january 2015s21.q4cdn.com/.../nevro_2015-01_jpm-deck_v001_r71d06.pdf · 2016-03-02 · leadership...

[ 1 ]

JANUARY 2015

Leadership Through Innovation TM[ 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, 2014. You may getthese documents for free by visiting EDGAR on the SEC’s website at www.sec.gov.

http://www.sec.gov/


Positioned to Be a Leader in Neuromodulation

ATTRACTIVE MarketGrowing $1.5B Market,

Existing Reimbursement, Potential to Take Share and

Grow Existing Market

DIFFERENTIATED TechnologyFirst SCS to Deliver Significant &

Sustained Back Pain Relief

FIRST in Class EvidenceFirst Pivotal RCT with

Comparative Effectiveness Data, All Primary and

Secondary Endpoints Met

DEFINED PATH to U.S. Commercialization Early 2016 Pending FDA Approval

DEMONSTRATED ExecutionCommercial Success in Europe and Australia

2,500 Patients in 15 MARKETS Over 4 YEARS


PROPRIETARY HF10 THERAPY

Advancing Spinal Cord Stimulation (SCS)

DEMONSTRATEDResults via First Pivotal RCT

with ComparativeEffectiveness Data

SIGNIFICANTand

SUSTAINEDChronic Leg & Back

Pain Relief


2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012

MDT STJ BSX

~ $25K per Procedure

~ 40K Procedures per Year in US

SCS Global Market Revenue(Millions)

CAGR 8%

$300$378

$469$544

$647$745

$854$952

$1,100$1,200

$1,300$1,400

Large and Growing Underserved Market

$1.5 Billion SCS Market Today

$300MInt’l

$1.2BUS

Established Reimbursement

Established Clinical Pathways

PRIMARILYLEG PAIN


“ ”

“Compared with baseline, at 24 months, the 42 patients experienced lower levels of leg pain (P < 0.0001)but no significant difference in back pain (P = 0.21). ”(1)

Traditional SCS:Lack of Evidence Supporting Efficacy in Back Pain

“ ”

“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)


Potential to Expand the Market by Treating Back Pain

LEG AND BACK PAIN BACK PAINLEG PAIN

Traditional SCS


Traditional SCS Relies on Paresthesia

Step 2Insert Lead

Step 4 Reposition and Reprogram

Leads to Redirect the Paresthesia

Step 3 Wake Up Patient,

Ask Questions to Assess Paresthesia Coverage

Step 1Sedate Patient

Variable Procedure

PHYSICIAN Impact

Uncomfortable Stimulation

PATIENT Impact


Limitations of Traditional SCS Therapy

Two Published Prospective Randomized SCS Studies with Long-term Data Focused Only on Leg Pain

LIMITED CLINICAL EVIDENCE

No Prospective, Randomized Study Supporting Efficacy of Traditional SCS for Back Pain

LACK OF EVIDENCE SUPPORTING EFFICACY IN BACK PAIN

Relies on a Constant Tingling Sensation to Mask Pain

Can Result in Unpleasant or Uncomfortable Stimulation in Many Patients

PARESTHESIA BASED THERAPY

Requires Patient to Provide Intraoperative Feedback to Properly Place Leads

Creates Procedure Variability Impacting Physician’s Schedule and Patient Comfort

PARESTHESIA BASED PROCEDURE

LACK OF COMPARATIVE EFFECTIVENESS BETWEEN DEVICES

No Evidence Differentiating Existing Commercial Devices


Nevro Provides Meaningful Benefit to Patients & Physicians

DRIVE SLEEP MOVE

Step 2Insert Lead

Step 4 Reposition and Reprogram

Leads to Redirect the Paresthesia

Step 3Wake Up Patient,

Ask Questions to Assess Paresthesia Coverage

Step 1Sedate Patient

Enabling Patients to Do Everyday Activities Without Uncomfortable Stimulation

Reduces Variability of Procedure

PHYSICIANS

PATIENTS


Clinical Evidence Overview

U.S. Pivotal

RCT

(SENZA-RCT)

E.U. Multicenter

Implant Study

(SENZA-EU)

U.S. Temporary Trial Study

• 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)

• 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 (no implant)

▫ 5 centers, 24 patients, acute follow-up

▫ Evaluated safety and efficacy in humans

▫ Published in Neuromodulation


101 HF10 Therapy, 97 Traditional SCS Therapy

Leg and Back VAS ≥ 5

SENZA-RCT:Background & Trial Design

198 RANDOMIZED, 1:1 RANDOMIZATION

Composite Efficacy and Safety Endpoint Measured at 3 Months

Response Rate: % of Patients with ≥50% Reduction in Back Pain (VAS Score)

