From Recovery to Renewed Growth - J.P. Morgan 40th Annual Healthcare Conference JANUARY 10, 2022
←
→
Page content transcription
If your browser does not render page correctly, please read the page content below
From Recovery to Renewed Growth J.P. Morgan 40th Annual Healthcare Conference D. KEITH GROSSMAN CHAIRMAN, CEO & PRESIDENT JANUARY 10, 2022
Forward-Looking Statements In addition to historical information, this presentation contains forward-looking statements reflecting the company's current beliefs and expectations of management made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, including: our belief that SCS market growth will be enhanced by pent-up demand; our belief in the continuing growth fundamentals of the SCS market; our belief that our core back & leg business is poised for recovery as the COVID impact recedes, trialing activity continues to improve, and pent-up demand comes back into the system; our belief that we are well- positioned for SCS market expansion and that we will outperform and outgrow a growth market; our belief that the PDN and NSRBP opportunities are set to outpace core back & legal market growth and expand the available total addressable market for SCS therapies; our belief that there is an opportunity for an improved margin profile as we continue to scale; our belief that Nevro has continued to gain market share; our beliefs around the size of the PDN and NSRBP markets; our belief that, as the impact of COVID on the SCS market begins to recede, our new growth drivers will start to thrive as well; our belief that the safety and efficacy data from the SENZA-PDN and SENZA-NSRBP RCTs will be used to support market penetration, physician referral decisions and market access initiatives to ensure adequate payer coverage of these procedures; our expectation of steady reimbursement progress for PDN with published clinical results and a robust clinical dossier; and our expectations that our Costa Rica manufacturing facility is validated and approved in 2022, which we believe will contribute to margin improvement. 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 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 and the costs and expenses of operating our business; 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 Quarterly Report on Form 10-Q filed on November 8, 2021, 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. 2
Nevro: Positioned to Pace-setting leader in 3 large, underpenetrated SCS markets Outperform Unique and differentiated 10 kHz Therapy with superior outcomes Multiple growth opportunities with expanded indications Pent-up demand additive to growth Meaningful leverage opportunities to drive profitability and cash flow 3 3
As the impact of COVID on our market begins to recede, new Chronic-pain treatments have been among the hardest hit and slowest device segments to return, but growth fundamentals of the Spinal Cord growth drivers will start Stimulation (SCS) market remain. to thrive as well. Core Back & Leg business is poised for recovery as the COVID impact recedes, trialing activity continues to improve, and pent-up demand comes back into the system. Well-positioned for market expansion: Painful Diabetic Neuropathy (PDN) and Non-Surgical Refractory Back Pain (NSRBP) set to outpace market growth and expand available TAM. Opportunity for an improved margin profile as we continue to scale. 4
Trials – our most important leading indicator Trial rates in U.S. steadily improved in 2H of 2021, approaching pre-COVID 2019 levels U.S. PDN trials (% of total U.S. trial volume) Sept 2021 ~6% Dec 2021 Grew to ~8% 5
Total Addressable U.S. Lower Back & Leg Market² Large, $17.9B Annually, ~8% Penetrated underpenetrated FBSS: Failed Back Surgery Syndrome NSRBP: Non-Surgical Refractory Back Pain back & leg market $6.5B 36% 2021 Global SCS Market SURGICAL (FBSS) $2.3B Annually¹ 285K Patients/Yr $11.4B NON-SURGICAL $1.8 Billion $0.5 Billion ~14% Penetrated 64% (NSRBP) United States International 500K Patients/Yr ~5% Penetrated More than 100,000 patients treated annually 1Includes DeNovo and Replacement 2Includes DeNovo patients only Sources: Komodo claims data, as of September 2021; Company data Sources: Komodo claims data, as of September 2021; Company data 6
Sustainable mid-to-high single-digit historical SCS Est. Market CAGR market growth 2011-2018 9% SCS Worldwide Market Estimate 2015-2019 11% Market Size ($ in millions) 3000 2011-2021 6% 2000 Despite COVID impact, 1000 market growth 2011 2012 2013 2014 2015 2016 2017 2018 2019 2020 2021 fundamentals are strong Est. 7 Sources: Company data, Nevro estimates
