Inspire Medical Systems, Inc. September 2019 NYSE: INSP 1
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-looking statements by terms such as ‘‘may,’’ ‘‘will,’’ ‘‘should,’’ ‘‘expect,’’ ‘‘plan,’’ ‘‘anticipate,’’ ‘‘could,’’ “future,” “outlook,” ‘‘intend,’’ ‘‘target,’’ ‘‘project,’’ ‘‘contemplate,’’ ‘‘believe,’’ ‘‘estimate,’’ ‘‘predict,’’ ‘‘potential,’’ ‘‘continue,’’ or the negative of these terms or other similar expressions, although not all forward-looking statements contain these words. The forward-looking statements in this presentation relate to, among other things, statements regarding our clinical data growth, product development, indication expansion, market development, and prior authorization approvals. These forward-looking statements are based on management’s current expectations and involve known and unknown risks and uncertainties that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, estimates regarding the annual total addressable market for our Inspire therapy in the U.S. and our market opportunity outside the U.S.; future results of operations, financial position, research and development costs, capital requirements and our needs for additional financing; commercial success and market acceptance of our Inspire therapy; our ability to achieve and maintain adequate levels of coverage or reimbursement for our Inspire system or any future products we may seek to commercialize; competitive companies and technologies in our industry; our ability to enhance our Inspire system, expand our indications and develop and commercialize additional products; our business model and strategic plans for our products, technologies and business, including our implementation thereof; our ability to accurately forecast customer demand for our Inspire system and manage our inventory; our dependence on third-party suppliers, contract manufacturers and shipping carriers; consolidation in the healthcare industry; our ability to expand, manage and maintain our direct sales and marketing organization, and to market and sell our Inspire system in markets outside of the U.S.; risks associated with international operations; our ability to manage our growth; our ability to increase the number of active medical centers implanting Inspire therapy; our ability to hire and retain our senior management and other highly qualified personnel; risk of product liability claims; risks related to information technology and cybersecurity; risk of damage to or interruptions at our facilities; our ability to commercialize or obtain regulatory approvals for our Inspire therapy and system, or the effect of delays in commercializing or obtaining regulatory approvals; FDA or other U.S. or foreign regulatory actions affecting us or the healthcare industry generally, including healthcare reform measures in the U.S. and international markets; the timing or likelihood of regulatory filings and approvals; risks related to our debt and capital structure; our ability to establish and maintain intellectual property protection for our Inspire therapy and system or avoid claims of infringement; tax risks; risks that we may be deemed an investment company under the Investment Company Act of 1940; regulatory risks; the volatility of the trading price of our common stock; and our expectations about market trends. Other important factors that could cause actual results, performance or achievements to differ materially from those contemplated in this presentation can be found under the caption “Risk Factors” in our Annual Report on Form 10-K for the year ended December 31, 2018, as such factors may be updated from time to time in our other filings with the SEC, which are accessible on the SEC’s website at www.sec.gov. These and other important factors could cause actual results to differ materially from those indicated by the forward-looking statements made in this