Forward Looking Statements and Further Information

Transcription

1 JANUARY 2015 [ 1 ]

2 Forward Looking Statements and Further Information SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS This presentation contains forward-looking statements. All statements other than statements of historical facts contained in this presentation, including statements regarding our future results of operations and financial position, business strategy, prospective products, availability of funding, clinical trial results, product approvals and regulatory pathways, timing and likelihood of success, plans and objectives of management for future operations, and future results of current and anticipated products, are forward-looking statements. These statements involve known and unknown risks, uncertainties and other important factors 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. Because forward-looking statements are inherently subject to risks and uncertainties, some of which cannot be predicted or quantified and some of which are beyond our control, you should not rely on these forward-looking statements as predictions of future events. The events and circumstances reflected in our forward-looking statements may not be achieved or occur and actual results could differ materially from those projected in the forward-looking statements. Except as required by applicable law, we do not plan to publicly update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise. This presentation concerns products that are under clinical investigation and which have not yet been approved for marketing by the U.S. Food and Drug Administration (FDA). The Senza System is currently limited by Federal law to investigational use, and no representation is made as to its safety or effectiveness for the purposes for which it is being investigated. FURTHER INFORMATION You should read the periodic and current reports and other documents that Nevro Corp. files with the SEC for more complete information about the company, including the Quarterly Report on Form 10-Q for the quarter ended September 30, You may get these documents for free by visiting EDGAR on the SEC s website at [ 2 ]

3 Positioned to Be 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 DEFINED PATH to U.S. Commercialization Early 2016 Pending FDA Approval DEMONSTRATED Execution Commercial Success in Europe and Australia 2,500 Patients in 15 MARKETS Over 4 YEARS [ 3 ]

4 Advancing Spinal Cord Stimulation (SCS) SIGNIFICANT and SUSTAINED Chronic Leg & Back Pain Relief PROPRIETARY HF10 THERAPY DEMONSTRATED Results via First Pivotal RCT with Comparative Effectiveness Data [ 4 ]

5 Large and Growing Underserved Market $1.5 Billion SCS Market Today SCS Global Market Revenue (Millions) $300 MDT STJ BSX $378 $469 $544 $647 $745 CAGR 8% $854 $952 $1,400 $1,300 $1,200 $1,100 PRIMARILY LEG PAIN $300M Int l $1.2B US ~ $25K per Procedure ~ 40K Procedures per Year in US Established Reimbursement Established Clinical Pathways [ 5 ]

6 Traditional SCS: Lack of Evidence Supporting Efficacy in Back Pain Compared with baseline, at 24 months, the 42 patients experienced lower levels of leg pain (P < ) but no significant difference in back pain (P = 0.21). (1) We excluded patients from the study if they had a chief complaint of axial (low back) pain exceeding radicular (hip, buttock, and leg) pain. (2) [ 6 ]

7 Potential to Expand the Market by Treating Back Pain LEG PAIN LEG AND BACK PAIN BACK PAIN Traditional SCS [ 7 ]

8 Traditional SCS Relies on Paresthesia Step 1 Sedate Patient Step 2 Insert Lead Step 3 Wake Up Patient, Ask Questions to Assess Paresthesia Coverage Step 4 Reposition and Reprogram Leads to Redirect the Paresthesia PHYSICIAN Impact Variable Procedure PATIENT Impact Uncomfortable Stimulation [ 8 ]

9 Limitations of Traditional SCS Therapy LIMITED CLINICAL EVIDENCE Two Published Prospective Randomized SCS Studies with Long-term Data Focused Only on Leg Pain LACK OF EVIDENCE SUPPORTING EFFICACY IN BACK PAIN No Prospective, Randomized Study Supporting Efficacy of Traditional SCS for Back Pain LACK OF COMPARATIVE EFFECTIVENESS BETWEEN DEVICES No Evidence Differentiating Existing Commercial Devices PARESTHESIA BASED THERAPY Relies on a Constant Tingling Sensation to Mask Pain Can Result in Unpleasant or Uncomfortable Stimulation in Many Patients PARESTHESIA BASED PROCEDURE Requires Patient to Provide Intraoperative Feedback to Properly Place Leads Creates Procedure Variability Impacting Physician s Schedule and Patient Comfort [ 9 ]

