LEADERSHIP THROUGH INNOVATION...4.St. Jude Medical Proclaim Implantable Pulse Generator Clinician's...

15
LEADERSHIP THROUGH INNOVATION William Blair 37 th Annual Growth Stock Conference

Transcript of LEADERSHIP THROUGH INNOVATION...4.St. Jude Medical Proclaim Implantable Pulse Generator Clinician's...

Page 1: LEADERSHIP THROUGH INNOVATION...4.St. Jude Medical Proclaim Implantable Pulse Generator Clinician's Manual, Models 3660, 3662, 3665, 3667. Published on October 2016. Responder rates

LEADERSHIPTHROUGHINNOVATIONWilliam Blair 37th Annual Growth Stock Conference

Page 2: LEADERSHIP THROUGH INNOVATION...4.St. Jude Medical Proclaim Implantable Pulse Generator Clinician's Manual, Models 3660, 3662, 3665, 3667. Published on October 2016. Responder rates

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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.

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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

Page 4: LEADERSHIP THROUGH INNOVATION...4.St. Jude Medical Proclaim Implantable Pulse Generator Clinician's Manual, Models 3660, 3662, 3665, 3667. Published on October 2016. Responder rates

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

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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

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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

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HF10 THERAPY ADVANTAGESTHE ONLY CLINICALLY SUPERIOR PARESTHESIA-FREE SCS THERAPY

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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

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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)

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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

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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

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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

Page 11: LEADERSHIP THROUGH INNOVATION...4.St. Jude Medical Proclaim Implantable Pulse Generator Clinician's Manual, Models 3660, 3662, 3665, 3667. Published on October 2016. Responder rates

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)

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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

Page 13: LEADERSHIP THROUGH INNOVATION...4.St. Jude Medical Proclaim Implantable Pulse Generator Clinician's Manual, Models 3660, 3662, 3665, 3667. Published on October 2016. Responder rates

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

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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

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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