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INTERSECT ENT, INC. FORM 8-K (Current report filing) Filed 05/11/15 for the Period Ending 05/11/15 Address Telephone CIK Symbol SIC Code Fiscal Year 1555 ADAMS DRIVE MENLO PARK, CA 94025 650-641-2100 0001271214 XENT 3841 - Surgical and Medical Instruments and Apparatus 12/31 http://www.edgar-online.com © Copyright 2015, EDGAR Online, Inc. All Rights Reserved. Distribution and use of this document restricted under EDGAR Online, Inc. Terms of Use. UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): May 11, 2015 Intersect ENT, Inc. (Exact name of registrant as specified in its charter) Delaware 001-36545 20-0280837 (State or other jurisdiction of incorporation) (Commission File Number) (IRS Employer Identification No.) Intersect ENT, Inc. 1555 Adams Drive Menlo Park, California 94025 (Address of principal executive offices, including zip code) (650) 641-2100 (Registrant’s telephone number, including area code) Not Applicable (Former name or former address, if changed since last report.) Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions: Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) Item 7.01 Regulation FD Disclosure On May 11, 2015, Intersect ENT, Inc. made available its updated Corporate Presentation. A copy of the Corporate Presentation is attached as Exhibit 99.1. The information in this Item 7.01 and Exhibit 99.1 of this Current Report on Form 8-K are being furnished and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934 as amended (Exchange Act), or otherwise subject to the liabilities of that Section or Sections 11 and 12(a)(2) of the Securities Act of 1933, as amended (Securities Act). The information in this Item 7.01 and Exhibit 99.1 shall not be deemed incorporated by reference in any filing under the Securities Act, or the Exchange Act, except as expressly set forth by specific reference in such a filing. Item 9.01 (d) Financial Statements and Exhibits. Exhibits Exhibit No. Description 99.1 Corporate Presentation dated May 2015. SIGNATURES Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized. Intersect ENT, Inc. Dated: May 11, 2015 By: /s/ Jeryl L. Hilleman Jeryl L. Hilleman Chief Financial Officer INDEX TO EXHIBITS Exhibit No. Description 99.1 Corporate Presentation dated May 2015. Exhibit 99.1 Company Presentation MAY 2015 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. 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. 1 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 2 Chronic Sinusitis: Significant Unmet Need DEBILITATING INFLAMMATORY CONDITION 1 in 8 Adults 3.5M Managed by ENT 500,000+ Surgeries / Year Top 10 Most Costly Condition for US Employers 3 1st Two Commercial Products st 1 Drug Releasing Implants for Chronic Sinusitis Patients Only PMA Approval for CS Patients IMPROVING SURGICAL OUTCOMES 60,000+ Patients to Date Reduced Inflammation, Scarring and Need for Additional Surgery and Oral Steroids 4 Intersect ENT Opportunity ANNUAL REVENUE ($M) LARGE MARKET $4.8B TAM in US $39 UNIQUE PRODUCTS st 1 and Only Drug Releasing Implants in ENT $18 PRODUCT PIPELINE In-Office Products to Serve Continuum of Care TRACK RECORD Strong Revenue Growth and Gross Margins (70+%) $6 2012 2013 2014 5 CS Treatment Pathway MEDICATION TO TREAT SURGERY TO OPEN (FESS) MANAGEMENT TO MAINTAIN Oral Steroids Reduce Inflammation but