Inspire Medical Systems, Inc. · NYSE:INSP
Inspire Medical Systems — Investor Presentation (January 2019)
40 slides from Inspire Medical Systems's investor presentation, Jan 7, 2019
Slide 1: Inspire Medical Systems, Inc. January 2019
Inspire Medical Systems, Inc. s January 2019 NYSE: INSP
Slide 2: Disclaimer
Disclaimer This presentation contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements other than statements of historical facts contained in this presentation are forward-looking statements. In some cases, you can identify forward
Slide 3: Innovative Neurostimulation Solution for Moderate to Severe OSA
Inspire is an Innovative Neurostimulation Solution for Patients with Moderate to Severe OSA Our History & Key Milestones First and only FDA-approved neurostimulation technology for OSA 1990s: Medtronic begins early work on the development of Inspire More than 4,000 patients treated with Inspire ther
Slide 4: Strong Management Team
Strong Management Team Other Key Management • Steve Jandrich – Chief Compliance Officer, VP, Human Resources • Kathy Sherwood – VP, Global Market Access • Howard Green – VP, Marketing 3 • Andreas Henke – VP, Commercial Operations, Europe • John Rondoni – VP, Product Development, Tim Herbert Rick Buc
Slide 5: Obstructive Sleep Apnea is a Serious and Chronic Disease
Obstructive Sleep Apnea (OSA) is a Serious and Chronic Disease OSA is Caused by a Blocked or Partially Blocked Airway Blockage prevents airflow to the lungs Results in repeated arousals and oxygen de-saturations Severity of sleep apnea is measured by frequency of apnea or hypopnea events per h
Slide 6: Sleep Apnea is a Major Public Health Problem & Awareness is Building
Sleep Apnea is a Major Public Health Problem & Awareness is Building Metrics – Week of January 22, 2018 55,823 (+22%) 12,199 (+43%) Web Sessions Doctor Searches 548 (+42%) 202 (+59%) 184 (+25%) Calls Emails CHT Sign-Ups (+) represents change Week over Week 6 ____________________ Source: The New York
Slide 7: Current Treatment Options Have Significant Limitations
Current Treatment Options such as CPAP and Invasive Surgery have Significant Limitations Continuous Positive Airway Pressure (CPAP) is the Leading Therapy for OSA Drivers of CPAP Non-Compliance Delivered through a face or nasal mask that connects through a Mask Discomfort hose to a bedside air pum
Slide 8: A Strong Market Opportunity Exists for an Alternative to CPAP
A Strong Market Opportunity Exists for an Alternative to CPAP that is Effective and Minimally Invasive Prevalence & Economic Costs Our Estimated Annual U.S. Market Opportunity Sleep apnea affects +100 million people worldwide (1) Approximately 17 million individuals in the Adults with Moderate t
Slide 9: Our Inspire Therapy is a Disruptive Solution for Patients with OSA
Our Inspire Therapy is a Disruptive Solution for Patients with OSA Inspire System Inspire Procedure 3 Stimulation Lead 1 Pressure Sensing Lead Hypoglossal Nerve 2 Neurostimulator Remote control and three implantable components: Approximately a 2-hour outpatient procedure Requires three small i
Slide 10: Inspire Therapy Overcomes Many Limitations with a Safe and Effective Solution
Inspire Therapy Overcomes Many of These Limitations with a Safe and Effective Solution Mild Stimulation is a Clear Mechanism of Action Inspire Therapy Offers Significant Benefits Strong safety profile Effective and durable treatment Closed-loop system Strong patient compliance High patient
Slide 11: Objective Measures Show the Impact of Inspire Therapy on OSA
Objective Measures Show the Impact of Our Inspire Therapy on OSA Polysomnogram Before and After Activation of Inspire System Inspire system turned on 12:23:00 AM 12:23:30 AM 12:24:00 AM 12:24:30 AM 12:25:00 AM 12:25:30 AM 12:26:00 AM 12:26:30 AM 12:27:00 AM 12:27:30 AM 12:28:00 AM 12:28:30 AM 12:29:
Slide 12: Clinical Evidence
Clinical Evidence
Slide 13: Significant Body of Clinical Evidence in ~980 Patients
Inspire in ~980 Patients~980 inInspire Studies 16 Across SignificantClinicalof Evidence Body Evaluating 13 (1) ____________________ Independent Company Sponsored Due to the inclusion of certain patients in multiple studies, six studies are not shown in the table because they do notdo they add any be