presentation. Any such forward-looking statements represent management’s estimates as of the date of this presentation. While we may elect to update such forward-looking statements at some point in the future, unless required by applicable law, we disclaim any obligation to do so, even if subsequent events cause our views to change. Thus, one should not assume that our silence over time means that actual events are bearing out as expressed or implied in such forward-looking statements. These forward-looking statements should not be relied upon as representing our views as of any date subsequent to the date of this presentation. This presentation contains trademarks, trade names and service marks of other companies, which are the property of their respective owners. We do not intend our use or display of other parties' trademarks, trade names or service marks to imply, and such use or display should not be construed to imply, a relationship with, or endorsement or sponsorship of us by, these other parties. © Inspire Medical Systems, Inc. 2 All Rights Reserved INSPIRE CONFIDENTIAL
© Inspire Medical Systems, Inc. 3 All Rights Reserved INSPIRE CONFIDENTIAL
Inspire is an Innovative Neurostimulation Solution for Moderate to Severe Obstructive Sleep Apnea (OSA) � First and only FDA-approved neurostimulation Our History & Key Milestones technology for OSA 1990s: Medtronic (MDT) begins early work on the development of Inspire � More than 6,000 patients treated with Inspire therapy 2001: Initial clinical results published by MDT 2007: Inspire is founded after being spun-out � Alternative for the estimated 35 – 65% of non-CPAP of Medtronic compliant patients 2011: Initiated Phase III pivotal STAR trial; CE mark received in Europe � ~$10bn annual U.S. market opportunity 2014: STAR results published in the New England Journal of Medicine in January; � Innovative, closed-loop, minimally invasive solution received PMA approval from the FDA in April � Safe, comfortable, and convenient therapy 2015: 18-month STAR data published; revenues of $8.0M � Significant body of clinical evidence involving >1,500 2016: 1,000th implant milestone; revenues of patients across 22 studies $16.4M 2017: Launched Inspire IV neurostimulator in � Strong customer base and growing sales team U.S.; announced 5-year STAR results; 2,000th � Growing reimbursement with 142 million covered lives implant; revenues of $28.6M 2018: Inspire IV CE mark; 5-year STAR results publication; initial public offering on NYSE; � Proven management team leading 200+ employees Aetna begins covering the Inspire therapy; revenues of $50.6M 2019: 6,000th patient receives Inspire therapy; Many BCBS plans and United Healthcare write positive coverage © Inspire Medical Systems, Inc. 4 All Rights Reserved INSPIRE CONFIDENTIAL
Strong Management Team Other Key Management Steve Jandrich VP, Human Resources & Chief Compliance Officer Ivan Lubogo Sr. VP, U.S. Sales Martin Abrams VP, Marketing & Customer Experience Andreas Henke VP, European Operations Quan Ni, PhD VP, Research & Clinical Affairs John Rondoni VP, Product Development, Tim Herbert Rick Buchholz Randy Ban Operations & Quality President, CEO & Chief Commercial Kathy Sherwood VP, Global Market Access Chief Financial Officer Founder Officer � 30+ Years of Experience � 25+ Years of Experience � 25+ Years of Experience © Inspire Medical Systems, Inc. 5 All Rights Reserved INSPIRE CONFIDENTIAL
