8-K - CVRX - Equibles

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 8-K

CURRENT REPORT

Pursuant to Section 13 or 15(d) ofthe Securities Exchange Act of 1934

Date of report (Date of earliest event reported): June 5, 2023

CVRx,

Inc.

(Exact name of registrant as specified in its charter)

Delaware	001-40545	41-1983744
(State<br> or other jurisdiction of<br><br> incorporation)	(Commission<br><br> File Number)	(I.R.S.<br> Employer<br><br> Identification No.)

9201West Broadway Avenue**, Suite 650**

Minneapolis,

MN 55445

(Address of principal executive offices) (Zip Code)

(763

)

416-2840

(Registrant’s telephone number, including area code)

N/A

(Former name or former address, if changed since last report)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):

¨ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

¨ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

¨ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

¨ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:

Title<br> of each class	Trading<br> Symbol(s)	Name<br> of each exchange<br><br> <br>on which registered
Commonstock, par value $0.01 per share	CVRX	The Nasdaq Global Select Market

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).

Emerging growth company x

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ¨

Item 5.07 Submission of Matters to a Voteof Security Holders.

On June 5, 2023, CVRx, Inc. (the “Company”) held its 2023 annual meeting of stockholders (the “Annual Meeting”). Voting results for each matter submitted to a vote at the Annual Meeting are provided below.

Proposal1. Election of Directors. The two nominees for Class II director were elected to serve until the 2026 annual meeting of stockholders and until their successors are duly elected and qualified, by the votes set forth in the table below.

Nominee	For	Withheld	Broker Non-Votes
Kevin Hykes	12,368,856	617,120	5,809,856
Joseph Slattery	11,896,881	1,089,095	5,809,856

Proposal2. The stockholders ratified the appointment of Grant Thornton LLP as the Company’s independent registered public accounting firm for the fiscal year ending December 31, 2023, by the votes set forth in the table below.

For	Against	Abstain
18,785,665	641	9,526

Item 7.01. Regulation FD Disclosure.

The Company intends to present the presentation materials attached hereto as Exhibit 99.1, and incorporated herein by reference, at the 43rd Annual William Blair Growth Stock Conference on June 8, 2023 and related investor meetings.

The information contained in this Item 7.01, including Exhibit 99.1, is being furnished and shall not be deemed to be “filed” with the Securities and Exchange Commission for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section and is not incorporated by reference into any filing under the Securities Act of 1933, as amended, or the Exchange Act, whether made before or after the date hereof, except as expressly set forth by specific reference in such a filing.

Item 9.01. Financial Statements and Exhibits.

(d) Exhibits

Exhibit
No.	Description
99.1	Presentation of CVRx, Inc., dated<br> June 8, 2023
104	Cover Page Interactive Data<br> File (embedded within the Inline XBRL document)

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

	CVRx, Inc.
Date: June 8, 2023	By:	/s/ Jared Oasheim
		Name: Jared Oasheim
		Its: Chief Financial Officer

