2014 |
Challenges Across the Continuum of Care CS Treatment Pathway 6 Oral Steroids Reduce Inflammation but Can Cause Side Effects MEDICATION TO TREAT Surgery Opens Pathways but Can Result in Post-Operative Scarring and Inflammation SURGERY TO OPEN (FESS) Within One Year, 64% Symptom Recurrence and 10% Revision Surgery MANAGEMENT TO MAINTAIN |
Our Solution Portfolio 7 MEDICATION TO TREAT SURGERY TO OPEN MANAGEMENT TO MAINTAIN NOVA RESOLVE PROPEL Office Treatment for Primary CS Patients Office Treatment for Recurrent CS Patients Treatment to Improve Surgical Outcomes 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. Stenting & Local Drug Delivery via Bioabsorbable Implant Technology |
PROPEL / PROPEL MINI How It Works 8 OPENS Self-expanding Implant Conforms to and Holds Open Sinus DELIVERS Sustained, Targeted Delivery of Steroid Over 30 Days MAINTAINS Opening by Reducing Post-operative Inflammation and Scarring ETHMOID SINUS Advanced into Surgically Enlarged Sinus Cavity |
PROPEL Clinically Proven Surgical Outcomes 9 Meta-analysis: Han JK, Marple BF, Smith TL et al. Int Forum Allergy Rhinol, Vol. 2, No. 4, July/August 2012 • 3 Prospective Trials, 200+ Patients • Only Device Used in Sinus Surgery Backed by Level 1a Evidence Reduction in Post-Operative Medical and Surgical Interventions Meta-Analysis of Two Prospective, Multicenter, Randomized, Controlled, Double-Blind Studies POST-OPERATIVE INTERVENTION p=0.0008 35% INFLAMMATION (POLYPOSIS) p<0.0001 46% NEED FOR ORAL STEROIDS p=0.0023 40% SCARRING (ADHESIONS) p=0.0013 70% |
1 in 4 Accounts 1 in 5 Sinus Surgeons 1 in 15 Patients PENETRATION* Early in Early in Adoption Cycle Adoption Cycle PROPEL Commercial Success 10 REIMBURSEMENT • FESS ~$14K • Propel Treated as Surgical Supply • ASP $728 REVENUE ($M) SALESFORCE • US Only • 66 Territory Managers • 10,000 ENTs • 7,500 Perform FESS 78% Q1’15 vs. Q1’14 78% Q1’15 vs. Q1’14 * Intersect ENT internal estimates through Q115 $4.2 $7.0 $7.5 $8.5 $9.1 $13.4 $13.4 Q313 Q413 Q114 Q214 Q314 Q414 Q115 |
11 Strong Base to Drive Forward Revenue CONSISTENT ANNUALIZED SALES/TERRITORY MGR ($000) GROWING BASE OF RECURRING REVENUE ($M) Ending # of TMs Annualized Sales/TM New Reorder 85% PROPEL 0 10 20 30 40 50 60 70 $- $200 $400 $600 $800 $1,000 $1,200 Q1/14 Q2/14 Q3/14 Q4/14 Q1/15 $0 $2 $4 $6 $8 $10 $12 $14 $16 Q1/14 Q2/14 Q3/14 Q4/14 Q1/15 |
GOAL Demonstrate Reduction in Need for Post-Operative Interventions Such as Additional Surgery and Oral Steroids PROPEL MINI Expanding Indications 12 FRONTAL SINUS INVESTIGATIONAL Seeking Expanded Indication for Placement in Frontal Sinus 25% of Sinus Surgeries PROGRESS Currently Enrolling Prospective, Randomized, Blinded, Multi-Center Trial 80 Patients | 14 Sites PROPEL mini for frontal indication is an investigational device. Limited by Federal (or United States) law to investigational use |
NOVA RESOLVE PROPEL Office Treatment for Primary CS Patients Office Treatment for Recurrent CS Patients Treatment to Improve Surgical Outcomes MEDICATION TO TREAT MANAGEMENT TO MAINTAIN Our Solution Portfolio: In-Office Therapies 13 SURGERY TO OPEN 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. |
RESOLVE How It Works 14 Investigational Drug Only. Not approved for sale in U.S. • For Patients with Refractory CS/Polyps • To Dilate Obstructed Cavity • To Deliver Steroid Over 90 Days • Less Invasive, More Cost Effective vs. Revision Surgery IN-OFFICE POST PRIOR SURGICAL TREATMENT Ethmoid Sinus Pre-implant Immediately Post-implant 6 Weeks Post-implant ETHMOID SINUS Designed: |
