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JP Morgan Healthcare Conference January 2025 NASDAQ: CVRX
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2 Cautionary Note Regarding Forward-Looking Statements This presentation by CVRx, Inc. (the “Company”) contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements other than statements of historical facts are forward-looking statements, including statements regarding our future financial performance (including, specifically, our 2025 expected operating and financial results), our anticipated growth strategies, anticipated trends in our industry, our business prospects and our opportunities . In some cases, you can identify forward-looking statements by terms such as “may,” “will,” “should,” “expect,” “plan,” “anticipate,” “could,” “outlook,” “guidance,” “intend,” “target,” “project,” “contemplate,” “believe,” “estimate,” “predict,” “potential” or “continue” or the negative of these terms or other similar expressions, although not all forward-looking statements contain these words. The forward-looking statements in this presentation are only predictions and are based largely on our current expectations and projections about future events and financial trends that we believe may affect our business, financial condition, and results of operations. These forward-looking statements speak only as of the date of this presentation and are subject to a number of known and unknown risks, uncertainties and assumptions, including, but not limited to, our history of significant losses, which we expect to continue; our limited history operating as a commercial company and our dependence on a single product, Barostim; our limited commercial sales experience marketing and selling Barostim; our ability to demonstrate to physicians and patients the merits of our Barostim; any failure by third-party payors to provide adequate coverage and reimbursement for the use of Barostim; our competitors’ success in developing and marketing products that are safer, more effective, less costly, easier to use or otherwise more attractive than Barostim; any failure to receive access to hospitals; our dependence upon third- party manufacturers and suppliers, and in some cases a limited number of suppliers; a pandemic, epidemic or outbreak of an infectious disease in the U.S. or worldwide; product liability claims; future lawsuits to protect or enforce our intellectual property, which could be expensive, time consuming and ultimately unsuccessful; any failure to retain our key executives or recruit and hire new employees; impacts on adoption and regulatory approvals resulting from additional long-term clinical data about our product; and other important factors that could cause actual results, performance or achievements to differ materially from those that are found in “Part I, Item 1A. Risk Factors” in our Annual Report on Form 10-K for the year ended December 31, 2023 and in “Part 2, Item 1A. Risk Factors” in our Quarterly Report on Form 10-Q for the quarter ended September 30, 2024, as such factors may be updated from time to time in our other filings with the Securities and Exchange Commission. Except as required by applicable law, we do not plan to publicly update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise. Market & Industry Data This presentation includes market and industry data and forecasts that the Company has developed from independent research reports, publicly available information, various industry publications, other published industry sources or the Company’s internal data and estimates. Independent research reports, industry publications and other published industry sources generally indicate that the information contained therein was obtained from sources believed to be reliable, but do not guarantee the accuracy and completeness of such information. Although the Company believes that the publications and reports are reliable, the Company has not independently verified the data and makes no representation or warranty with respect to the accuracy of such information. 2 Disclaimer
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33 Company overview $2.2B annual market opportunity Well-defined patient population with limited treatment options Highly differentiated therapy with a compelling safety profile and high response rate Focused plan to drive Barostim therapy to standard of care World’s first neuromodulation therapy to improve heart failure symptoms
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44 1. Martin et al. 2024 Heart Disease and Stroke Statistics. Circulation. 2024. Heart failure (HF) is a burdensome, life-limiting disease affecting over 6M people living in the U.S.1 >8M physician office visits1 >1.1M hospital discharges1 >1.3M emergency room visits1 Annual costs expected to reach $70B by 20301 All figures are annual estimates for the U.S.