Slide 14: Overview of the STAR Trial
Overview of the STAR Trial Multi-center, prospective, single-group, Phase III pivotal trial 12 Month Results Publication: Evaluated 126 patients who had difficulty either accepting or New England Journal of Medicine adhering to CPAP 22 medical centers across the United States and Europe Trial
Slide 15: STAR Trial Met Both Primary Endpoints
STAR Trial Met Both Primary Endpoints & Showed Statistically Significant Reductions in AHI & ODI Significant Reduction in Severity of OSA Meaningful Levels of Compliance Post-Implantation Apnea-Hypopnea Index (Median) Oxygen Desaturation Index (Median) 29.3 25.4 9.0 9.7 7.4 8.6 6.0 6.2 4.8 4.6 Event
Slide 16: Additional STAR Findings on Compliance and Quality of Life
Additional STAR Findings Showed Meaningful Improvement in Compliance and Quality of Life Metrics Inspire has Substantial Positive Implications …and has Resulted in Meaningful Impact to on Patient Compliance… Patients' Quality of Life Functional Outcomes of Sleep Self-Reported Device Use Questionnair
Slide 17: Clinical Evidence Replicated Across Multiple Studies
Inspire’s Compelling Clinical Evidence has been Replicated Across Multiple Studies Company sponsored, multi-center post-approval study Apnea Hypopnea Index (Median) P<0.001 in Germany (N=60) 28.6 German Measurements: 2 months, 6 months and 1 year 67% Reduction Post-Market 9.5 Study Publication
Slide 18: Independent Cleveland Clinic Comparison Study of Inspire vs. UPPP
Independent Cleveland Clinic Comparison Study of Inspire vs. UPPP Independent retrospective study conducted by multi- Pre vs Post Operative AHI for UPPP vs HNS Groups (Mean) disciplinary team of physicians from the Cleveland Clinic P= 0.02 P<0.001 (N=40) 40.3 29% Reduction 38.9 28.8 88% Reduction
Slide 19: Building Clinical Data with the ADHERE Patient Registry
We Intend to Continue to Build the Depth of Our Clinical Data with Our ADHERE Patient Registry ADHERE Patient Registry Our post-implantation study with the goal of collecting data on a group in excess of 2,500 patients Registry Results from 508 Patients Registry study designed to be Apnea Hypopnea
Slide 20: Product and Indication Expansion
Product and Indication Expansion
Slide 21: Continuous Product Development & Indication Expansion
We are Committed to Continuous Product Development & Indication Expansion Indication Expansion Product Pipeline Working with the FDA to expand indication in the 5th generation neurostimulator is in the concept U.S. to patients as young as 12 years of age phase of development (including Down synd
Slide 22: Inspire Cloud: Longitudinal Care
Inspire Cloud: Longitudinal Care Longitudinal Care Care team Inspire cloud Referral network Inspire Cloud was launched at the AASM (American Academy of Sleep Medicine) annual meeting June 2018 ____________________ Not actual data; for illustrative purposes only. Monitors Adherence Strengthens th
Slide 23: Reimbursement
Reimbursement
Slide 24: Focused on Coding, Payment and Coverage
Our Team is Focused on All Aspects of Reimbursement, which Include Coding, Payment and Coverage Coding Payment Coverage • Physician • Physician • Medicare • Facility • Facility • Commercial • Neurostimulator and stimulation • National Medicare average payment • Approximately 300 commercial lead: CPT
Slide 25: Developing Positive Coverage Policies – Leveraging the Aetna Policy Decision
Developing Positive Coverage Policies – Leveraging the Aetna Policy Decision United Anthem Aetna Healthcare 14 BCBS Plans: 22.2 M California & 45.7 M HCSC Georgia ++ BCBS 38.7 M IL/TX 14.6M BCBS Cigna, Focus on local payments BCBS Others Humana Small Regional Plans 9 BCBS Plans: 17.4MM & others focu
Slide 26: Evidence Street Complete Positive Technical Assessment
Evidence Street Complete Positive Technical Assessment Report summarized that the evidence is sufficient to determine that the Inspire therapy results in a meaningful improvement in the net health outcome for patients meeting the following selection criteria o Age ≥ 22 years in adults or adolescen
