Nevro #JPM16 Presentation
Transcript of Nevro #JPM16 Presentation
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JANUARY 2016
34th Annual J.P. Morgan Healthcare Conference
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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
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Product and
Therapy
Overview
HF10™ Therapy Senza® SCS System SENZA‐RCT
Frequency Anatomical Lead
Placement
Waveform
Characteristics Programming
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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
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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
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‐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)
Non‐responders (n=39)
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‐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
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
u a l S u b j e c t s
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SENZA‐
RCT:
Individual
Leg
Pain
Reduction
Each line represents a patient
Decrease in Leg Pain from Baseline – 12 Months
HF10 Therapy Subjects
‐100%
‐80%
‐60%
‐40%
‐20% 0% 20% 40% 60% 80% 100%
( n = 8 9 )
Responders (n=72)
81%
Responder rate
Non‐responders (n=17)
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 )
Non‐responders (n=40)
50%
Responder rate
Responders (n=40)
Traditional SCS Subjects
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
I n d i v i d
u a l S u b j e c t s
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SENZA‐
RCT:
Individual
Leg
Pain
Reduction
Each line represents a patient
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
• Responders are defined as subjects experiencing 50% or greater pain
relief
I n d i v i d
u a l S u b j e c t s
HF10 Therapy Subjects
Traditional
SCS
Subjects
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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
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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
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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
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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
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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
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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
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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
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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
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Multiple
Potential
Label
Expansion
Opportunities
Refractory Chronic Migraine
Chronic Intractable Neck and
Upper Extremity Pain
Non‐Surgical
Low
Back
PainFOCUSED
ON
PAIN
&
PAIN SPECIALISTS
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Leadership Through Innovation TM
[ 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
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[ 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
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[ 22 ]
JANUARY 2016