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 hour, which is referred to as the Apnea-Hypopnea Index (AHI) Normal range: Moderate sleep apnea: AHI < 5 events per hour 15 ≤ AHI < 30 events per hour Mild sleep apnea: Severe sleep apnea: Airway obstruction 5 ≤ AHI < 15 events per hour AHI ≥ 30 events per hour during breathing Inspire’s Focus Most Patients Are Unaware of Their Condition and Untreated OSA Multiplies Serious Health Risks • High risk patients: obese, male or of advanced age Increased Risk of Mortality 5 • Common first indicator: heavy snoring 2x • Other indicators: The risk for stroke1 • Lack of energy • Memory or concentration 2x • Headaches problems The risk for sudden cardiac death2 • Depression • Excessive daytime 5x % Surviving The risk for cardiovascular mortality3 • Nighttime gasping sleepiness 57% • Dry mouth Increased risk for recurrence of Atrial Fibrillation after ablation4 Years of Follow-up ____________________ Source: Company Website 4. Li et al, Europace 2014. 1. Redline et al, The Sleep Heart Health Study. Am J Res and Crit Care Med 2010. 5. Prospective Study of Obstructive Sleep Apnea and Incident Coronary Heart Disease and Heart Failure from 2. Gami et al, J Am Coll Cardiol 2013. SHHS and Wisconsin Sleep Cohort Study. 3. Young et al, J Sleep 2008. © Inspire Medical Systems, Inc. 6 All Rights Reserved INSPIRE CONFIDENTIAL
Current Treatment Options such as CPAP and Invasive Surgery have Significant Limitations Continuous Positive Airway Pressure (CPAP) is the Leading Therapy for OSA • Delivered through a mask that connects through a Drivers of Non-Compliance hose to a bedside air pump � Mask Discomfort • Demonstrated improvements in patient-reported � Mask Leakage sleep quality and reductions in daytime sleepiness � Pressure Intolerance Ina � Skin Irritation • Long-term limitations as a therapeutic option, � Nasal Congestion primarily due to low patient compliance � Nasal Drying (approximately 35% – 65%) � Nosebleeds • Low patient compliance as many patients find the � Claustrophobia mask or treatment cumbersome, uncomfortable � Lack of Intimacy and loud Invasive Surgery • Several variations of sleep surgery • Success rates vary widely (30% - 60%)1 Ina • Irreversible anatomy alteration • In-patient surgery with extended recovery Uvulopalatopharyngoplasty Maxillomandibular Advancement (UPPP) (MMA) ____________________ 1. Shah, Janki, et al; American Journal of Otolaryngology (2018). Uvulopalatopharyngoplasty vs. CN XII stimulation for treatment of obstructive sleep apnea: A single institution experience. © Inspire Medical Systems, Inc. 7 All Rights Reserved INSPIRE CONFIDENTIAL
A Strong Market Opportunity Exists for an Alternative to CPAP that is Effective and Minimally Invasive Prevalence & Economic Costs Adults with Moderate to Severe OSA • Less: 65% CPAP Published literature � Sleep apnea affects +100 million people Prescribed CPAP2 = Compliant estimates CPAP 1 worldwide ~2 million non-compliance rates of � Approximately 17 million individuals in the 35% - 65% U.S. with moderate to severe OSA • Annually, ~2 million adult patients are 35% of CPAP Non- prescribed a CPAP device 2 • Less: 30% Compliant Adults = Anatomy � Annual U.S. economic costs of untreated ~700,000 Challenges moderate to severe OSA are between $65 - $165 billion3 � OSA economic costs are potentially greater than asthma, heart failure, stroke, and hypertensive disease 70% Inspire Anatomy • Multiplied by: our Eligible = ~500,000 ASP � OSA is associated with an increase in: • Rate & severity of vehicle accidents • Increased healthcare utilization • Reduction of work performance Inspire U.S. Market = • Occupational injuries ~$10 billion ____________________ Note: ASP constitutes abbreviation for average selling price. 1. Source: World Health Organization. 2. Company estimates. 3. Represents moderate to severe OSA. Source: McKinsey & Company, 2010. © Inspire Medical Systems, Inc. 8 All Rights Reserved INSPIRE CONFIDENTIAL
Inspire Therapy is a Proven 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 two-hour outpatient procedure Pressure sensing lead: detects when the •1 � Requires three small incisions patient is attempting to breathe � Patients typically recover quickly and resume •2 Neurostimulator: houses the electronics and normal activities in just a few days battery power for the device � System activation occurs 30 days after implantation •3 Stimulation lead: delivers electrical stimulation � Patient controls system by turning on the device to the hypoglossal nerve each night with the remote control before going to sleep © Inspire Medical Systems, Inc. 9 All Rights Reserved INSPIRE CONFIDENTIAL
