Cvrx, Inc. · NASDAQ:CVRX
Cvrx — 43rd Annual William Blair Growth Stock Conference, June 2023
22 slides from Cvrx's conference presentation, Jun 8, 2023
Slide 1: 43rd Annual William Blair Growth Stock Conference, June 2023
43rd Annual William Blair Growth Stock Conference, June 2023
Slide 2: Cautionary Note Regarding Forward-Looking Statement
2 Cautionary Note Regarding Forward-Looking Statement 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 statement
Slide 3: Company Overview
3 • CVRx has the first and only FDA-approved device leveraging the power of the brain to treat cardiovascular diseases • Barostim was approved by FDA in 2019 for a $1.4 billion annual U.S. market opportunity in heart failure • Proven management team leading 180+ employees • Manufacturing capacity is
Slide 4: CVRx Management Team
4 CVRx Management Team Nadim Yared President & Chief Executive Officer Jared Oasheim Chief Financial Officer Paul Verrastro Chief Marketing & Strategy Officer Craig Palmer Senior Vice-President of US Sales Liz Galle Vice-President of Clinical Research Thomas Hengsteler VP, European Sales & Marketing
Slide 5: Baroreflex is integral to maintaining cardiovascular homeostasis
5 Baroreflex is integral to maintaining cardiovascular homeostasis Baroreceptor Signaling Modulate Autonomic Nervous System Regulate Cardiovascular System
Slide 6: 1. Large Market Opportunity
6 1. Large Market Opportunity Assumptions: (1) Average selling price of $25,000 (2) Excludes replacement market of approx. 30-40% of de novo market in the future (+$0.9B-$1.2B) (3) Market data reflects our estimates involving a number of assumptions and limitations U.S. 6.3 million patients 5 EU Cou
Slide 7: 2. Straightforward Patient Identification
7 2. Straightforward Patient Identification Barostim Heart Failure Symptoms + NYHA II/III + LVEF ≤ 35% ICD NT-proBNP < 1600pg/ml ? Yes
Slide 8: 3. One-hour Outpatient Procedure
8 3. One-hour Outpatient Procedure Ends like a pacemaker or ICD procedure, without any hardware in the heart Starts like a standard endarterectomy, without opening any artery 1 Preparation 2 3 4 Lead Placement IPG Placement Closure
Slide 9: 4. Favorable Hospital Economics
9 * Payment codes such as APC 5465 are indexed to adjust for cost of living and thus vary by location. These payments generally cover the hospital’s costs for the device and the implantation procedure. ** APC 5465 was $29,445 for CY2021 and $30,063 for CY2022. • CMS granted Barostim add-on payments
Slide 10: 5. Proven Go-to-market Strategy
10 5. Proven Go-to-market Strategy Goal: add 3 new account managers every quarter • Hiring process based on: • Location • Expertise • Network Goal: 6-month ramp for new account managers to create new Territories Goal: 5 Active Implanting Centers per Territory Goal: 12 Barostim units per AIC per year
Slide 11: BeAT-HF Pre-Market Trial: 6-Month Symptom Improvement
11 *Data from different studies and different patient populations may not be directly comparable 1. Zile MR, et al. J Am Coll Cardiol 2020; 76:1-13. 2. Rector TS, et al. J Card Fail. 1995;1(3):201-216. 3. Higgins SL, et al. J Am Coll Cardiol 2003;42:1454 –1459. 4. Abraham WT, et al. N Engl J Med 200
Slide 12: GDMT produces modest improvements in exercise capacity compared to CRT and BAT
12 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 A
Slide 13: Tolerance, titration and discontinuation of GDMT
13 Savarese G et al, Heart Failure Drug Treatment—Inertia, Titration, and Discontinuation (EVOLUTION HF), J Am Coll Cardiol HF. 2023; 11:1–14 Tolerance, titration and discontinuation of GDMT Large proportions of the HF patient population remain under target dose or have discontinued GDMT at 1 year
Slide 14: US Heart Failure Sales Achieved with 6-Month Data
14 US Heart Failure Sales Achieved with 6-Month Data 14 Territories Active Implanting Centers US HF Revenue $175 $65 $140 $607 $1,258 $2,001 $2,468 $2,702 $2,928 $3,781 $4,901 $5,960 $0K $1,000K $2,000K $3,000K $4,000K $5,000K $6,000K 0 20 40 60 80 100 120 Q1 '20 Q2 '20 Q3 '20 Q4 '20 Q1 '21 Q2 '21 Q
Slide 15: BeAT-HF Summary of Key Evidence
BeAT-HF Summary of Key Evidence Description Composite CV Mortality and HF Morbidity Rate Ratio = 0.94 All-cause Mortality (death, LVAD, heart transplant) Hazard Ratio = 0.66 Hierarchical Win Ratio (CV mortality, HF morbidity, QOL) Win Ratio = 1.26 Related MANCE-free Rate* *Major Adverse Neurologic a
Slide 16: Conclusion
Conclusion Totality of evidence indicates that BAT is a safe, effective and durable treatment for patients with heart failure with reduced ejection fraction 16
Slide 17: Key takeaways
17 The post-market phase of BeAT-HF confirmed the long-term durability of safety and symptomatic improvements, and the sustainability of the extent of the improvements. The reduction of all-cause death, LVAD and heart transplant is meaningful (34% reduction, nominal p-value 0.054). The pre-specified
Slide 18: Next steps
18 One or more manuscripts will be written by the executive steering committee for submission to peer-reviewed journals. A collaborative effort between CVRx, FDA and key academic institutions will continue analyzing the impact of COVID on heart-failure clinical trials, particularly on BeAT-HF. Next
Slide 19: US Heart Failure Sales Growth Continues
19 US Heart Failure Sales Growth Continues Territories Active Implanting Centers US HF Revenue $175 $65 $140 $607 $1,258 $2,001 $2,468 $2,702 $2,928 $3,781 $4,901 $5,960 $6,786 $0K $1,000K $2,000K $3,000K $4,000K $5,000K $6,000K $7,000K 0 20 40 60 80 100 120 140 160 Q1 '20 Q2 '20 Q3 '20 Q4 '20 Q1 '2
Slide 20: Highlights Financial Results
20 Highlights Financial Results Q1 '21 Q2 '21 Q3 '21 Q4 '21 Q1 '22 Q2 '22 Q3 '22 Q4 '22 Q1 '23 OUS $1,248 $1,018 $823 $800 $1,018 $1,094 $1,146 $1,190 $1,037 US Legacy $354 $104 $104 $156 $130 $156 $139 $26 $156 US HF $1,258 $2,001 $2,468 $2,702 $2,928 $3,781 $4,901 $5,960 $6,786 $0 $1,000 $2,000 $3
Slide 21: 2023 Guidance as of April 27, 2023
21 • For the full year of 2023, we expect: • Total revenue between $35.5 million and $38.0 million; • Gross margin between 80% and 83%; • Operating expenses between $76.0 million and $80.0 million • For the second quarter of 2023, we expect total revenue between $8.2 million and $8.8 million 2023 Gu
Slide 22: Questions?
Barostim” Questions? One aerer
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