10 Nevro Provides Meaningful Benefit to Patients & Physicians PHYSICIANS Step 1 Sedate Patient Step 2 Insert Lead Reduces Variability of Procedure PATIENTS Step 3 Wake Up Patient, Ask Questions to Assess Paresthesia Coverage Step 4 Reposition and Reprogram Leads to Redirect the Paresthesia DRIVE SLEEP MOVE Enabling Patients to Do Everyday Activities Without Uncomfortable Stimulation [ 10 ]

11 Clinical Evidence Overview U.S. Pivotal RCT (SENZA-RCT) U.S. Randomized Controlled Pivotal Trial RCT comparing HF10 and traditional SCS 11 US centers, 198 patients randomized Comparative long-term safety and efficacy (1 year follow-up) E.U. Multicenter Implant Study (SENZA-EU) Multicenter Long-Term Study Single arm, open label European study 2 centers, 82 patients trialed Long-term safety and efficacy (2 year follow-up) Published in Pain Medicine U.S. Temporary Trial Study U.S. Temporary Trial Study (no implant) 5 centers, 24 patients, acute follow-up Evaluated safety and efficacy in humans Published in Neuromodulation [ 11 ]

12 SENZA-RCT: Background & Trial Design 198 RANDOMIZED, 1:1 RANDOMIZATION 101 HF10 Therapy, 97 Traditional SCS Therapy Leg and Back VAS 5 NON-INFERIORITY STUDY WITH ACTIVE CONTROL ARM Boston Scientific s FDA-approved Precision Plus System Control Arm PRIMARY ENDPOINT Composite Efficacy and Safety Endpoint Measured at 3 Months Response Rate: % of Patients with 50% Reduction in Back Pain (VAS Score) SECONDARY ENDPOINT % Change in Back Pain, Leg Pain, Function, 6 and 12 Month Paresthesia Perception [ 12 ]

13 Met Primary Endpoint SENZA-RCT: Primary Endpoint By Analysis Population Non-Inferiority of HF10 Therapy Demonstrated and Post-Hoc Analysis Supports Superiority of HF10 Therapy Over Traditional SCS in All Primary and Secondary Endpoints 100% Nevro (HF10) Control (Trad SCS) Non-Inferiority Margin 80% 75.7% 75.0% 80.9% 60% 40% 20% 37.7% 37.9% 42.5% 0% ITT PP PS 10% Non-Inferiority p-value: <0.001 Superiority p-value < (Post-Hoc Analysis) Difference In Rates: Control Minus Test No unanticipated device-related SAEs reported Study-Related Serious Adverse Events (SAEs): Nevro: 5 SAEs in 4 subjects (4.0%), Control: 8 SAEs in 7 subjects (7.2%) [ 13 ]

14 Back Pain (VAS score) Back Pain Relief (% change in VAS score) SENZA-RCT: Back Pain Permanent Implant Subset At 12 Months, Mean Back Pain VAS Decreased 66% with HF10 Therapy Compared to a Decrease of 45% for Traditional SCS Therapy Nevro (HF10) Control (Trad SCS) % 90% 80% 70% 60% 50% 40% 30% 20% 10% 0% 66.4% 44.7% Assessment (months) Assessment (months) 10% non-inferiority p-value: <0.001 Superiority p-value < (post-hoc analysis) [ 14 ]

15 Leg Pain (VAS score) Leg Pain Relief (% change in VAS score) SENZA-RCT: Leg Pain Permanent Implant Subset At 12 Months, Mean Leg Pain VAS Decreased 70% with HF10 Therapy Compared to a Decrease of 48% for Traditional SCS Therapy Nevro (HF10) Control (Trad SCS) % 90% 80% 70% 60% 50% 40% 30% 20% 10% 0% 69.5% 48.0% Assessment (months) Assessment (months) 10% non-inferiority p-value: <0.001 Superiority p-value < (post-hoc analysis) [ 15 ]