Inspire Therapy is 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 satisfaction � Minimally invasive outpatient procedure � ~11-year battery life (without recharging) � Utilizes patient’s natural physiology � Short recovery times post surgery � Patient controlled therapy Long-term outcomes demonstrate that Inspire therapy addresses the shortfalls of current treatments © Inspire Medical Systems, Inc. 10 All Rights Reserved INSPIRE CONFIDENTIAL
Objective Measures Show the Impact of Inspire Therapy on OSA Polysomnogram Before and After Activation of Inspire System Inspire system turned on Airflow Breathing Oxygen Saturation OSA events No OSA events After activating the Inspire system, the patient exhibited a more regular breathing pattern, higher and more consistent blood oxygen levels, and fewer or no transient arousals © Inspire Medical Systems, Inc. 11 All Rights Reserved INSPIRE CONFIDENTIAL
Clinical Evidence © Inspire Medical Systems, Inc. 12 All Rights Reserved INSPIRE CONFIDENTIAL
Significant Body of Clinical Evidence Evaluating Inspire in >1,500 Patients Across 22 Studies1 Patients Clinical Studies Evaluated Stimulation Therapy for Apnea Reduction (STAR) 126 German Post-Market Study 60 ADHERE Patient Registry 508 Company Company Sponsored Pediatric / Down Syndrome 26 Inspire vs. traditional sleep surgery 248 (Cleveland Clinic, Thomas Jefferson, UPenn) Independent Studies in Single Centers 2 150 Independent Studies of Specific Populations 418 Independent German and French Experience 143 (Munich, Lubeck, Bordeaux) Total Patients Evaluated Above 1,679 1. Due to the inclusion of certain patients in multiple studies, some studies are not shown in the table because they do not add any incremental patients to the overall total. 2. Includes Thomas Jefferson University Hospital (TJUH) & University of Pittsburgh Medical Center (UPMC); University Hospitals – Cleveland; Non- Academic Hospital in San Diego; and University of Pennsylvania. © Inspire Medical Systems, Inc. 13 All Rights Reserved INSPIRE CONFIDENTIAL
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 (ODI) (Median) 29.3 25.4 9.0 9.7 7.4 8.6 6.0 6.2 4.8 4.6 Events per Hour per Events Events per Hour per Events Baseline 12 Month 18 Month 3 Year 5 Year Baseline 12 Month 18 Month 3 Year 5 Year N=126 N=124 N=123 N=98 N=71 N=126 N=124 N=123 N=98 N=71 All p values <0.001 vs. baseline All p values <0.001 vs. baseline results in median results in median Withdrawal of Inspire Therapy Resulted in Reversal of Therapeutic Benefit, Further Demonstrating Inspire’s Effectiveness Apnea-Hypopnea Index (Mean) Oxygen Desaturation Index (Mean) 31.3 30.1 26.7 26.8 25.8 23.0 8.9 8.0 7.2 7.6 6.3 6.0 Score (Events/hr) Score (Events/hr) Score Baseline 1 Year Randomized, Therapy- Baseline 1 Year Randomized, Therapy- withdrawal Trial withdrawal Trial Therapy-maintenance Group (N=23) Therapy-withdrawal Group (N=23) Therapy-maintenance Group (N=23) Therapy-withdrawal Group (N=23) © Inspire Medical Systems, Inc. 14 All Rights Reserved INSPIRE CONFIDENTIAL
Additional STAR Findings Showed Meaningful Improvement in Quality of Life Metrics Functional Outcomes of Sleep Questionnaire (Median) Epworth Sleepiness Scale (Median) Normalized daytime functioning = 17.9 18.2 18.4 18.8 18.7 11.0 Normalized daytime sleepiness = 10.0 14.6 6.0 6.0 6.0 6.0 Baseline 12 Mo. 18 Mo. 3 Yr. 5 Yr. Baseline 12 Mo. 18 Mo. 3 Yr. 5 Yr. N=126 N=124 N=123 N=98 N=92 N=126 N=124 N=123 N=98 N=92 All p values <0.001 vs. baseline results All p values <0.001 vs. baseline results No or Soft Snoring (Median) Bed Partner Leaves Room (Median) 86% 87% 90% 81% 30% 17% 5% 4% 3% 1% Baseline 12 Mo. 18 Mo. 3 Yr. 5 Yr. Baseline 12 Mo. 18 Mo. 3 Yr. 5 Yr. N=108 N=103 N=103 N=100 N=80 N=108 N=103 N=103 N=100 N=80 © Inspire Medical Systems, Inc. 15 All Rights Reserved INSPIRE CONFIDENTIAL