NON-INFERIORITY STUDY WITH ACTIVE CONTROL ARM

Boston Scientific’s FDA-approved Precision Plus System Control Arm

PRIMARY ENDPOINT

% Change in Back Pain, Leg Pain, Function, 6 and 12 Month

Paresthesia Perception

SECONDARY ENDPOINT


SENZA-RCT: Primary Endpoint By Analysis Population

10% Non-Inferiority p-value: <0.001 Superiority p-value < 0.001 (Post-Hoc Analysis)

75.7% 75.0% 80.9%

37.7% 37.9% 42.5%

0%

20%

40%

60%

80%

100%

ITT PP PS

Met

Pri

mar

y En

dp

oin

t

Non-Inferiority of HF10 Therapy Demonstrated and Post-Hoc Analysis SupportsSuperiority of HF10 Therapy Over Traditional SCS in All Primary and Secondary Endpoints

Nevro (HF10) Control (Trad SCS)

Difference In Rates: Control Minus Test

Non-InferiorityMargin

No unanticipated device-related SAEs reportedStudy-Related Serious Adverse Events (SAEs): Nevro: 5 SAEs in 4 subjects (4.0%), Control: 8 SAEs in 7 subjects (7.2%)


SENZA-RCT:Back Pain – Permanent Implant Subset

At 12 Months, Mean Back Pain VAS Decreased 66% with HF10 Therapy Comparedto a Decrease of 45% for Traditional SCS Therapy

0

1

2

3

4

5

6

7

8

9

10

0 3 6 9 12

Bac

k P

ain

(V

AS

sco

re)

Assessment (months)

0%

10%

20%

30%

40%

50%

60%

70%

80%

90%

100%

0 3 6 9 12

Bac

k P

ain

Re

lief

(% c

han

ge in

VA

S sc

ore

)

Assessment (months)

10% non-inferiority p-value: <0.001Superiority p-value < 0.001 (post-hoc analysis)


4.3

2.5

44.7%

66.4%


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

10% non-inferiority p-value: <0.001Superiority p-value < 0.001 (post-hoc analysis)


0

1

2

3

4

5

6

7

8

9

10

0 3 6 9 12

Leg

Pai

n (

VA

S sc

ore

)

Assessment (months)

0%

10%

20%

30%

40%

50%

60%

70%

80%

90%

100%

0 3 6 9 12

Leg

Pai

n R

elie

f(%

ch

ange

in V

AS

sco

re)

Assessment (months)

3.9

2.1

48.0%

69.5%


SENZA-RCT: Responder Rates at 12 months Permanent Implant Subset

*Superiority p-value < 0.001 (post-hoc analysis)

BACK PAIN LEG PAIN

84.3%

76.4% 78.7%

43.8%

51.9% 51.3%

0%

10%

20%

30%

40%

50%

60%

70%

80%

90%

100%

Month 3 Month 6 Month 12

Bac

k P

ain

Re

spo

nd

er

Rat

e

83.1% 80.9% 78.7%

55.0% 54.4%51.3%

0%

10%

20%

30%

40%

50%

60%

70%

80%

90%

100%

Month 3 Month 6 Month 12

Leg

Pai

n R

esp

on

de

r R

ate

Nevro: Statistically Superior Responder Rates for Back and Leg Pain*

Nevro (HF10 Therapy)

Control (Trad SCS)


Demonstrated Elimination of Paresthesia

PATIENTS REPORTING UNCOMFORTABLE STIMULATION

0.0%

46.5%

Nevro Control

Month 3 Month 12

0.0%

44.4%

Nevro Control

Nevro (HF10 Therapy)

Control (Trad SCS)


0

1

2

3

4

5

6

7

8

9

10

0 3 6 9 12

Bac

k P

ain

(V

AS

sco

re)

Assessment (months)

SENZA-RCT 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

Comparison of SENZA-RCT and EU Study

18

EU Study: Al-Kaisy, Van Buyten, Smet, et al. Pain Medicine. 2013.

