LEADERSHIP THROUGH INNOVATION...4.St. Jude Medical Proclaim Implantable Pulse Generator Clinician's...
Transcript of LEADERSHIP THROUGH INNOVATION...4.St. Jude Medical Proclaim Implantable Pulse Generator Clinician's...
LEADERSHIPTHROUGHINNOVATIONWilliam Blair 37th Annual Growth Stock Conference
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; and our expectations regarding our commercialization efforts. 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 continue 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 February 23, 2017 and our Quarterly Report on Form 10-Q filed on May 8, 2017, 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.
3
NEVRO: A LEADER IN NEUROMODULATION
DIFFERENTIATED Technology
First-in-Class EVIDENCE
Demonstrated EXECUTION
PLATFORM Potential
• Publication of Long-Term Superior Patient Outcomes• Only Therapy That Is 100% Paresthesia-Free and Clinically
Superior to Traditional SCS
• Commercial Success in the United States and Internationally• ~15% Market Share by Fifth Full Quarter of U.S. Launch
• Protected by 100+ Patents• Differentiated Mechanism of Action
• Groundbreaking Clinical Trial Presentations of Potential New Indications
18,000+ Patients in 17 MARKETS Over 6 YEARS
PENETRATING AND GROWING THE SCS MARKETEXPANDING MARKET TO UNDER-TREATED BACK PAIN SEGMENT OF CHRONIC PAIN PATIENT POPULATION
BACK PAIN
Established Reimbursement
Established Clinical Pathways
LEG PAIN
Traditional SCSPrimarily Leg Pain
~$1.7 BillionSCS Market Today
HF10™ Therapy
TOTAL MARKET PATIENT MIX
LEG AND BACK
4
EST. U.S. SCS MARKET GROWTH RATE
4%
5%
4%
7%
0%
3%
11% 11%
0%
3%
6%
9%
12%
15%
2010 2011 2012 2013 2014 2015 2016 2017E
Source: Analyst Estimates
NEVRO U.S. LAUNCH
5
Trial Success Ratio:
~85%
OUR RESULTS: HF10 REAL WORLD EXPERIENCE
~30%
~15%
~50%
~5%
Predom. Back
Predom. Leg
Back & Leg
Other
NEVRO PATIENT MIXPain Distribution of HF10-Treated Patients
Since U.S. Launch
HF10 THERAPY ADVANTAGESTHE ONLY CLINICALLY SUPERIOR PARESTHESIA-FREE SCS THERAPY
6
100% PARESTHESIA-FREE PAIN RELIEFNo Uncomfortable Stimulation
CLINICAL EVIDENCE SUPPORTDurable Results for Back & Leg Pain Demonstrated through 24 Months
INTRAOPERATIVE WORKPLACE EFFICIENCIESMore Predictable Procedures Due to Eliminating Need for Paresthesia Mapping
BACK PAIN EFFICACYSuperior Efficacy in Treatment of Back Pain
SUPERIOR PATIENT OUTCOMESClinically Meaningful Superior Pain Relief and Responder Rates
7
HF10 THERAPY: LEADS IN CLINICAL EFFECTIVENESS
1. Al-Kaisy A, et. al. 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 Med. 2014;15:347-354. Internal data on file.2. Kapural, Leonardo et. al. 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. Anesthesiology Vol. 123 No 4.
October 2015.3. Kumar K 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 (2007), doi:10.1016/j.pain.2007.07.028. 6-month data shown.4. St. Jude Medical Proclaim™ Implantable Pulse Generator Clinician's Manual, Models 3660, 3662, 3665, 3667. Published on www.sjm.com October 2016.
PAIN REDUCTION IN PROSPECTIVE SCS TRIALS (3 MONTHS)
0 (No Pain)
10(Worst Pain)
5
HF10 Therapy (SENZA-EU)1
HF10 Therapy (SENZA-RCT)2
HF10 Therapy (SENZA-RCT)2
Trad. SCS – Boston Scientific (SENZA-RCT)2
Trad. SCS - Boston Scientific (SENZA-RCT)2
Trad. SCS – Medtronic (PROCESS)3
Trad. SCS– St. Jude Medical (SUNBURST)4
Burst– St. Jude Medical (SUNBURST)4
1 32 6 87 94
Trad. SCS – St. Jude Medical (SUNBURST)4
Burst– St. Jude Medical (SUNBURST)4
BACK PAIN
LEG PAIN
OVERALL PAIN
VAS (cm)
8
HF10 THERAPY: DEMONSTRATES SUPERIOR RESPONDER RATES
1. Al-Kaisy A, et. al. 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 Med. 2014;15:347-354. 2. Kapural, Leonardo et. al. 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. Anesthesiology Vol. 123 No 4.