Summary of Selected Clinical Studies German Post- ADHERE Patient TJUH and UPMC STAR Trial Market Study1 Registry1 Evaluation2 # of Inspire Patients 124 97 56 508 48 / 49 Time Following 12 5 Years 12 Months 12 Months 3 Months Implantation Months AHI – Baseline 29.3 29.3 28.6 34.0 35.9 / 35.3 AHI – Therapy 9.0 6.2 9.5 7.0 6.3 / 6.3 ESS – Baseline 11.0 11.0 13.0 12 11.1 / 10.9 ESS – Therapy 6.0 6.0 6.5 7 5.8 / 6.6 FOSQ – Baseline 14.6 14.6 13.7 * * FOSQ – Therapy 18.2 18.7 18.6 * * 86% daily; Average 39 hours per Average >45 hours Therapy 80% Average 5.7 hours 93% 5+ week; 89% ≥20 hours per week; >75% ≥40 Compliance daily per night days per week hours per week weekly ____________________ 1. Represents median results. 2. Represents mean results. © Inspire Medical Systems, Inc. 16 All Rights Reserved INSPIRE CONFIDENTIAL
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 Apnea Hypopnea Index (Median) Epworth Sleepiness Scale (Median) Normalized daytime sleepiness = 10.0 12 P<0.0001 be retrospective and 34.0 P<0.0001 42% prospective Reduction 7 � 14 centers were involved 79% Reduction in registry 7.0 � Registry enrolled 1,300 Baseline 12 Months Baseline 12 Months patients between October N=499 N=227 N=443 N=241 2016 and July 2019 Inspire is Better Would Recommend to Overall Patient Patients would Experience than CPAP Friends / Family Satisfaction Choose Inspire Again Adherence Monitoring: Average home device use: 96% 96% 94% 94% 5.7 hours / night Early results from the ADHERE registry show Inspire therapy is an effective treatment for OSA in a real-world setting ____________________ Note: Latest registry data as of November 2018. © Inspire Medical Systems, Inc. 17 All Rights Reserved INSPIRE CONFIDENTIAL
Product and Indication Expansion © Inspire Medical Systems, Inc. 18 All Rights Reserved INSPIRE CONFIDENTIAL
We are Committed to Continuous Product Development & Indication Expansion Indication Expansion Product Pipeline � Working with the FDA to expand indication in � 5th generation neurostimulator is in the development the U.S. to patients as young as 12 years of phase age (including Down syndrome) � Inspire Cloud, which has been launched, is being designed to allow physicians to monitor patient � Patients born with Down syndrome compliance and therapy efficacy have higher rates of OSA than the general pediatric population Sample Inspire Cloud � 50-patient investigator-initiated trial in Dashboard process to demonstrate the safety and efficacy of Inspire therapy for treating Down syndrome patients1 ____________________ Not actual data; for illustrative purposes only. 1. Published in JAMA Otolaryngology – Head & Neck Surgery. © Inspire Medical Systems, Inc. 19 All Rights Reserved INSPIRE CONFIDENTIAL
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 the Referral Network � Generates Complete Patient Therapy Reports � Creates Care Coordination Hub � Insight into Center-Wide Therapy Outcomes � Fits into Existing Sleep Clinic Workflows © Inspire Medical Systems, Inc. 20 All Rights Reserved INSPIRE CONFIDENTIAL
Reimbursement © Inspire Medical Systems, Inc. 21 All Rights Reserved INSPIRE CONFIDENTIAL