Analysis of permanent implant population

US Pivotal RCT EU Study

Consistency of Senza Clinical Results


Published Prospective SCS Studies Prior to Nevro

Leg Pain (VAS, Response, N) Back Pain (VAS, Response, N)

Study System PatientTrial

Success Base 6m 12m 24m Base 6m 12m 24m

NR: Not reportedStudies with minimum 6 month follow up

Oakley7

2007Boston Precision

Predom Leg Pain

49/65 75%4

VAS 8 3.9 2.2 NR NR NR NR NR

Response5 — 55% 75% NR NR NR NR NR

N 49 33 12 NR NR NR NR NR

Schultz8

2012Medtronic

Restore SensorPredom Leg Pain

NA1

VAS 5.9 4.3 2 NR NR NR NR NR NR

Response5 — NR NR NR NR NR NR NR

N 76 71 2 NR NR NR NR NR NR

North9

2005Medtronic

ItrelPredom Leg Pain

17/24 71%4

VAS NR NR NR NR NR NR NR NR

Response5 — NR NR 47%3 NR NR NR NR

N 24 24 NR 19 NR NR NR NR

Kumar10,11

2008Medtronic

SynergyPredom Leg Pain

43/52 VAS 7.6 4 4.4 4.4 5.5 4.1 4.5 4.8

83%4 Response5 — 48% 38% 40% — NR NR NR

N 52 50 42 42 52 50 42 42




Oakley7


Predom Leg Pain

49/65 75%4




Schultz8

2012Medtronic


NA1




North9

2005Medtronic


17/24 71%4




Kumar10,11

2008Medtronic


43/52 VAS 7.6 4 4.4 4.4 5.5 4.1 4.5 4.8

83%4 Response5 — 48% 38% 40% — NR NR NR

N 52 50 42 42 52 50 42 42


Comparison to Published Prospective SCS Studies




SENZA-RCT2014

Nevro Senza

Back & Leg Pain

81/92 VAS 7.1 2.3 2.1 TBD 7.5 2.7 2.5 TBD

88%4 Response5 — 81% 79% TBD — 73% 79% TBD

N 90 90 90 TBD 90 90 90 TBD

Al-Kaisy & Van Buyten6

2013

Nevro Senza

Predom Back Pain

72/82 88%4

VAS 5.4 1.5 2 2.3 8.4 2.7 2.8 3.3

Response5 — 86% 65% 71% — 74% 70% 60%

N 72 72 67 65 72 72 67 65

SENZA-RCT 2014

Boston PrecisionBack &

Leg Pain

71/87 VAS 7.6 3.6 3.9 TBD 7.8 4.2 4.3 TBD

82%4 Response5 — 54% 51% TBD — 52% 51% TBD

N 81 81 81 TBD 81 81 81 TBD

Oakley7


Predom Leg Pain

49/65 75%4




Schultz8

2012Medtronic


NA1




North9

2005Medtronic


17/24 71%4




Kumar10,11

2008Medtronic


43/52 VAS 7.6 4 4.4 4.4 5.5 4.1 4.5 4.8

83%4 Response5 — 48% 38% 40% — NR NR NR

N 52 50 42 42 52 50 42 42

NR: Not reportedStudies with minimum 6 month follow up


BACK PAIN LEG PAIN

Comparison to Published, Prospective Results

Nevro:Higher

Response Rate

With GreaterPain Reductionat 12 Months

12-Month Follow-Up

42% 48%63% 70%

0%20%40%60%80%

MedtronicSynergy(Kumar)

BostonScientificPrecision

(SENZA-RCT)

Nevro HF10 (Al-Kaisy)

Nevro HF10(SENZA-RCT)

% VAS Reduction

38%

51%

65%

79%

0%

20%

40%

60%

80%



(SENZA-RCT)

Nevro HF10(Al-Kaisy)


Responder Rate

18%

45%

67% 66%

0%20%40%60%80%



(SENZA-RCT)

Nevro HF10 (Al-Kaisy)


% VAS Reduction

Not Reported

51%

70%79%

0%

20%

40%

60%

80%



(SENZA-RCT)

Nevro HF10(Al-Kaisy)


Responder Rate


North American Neuromodulation Society (NANS)December 2014

Presented at the Plenary Session Groundbreaking Clinical Trial Results


Expected Path to US Market

2014 2015 2016

Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2

US Launch

Clinical PMA

Module

ProjectedPMA Approval

FDA Review

FDA Advisory

PanelMeeting

PivotalStudy

June 2014 – Submitted PMA Application to FDA

Early 2016 – Launch


Multiple Label Expansion Opportunities

Refractory Chronic Migraine

Ongoing Feasibility

Chronic Intractable Neck and Upper Extremity Pain

Ongoing Feasibility

Pre-Spinal Surgery

Ongoing FeasibilityFOCUSED ON PAIN &PAIN SPECIALISTS


Well Positioned for US Commercialization

Highly Differentiated Technology Backed by Clinical Evidence

STRATEGY

Efficiently Target Relevant Accountsin a Responsible Way

TEAM

Hire Experienced Sales Reps Pre-Approval, Additional Scale Over Following 24 Months