Exhibit 99.1

43rd Annual William Blair Growth Stock Conference,<br>June 2023
2<br>Cautionary Note Regarding Forward-Looking Statement<br>This presentation by CVRx, Inc. (the “Company”) contains forward-looking statements within the meaning of the Private Securities Litigation<br>Reform Act of 1995. All statements other than statements of historical facts are forward-looking statements, including statements regarding<br>our future financial performance (including, specifically, our 2023 expected operating and financial results), our anticipated growth strategies,<br>anticipated trends in our industry, our business prospects and our opportunities. In some cases, you can identify forward-looking statements<br>by terms such as “may,” “will,” “should,” “expect,” “plan,” “anticipate,” “could,” “outlook,” “guidance,” “intend,” “target,” “project,”<br> “contemplate,” “believe,” “estimate,” “predict,” “potential” or “continue” or the negative of these terms or other similar expressions, although<br>not all forward-looking statements contain these words.<br>The forward-looking statements in this presentation are only predictions and are based largely on our current expectations and projections<br>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<br>assumptions, including, but not limited to, our history of significant losses, which we expect to continue; our limited history operating as a<br>commercial company and our dependence on a single product, Barostim; our ability to establish and maintain sales and marketing<br>capabilities; our ability to demonstrate to physicians and patients the merits of our Barostim; any failure by third-party payors to provide<br>adequate coverage and reimbursement for the use of Barostim; our competitors’ success in developing and marketing products that are safer,<br>more effective, less costly, easier to use or otherwise more attractive than Barostim; any failure to receive access to hospitals; our<br>dependence upon third-party manufacturers and suppliers, and in some cases a limited number of suppliers; a pandemic, epidemic or<br>outbreak of an infectious disease in the U.S. or worldwide, including the outbreak of the novel strain of coronavirus, COVID-19; any failure of<br>clinical studies for future indications to produce results necessary to support regulatory clearance or approval in the U.S. or elsewhere; product<br>liability claims; future lawsuits to protect or enforce our intellectual property, which could be expensive, time consuming and ultimately<br>unsuccessful; any failure to retain our key executives or recruit and hire new employees; and other important factors that could cause actual<br>results, performance or achievements to differ materially from those that are found in “Part I, Item 1A. Risk Factors” in our Annual Report on<br>Form 10-K for the year ended December 31, 2022. Except as required by applicable law, we do not plan to publicly update or revise any<br>forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise.<br>Market & Industry Data<br>This presentation includes market and industry data and forecasts that the Company has developed from independent research reports,<br>publicly available information, various industry publications, other published industry sources or the Company’s internal data and estimates.<br>Independent research reports, industry publications and other published industry sources generally indicate that the information contained<br>therein was obtained from sources believed to be reliable, but do not guarantee the accuracy and completeness of such information. Although<br>the Company believes that the publications and reports are reliable, the Company has not independently verified the data and makes no<br>representation or warranty with respect to the accuracy of such information.
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3<br> • CVRx has the first and only FDA-approved<br>device leveraging the power of the brain to<br>treat cardiovascular diseases<br> • Barostim was approved by FDA in 2019 for a<br>$1.4 billion annual U.S. market opportunity<br>in heart failure<br> • Proven management team leading 180+<br>employees<br> • Manufacturing capacity is 5,000 systems per<br>shift per year at facility in Minneapolis, MN<br> • Strong financial profile with 80%+ gross<br>margin<br> • Well-capitalized balance sheet with over<br>$100 million in cash (as of March 31, 2023)<br>3<br>Company Overview
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4<br>CVRx Management Team<br>Nadim Yared<br>President & Chief<br>Executive Officer<br>Jared Oasheim<br>Chief Financial<br>Officer<br>Paul Verrastro<br>Chief Marketing & Strategy<br>Officer<br>Craig Palmer<br>Senior Vice-President of<br>US Sales<br>Liz Galle<br>Vice-President of Clinical<br>Research<br>Thomas Hengsteler<br>VP, European Sales &<br>Marketing<br>Paul Pignato<br>VP, Operations<br>Jonelle Burnham<br>VP, General Counsel<br>Al Crouse<br>VP, Quality Assurance<br>and Regulatory Affairs<br>Ivana Stojanovic<br>VP, Market Access and<br>DTC Marketing<br>Jim Georgakopoulos<br>Distinguished Scientist