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5 1. Adapted from Greenhalgh et al. BMC Cardiovascular Disorders (2017) 17:156. 2. Heidenreich PA, et al. 2022 AHA/ACC/HFSA Guideline for the Management of Heart Failure. Circulation. 2022;145:e895–e1032; Class I and Class IIa recommendations. 3. CVRx data on file. 4. Gerra et al. 2025. Cardiac resynchronization therapy (CRT) nonresponders in the contemporary era: A state-of-the-art review. Heart Rhythm. Heart failure is a progressive disease characterized by steady decline in quality of life (QoL), with limited treatment options Early-Stage Disease Progression End-Stage Drugs CRT TransplantLVAD Hospitalizations Quality of Life1 Guideline Therapies2 Mid-Stage • 70% not indicated for CRT2,3 • 25% CRT non-responder rate4
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6 1. Heidenreich PA, et al. 2022 AHA/ACC/HFSA Guideline for the Management of Heart Failure. Circulation 2022. 2. Vaduganathan M, et al. Estimating lifetime benefits of comprehensive disease-modifying pharmacological therapies in patients with heart failure with reduced ejection fraction: a comparative analysis of three randomised controlled trials. Lancet Vol 396, Issue 10244, P121-128, July 11, 2020. 3. Rahamim E, et al. Contemporary Pillars of Heart Failure with Reduced Ejection Fraction Medical Therapy. J. Clin. Med. 2021, 10, 4409. Heart failure drug therapies have been shown to improve survival 1.4-6.3years ARNI Β-Blockers MRA SGLT2i Estimated aggregate mortality benefit of comprehensive quadruple therapy in HFrEF1 2022 AHA/ACC/HFSA HF Guidelines1-3
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7 1. Adapted from Lewis G et al, Developments in Exercise Capacity Assessment in Heart Failure Clinical Trials and the Rationale for the Design of METEORIC-HF. Circ Heart Fail. 2022 May. 15(5):510-524. 2. Heidenreich PA, et al. 2022 AHA/ACC/HFSA Guideline for the Management of Heart Failure. Circulation. 2022;145:e895–e1032; Class I and Class IIa recommendations. 3. CVRx data on file. …but these drugs have minimal impact on QoL*; CRT has shown meaningful improvements in QoL, but few patients are eligible CRT (n=12) Class I CRT indication Drugs1 NYHA II & III EF ≤ 35% GDMT n = # of studies *Note: Exercise capacity is a commonly used surrogate for quality of life in HF patients 30% 70% Not indicated for CRT2,3 Class I or IIa CRT indication2,3
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8 1. Calvert MJ, et al. Eur J Heart Fail 2005; 7:243-251. 2. E. Stanek, et al. Preferences for treatment outcomes in patients with heart failure: symptoms versus survival J Card Fail 2000; 6:225-232. 65% would even accept shorter life with fewer symptoms2 66% 68% 76% 50% HF negatively impacts quality of life particularly among those with reduced ejection fraction (HFrEF) Majority of patients value symptom improvement over longevity have mobility problems1 report pain or discomfort1 find usual activities difficult1 have anxiety or depression1 …leaving the majority of HF patients to suffer from significantly diminished quality of life
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Early-Stage End-Stage Drugs TransplantLVAD Therapies2 9 1. Adapted from Greenhalgh et al. BMC Cardiovascular Disorders (2017) 17:156. 2. Heidenreich PA, et al. 2022 AHA/ACC/HFSA Guideline for the Management of Heart Failure. Circulation. Barostim addresses this significant and long-standing unmet need in the heart failure treatment continuum Disease Progression Quality of Life1 Barostim Window of Opportunity Barostim Heart failure “Forgotten Middle” CRT
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10 $2.2B U.S. annual net addressable market for Barostim 6.2M HF Prevalence 1.3M HF Incidence 290K NYHA II/III with EF ≤ 35% 76K Annual net addressable patients* *Calculated using NYHA III & II (with a recent history of III); LVEF ≤ 35%; NT-proBNP < 1600pg/ml; mentally and clinically fit; on guideline-recommended therapies $2.2B Barostim U.S. Market (Assumes $29K ASP)
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Barostim Therapy 11
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12 Barostim system components Barostim Generator Carotid Sinus Lead Barostim Programmer (Average battery life of 6 years)
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13 1. Instructions for Use 900133-001 Rev. D available at www.cvrx.com/ifu. 2. Zile M, Presented at THT 2023, March 21, 2023. Barostim is implanted in a 60-min procedure1, with 97% freedom from major complications2 Stimulation Electrode Tunneled Lead Generator 1 2 3 • Implanted on either an inpatient or outpatient basis • Requires a small incision in both the neck and chest • Entirely extravascular, with no leads in the heart or vasculature • Procedure is proven safe; achieved a 97% MANCE-free rate 2 MANCE - Major Adverse Neurological and Cardiovascular Events includes all events that occur within 6 months of implant