EXPERTISE

Employ Deep Neuromodulation Market Knowledge and Contacts

LEVERAGE

Clinical Data, Innovation, & International Market Success

July 2014:PMA Submitted

Early 2016:Expected

Commercialization, pending FDA approval


EXTENSIVE PATENT PROSECUTION HISTORY ACROSS

MULTIPLE JURISDICTIONS

61 PATENTS IN US, EU, AND AUSCore Technology and Commercial

Advantages Covered Until Aug. 2032 IP PIPELINE:

114 Pending Applications Globally

LARGE PORTFOLIO

Broad And Tailored,System and Method Claims

Paresthesia-free Therapy between 1.5kHz to 100 kHz

Intellectual Property Overview

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

Broad System ClaimsUS Patent No. 8,712,533


Financial Overview

12 Months Ended 31 Dec.Unaudited

9 Months Ended 30 Sept.

($ in millions) 2012 2013 2013 2014

Revenue $18.2 $23.5 $17.3 $22.9

Gross Profit 10.6 14.0 10.4 14.6

Gross Margin 58.2% 59.6% 60.1% 63.8%

R&D 15.7 20.3 15.7 15.1

SG&A 14.1 18.8 13.3 20.7

Total Opex 29.8 39.1 29.0 35.8

Loss from Operations

($19.1) ($25.2) ($18.6) ($21.2)

Revenue ($ in millions)

EU

Australia

Growing Revenues

International SCS Market is 20% of Global SCS Market

Launched in Europe and Australia in 2011

Available in 15 Countries, with Direct Sales Force in 8 Countries

Reimbursed Under Existing SCS Codes

Favorable Gross Margin

Efficient Manufacturingand Cost Structure

Income Statement

$13.1$16.5

$12.3$15.1

$5.1

$7.1

$5.0

$7.8$18.2

$23.5

$17.3

$22.9

2012 2013 1Q-3Q2013 1Q-3Q2014


Australia Revenue Growth

$0

$1

$2

$3

$4

$5

$6

$7

$8

2012 2013

Rev

enu

e ($

mm

)

NOT ACAPITATED SYSTEM

Annual Comparison 9 Months Comparison

YoYGrowth39%

YoYGrowth55%

PRIVATE PAY MARKET

PRIMARILYRECHARGEABLE

$0

$1

$2

$3

$4

$5

$6

$7

$8

2013 2014

Rev

enu

e ($

mm

)


Positioned to Be a Leader in Neuromodulation

ATTRACTIVE MarketGrowing $1.5B Market,

Existing Reimbursement, Potential to Take Share and

Grow Existing Market

DIFFERENTIATED TechnologyFirst SCS to Deliver Significant &

Sustained Back Pain Relief

FIRST in Class EvidenceFirst Pivotal RCT with

Comparative Effectiveness Data, All Primary and

Secondary Endpoints Met

DEFINED PATH to U.S. Commercialization Early 2016 Pending FDA Approval

DEMONSTRATED ExecutionCommercial Success in Europe and Australia

2,500 Patients in 15 MARKETS Over 4 YEARS

[ 30 ]

Thank You


Slide 61 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;63:762–70.”2 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;56:98–106.”

Slide 19 & 201NA: Not applicable, subjects already implanted2At follow-up of 16 weeks post implantation

3At follow-up of 2.9±1.1 years4Trial 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 phase5Response rate defined as % of patients who had at least 50% reduction in VAS score from baseline6Al-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: 347-354

7 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 38Schultz, D., Webster, L., et al. Sensor-Driven Position-Adaptive Spinal Cord Stimulation for Chronic Pain. Pain Physician 2012; 15:1-129North RB, Kidd DH, Farrokhi F, Piantadosi SA. Spinal Cord Stimulation Versus Repeated Lumbosacral Spine Surgery for Chronic Pain: A Randomized, Controlled Trial. Neurosurgery 2005;56:98–106.”

10Kumar 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;63:762–70.”11Kumar 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:10.1016/j.pain2007.07.028

Footnotes

january 2015s21.q4cdn.com/.../nevro_2015-01_jpm-deck_v001_r71d06.pdf · 2016-03-02 · leadership...

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