16 Back Pain Responder Rate Leg Pain Responder Rate SENZA-RCT: Responder Rates at 12 months Permanent Implant Subset Nevro: Statistically Superior Responder Rates for Back and Leg Pain * BACK PAIN LEG PAIN 100% 90% 80% 70% 60% 50% 84.3% 43.8% 76.4% 78.7% 51.9% 51.3% 100% 90% 80% 70% 60% 50% 83.1% 80.9% 78.7% 55.0% 54.4% 51.3% 40% 40% 30% 30% 20% 20% 10% 0% Month 3 Month 6 Month 12 10% 0% Month 3 Month 6 Month 12 Nevro (HF10 Therapy) Control (Trad SCS) *Superiority p-value < (post-hoc analysis) [ 16 ]

17 Demonstrated Elimination of Paresthesia PATIENTS REPORTING UNCOMFORTABLE STIMULATION Month 3 Month % 44.4% Nevro (HF10 Therapy) Control (Trad SCS) 0.0% 0.0% Nevro Control Nevro Control [ 17 ]

18 Back Pain (VAS score) 18 Consistency of Senza Clinical Results Comparison of SENZA-RCT and EU Study SENZA-RCT US Pivotal RCT EU Study EU Study Trial Phase Success Rate US Pivotal RCT: 88% EU Study: 88% ODI Reduction US Pivotal RCT: 16 Point Reduction EU Study: 17 Point Reduction Assessment (months) Analysis of permanent implant population EU Study: Al-Kaisy, Van Buyten, Smet, et al. Pain Medicine [ 18 ]

19 Published Prospective SCS Studies Prior to Nevro Leg Pain (VAS, Response, N) Back Pain (VAS, Response, N) Study System Patient Oakley Schultz North Oakley Kumar 10,11 Schultz North Kumar 10, Boston Precision Predom Leg Pain Medtronic Restore Sensor Medtronic Itrel Boston Medtronic Precision Predom Predom Synergy Leg Leg Pain Pain Medtronic Restore Sensor Medtronic Itrel Medtronic Synergy Predom Leg Pain Predom Leg Pain Predom Leg Pain Predom Leg Pain Predom Leg Pain Trial Success Base 6m 12m 24m Base 6m 12m 24m 49/65 75% 4 VAS NR NR NR NR NR NR NR NR 17/24 71% 4 Response 5 NR NR 47% 3 NR NR NR NR N NR 19 NR NR NR NR VAS NR NR NR NR NR 49/65 43/52 VAS % Response 83% 4 Response 5 55% 48% 75% 38% 40% NR NR NR NR NR NR NR NR N NR 42 NR 52 NR 50 NR 42 NR 42 NA 1 Response 5 NR NR NR NR NR NR NR VAS NR NR NR NR NR NR 17/24 71% 4 VAS NR NR NR NR NR Response 5 55% 75% NR NR NR NR NR N NR NR NR NR NR NA 1 Response 5 NR NR NR NR NR NR NR VAS NR NR NR NR NR NR N NR NR NR NR NR NR N NR NR NR NR NR NR VAS NR NR NR NR NR NR NR NR Response 5 NR NR 47% 3 NR NR NR NR N NR 19 NR NR NR NR 43/52 VAS % 4 Response 5 48% 38% 40% NR NR NR N NR: Not reported Studies with minimum 6 month follow up [ 19 ]