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 • 2019 National Medicare average • Over 375 commercial payors in the lead: CPT code 64568 for Cranial facility payment of approximately U.S. have paid for the Inspire Nerve Stimulator $27,700 procedure, mostly through prior authorization • Sensing lead: CPT code 0466T • Proposed 2020 National Medicare (Category III) payment ~ $29,000 • Medicare payment in most MACs • Physician society working to • Covers the cost of the device and • Government contract for VA / convert to a Category I code the procedure for implantation Military hospitals 2018 U.S. Implant Mix Two-pronged Approach to Reimbursement Part 1: Work with all payers to educate on the therapy 30% during annual and mid-cycle reviews to develop positive Commercial coverage policies (i.e., Aetna was a mid-cycle) 60% Medicare Part 2: Work with physicians and centers to obtain prior VA authorizations from payers as most have negative 10% coverage policies today, yet approve procedures after appeal cycles © Inspire Medical Systems, Inc. 22 All Rights Reserved INSPIRE CONFIDENTIAL
Developing Positive Coverage Policies – Currently, 41 Policies Covering 142 Million Lives United Anthem 14 BCBS Cigna Healthcare Plans: (15M) (41M) California & Georgia ++ (40M) Humana HCSC BCBS (12M) BCBS Others (12M) Aetna IL/TX BCBS (15M) (22M) 25 Other BCBS Plans: MI, FEP, Highmark, Independence, NC, 13 other NJ, CA, TN, AL, MA, Regence, Premera, Medicare: regional LA, Excellus, Focus on local payments plans Wellmark, SC, etc. (9M) (55M) 12 Medicare MAC 26 (of 36) BCBS policies issued Jurisdictions covering 70M lives since Jan 2019 Indicates Insurers with Positive Coverage Policies or positive technical assessments © Inspire Medical Systems, Inc. 23 All Rights Reserved INSPIRE CONFIDENTIAL
U.S. Commercial Prior Authorization Submissions Continued focus on Prior Authorization Submissions Total Submissions • Q3 2018 included a bolus of Aetna resubmissions following the issuance of the coverage policy 2019: 1,457 (H1 ‘19) • Q1 2019 is revised as there were 34 additional submissions not included in prior quarter reporting (these were second submissions as a result of a new positive 2018: 2,477 insurance policy) 2017: 1,506 2016: 960 Past Quarter Submissions 800 70 722 735 700 661 619 639 60 600 558 50 488 500 445 40 400 303 30 268 270 56 57 300 258 51 209 225 48 49 43 20 Quarterly Total Submissions Total Quarterly 38 200 34 21 20 21 23 10 Submissions Average Weekly Quarterly 100 16 17 0 0 Q1'16 Q2'16 Q3'16 Q4'16 Q1'17 Q2'17 Q3'17 Q4'17 Q1'18 Q2'18 Q3'18 Q4'18 Q1'19 Q2'19 Qtrly Weekly Average Submissions Qtrly Total Submissions © Inspire Medical Systems, Inc. 24 All Rights Reserved INSPIRE CONFIDENTIAL
U.S. Commercial Prior Authorization Approvals Many patients who are willing to work through the Total Approvals process are approved; shortly after approval, 2019: 1,024 (H1 ‘19) the process shifts to scheduling the placement 2018: 1,230 of the Inspire system. 2017: 583 2016: 330 Past Quarter Approvals 581 600 50 45 500 443 40 395 35 400 373 30 300 25 249 213 45 190 20 200 34 Quarterly Quarterly TotalApprovals 126 133 134 29 30 15 96 103 19 10 100 59 72 16 15 Quarterly Weekly Average Approvals 8 10 10 10 5 5 7 6 0 0 Q1'16 Q2'16 Q3'16 Q4'16 Q1'17 Q2'17 Q3'17 Q4'17 Q1'18 Q2'18 Q3'18 Q4'18 Q1'19 Q2'19 Qtrly Weekly Average Approvals Qtrly Total Approvals © Inspire Medical Systems, Inc. 25 All Rights Reserved INSPIRE CONFIDENTIAL
The Prior Authorization Metrics are Steadfastly Improving with Every New Positive Coverage Policy Case-by-Case Submissions, Reviews & Approvals Process If denied If denied If denied Prepare/Submit an EMR Prepare/Submit an Prepare/Submit a 1st Prepare/Submit a 2nd appeal Prior Authorization level appeal level appeal (External Medical Review) Approval typically takes approximately 2-3 months (2019 mean time to approval improved but still early in the FY) Prior Authorization Approval Track Record Following a Complete Appeal Review Cycle Percentage of Patient Approvals – 2018 Percentage of Patient Approvals – 2019 YTD 75% Approved 90% Approved Denied at EMR Denied at EMR Dismissed +2,4771 Dismissed 15% +1,4572 10% 8% 2% Overall approval rates are ~55% as many patients do not receive a full review (drop out or are blocked) ≈72% 1. Indicates number of patient submissions in 2018 in 2019 2. Indicates number of patient submissions in 2019 © Inspire Medical Systems, Inc. 26 All Rights Reserved INSPIRE CONFIDENTIAL
