nevro #jpm16 presentation

7/23/2019 Nevro #JPM16 Presentation

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[ 1 ]

JANUARY 2016

34th Annual J.P. Morgan Healthcare Conference



Leadership Through Innovation TM

[ 3 ]

Nevro: 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

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




[ 4 ]

Product and

Therapy

Overview

HF10™ Therapy Senza® SCS System SENZA‐RCT

Frequency Anatomical Lead

Placement

Waveform

Characteristics Programming




[ 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 5.9 4.3

Response —

N 76 71

North

2005

Medtronic

Itrel

Predom

Leg Pain

17/24

71%

VAS

Response — 47%

N 24 24 19

Kumar

2008

Medtronic

Synergy

Predom

Leg Pain

43/52

83%

VAS 7.6 4 4.4 4.4 5.5 4.1 4.5 4.8

Response — 48% 38% 40% —

N 52 50 42 42 52 50 42 42

Note:

Blank cells

are

not

reported




[ 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

2011

EUROPEANMULTICENTER,

24‐MONTH STUDY

(SENZA‐EU)

2009US FEASIBILITY STUDY

2014

US PIVOTAL

STUDY

(SENZA‐RCT)

P R O S P E C T I V E ,

L O N G

‐ T E R M

R A N D O M I Z

E D ,

C O N T R O L L E D

F E A S I B I L I T Y

STEPWISE EVIDENCE GENERATION




[ 7 ]

‐100%

‐80%

‐60%

‐40%

‐20% 0% 20% 40% 60% 80% 100%

SENZA‐

RCT:

Individual

Back

Pain

Reduction

Each line represents a patient

• Each horizontal line represents the response of a study subject

• Responders are defined as subjects experiencing 50% or greater pain

relief

79%

Responder rate

Responder Rates: P<0.001

HF10 Therapy Subjects Traditional SCS Subjects

( n = 8 9 )

I n d i v i d

u a l S u b j e c t s ( n = 8 0 )

Decrease in Back Pain from Baseline – 12 Months Decrease in Back Pain from Baseline – 12 Months

I n d i v i d

u a l S u b j e c t s

Responders (n=70)

Non‐responders (n=19)

‐100%

‐80%

‐60%

‐40%

‐20% 0% 20% 40% 60% 80% 100%

51%

Responder rate

Responders (n=41)





[ 8 ]

‐100%

‐80%

‐60%

‐40%

‐20% 0% 20% 40% 60% 80% 100%

SENZA‐

RCT:

Individual

Back

Pain

Reduction




relief

Responder Rates: P<0.001

HF10 Therapy Subjects

Traditional

SCS

Subjects

Decrease in Back Pain from Baseline – 12 Months

I n d i v i d





[ 9 ]

SENZA‐

RCT:

Individual

Leg

Pain

Reduction


Decrease in Leg Pain from Baseline – 12 Months


‐100%

‐80%

‐60%

‐40%

‐20% 0% 20% 40% 60% 80% 100%

( n = 8 9 )

Responders (n=72)

81%

Responder rate


Responder Rates: P=0.003

‐100%

‐80%

‐60%

‐40%

‐20% 0% 20% 40% 60% 80% 100%

I n d i v i d

u a l S u b j e c t s ( n = 8 0 )


50%

Responder rate

Responders (n=40)

Traditional SCS Subjects

Decrease in Leg Pain from Baseline – 12 Months



relief

I n d i v i d





[ 10 ]

SENZA‐

RCT:

Individual

Leg

Pain

Reduction


Decrease in Leg Pain from Baseline – 12 Months‐100%

‐80%

‐60%

‐40%

‐20% 0% 20% 40% 60% 80% 100%

Responder Rates: P=0.003• Each horizontal line represents the response of a study subject


relief

I n d i v i d



Traditional

SCS

Subjects




[ 11 ]

LEG PAIN

Traditional SCSPrimarily Leg Pain

LEG AND BACK PAIN BACK PAIN

Large

and

Growing

Underserved

Market

HF10™ Therapy

$1.5

BillionSCS Market Today

LEG AND BACK PAIN BACK PAIN

Established Reimbursement

Established Clinical Pathways




[ 12 ]

Back Pain EfficacySuperior efficacy in treatment of back pain

Multiple

Therapy

Advantages

Paresthesia‐Free Pain Relief No

uncomfortable

stimulation

HF10 Therapy Advantages

Intraoperative Workflow EfficienciesMore predictable procedures due to lack of paresthesia mapping

(anatomical placement)

Superior Responder RatesDurable Results Demonstrated through 24 Months

Superior Pain

Relief

Durable Results Demonstrated through 24 Months




[ 13 ]

2015

HighlightsFDA 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 VictoryU.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 PaymentCenters 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

Successful US LaunchGrowing 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

Consistent International Performance~70% YoY growth in 1Q15, ~80% growth in 2Q15 and ~50% growth in 3Q15 on a constant currency basis




[ 14 ]

CMS Approves Transitional Pass‐Through Payment

for

Outpatient

Use

of

Senza SCS

System

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

Effective January

1,

2016




[ 15 ]

Executing

on

U.S.

Launch

Strategy

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

RESPONSIBLY ROLLING OUT HF10 THERAPY




[ 16 ]

U.S.

Sales

Organization

52

70

92100

At Launch

5/8/15

Q2 Q3 YE15

100 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

Rep Productivity GoalsReps Trained & In Field




[ 17 ]

Nevro

Is

Penetrating

AND Growing

the

SCS

Market

~30%

~15%

~50%

~5%

Pain Distribution of HF10 Treated Patients

U.S.

Launch

through

Jan

1,

2016Predominant Back

Predominant Leg

Back & Leg

Other




[ 18 ]

2015

Quarterly

Revenue

Ramp

FY16 Preliminary Worldwide Revenue Guidance: $145.0M ‐ $155.0M

$9.7$11.3

$10.9 ~$13.1

$0.1

$4.5

~$19.5

1Q15 2Q15 3Q15 4Q15E

U.S. Revenue

International Revenue4Q15E

U.S. Range: $19.5M ‐ $19.8M

Int’l Range: $13.1M ‐ $13.3M

$ in Millions (unaudited)

$9.7$11.4

$15.4

~$32.6

FY15 Preliminary Estimated Revenue: $69.1M ‐ $69.6M




[ 19 ]

Multiple

Potential

Label

Expansion

Opportunities

Refractory Chronic Migraine

Chronic Intractable Neck and

Upper Extremity Pain

Non‐Surgical

Low

Back

PainFOCUSED

ON

PAIN

&

PAIN SPECIALISTS




[ 20 ]

Nevro:

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

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




[ 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

RICH CARTER VP Finance

BRAD GLINER VP Clinical & Regulatory

MIKE HALL General Counsel

TAMARA ROOK VP HE&R

Relative Value Scale

Update Committee (RUC)Center forPain Relief



[ 22 ]

JANUARY 2016

nevro #jpm16 presentation

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