Can Cause Side Effects Surgery Opens Pathways but Can Result in Post-Operative Scarring and Inflammation Within One Year, 64% Symptom Recurrence and 10% Revision Surgery Challenges Across the Continuum of Care 6 Our Solution Portfolio MEDICATION TO TREAT SURGERY TO OPEN MANAGEMENT TO MAINTAIN Stenting & Local Drug Delivery via Bioabsorbable Implant Technology NOVA PROPEL RESOLVE Office Treatment for Primary CS Patients Treatment to Improve Surgical Outcomes Office Treatment for Recurrent CS Patients NOVA and RESOLVE are investigational and not currently available for sale in the United States. The implants are limited by federal (or United States) law to investigational use only. 7 PROPEL / PROPEL MINI How It Works ETHMOID SINUS Advanced into Surgically Enlarged Sinus Cavity OPENS DELIVERS MAINTAINS Self-expanding Implant Conforms to and Holds Open Sinus Sustained, Targeted Delivery of Steroid Over 30 Days Opening by Reducing Post-operative Inflammation and Scarring 8 PROPEL Clinically Proven Surgical Outcomes Reduction in Post-Operative Medical and Surgical Interventions Meta-Analysis of Two Prospective, Multicenter, Randomized, Controlled, Double-Blind Studies • 3 Prospective Trials, 200+ Patients • Only Device Used in Sinus Surgery Backed by Level 1a Evidence POST-OPERATIVE INTERVENTION INFLAMMATION (POLYPOSIS) NEED FOR ORAL STEROIDS SCARRING (ADHESIONS) 35% 46% 40% 70% p=0.0008 p<0.0001 p=0.0023 p=0.0013 Meta-analysis: Han JK, Marple BF, Smith TL et al. Int Forum Allergy Rhinol, Vol. 2, No. 4, July/August 2012 9 PROPEL Commercial Success REVENUE ($M) 78% $13.4 $7.0 $8.5 $7.5 $13.4 Q1’15 vs. Q1’14 $9.1 PENETRATION* $4.2 1 in 4 Accounts Q313 Q413 Q114 Q214 SALESFORCE • • • • US Only 66 Territory Managers 10,000 ENTs 7,500 Perform FESS Q314 Q414 Q115 REIMBURSEMENT • FESS ~$14K • Propel Treated as Surgical Supply • ASP $728 1 in 5 Sinus Surgeons 1 in 15 Patients Early in Adoption Cycle * Intersect ENT internal estimates through Q115 10 PROPEL Strong Base to Drive Forward Revenue CONSISTENT ANNUALIZED SALES/TERRITORY MGR ($000) $1,200 70 $1,000 60 $800 50 GROWING BASE OF RECURRING REVENUE ($M) $16 $14 $12 40 $600 $- $6 20 $4 10 $2 0 $0 Q1/14 Q2/14 Q3/14 Q4/14 Q1/15 Ending # of TMs Annualized Sales/TM 85% $8 30 $400 $200 $10 Q1/14 New Q2/14 Q3/14 Q4/14 Q1/15 Reorder 11 PROPEL MINI Expanding Indications Seeking Expanded Indication for Placement in Frontal Sinus FRONTAL SINUS 25% of Sinus Surgeries INVESTIGATIONAL PROGRESS Currently Enrolling Prospective, Randomized, Blinded, Multi-Center Trial 80 Patients | 14 Sites GOAL Demonstrate Reduction in Need for Post-Operative Interventions Such as Additional Surgery and Oral Steroids PROPEL mini for frontal indication is an investigational device. Limited by Federal (or United States) law to investigational use 12 Our Solution Portfolio: In-Office Therapies MEDICATION TO TREAT SURGERY TO OPEN MANAGEMENT TO MAINTAIN NOVA PROPEL RESOLVE Office Treatment for Primary CS Patients Treatment to Improve Surgical Outcomes Office Treatment for Recurrent CS Patients 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. 