20 Comparison to Published Prospective SCS Studies Study System Patient SENZA-RCT 2014 Al-Kaisy & Van Buyten SENZA-RCT 2014 Oakley Schultz North Kumar 10, Nevro Senza Nevro Senza Boston Precision Back & Leg Pain Predom Back Pain Back & Leg Pain Boston Precision Predom Leg Pain Medtronic Restore Sensor Medtronic Itrel Medtronic Synergy Predom Leg Pain Predom Leg Pain Predom Leg Pain Leg Pain (VAS, Response, N) Back Pain (VAS, Response, N) Trial Success Base 6m 12m 24m Base 6m 12m 24m 81/92 VAS TBD TBD 88% 4 Response 5 81% 79% TBD 73% 79% TBD N TBD TBD 72/82 88% 4 VAS Response 5 86% 65% 71% 74% 70% 60% N /87 VAS TBD TBD 82% 4 Response 5 54% 51% TBD 52% 51% TBD N TBD TBD 49/65 75% 4 VAS NR NR NR NR NR Response 5 55% 75% NR NR NR NR NR N NR NR NR NR NR NA 1 Response 5 NR NR NR NR NR NR NR VAS NR NR NR NR NR NR 17/24 71% 4 N NR NR NR NR NR NR VAS NR NR NR NR NR NR NR NR Response 5 NR NR 47% 3 NR NR NR NR N NR 19 NR NR NR NR 43/52 VAS % 4 Response 5 48% 38% 40% NR NR NR N NR: Not reported Studies with minimum 6 month follow up [ 20 ]

21 Comparison to Published, Prospective Results BACK PAIN 12-Month Follow-Up LEG PAIN Responder Rate Responder Rate 80% 60% 40% 20% Not Reported 51% 70% 79% Nevro: Higher Response Rate 80% 60% 40% 20% 38% 51% 65% 79% 0% Medtronic Synergy (Kumar) Boston Scientific Precision (SENZA-RCT) Nevro HF10 (Al-Kaisy) Nevro HF10 (SENZA-RCT) 0% Medtronic Synergy (Kumar) Boston Scientific Precision (SENZA-RCT) Nevro HF10 (Al-Kaisy) Nevro HF10 (SENZA-RCT) % VAS Reduction % VAS Reduction 80% 60% 40% 20% 0% 18% Medtronic Synergy (Kumar) 45% Boston Scientific Precision (SENZA-RCT) 67% 66% Nevro HF10 (Al- Kaisy) Nevro HF10 (SENZA-RCT) With Greater Pain Reduction at 12 Months 80% 60% 40% 20% 0% 42% Medtronic Synergy (Kumar) 48% Boston Scientific Precision (SENZA-RCT) 63% Nevro HF10 (Al- Kaisy) 70% Nevro HF10 (SENZA-RCT) [ 21 ]

22 North American Neuromodulation Society (NANS) December 2014 Presented at the Plenary Session Groundbreaking Clinical Trial Results [ 22 ]

23 Expected Path to US Market Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 June 2014 Submitted PMA Application to FDA Pivotal Study Clinical PMA Module FDA Review FDA Advisory Panel Meeting Projected PMA Approval US Launch Early 2016 Launch [ 23 ]

24 Multiple Label Expansion Opportunities Refractory Chronic Migraine Ongoing Feasibility Chronic Intractable Neck and Upper Extremity Pain Ongoing Feasibility FOCUSED ON PAIN & PAIN SPECIALISTS Pre-Spinal Surgery Ongoing Feasibility [ 24 ]

25 Well Positioned for US Commercialization LEVERAGE Clinical Data, Innovation, & International Market Success TEAM EXPERTISE Employ Deep Neuromodulation Market Knowledge and Contacts Hire Experienced Sales Reps Pre-Approval, Additional Scale Over Following 24 Months July 2014: PMA Submitted Early 2016: Expected Commercialization, pending FDA approval STRATEGY Efficiently Target Relevant Accounts in a Responsible Way Highly Differentiated Technology Backed by Clinical Evidence [ 25 ]

26 Intellectual Property Overview 61 PATENTS IN US, EU, AND AUS Core Technology and Commercial Advantages Covered Until Aug IP PIPELINE: 114 Pending Applications Globally LARGE PORTFOLIO Broad And Tailored, System and Method Claims Paresthesia-free Therapy between 1.5kHz to 100 khz EXTENSIVE PATENT PROSECUTION HISTORY ACROSS MULTIPLE JURISDICTIONS Broad System Claims US Patent No. 8,712,533 A Spinal Cord Modulation System... Configured to Generate a Non-Paresthesia-Producing Therapy Signal... at a Frequency in a Frequency Range from 1.5 khz to 100 khz [ 26 ]