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1. Adapted from Packer M, The neurohormonal hypothesis: A theory to explain the mechanism of disease progression in heart failure. JACC 1992 Heart failure symptoms and disease progression are driven by the body’s “fight or flight” response Pumping FunctionWeakened heart 1 Baroreceptor Signaling Reduced stretch sensed by baroreceptors 2 Brain interprets as CV crisis, activates fight or flight response 3 Sympathetic Activity Neurohormone* Release Chronic excess neurohormones damage organs Heart Failure Symptoms 4 Disease Progression * Norepinephrine, Angiotensin II, Aldosterone, etc Disease Progression
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1. Adapted from Packer M, The neurohormonal hypothesis: A theory to explain the mechanism of disease progression in heart failure. JACC 1992 Drug therapies work by blocking specific excess neurohormones Disease Progression Pumping FunctionWeakened heart 1 Baroreceptor Signaling Reduced stretch sensed by baroreceptors 2 Brain interprets as CV crisis, activates fight or flight response 3 Neurohormone* Release Neurohormonal blockade is the basis of drug therapy Chronic excess neurohormones damage organs Heart Failure Symptoms 4 Disease Progression * Norepinephrine, Angiotensin II, Aldosterone, etc Sympathetic Activity
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1. Adapted from Packer M, The neurohormonal hypothesis: A theory to explain the mechanism of disease progression in heart failure. JACC 1992 Barostim complements drug therapy by acting upstream to restore signaling and reduce neurohormonal activation Disease Progression Pumping FunctionWeakened heart 1 Baroreceptor Signaling Reduced stretch sensed by baroreceptors 2 Brain interprets as CV crisis, activates fight or flight response 3 Neurohormone* Release Barostim increases baroreceptor signaling2 Neurohormonal blockade is the basis of drug therapy Chronic excess neurohormones damage organs Heart Failure Symptoms 4 Disease Progression * Norepinephrine, Angiotensin II, Aldosterone, etc Sympathetic Activity
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17 1. Zile MR, et al. European Journal of Heart Failure. 2024. 2. Gremeaux V, et al. Arch Phys Med Rehabil. 2011;92(4):611-619. 3. Rector TS, et al. J Card Fail. 1995;1(3):201-216. 4. Abraham WT, et al. Symptomatic endpoint responder rates to Barostim Therapy, ESC Abstract 2019. Barostim is an effective, predictable, and durable therapy to improve quality of life for HF patients Exercise Capacity Quality of Life Functional Status ~2X Clinically Meaningful Improvement1,2 2X Clinically Meaningful Improvement1,3 68% Improved 1+ NYHA Class1 High Response Rate 94% Clinically relevant response rate4
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18 1. Adapted from Lewis G et al, Developments in Exercise Capacity Assessment in Heart Failure Clinical Trials and the Rationale for the Design of METEORIC-HF. Circ Heart Fail. 2022 May; 15(5):510-524. 2. Abraham WT, Zile MR et al. JACC: Heart Failure 2015 June; 3(6):487-496. 3. Zile MR, et al. J Am Coll Cardiol 2020; 76:1-13. 4. Heidenreich PA, et al. 2022 AHA/ACC/HFSA Guideline for the Management of Heart Failure. Circulation. 2022;145:e895–e1032; Class I and Class IIa recommendations. 5. CVRx data on file. Barostim offers a QoL* improvement comparable to CRT for the 70% of patients who are not indicated for CRT Class I CRT indication CRT (n=12) NYHA II & III EF ≤ 35% GDMT Drugs1 30% 70% Not indicated for CRT4,5 Class I or IIa CRT indication4,5 n = # of studies *Note: Exercise capacity is a commonly used surrogate for Quality of Life in HF patients
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19 1. Instructions for Use 900133-001 Rev. D available at www.cvrx.com/ifu & Zile M, Presented at THT 2023, March 21, 2023. 2. Zile MR, et al. J Am Coll Cardiol 2020;76:1-13. The BeAT-HF trial showed a positive signal to reduce all-cause mortality and a significant reduction in serious cardiovascular events -34% Relative Reduction in All-cause death, LVAD or transplant out to >4 years1 p=0.054 Note: Not a powered endpoint -51% Reduction in Serious Cardiovascular Events2 p = 0.023 Note: Not a powered endpoint
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20 1. Abraham WT, et al. JACC Heart Fail 2015 3(6):487-496. 2. Pham, Vu, et al. Effects of BAT with Maximally-Tolerated GDMT on Hospitalization Rates in Patients with HFrEF, ACC 2024 abstract 1244-123. * Data are presented in the abstract as hospitalizations/month, but are represented here as hospitalizations/year for ease of comparison A growing body of evidence, free of the confounding impact of COVID-19, suggests a significant and consistent effect on HF hospitalizations HOPE4HF publication1 (Pre-COVID-19) USC Keck ACC abstract2 (Post-COVID-19) 78% (p = 0.01) n= 57 Fewer hospitalizations in the 6 months post- vs. 6 months pre-Barostim implant Fewer hospitalizations in the 12 months post- vs. 12 months pre-Barostim implant* 0 0.2 0.4 0.6 0.8 1 1.2 1.4 Pre Post Hospitalizations per year* (p = 0.046) n = 12 0 0.1 0.2 0.3 0.4 0.5 0.6 0.7 Pre Post Hospitalizations per year (p = 0.01) n= 57