13 RESOLVE How It Works IN-OFFICE POST PRIOR SURGICAL TREATMENT Designed: ETHMOID SINUS • For Patients with Refractory CS/Polyps • To Dilate Obstructed Cavity • To Deliver Steroid Over 90 Days • Less Invasive, More Cost Effective vs. Revision Surgery Ethmoid Sinus Pre-implant Immediately Post-implant 6 Weeks Post-implant Investigational Drug Only. Not approved for sale in U.S. 14 RESOLVE Promising Results Reduction in Polyp Burden and Patient Symptoms THREE TRIALS COMPLETE • Pilot (12) Prospective, Multicenter, Randomized, Controlled, Blinded 100 Patient Study • PK Study (5) • RESOLVE (100) CHANGE IN OBSTRUCTION/ CONGESTION SCORE CHANGE IN BILATERAL POLYP GRADE 0 -0.2 Treatment Control -0.4 -0.6 -0.8 -1 p<0.05 All pts (n=100) > Grade 2 polyps (n=74) p = ns p<0.05 0.0 -0.2 -0.4 -0.6 -0.8 -1.0 -1.2 -1.4 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 bioabsorbabl e steroid releasing sinus implants for in-office treatment of recurrent sinonasal polyposis. Int Forum Allergy Rhinol. 2014;4:861-870. 15 RESOLVE IND Clinical Program STUDY DESCRIPTION N SITES PILOT Non-Randomized Open Label Single Cohort 12 4 PHARMACOKINETIC (PK) Non-Randomized Open Label Single Cohort 5 1 100 18 300 45 RESOLVE Phase II / III Randomized 1:1 Blinded PUBLISHED Implants vs. Sham Procedure RESOLVE II Phase III Randomized 2:1 Blinded Implants vs. Sham Procedure 16 NOVA How It Works IN-OFFICE or SURGICAL SOLUTION FRONTAL AND MAXILLARY SINUSES • • • • 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) Frontal Placement Maxillary Placement Investigational Device Only. Not approved for sale in U.S. 17 Large U.S. Market Opportunity SURGICAL $830M NOVA PRIMARY 2.3M Patients $2.8B PROPEL 540K Patients $4.8B in US $1.1B RESOLVE REFRACTORY 770K Patients 18 Emerging Opportunity Outside the US ~250K FESS / Year ~450K FESS / Year ~540K FESS / Year ATTRACTIVE MARKET OPPORTUNITIES Targeting 4-6 Large Markets in Europe and Asia Pacific PROPEL has CE Mark Approval DEVELOPING MARKET COMMERCIALIZATION PLANS Regulatory Pathways (Especially China, Japan) Reimbursement Activities KOL Development Market Entry Strategy 19 Industry Landscape MEDICATION TO TREAT STEROIDS SURGERY TO OPEN MANAGEMENT TO MAINTAIN SURGICAL TOOLS / SUPPLIES We Are a Unique Solution – Complementary to Other Technologies 20 Multiple Barriers to Entry CLINICAL REGULATORY • Level 1a Evidence • Only Drug Releasing Implants in ENT • Award Winning Clinical Science • Two PMA Approvals • 15 Peer-Reviewed Publications • RESOLVE: NDA Pathway INTELLECTUAL PROPERTY R&D / MANUFACTURING 2 • 55 Issued Patents (29 US / 26 OUS) • 50,000 ft Facility in Menlo Park, CA • 37 Pending Patents (13 US / 24 OUS) • • Covers Sinus Delivery of Drug Releasing Implants Specialized Capabilities in Bioabsorbable DES • Robust Quality System 21 Outlook: Milestones GROWTH LEVERS Commercial PROPEL Clinical International RESOLVE Clinical NOVA Clinical 2015 2016 2017 2018 Ongoing Execution PROGRESS Frontal Indication Enrollment Complete Frontal Indication PROPEL mini PMA-S Approval Lay OUS Groundwork RESOLVE II Enrollment Commenced RESOLVE II Enrollment Complete Clinical Trials PMA-S Approval frontal NDA Approval PMA-S Approval maxillary 22 Experienced Leadership MANAGEMENT TEAM LISA EARNHARDT JERI HILLEMAN President & CEO CFO CHAS McKHANN RICH KAUFMAN Chief Commercial Officer COO, SVP R&D & Operations ROB BINNEY JAMES STAMBAUGH VP Sales VP Clinical Affairs SUSAN STIMSON AMY WOLBECK VP Marketing VP Regulatory Affairs & Quality EXPERIENCE INCLUDES 23 $4.8B US Market 1st and ONLY Drug Releasing Implants in ENT EMERGING In - Office Portfolio TRACK RECORD Strong Revenue Growth & GMs 24 NASDAQ: XENT