Commercial Development © Inspire Medical Systems, Inc. 27 All Rights Reserved INSPIRE CONFIDENTIAL
We have a Targeted Approach to Market Development and Patient Outreach 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 demand through patient channels Local Physician to Patient Direct-to-Patient Channels / Self-Referred Radio Physician Word of Mouth Cardiac Dental Practice / Practice EP1 Referrals Referrals 1st Half 2019 Website Results Inspire Program Core Team Sleep Sleep Practice Practice Refer and Referrals Manage 341K Doctor 21K Doctor 2M Visitors Searches Contacts (+48% YoY) (+41% YoY) (+31% YoY) ____________________ 1. Electrophysiologists (EP) © Inspire Medical Systems, Inc. 28 All Rights Reserved INSPIRE CONFIDENTIAL
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 Patients � 59 Territory Managers (reps) in U.S. and 7 in Europe Centers � Managed by Regional Sales Managers (10) � Supported by Therapy Awareness Managers and Field Clinical Representatives � Target for each rep to manage 5 – 8 active centers ENT per territory Physicians Encourage and sponsor additional publications of Focus on building long-lasting physician relationships � � clinical data � Support physicians through all aspects of a case � Increase awareness through training and education � Identify new regions with high-volume medical centers � Continue various direct-to-patient marketing initiatives Summary: Continue to build capacity to treat patients by adding centers, hiring Territory Managers, and adding support structure, including Regional Managers and staff to cover implant cases and activations © Inspire Medical Systems, Inc. 29 All Rights Reserved INSPIRE CONFIDENTIAL
Keys To Driving a Strong Territory Territory Manager Strategy � New Centers and Territory Framing How TMs Spend their Time � Leading with four Area Vice-Presidents � Building Regional Manager Team; targeting FCRs to 13 RMs by the end of 2019 Support � Adding Field Clinical Reps (FCRs) to AttendAttend DISE, DISE, support implants Find The Right Find The Cases & Centers Cases & Right Follow up � Continue adding Territory Managers Follow up Centers � Ended Q2 2019 with 59 U.S. Territory Managers (added 6 in Q2 2019) � Sales Training Drive Manage Prior Drive Patient � Inspire University conducted quarterly for Authorization,Patient Flow & new employees CodingFlow & Practice & PaymentPractice Readiness � Free up selling time for tenured reps to Readiness focus on driving patient flow � Invest in FCRs to cover cases and activations © Inspire Medical Systems, Inc. 30 All Rights Reserved INSPIRE CONFIDENTIAL
The Great Balancing Act KEEPING CONTROL WHILE GROWING FAST Focus on the rapid scaling of commercialization while ensuring proper training to maintain control of high-quality therapy outcomes © Inspire Medical Systems, Inc. 31 All Rights Reserved INSPIRE CONFIDENTIAL
The Inspire Control System Prevalence Pool 17M people in the U.S. with Incidence Pool OSA, of which 500k new End Goal: Strong ≈25% could be cases per year treated with who could be Patient Outcomes Inspire treated using Inspire Question 3: How Question 1: How Question 2: How Question 4: How Question 5: How to direct patients to find these to improve the to improve time to scale the to the correct patients and yield to increase and approval business without physician to connect them to contacts to rates from losing quality in prevent the proper healthcare insurance patient unnecessary healthcare providers? companies? outcomes? provider? visits? Continuous addition of new sales reps and opening new hospitals Insurance Approvals Physician Appointment Direct-to-Patient • 142M covered lives in the U.S. ≈50% are new sleep Outreach Process • Policies significantly improve apnea patients and need approval rates and reduces to try CPAP first time to approval Patient ≈25% of patients are not • Many patients still required to receives proper candidates go thru prior auth process ≈25% are good Inspire Inspire Patient makes Patient proceeds • Medicare is closely tracked and Patient candidates appointment to for insurance expect formal LCDs in 2019 scheduled for see doctor approval Inspire © Inspire Medical Systems, Inc. 32 All Rights Reserved INSPIRE CONFIDENTIAL