October 2015.3. Kumar K 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 (2007), doi:10.1016/j.pain.2007.07.028. 6-month data shown.4. St. Jude Medical Proclaim™ Implantable Pulse Generator Clinician's Manual, Models 3660, 3662, 3665, 3667. Published on www.sjm.com October 2016. Responder rates only reported for overall pain.
48%
44%
39%
55%
84%
32%
83%
74%
-100% -90% -80% -70% -60% -50% -40% -30% -20% -10% 0%
RESPONDER RATES IN PROSPECTIVE SCS TRIALS (3 MONTHS)
Burst– St. Jude Medical (SUNBURST)4
Trad. SCS– St. Jude Medical (SUNBURST)4
HF10 Therapy– Nevro (SENZA-RCT)2
HF10 Therapy– Nevro (SENZA-RCT)2
HF10 Therapy– Nevro (SENZA-EU)1
Trad. SCS– Boston Scientific (SENZA-RCT)2
Trad. SCS– Boston Scientific (SENZA-RCT)2
Trad. SCS– Medtronic (PROCESS)3
100% 90% 80% 70% 40% 30% 20% 10% 0%60% 50%
BACK PAIN
LEG PAIN
OVERALL PAIN
9
HF10 THERAPY: DEMONSTRATES SUPERIOR RESPONDER RATES OVERTHE LONG-TERM
RESPONDER RATES IN PROSPECTIVE SCS TRIALS1,2,3,4
1. Kapural L, et al. Comparison of 10-kHz High-Frequency and Traditional Low-Frequency Spinal Cord Stimulation for the Treatment of Chronic Back and Leg Pain: 24-month Results from a Multicenter, Randomized, Controlled Pivotal Trial. Neurosurgery. Published 09 2016 [Epub ahead of Print]. 2. Kapural L. et al. 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. Anesthesiology Vol. 123 No 4. October 2015. 3. Kumar K 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 (2007), doi:10.1016/j.pain.2007.07.028. 4. Kumar K, 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. 5. North RB, et al. Spinal Cord Stimulation Versus Repeated Lumbosacral Spine Surgery for Chronic Pain: A Randomized, Controlled Trial. Neurosurgery 2005;56:98–106. 6. St. Jude Medical Proclaim™ Implantable Pulse Generator Clinician's Manual, Models 3660, 3662, 3665, 3667. 7. American Society of Regional Anesthesia and Pain Medicine (ASRA) 15th Annual Pain Medicine Meeting in November 2016, The Predictive Value of Short-Term Spinal Cord Stimulation Trials in Determining Long-Term Pain Relief. Available online at http://www.epostersonline.com/ASRAPain16/node/894.
n = 171 to 12 months (n = 90 test, n = 81 control); n = 156 at 18 and 24 months (n = 85 test, n =71 control), p-value < 0.001 at all time points 3 months and beyond.
HF10 Therapy– Nevro (SENZA-RCT)
HF10 Therapy– Nevro (SENZA-RCT)
HF10 Therapy– Nevro (SENZA-EU)
88%
75%
85%
76%81% 79% 76%82%
61%44%
52% 49% 51%
49%
0%
10%
20%
30%
40%
50%
60%
70%
80%
90%
100%
End of Trial 1 mo 3 mo 6 mo 9 mo 12 mo 24 mo
HF10 therapy Traditional SCS
Re
spo
nd
er
Rat
e f
or
Pri
mar
y O
utc
om
es
Sub
ject
sw
ith
50
% o
r m
ore
pai
n r
elie
f
Kumar North SUNBURST™ - Traditional at Trial, Burst at 3 months
10
LONGER-TERM PATIENT FEEDBACK IN 2,500 PATIENTSHow likely are you to recommend Nevro to
someone who has similar pain?
Since having your device, how would you describe the change in activity limitations, symptoms, emotions and overall quality of life?
How would you rate the Nevro device in comparison to the previous SCS you experienced? (if the Patient had SCS prior to Nevro)
How often do you use your remote control to adjust your therapy?
84% likely or very likely to
recommend HF10 therapy
87% cite an improvement
88% of failed SCS patients
rate HF10 therapy better
n = 2,252 n = 2,465
n = 2,483 n = 288
Number of Replies Number of Replies
85% use remote less than
once per week
Number of Replies Number of Replies
NEVRO REVENUE RAMPSUCCESSFUL U.S. LAUNCH AND CONTINUED ADOPTION IN INTERNATIONAL MARKETS
11
$0.1 $4.5
$19.8$29.5
$40.6$47.2
$56.0 $53.1
$9.7$11.3
$10.9
$13.3
$12.2
$14.8$13.7
$14.5$15.3
1Q15 2Q15 3Q15 4Q15 1Q16 2Q16 3Q16 4Q16 1Q17
International Revenue
U.S. Revenue
$9.7 $11.4$15.4
$33.1
$ in Millions
$41.7
$55.4
$60.9
WORLDWIDE REVENUE TREND
REPS TRAINED & IN FIELD
$70.5
52 70 92 100 113140 165 193
232
4646
50 52 5357
6069
71
AtLaunch5/8/15
2Q15 3Q15 4Q15 1Q16 2Q16 3Q16 4Q16 1Q17
Int'l Sales Force
U.S. Sales Force
$68.4
U.S. REP PRODUCTIVITY GOALS
• Goal of $1.3 to $1.5 million in 12 to 15 months per rep
2016: FIRST FULL YEAR OF U.S. LAUNCH
$228.5M total revenue
$173.3M U.S.