RESOLVE Promising Results 15 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. • Pilot (12) • PK Study (5) • RESOLVE (100) Reduction in Polyp Burden and Patient Symptoms Prospective, Multicenter, Randomized, Controlled, Blinded 100 Patient Study -1 -0.8 -0.6 -0.4 -0.2 0 CHANGE IN BILATERAL POLYP GRADE Treatment Control p<0.05 -1.4 -1.2 -1.0 -0.8 -0.6 -0.4 -0.2 0.0 All pts (n=100) > Grade 2 polyps (n=74) CHANGE IN OBSTRUCTION/ CONGESTION SCORE p<0.05 p = ns THREE TRIALS COMPLETE |
RESOLVE IND Clinical Program 16 STUDY STUDY DESCRIPTION DESCRIPTION N N SITES SITES PUBLISHED PUBLISHED PILOT Non-Randomized Open Label Single Cohort 12 4 PHARMACOKINETIC (PK) Non-Randomized Open Label Single Cohort 5 1 RESOLVE Phase II / III Randomized 1:1 Blinded Implants vs. Sham Procedure 100 18 RESOLVE II Phase III Randomized 2:1 Blinded Implants vs. Sham Procedure 300 45 |
NOVA How It Works 17 Investigational Device Only. Not approved for sale in U.S. • Primary (Including Post Dilation) or Revision Patients • Hourglass Shape to Maximize Tissue Apposition and Support • Regulatory Pathway: PMA-S • Feasibility Study Completed (15 Patients, 2 US Sites) IN-OFFICE or SURGICAL SOLUTION FRONTAL AND MAXILLARY SINUSES Frontal Placement Maxillary Placement |
SURGICAL PROPEL 540K Patients Large U.S. Market Opportunity 18 $4.8B in US $830M $1.1B $2.8B NOVA PRIMARY 2.3M Patients RESOLVE REFRACTORY 770K Patients |
Emerging Opportunity Outside the US 19 ~540K FESS / Year ~450K FESS / Year ~250K FESS / Year ATTRACTIVE MARKET OPPORTUNITIES DEVELOPING MARKET COMMERCIALIZATION PLANS Targeting 4-6 Large Markets in Europe and Asia Pacific Regulatory Pathways (Especially China, Japan) Reimbursement Activities Market Entry Strategy KOL Development PROPEL has CE Mark Approval |
Industry Landscape 20 We Are a Unique Solution – Complementary to Other Technologies STEROIDS MEDICATION TO TREAT SURGERY TO OPEN MANAGEMENT TO MAINTAIN SURGICAL TOOLS / SUPPLIES |
Multiple Barriers to Entry 21 REGULATORY • Only Drug Releasing Implants in ENT • Two 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 • 55 Issued Patents (29 US / 26 OUS) • 37 Pending Patents (13 US / 24 OUS) • Covers Sinus Delivery of Drug Releasing Implants CLINICAL • Level 1a Evidence • Award Winning Clinical Science • 15 Peer-Reviewed Publications • • • |
Outlook: Milestones 22 GROWTH LEVERS 2015 2016 2017 2018 NOVA RESOLVE PROPEL PROGRESS Frontal Indication Enrollment Complete Frontal Indication PROPEL mini PMA-S Approval RESOLVE II Enrollment Complete NDA Approval PMA-S Approval maxillary Clinical Trials RESOLVE II Enrollment Commenced Commercial Clinical International Ongoing Execution Lay OUS Groundwork Clinical Clinical PMA-S Approval frontal |
Experienced Leadership 23 MANAGEMENT TEAM LISA EARNHARDT President & CEO RICH KAUFMAN COO, SVP R&D & Operations JERI HILLEMAN CFO ROB BINNEY VP Sales SUSAN STIMSON VP Marketing JAMES STAMBAUGH VP Clinical Affairs AMY WOLBECK VP Regulatory Affairs & Quality CHAS McKHANN Chief Commercial Officer EXPERIENCE INCLUDES |
24 $4.8B US Market 1 and ONLY Drug Releasing Implants in ENT EMERGING In-Office Portfolio TRACK RECORD Strong Revenue Growth & GMs st |
NASDAQ: XENT |