34 th Annual J.P. Morgan Healthcare Conference
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1 JANUARY th Annual J.P. Morgan Healthcare Conference [ 1 ]
2 Forward Looking Statements SPECIAL NOTE REGARDING FORWARD LOOKING STATEMENTS In addition to historical information, this presentation contains forward looking statements with respect to our business, capital resources, strategic initiatives and growth reflecting the current beliefs and expectations of management made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, including regarding continuing adoption of, and interest in, Senza in the U.S. and international markets; our beliefs regarding market size and share for Senza; our beliefs regarding the advantages of Senza and HF10 therapy; our expectations regarding our commercialization efforts; our expectations for U.S., international and worldwide revenue for the fourth quarter and full year of 2015; and our expectations for worldwide revenue for the full year These forward looking statements are based upon information that is currently available to us or our current expectations, speak only as of the date hereof, and are subject to numerous risks and uncertainties, including our ability to successfully commercialize our products; our ability to manufacture our products to meet demand; the level and availability of third party payor reimbursement for our products; our ability to effectively manage our anticipated growth; our ability to protect our intellectual property rights and proprietary technologies; our ability to operate our business without infringing the intellectual property rights and proprietary technology of third parties; competition in our industry; additional capital and credit availability; our ability to attract and retain qualified personnel; and product liability claims. These factors, together with those that are described in greater detail in our Annual Report on Form 10 K filed on March 18, 2015 and our Quarterly Report on Form 10 Q filed on November 9, 2015, as well as any reports that we may file with the Securities and Exchange Commission in the future, may cause our actual results, performance or achievements to differ materially and adversely from those anticipated or implied by our forward looking statements. We expressly disclaim any obligation, except as required by law, or undertaking to update or revise any such forward looking statements. Our preliminary operating results for the quarter and full year ended December 31, 2015 are subject to adjustment as we complete our year end audit and other processes and are not necessarily indicative of our operating results for any future period. [ 2 ]
3 Nevro: A Leader in Neuromodulation ATTRACTIVE Market Growing $1.5B Market, Existing Reimbursement, Potential to Take Share and Grow Existing Market DIFFERENTIATED Technology First SCS to Deliver Significant & Sustained Back Pain Relief FIRST in Class Evidence First Pivotal RCT with Comparative Effectiveness Data, All Primary and Secondary Endpoints Met EXECUTION of U.S. Commercial Launch FDA Approval Secured in May 2015 and Now Executing on Successful U.S. Launch DEMONSTRATED Execution Commercial Success in Europe and Australia 6,000+ Patients in 17 MARKETS Over 5 YEARS [ 3 ]
4 Product and Therapy Overview HF10 Therapy Senza SCS System SENZA RCT Frequency Anatomical Lead Placement Waveform Characteristics Programming [ 4 ]
5 Historically, Limited Data Existed in the SCS Space PUBLISHED RCT STUDIES PRIOR TO NEVRO S SENZA RCT Only three prospective studies with at least six month follow up had been published Prior studies focused on leg pain as the primary endpoint If reported, there was limited efficacy for back pain Leg Pain Back Pain Study System Patients Trial Success Base 6m 12m 24m Base 6m 12m 24m Schultz 2012 Medtronic Restore Sensor Predom Leg Pain NA VAS Response N North 2005 Medtronic Itrel Predom Leg Pain 17/24 71% VAS Response 47% N Kumar 2008 Medtronic Synergy Predom Leg Pain 43/52 83% VAS Response 48% 38% 40% N Note: Blank cells are not reported [ 5 ]