Nevro has continued to gain share. Nevro SCS market share 18-20 % after 2015 market entry Continuing to win in a difficult 2021 market Market Share Estimate by Competitor 40% As of October ‘21, believe we are only company well into 30% positive YTD procedure growth in the U.S. vs. 2019 20% Based on claims data as of Nevro’s 3Q’21 earnings 10% call, U.S. perm procedures were up +4%, while total market SCS perms were down -8%. 0% 2015 2016 2017 2018 2019 2020 2021 (YTD thru Oct) NVRO Competitor 1 Competitor 2 Competitor 3 8 Sources: Guidepoint and Nevro data
NEVRO: Positioned to outgrow a 06 PDN launch growth market 05 NSRBP coverage 04 expansion Market share gains 03 in core back/leg SCS business 02 Continued commercial execution R&D: planned 01 Comprehensive technology evolution HFX solution Sustainable market growth enhanced by return of pent-up demand 9
Omnia SCS System ™ One system. Maximum versatility. Delivers widest range of frequencies, including proprietary 10 kHz Therapy Includes 35 customizable programs, with ability to easily pair widest array of waveforms Upgradeable to future waveforms and frequencies Includes new, intuitive patient accessories New Trial Stimulator is smaller, with more contoured, cable-free system 11
Omnia powered by HFX Connect ™ ™ Expanded versatility to remotely optimize patient care. Proprietary cloud-based patient management system Prior authorization and Data-driven programming informed by appeal support outcomes across 80k+ patients Benefit verification Ongoing support with proactive Reimbursement education reporting for long-term success Patient support professionals, trained in patient education Remote therapy optimization Post-procedure support 12
Introducing HFX for PDN* ™ A New Treatment Option for Painful Diabetic Neuropathy HFX IS THE ONLY SCS TREATMENT OPTION APPROVED BY THE FDA TO TREAT PDN * HFX is a comprehensive solution that includes a Senza spinal cord stimulation system and support services for the treatment of chronic pain. Throughout this presentation HFX™ for PDN means that a patient has been implanted with a Senza System and programmed to include a frequency of 10 kHz. 13
PDN: Large patient population with significant unmet need. PREVALENCE INCIDENCE Diagnosed 20% 45% Annual TAM PWD with PDN Refractory to CMM ~$3.5-5.0 Billion 26.8 MM PATIENTS 5.3 MM PATIENTS 2.3 MM PATIENTS 140K-200K PATIENTS Current Treatment Options Demonstrate Mild Efficacy and Low Adherence PWD = Patients with Diabetes PDN = Painful Diabetic Neuropathy CMM = Conventional Medical Management TAM = Total Addressable Market Sources: CDC National Diabetes Statistics Report 2020; Schmader KE. Epidemiology and impact on quality of life of postherpetic neuralgia and painful diabetic neuropathy. Clin J Pain. 2002;18(6):350-354; 14 Trinity Partners Market Research 2017
PDN patients suffer from chronic, debilitating pain with no good options. Bladder / bowel problems What is PDN? Muscle weakness Nerve damage caused by chronically high blood sugar and diabetes Coordination Most common complication of diabetes difficulties Develops 5-10 years post-onset of diabetes Symptoms Numbness, loss of sensation, Stabbing and sometimes pain in the pain Sensitivity feet, legs, or hands to touch Consequences May not feel heat, cold, or pain in feet, Numbness, especially legs, or hands in arms and legs Unaware of cuts or wounds Infections, ulcers, amputations, falls, Burning hospital admissions, QoL, or even death pain 15 Sources: Trinity Partners Market Research 2017; Mayo Clinic; Nevro Senza-PDN RCT 6-month manuscript
PDN Market The Power of a Opportunity PDN Indication 1% penetration = ~$500M Increase referrals and access to new accounts On-label treatment Level 1 Scientific Data Expand PDN coverage $47 Billion 2.3M Patients Nevro is ONLY company with specific on-label indication for treating PDN 16