Financials © Inspire Medical Systems, Inc. 33 All Rights Reserved INSPIRE CONFIDENTIAL
Quarterly Revenue ($ in Millions) 2019 Revised Outlook: FY2019 revenue of $73M - $75M, up 44% - 48% from FY2018 revenue of $50.6M $18.0 (Prior guidance of $69M - $72M following Q1 2019 results) $16.6 $16.3 $13.1 $10.9 $10.0 $10.0 $7.3 $6.0 $5.3 $4.7 $5.2 $3.6 $3.0 1Q16 2Q16 3Q16 4Q16 1Q17 2Q17 3Q17 4Q17 1Q18 2Q18 3Q18 4Q18 1Q19 2Q19 151% 170% 121% 89% 79% 69% 56% 91% 90% 81% 80% 66% 62% 65% % YoY Revenue Growth © Inspire Medical Systems, Inc. 34 ____________________ Quarterly amounts are unaudited All Rights Reserved INSPIRE CONFIDENTIAL
Annual Revenue and Gross Margins Annual Revenue ($ in millions) Annual Gross Margin 2016 – 2018 CAGR: 75.7% 2016-2018 Improvement: +390bps Guidance [$72-75] Guidance [81-83%] 80.1% $50.6 78.9% $28.6 76.2% $16.4 2016 2017 2018 2019 2016 2017 2018 2019 2019 Revised Outlook: FY2019 revenue of $72M - $75M, up 44% - 48% from FY2018 revenue of $50.6M (prior guidance of $69M - $72M). FY2019 gross margin between 81% - 83% (prior guidance of 80% - 82%) © Inspire Medical Systems, Inc. 35 All Rights Reserved INSPIRE CONFIDENTIAL
In Q2 2019, Inspire Experienced Strong YoY Growth YoY Revenue ($ in millions) YoY Gross Margin YoY Growth: 65% $18.0 YoY Increase: 200bps Territory Managers EQ2 2019: 59 82.8% EQ2 2018: 36 Q2 2018 & 2019 Revenue Mix $10.9 US OUS 13% 80.8% 87% Q2 2018 Q2 2019 Q2 2018 Q2 2019 © Inspire Medical Systems, Inc. 36 All Rights Reserved INSPIRE CONFIDENTIAL
Our Growth Strategies � Ensure strong and consistent patient outcomes globally through planned and controlled expansion and robust physician 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 � Leverage the prior authorization model while we work in parallel with payors to develop positive coverage policies � Invest in research and development to drive innovation and expand indications � Further penetrate existing and expand into new international markets © Inspire Medical Systems, Inc. 37 All Rights Reserved INSPIRE CONFIDENTIAL
Our Innovative Inspire Solution has a Significant First Mover Advantage Inspire Therapy is Strongly Positioned � FDA PMA approval since 2014 � More than 6,000 patients treated at over 270 medical Compelling Market centers across the U.S. and Europe Opportunity � Significant payor experience � 142 million covered lives in the U.S. Large and growing � Leverage highly effective prior authorization model prevalence of OSA � Over 1,500 individual patient submissions in 2017, over 2,450 in 2018, and over 1,450 in H1 2019 Significant economic � Evidence of safety and 5-year long-term sustained cost of untreated OSA efficacy � Consistent results across four sponsored and 18 independent clinical studies evaluating ~1,679 patients Urgent clinical need for � Ongoing enrollment of 2,500 patient ADHERE patient an effective alternative registry (>1,000 patients enrolled thru 1H 2019) to CPAP � Differentiated products built on years of development � Closed loop system that leverages our pressure sensing ~$10bn annual market lead and proprietary algorithm opportunity in the U.S. � Current device represents the 4th generation of our Inspire system, which has an ~11-year battery life and allows for MRI of head and extremities © Inspire Medical Systems, Inc. 38 All Rights Reserved INSPIRE CONFIDENTIAL
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