6 First Pivotal Study Conducted for FDA Approval THE LARGEST STUDY IN SCS HISTORY PROVIDING COMPARATIVE LEVEL I EVIDENCE FOR LEG AND BACK PAIN First study to directly compare SCS technologies First randomized study with back pain as a primary endpoint First SCS study to report on 100% of patients to 12 months Designed in consultation with and monitored by the FDA STEPWISE EVIDENCE GENERATION 2011 EUROPEAN MULTICENTER, 24 MONTH STUDY (SENZA EU) 2009 US FEASIBILITY STUDY 2014 US PIVOTAL STUDY (SENZA RCT) RANDOMIZED, CONTROLLED PROSPECTIVE, LONG TERM FEASIBILITY [ 6 ]
7 SENZA RCT: Individual Back Pain Reduction HF10 Therapy Subjects Traditional SCS Subjects (n=89) Individual Subjects Responders (n=70) 79% Responder rate Individual Subjects (n=80) Responders (n=41) 51% Responder rate Non responders (n=19) Non responders (n=39) 100% 80% 60% 40% 20% 0% 20% 40% 60% 80% 100% Decrease in Back Pain from Baseline 12 Months 100% 80% 60% 40% 20% 0% 20% 40% 60% 80% 100% Decrease in Back Pain from Baseline 12 Months Each horizontal line represents the response of a study subject Responders are defined as subjects experiencing 50% or greater pain relief Responder Rates: P<0.001 Each line represents a patient [ 7 ]
8 SENZA RCT: Individual Back Pain Reduction HF10 Therapy Subjects Traditional SCS Subjects Individual Subjects 100% 80% 60% 40% 20% 0% 20% 40% 60% 80% 100% Decrease in Back Pain from Baseline 12 Months Each horizontal line represents the response of a study subject Responders are defined as subjects experiencing 50% or greater pain relief Responder Rates: P<0.001 Each line represents a patient [ 8 ]
9 SENZA RCT: Individual Leg Pain Reduction HF10 Therapy Subjects Traditional SCS Subjects (n=89) Individual Subjects Responders (n=72) 81% Responder rate Individual Subjects (n=80) Responders (n=40) 50% Responder rate Non responders (n=17) Non responders (n=40) 100% 80% 60% 40% 20% 0% 20% 40% 60% 80% 100% Decrease in Leg Pain from Baseline 12 Months 100% 80% 60% 40% 20% 0% 20% 40% 60% 80% 100% Decrease in Leg Pain from Baseline 12 Months Each horizontal line represents the response of a study subject Responders are defined as subjects experiencing 50% or greater pain relief Responder Rates: P=0.003 Each line represents a patient [ 9 ]
10 SENZA RCT: Individual Leg Pain Reduction HF10 Therapy Subjects Traditional SCS Subjects Individual Subjects 100% 80% 60% 40% 20% 0% 20% 40% 60% 80% 100% Decrease in Leg Pain from Baseline 12 Months Each horizontal line represents the response of a study subject Responders are defined as subjects experiencing 50% or greater pain relief Responder Rates: P=0.003 Each line represents a patient [ 10 ]
11 Large and Growing Underserved Market LEG PAIN LEG AND BACK PAIN BACK PAIN Traditional SCS Primarily Leg Pain $1.5 Billion SCS Market Today Established Reimbursement Established Clinical Pathways HF10 Therapy [ 11 ]
12 Multiple Therapy Advantages HF10 Therapy Advantages Superior Pain Relief Durable Results Demonstrated through 24 Months Superior Responder Rates Durable Results Demonstrated through 24 Months Back Pain Efficacy Superior efficacy in treatment of back pain Paresthesia Free Pain Relief No uncomfortable stimulation Intraoperative Workflow Efficiencies More predictable procedures due to lack of paresthesia mapping (anatomical placement) [ 12 ]