$55.2M international (+26% YoY in cc)
12
REVENUE GROWTH DRIVERS
CONTINUED POSITIVE UPTAKE OF EXISTING TERRITORIES• “Go-deep” strategy in existing accounts and opening of new accounts within
existing territories• Continue hiring clinical support reps to support broader adoption
CONTINUED EXPANSION INTO NEW TERRITORIES• Fill remaining territories by hiring as many reps as we can efficiently hire and train
LAUNCH OF SURGICAL LEAD• Launched 1H17• Provides access to surgeons, who represent ~30% of the SCS market
INDICATION EXPANSIONCLINICAL ROADMAP
INVESTIGATE BROADER INDICATIONS
EXPANDING PAIN-RELATED INDICATIONS
CONTINUED MARKET EXPANSION IN BACK & LEG
• New sales force and/or new reimbursement codes
• Demonstration of clinical meaningfulness
• Assessing multiple new indications
e.g., Deep Brain Stimulation
• Expanding existing reimbursement or labeling
• Efficacy and publications to drive adoption
e.g., Upper Limb & Neck Pain, Painful Neuropathies, Non-Surgical Refractory Back Pain
• Clinical efficacy for back pain
• Superior long-term outcomes
• Translating clinical outcomes commercially
• Intraoperative efficiencies
Back & Leg Pain
13
14
HF10 THERAPY: EARLY PROGRESS IN PIPELINE INDICATIONS
PAIN REDUCTION IN PROSPECTIVE SCS TRIALS
1. Al-Kaisy A, et al. 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 Med. 2014;15:347-354.2. 1. Kapural L, et al. Comparison of 10-kHz High-Frequency and Traditional Low-Frequency Spinal Cord Stimulation for the Treatment of Chronic Back and Leg Pain: 24-month Results from a Multicenter, Randomized, Controlled Pivotal Trial. Neurosurgery. Published
09 2016 [Epub ahead of Print]. 3. Al-Kaisy A, et al. 10 kHz High-Frequency Spinal Cord Stimulation for Chronic Axial Low Back Pain in Patients with No History of Spinal Surgery: A Preliminary, Prospective, Open Label and Proof-of-Concept Study. Neuromodulation. 2016; 10:11 11/ner.12563.4. Internal data on file. Studies ongoing, so N’s do not reflect total sample size.
0 (No Pain)
10(Worst Pain)
5
HF10 Therapy (SENZA-EU) – 24 months (N=65)1
HF10 Therapy (SENZA-RCT) – 24 months (N=85)2
1 32 6 87 94
BACK PAIN
HF10 Therapy (SENZA-RCT) – 24 months (N=85)2LEG PAIN
PERIPHERAL NEUROPATHIC PAIN
VAS (cm)
NON-SURGICALBACK PAIN
NECK PAIN
HF10 Therapy (PPN Study) – 1 month (N=16)4
UPPER LIMB PAIN
HF10 Therapy (Al-Kaisy Virgin Back Study) – 12 months (N=20)3
HF10 Therapy (ULN-US Study) – 3 months (N=20)4
HF10 Therapy (ULN-US Study) – 3 months (N=12)4
HF10 Therapy (PPN Study) – Painful Diabetic Neuropathy subset – 1 month (N=6)4
HF10 Therapy (ULN-OUS Study) – 3 months (N=14)4
HF10 Therapy (ULN-OUS Study) – 3 months (N=10)4
15
NEVRO: A LEADER IN NEUROMODULATION
DIFFERENTIATED Technology
First-in-Class EVIDENCE
Demonstrated EXECUTION
PLATFORM Potential
• Publication of Long-Term Superior Patient Outcomes• Only Therapy That Is 100% Paresthesia-Free and Clinically
Superior to Traditional SCS
• Commercial Success in the United States and Internationally• ~15% Market Share by Fifth Full Quarter of U.S. Launch
• Protected by 100+ Patents• Differentiated Mechanism of Action
• Groundbreaking Clinical Trial Presentations of Potential New Indications
18,000+ Patients in 17 MARKETS Over 6 YEARS