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2121 Our revised go-to-market strategy is focused on driving Barostim to become Standard of Care for HFrEF Three Key Strategies Build a world-class sales organization Focus on developing sustainable Barostim Programs Address the barriers to adoption 1 2 3
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22 Recruit sales reps with strong therapy development backgrounds Strengthen training & development programs Align incentives to a program-oriented sales process We are building a world-class sales organization focused on developing sustainable programs with deep therapy adoption 1
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2323 Heart Failure Dx Volume Diagnostic Device Adoption in HFrEF New CV Technology Adoption All Potential Targets Highest Potential Targets HighLow High Low We will focus on developing sustainable Barostim programs by targeting centers with the highest potential for success 2
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2424 …and will replicate the elements present in Barostim centers that have achieved the deepest adoption 2 Clinical Champion(s) Sustainable Barostim Program Administrative Champion(s) GC/ICEPAPPHFS Referrers (Identify potential patients) Implanters (Technicians) VS / CTS Prescribers (Prescribe the therapy and send for implant) HFS* *May also be an EP, GC, or IC depending on account
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25 We have implemented a market development strategy focused on addressing the key barriers to adoption 3 : Increase therapy awareness among referrers and patients 2) Clinical Evidence: Develop more robust clinical evidence 3) Patient Access: Improve patient access to Barostim 1) Therapy Awareness
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26 : We are engaging more deeply with the referral network that surrounds targeted centers Sustainable Barostim Program Expanded Regional Medical Education Programs Launch of New APP-Focused Programs Launch of ASCEND Fellows Program GC/ICEPHFS NP PA HFS Fellow 1) Therapy Awareness
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27 2) Clinical Evidence: We are developing a steady cadence of clinical evidence to support Barostim therapy in two key areas Evidence of Improved Outcomes • Improved QoL & exercise capacity • Reduced HF and all-cause hospitalizations • Reduced arrythmias • Improved ejection fraction • Decreased diuretic needs Evidence Supporting Mechanism of Action • Reduced sympathetic nerve activity • Restored cardiac parasympathetic control • Anti-inflammatory effect • Reversed remodeling • Favorable hemodynamic effect Areas of Interest: Evidence Generation Channels: Barostim Investigator Initiated Research (BIIR) Real-World Evidence
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28 3) Patient Access: We made significant progress in 2024 to improve patient access and support therapy adoption Payment Coding Coverage Work toward permanent codes Leverage long-term data to impact public and private payer coverage policies Maintain appropriate payment for both inpatient & outpatient Recent Milestones Permanent inpatient payment secured > $43K (vs. $17-$23K) CMS Category I code approved Key Activities Outpatient new technology APC 1580 secured for 2025 (~$45K)
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29 Note: Estimated results for FY 2024 are preliminary, unaudited and represent the most recent current information available to management. Actual results may differ from these estimated financial results, including due to the completion of its financial closing procedures and final adjustments. Preliminary 2024 financial summary $6.1 $13.0 $22.5 $39.3 $51.2 $- $10 $20 $30 $40 $50 $60 2020 2021 2022 2023 2024 Millions Worldwide Revenue Gross Margin: 76% 72% 78% 84% 83%-85% 2024 Highlights •2024 WW Revenue: $51.1–$51.2M (~30%) •Q4 WW Revenue: $15.2–$15.3M (~35%) •Q4 US HF Revenue: $14.2–$14.3M (~40%) •US Territories: 48 (+3) •Active Implanting Centers: 223 (+15) •Cash Balance at End of Q4: $105.9M
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For the full year of 2025, we expect: • Total revenue between $63.0 million and $65.0 million; • Gross margin between 83% and 84%; • Operating expenses between $100.0 million and $104.0 million For the first quarter of 2025, we expect total revenue between $14.5 million and $15.0 million 2025 Guidance 30
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31 We have spent 2024 building a strong foundation for continued future growth Significantly strengthened executive and commercial teams Implemented a market development and commercial strategy focused on reaching standard of care Expanded the body of clinical evidence, including publication of impressive 24-month quality of life improvements Secured fundamental improvements across key aspects of patient access
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