13 2015 Highlights FDA Approval & Superiority Labeling for HF10 Therapy 12 Month Publication in Anesthesiology 12 Month SENZA RCT Results published in Anesthesiology (titled Novel 10 KHz High Frequency Therapy (HF10 Therapy) Is Superior to Traditional Low Frequency Spinal Cord Stimulation for the Treatment of Chronic Back and Leg Pain: The SENZA RCT Randomized Controlled Trial IPR Patent Challenge Victory U.S. Patent and Trademark Office denied Boston Scientific Petitions for Inter Partes Review of U.S. Patent No. 8,359,102 CMS Approval of Transitional Pass Through Payment Centers for Medicare & Medicaid Services (CMS) Approves a Transitional Pass Through Payment for High Frequency Stimulation under the Medicare Hospital Outpatient Prospective Payment System Effective Beginning January 1, 2016 Consistent International Performance ~70% YoY growth in 1Q15, ~80% growth in 2Q15 and ~50% growth in 3Q15 on a constant currency basis Successful US Launch Growing number of clinics across the U.S. are continuing to adopt HF10 therapy and outcomes in commercial use are consistent with clinical outcomes from SENZA RCT [ 13 ]
14 CMS Approves Transitional Pass Through Payment for Outpatient Use of Senza SCS System Effective January 1, 2016 CMS has determined that HF10 therapy has fulfilled its Substantial Clinical Improvement criteria based on Nevro s SENZA RCT pivotal study data This pass through payment to facilities for HF10 therapy for Medicare patients will be in addition to the established reimbursement for spinal cord stimulation devices In the past 10 years, HF10 therapy is 1 of only 11 medical devices to be granted outpatient pass through payment status by CMS [ 14 ]
15 Executing on U.S. Launch Strategy RESPONSIBLY ROLLING OUT HF10 THERAPY LEVERAGING INTERNATIONAL EXPERIENCE & CLINICAL EVIDENCE HIRING EXCEPTIONAL TALENT & PROVIDING RIGOROUS TRAINING DELIVERING CONSISTENT & SUPERIOR CLINICAL OUTCOMES EDUCATING THE MARKET ON THE PIVOTAL RCT DATA ESTABLISHING NEVRO AS THE LEADER IN NEUROMODULATION [ 15 ]
16 U.S. Sales Organization Reps Trained & In Field Rep Productivity Goals fully trained sales reps as of YE2015 Steady state rep productivity goal of $1.3 to $1.5 million Steady state achievement in 18 to 24 months At Launch 5/8/15 Q2 Q3 YE15 [ 16 ]
17 Nevro Is Penetrating AND Growing the SCS Market Pain Distribution of HF10 Treated Patients U.S. Launch through Jan 1, 2016 ~5% ~30% Predominant Back Predominant Leg Back & Leg Other ~50% ~15% [ 17 ]
18 2015 Quarterly Revenue Ramp $ in Millions (unaudited) FY15 Preliminary Estimated Revenue: $69.1M $69.6M U.S. Revenue International Revenue 4Q15E U.S. Range: $19.5M $19.8M Int l Range: $13.1M $13.3M ~$32.6 ~$19.5 $15.4 $9.7 $11.4 $0.1 $4.5 $9.7 $11.3 $10.9 ~$13.1 1Q15 2Q15 3Q15 4Q15E FY16 Preliminary Worldwide Revenue Guidance: $145.0M $155.0M [ 18 ]
19 Multiple Potential Label Expansion Opportunities Refractory Chronic Migraine Chronic Intractable Neck and Upper Extremity Pain FOCUSED ON PAIN & PAIN SPECIALISTS Non Surgical Low Back Pain [ 19 ]
20 Nevro: A Leader in Neuromodulation ATTRACTIVE Market Growing $1.5B Market, Existing Reimbursement, Potential to Take Share and Grow Existing Market DIFFERENTIATED Technology First SCS to Deliver Significant & Sustained Back Pain Relief FIRST in Class Evidence First Pivotal RCT with Comparative Effectiveness Data, All Primary and Secondary Endpoints Met EXECUTION of U.S. Commercial Launch FDA Approval Secured in May 2015 and Now Executing on Successful U.S. Launch DEMONSTRATED Execution Commercial Success in Europe and Australia 6,000+ Patients in 17 MARKETS Over 5 YEARS [ 20 ]
21 Experienced Industry Leadership MICHAEL DEMANE Chairman & CEO RAMI ELGHANDOUR President ANDREW GALLIGAN CFO DOUG ALLEAVITCH VP Quality & Operations MICHAEL ENXING VP Sales ANDRE WALKER Sr. VP R&D DAVID CARAWAY, MD, PHD Chief Medical Officer Center for Pain Relief Relative Value Scale Update Committee (RUC) RICH CARTER VP Finance BRAD GLINER VP Clinical &Regulatory MIKE HALL General Counsel TAMARA ROOK VP HE&R [ 21 ]
22 JANUARY 2016 [ 22 ]
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JANUARY 2015 [ 1 ] Forward Looking Statements and Further Information SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS This presentation contains forward-looking statements. All statements other than
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