Slide 27: Market Access Team Working with Patients and Physicians
Our Market Access Team is Highly Effective in Working with Patients and Physicians Case-by-Case Submissions, Reviews & Approvals Process Prepare/Submit an EMR Prepare/Submit an If denied Prepare/Submit an 1st If denied Prepare/Submit an 2nd If denied appeal Prior Authorization level appeal level app
Slide 28: U.S. Commercial Prior Authorization Submissions
U.S. Commercial Prior Authorization Submissions Total Submissions Key focus is to continue to grow individual patient prior 2018YTD: 1,838 authorizations while working with payors to develop 2017A: 1,506 positive coverage policies longer term 2016A: 960 Past Quarter Submission 700 661 60 619 600 558
Slide 29: U.S. Commercial Prior Authorization Approvals
U.S. Commercial Prior Authorization Approvals Many patients who are willing to work through the Total Approvals process benefit from an approval; shortly after this 2018YTD: 835 approval, the process shifts to scheduling the placement 2017A: 583 2016A: 330 of the Inspire system Past Quarter Approval
Slide 30: Commercial Development
Commercial Development
Slide 31: Targeted Approach to Market Development
We have a Targeted Approach to Market Development Inspire Approach to Market Development Direct-to-Patient Outreach Machine Inspire has built a referral network with physicians across the treatment continuum Company Sponsored Public Relations Differentiated marketing engine capable of generating
Slide 32: Sales Strategy Engages All Key Stakeholders
Our Sales Strategy Engages All Key Stakeholders Across the OSA Treatment Paradigm Holistic Approach to Engagement Across Key Stakeholders in the OSA Treatment Paradigm Sales Organization Sleep 40 Territory Managers (reps) in U.S. and 6 in Europe Centers Managed by Regional Sales Managers (7) S
Slide 33: Keys To Driving a Strong Territory
Keys To Driving a Strong Territory Territory Manager Strategy New Centers and Territory Framing How TMs Spend their Time Building Regional Manager Team and FCRs to currently have 7 RMs (added 3 in Q3) Support Adding Field Clinical Reps (FCRs) to support implants Attend DISE, Find The Continu
Slide 34: The Great Balancing Act
The Great Balancing Act KEEPING CONTROL WHILE GROWING FAST What does it take to start, then grow a business into a successful public company yet maintain total control of product performance? 34
Slide 35: The Inspire Control System
The Inspire Control System Prevalence Pool 17M people in the US with End Goal: Strong OSA of which ≈25% could Incidence Pool be treated by using 500k new cases per Patient Outcomes!!! Inspire year who could be treated using Inspire Question 1: How Question 3: How Question 2: How Question 4: How Ques
Slide 36: Financials
Financials
Slide 37: Revenue and Gross Margins Since 2015
Revenue and Gross Margins Since 2015 ($ in Millions) Revenue Gross Margin 2015 – 2017 CAGR: 88.8% 2015 – 2017 Improvement: +1,400bps 78.9% 79.8% 77.8% $34.0 76.2% $28.6 $18.6 64.9% $16.4 $8.0 2015 2016 2017 9M2017 9M2018 2015 2016 2017 9M2017 9M2018 2018 Outlook: FY2018 revenues of $47.5M - $48.0M,
Slide 38: Meaningful YoY Growth in 9M 2018
In 9M 2018, Inspire Experienced Meaningful YoY Growth YoY Revenue YoY Gross Profit YoY Growth: 83% YoY Growth: 88% $27.2 $34.0 $14.5 Territory Managers EQ3 2017 26 EQ3 2018 40 9M 2017 9M 2018 YoY Gross Margin $18.6 YoY Increase: 200bps 79.8% 77.8% 9M 2017 9M 2018 9M 2017 9M 2018 38
Slide 39: Our Growth Strategies
Our Growth Strategies Ensure strong and consistent patient outcomes globally through deliberate expansion and robust training Promote awareness among patients, ENT physicians, sleep centers and referring physicians Expand U.S. sales and marketing organization to drive adoption of our Inspire therapy
Slide 40: Significant First Mover Advantage
Our Innovative Inspire Solution has a Significant First Mover Advantage... Inspire Therapy is Strongly Positioned FDA PMA Approval Since 2014 – More than 4,000 patients treated at over 220 medical Compelling Market centers across the U.S. and Europe Opportunity Evidence of Safety and 5-Year Long-Ter
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