Proprietary 10 kHz Therapy provides substantial, durable relief in patients with PDN in clinical trial and real-world settings and compared to low-frequency SCS. Pain Relief over 12 Months Neurologic Improvement, Compared to Baseline Lower Limb Pain VAS (cm) https://care.diabetesjournals.org/look Proportions of Subjects up/doi/10.2337/dc21-1813 https://doi.org/10.1177/19322968211060316; https://doi.org/10.1177/19322968211060075 10 kHz Therapy + CMM (n=84) CMM (n=58) Crossover CMM + 10 kHz Therapy (n=58) Percentage of patients with ≥50% Pain Relief 6 MONTHS 12 MONTHS 86% 86% 86% of patients on 10 kHz Therapy had substantial, durable pain relief 10 kHz Therapy through 12 months, compared to 0% + CMM of patients on CMM alone. (n=84) MEAN PAIN RELIEF: 77.1% 84% of patients that elected to cross Crossover to 0% 10 kHz SCS 84% over to 10 kHz Therapy from CMM at 6 months, experience substantial relief CMM that was comparable to patients (n=58) assigned to 10 kHz Therapy at baseline MEAN PAIN RELIEF: 70.3% Petersen et al. Durability of High-Frequency 10-kHz Spinal Cord Stimulation for Patients With Painful Diabetic Neuropathy Refractory to Conventional Treatments: 12-Month Results From a Randomized Controlled Trial. Diabetes Care. 2022;45:e1–e4; https://doi.org/10.2337/dc21-1813. 17
Expect steady reimbursement progress with published clinical results and a robust clinical dossier. PAYER MIX FOR PDN PATIENTS Medicare Commercial Current State: 40% 60% Payers Payer Mix: 60% Commercial / 40% Medicare ~25% of PDN patients already covered ~25% Patients Recent PDN already Expect an increase in coverage occurring coverage covered in 2022 and beyond expansion effective March 1, 2022 Source: Payer Mix - IQVIA Claims Data; Other data cited as of 1/1/2022 18
Two-pronged reimbursement market access strategy for PDN Leverage prior authorization and In parallel, active discussions with 1 patient appeal process while 2 Medicare and commercial payers to working with payers to establish positive coverage policies broaden coverage Medicare Coverage Commercial Coverage ~40% of Total Addressable Market¹ ~60% of Total Addressable Market¹ Covered 5%² Covered Not Covered Case-by-Case Specific Non-Coverage Policy 50% 50% 25% 70% 19 ¹ Source: IQVIA Claims Data; As of 1/1/2022 ² Does not include the UnitedHealthcare positive coverage decision, which is effective 3-1-22
PDN already Preliminary, unaudited delivering worldwide PDN revenue: ~$4.0M revenue gains $1.7M Q3 2021 Q4 2021 Q4’21 U.S. PDN trials grew ~92% over Q3’21 PDN ~7% of U.S. trials in Q4 2021 Broader penetration and a more significant revenue contribution expected in 2022 and beyond 20
NSRBP: Clinical data expected to drive patient access and $11.4B Total market penetration. Addressable Market Submitted PMA Supplement to FDA for NSRBP Indication $510M Current Development of clinical data Market supports continued market penetration: Expanded payer coverage Only ~5% penetrated Increased referrals for 10 kHz Therapy 12-month data release at NANS 2022 and publication expected soon 21 NSRBP: Non-Surgical Refractory Back Pain; PMA: Pre-Market Approval
NANS 2022: Significant Clinical Presence 17 Abstracts Accepted for Presentation Three late-breaking presentations: SENZA-PDN RCT – 18-month results SENZA-NSRBP RCT – 12-month results SENZA-NSRBP RCT Cost-Effectiveness Data Saturday, January 15, 2022 Saturday, January 15, 2022 Saturday, January 15, 2022 8:40-8:55 am ET 9:25-9:40 am ET 5:15-5:25 pm ET Presenter: Dr. Erika Petersen Presenter: Dr. Leo Kapural Presenter: Dr. Jessica Jameson Highlights Complete 18-month results for SENZA-PDN RCT, including 12-month crossover results and analysis of healthcare resource utilization Twelve-month results for SENZA-NSRBP RCT, with 159 randomized participants from 15 study centers SENZA-NSRBP RCT cost-effectiveness data, for 10 kHz spinal cord stimulation 22
Continued progress on operating expense leverage. Adjusted OPEX Leverage Meaningful leverage 160% opportunities to drive profitability 120% Commercial organization 80% New Costa Rica manufacturing operations 40% Continued product enhancements 0% Q1 '19 Q2 '19 Q3 '19 Q4 '19 Q1 '20 Q2 '20 Q3 '20 Q4 '20 Q1 '21 Q2 '21 Q3 '21 Technology-enabled Adj. OPEX as a % of Revenue efficiencies Excluding all litigation-related and PDN expenses, YTD Q3 2021 operating expenses would be less than YTD Q3 2019 by almost $35 million, or 13% 23
In-house manufacturing expected to drive margin gains Gross margin expansion to mid-70s% over next Established very first insourced global 3-5 years manufacturing operations in Costa Rica Enables greater control and efficiency in our manufacturing processes Expect the facility to be validated and approved in 2022 Expect to have ~100 team members in Costa Rica by the end of 2022 Represents investment of $21 million by the end of 2022 24
Closing Thoughts 25
Nevro: Positioned to Outperform Pace-setting leader in three large, underpenetrated SCS markets Unique and differentiated 10 kHz technology with superior outcomes Multiple growth drivers via expanded indications Pent-up demand additive to growth Meaningful leverage opportunities to drive profitability and cash flow 26
You can also read