27 Financial Overview Revenue ($ in millions) $18.2 $5.1 $23.5 $7.1 $17.3 $5.0 $22.9 $7.8 Growing Revenues International SCS Market is 20% of Global SCS Market EU Australia $13.1 $16.5 $12.3 $15.1 Launched in Europe and Australia in 2011 Income Statement Q-3Q2013 1Q-3Q Months Ended 31 Dec. Unaudited 9 Months Ended 30 Sept. ($ in millions) Revenue $18.2 $23.5 $17.3 $22.9 Gross Profit Gross Margin 58.2% 59.6% 60.1% 63.8% R&D SG&A Total Opex Available in 15 Countries, with Direct Sales Force in 8 Countries Reimbursed Under Existing SCS Codes Favorable Gross Margin Efficient Manufacturing and Cost Structure Loss from Operations ($19.1) ($25.2) ($18.6) ($21.2) [ 27 ]

28 Revenue ($mm) Revenue ($mm) Australia Revenue Growth Annual Comparison 9 Months Comparison $8 $7 $6 $5 39% YoY Growth $8 $7 $6 $5 55% YoY Growth $4 $4 $3 $3 $2 $2 $1 $1 $ $ NOT A CAPITATED SYSTEM PRIVATE PAY MARKET PRIMARILY RECHARGEABLE [ 28 ]

29 Positioned to Be 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 DEFINED PATH to U.S. Commercialization Early 2016 Pending FDA Approval DEMONSTRATED Execution Commercial Success in Europe and Australia 2,500 Patients in 15 MARKETS Over 4 YEARS [ 29 ]

30 Thank You [ 30 ]

31 Footnotes Slide 6 Slide 19 & 20 1 Kumar K, Taylor RS, Jacques L, et al. The Effects of Spinal Cord Stimulation in Neuropathic Pain are Sustained:A 24-Month Follow-Up of the Prospective Randomized Controlled Multicenter Trial of the Effectiveness of Spinal Cord Stimulation. Neurosurgery 2008;63: North RB, Kidd DH, Farrokhi F, Piantadosi SA. Spinal Cord Stimulation Versus Repeated Lumbosacral Spine Surgery for Chronic Pain: A Randomized, Controlled Trial. Neurosurgery 2005;56: NA: Not applicable, subjects already implanted 2 At follow-up of 16 weeks post implantation 3 At follow-up of 2.9±1.1 years 4 Trial Success rates are based on the % of patients who had at least 50% reduction in VAS score from baseline at the end of the trial phase 5 Response rate defined as % of patients who had at least 50% reduction in VAS score from baseline 6 Al-Kaisy, A., Van Buyten, J., Smet, I., Palmisani, S., Pang, D., Smith, T. (2014). Sustained Effectiveness of 10 khz High-Frequency Spinal Cord Stimulation for Patients with Chronic, Low Back Pain: 24-Month Results of a Prospective Multicenter Study. Pain Medicine 2014; 15: Oakley, J., Krames, E., et al. A New Spinal Cord Stimulation System Effectively Relieves Chronic, Intractable Pain: A Multicenter Prospective Clinical Study. Neuromodulation 2007; Volume 10, Number 3 8 Schultz, D., Webster, L., et al. Sensor-Driven Position-Adaptive Spinal Cord Stimulation for Chronic Pain. Pain Physician 2012; 15: North RB, Kidd DH, Farrokhi F, Piantadosi SA. Spinal Cord Stimulation Versus Repeated Lumbosacral Spine Surgery for Chronic Pain: A Randomized, Controlled Trial. Neurosurgery 2005;56: Kumar K, Taylor RS, Jacques L, et al. The Effects of Spinal Cord Stimulation in Neuropathic Pain are Sustained:A 24-Month Follow-Up of the Prospective Randomized Controlled Multicenter Trial of the Effectiveness of Spinal Cord Stimulation. Neurosurgery 2008;63: Kumar K, Taylor RS, Jacques L, et al. Spinal Cord Stimulation Versus Conventional Medical Management for Neuropathic Pain: A Multicentre Randomised Controlled Trial in Patients with Failed Back Surgery Syndrome. Pain (200&), doi: /j.pain [ 31 ]