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5<br>Baroreflex is integral to maintaining cardiovascular<br>homeostasis<br>Baroreceptor<br>Signaling<br>Modulate<br>Autonomic<br>Nervous System<br>Regulate<br>Cardiovascular<br>System
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6<br>1. Large Market Opportunity<br>Assumptions:<br>(1) Average selling price of $25,000<br>(2) Excludes replacement market of approx. 30-40% of<br>de novo market in the future (+$0.9B-$1.2B)<br>(3) Market data reflects our estimates involving a<br>number of assumptions and limitations<br>U.S.<br>6.3 million patients<br>5 EU Countries<br>Initial Annual Market Opportunity ($/year)<br>$1.4 billion $1.5 billion<br>Initial Addressable Patient Incidence Rate<br>(patients/year)<br>55,000 61,000<br>Incidence (patients / year)<br>1.3 million 1.4 million<br>Prevalence (patients)<br>6.2 million 8.6 million<br>U.S.<br>$2.9B<br>Initial Annual Market Opportunity from U.S.<br>and largest 5 countries in Europe with initial<br>addressable HFrEF patient population<br> NYHA III & II (with a recent history of III); LVEF ≤ 35%; NT-proBNP < 1600pg/ml;<br>mentally and clinically fit; not indicated for CRT
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7<br>2. Straightforward Patient Identification<br>Barostim<br>Heart Failure Symptoms<br>+ NYHA II/III<br>+ LVEF ≤ 35%<br>ICD<br>NT-proBNP<br> < 1600pg/ml ?<br>Yes
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8<br>3. One-hour Outpatient Procedure<br>Ends like a pacemaker or ICD procedure, without any<br>hardware in the heart<br>Starts like a standard endarterectomy, without<br>opening any artery<br>1 Preparation 2 3 4<br>Lead<br>Placement<br>IPG<br>Placement Closure
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9<br>* Payment codes such as APC 5465 are indexed to adjust for cost of living and thus vary by location. These payments<br>generally cover the hospital’s costs for the device and the implantation procedure.<br>** APC 5465 was $29,445 for CY2021 and $30,063 for CY2022.<br> • CMS granted Barostim add-on payments for outpatient procedures<br>(Transitional Pass-Through or TPT)<br> • TPT is hospital-specific:<br>CPT<br>Code CPT Code Description<br>2023 Medicare<br>National<br>Average<br>Payment<br>0266T<br>Implantation or replacement of carotid<br>sinus baroreflex activation device; total<br>system<br>$29,358* +<br>TPT<br>0272T<br>0273T<br>Interrogation device evaluation (in person),<br>with interpretation and report $145<br>4. Favorable Hospital Economics<br>Coverage<br>Medicare<br>67%<br>Commercial<br>19%<br>Other<br>14%<br> • Claim-by-claim adjudication allowed by<br>CMS in all 7 MACs since July 2020<br> • Transitional Pass-Through (TPT) carries<br>a presumption of coverage<br>Payment
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10<br>5. Proven Go-to-market Strategy<br>Goal: add 3 new account<br>managers every quarter<br> • Hiring process based on:<br> • Location<br> • Expertise<br> • Network<br>Goal: 6-month ramp for<br>new account managers<br>to create new Territories<br>Goal: 5 Active Implanting<br>Centers per Territory<br>Goal: 12 Barostim units<br>per AIC per year<br> • Broad awareness<br>(Tradeshows/Webinars)<br> • Local referral development<br> • Direct-to-consumer<br>marketing<br>GOAL: Account Manager target<br>5 x 12 = 60 units per year x $25K = $1.5 million annual revenue<br>Increase<br>Productivity<br>Create<br>Territories (29)<br>Activate<br>Implanting<br>Centers (122)<br>Add Account<br>Managers<br>10
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11<br>*Data from different studies and different patient populations may not be directly comparable<br>1. Zile MR, et al. J Am Coll Cardiol 2020; 76:1-13.<br>2. Rector TS, et al. J Card Fail. 1995;1(3):201-216.<br>3. Higgins SL, et al. J Am Coll Cardiol 2003;42:1454 –1459.<br>4. Abraham WT, et al. N Engl J Med 2002;346:1845–1853.<br>5. 5. Gremeaux V, et al. Arch Phys Med Rehabil. 2011;92(4):611-619.<br>BeAT-HF Pre-Market Trial: 6-Month Symptom<br>Improvement1<br>52%<br>29%<br>13%<br>2%<br>0%<br>10%<br>20%<br>30%<br>40%<br>50%<br>60%<br>70%<br>Change in 6 month NYHA<br>Class<br>NYHA class<br>Barostim Control<br>Improved<br>2 NYHA<br>Classes<br>34%<br>Improved<br>CRT trial results<br>CONTAK CD3<br>NYHA III or IV<br>LVEF ≤ 35%<br>QRS > 120ms<br>20%<br>MIRACLE4<br>NYHA III<br>LVEF ≤ 35%<br>QRS > 130ms<br>30%<br>Improved<br>1 NYHA<br>Class<br>34%<br>Improve<br>-21<br>-6<br>-14<br>-25<br>-20<br>-15<br>-10<br>-5<br>0<br>Change in 6 month MLWHF<br>Quality of life<br>(MLWHF)<br>Clinically<br>Meaningful2<br>-5 Points<br>-14<br>Points<br>CRT trial results<br>CONTAK CD3<br>NYHA III or IV<br>LVEF ≤ 35%<br>QRS > 120ms<br>-11<br>MIRACLE4<br>NYHA III or IV<br>LVEF ≤ 35%<br>QRS > 130ms<br>-9<br>Barostim Control Diff<br>49<br>-8<br>60<br>-20<br>-10<br>0<br>10<br>20<br>30<br>40<br>50<br>60<br>70<br>Change in 6 month 6MHW<br>Exercise capacity<br>(6MHW)<br>Clinically<br>Meaningful5<br>25 Meters<br>CRT trial results<br>CONTAK CD3<br>NYHA III or IV<br>LVEF ≤ 35%<br>QRS > 120ms<br>39<br>MIRACLE4<br>NYHA III or IV<br>LVEF ≤ 35%<br>QRS > 130ms<br>29<br>Barostim Control Diff<br>+60<br>Meters
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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;<br>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<br>GDMT produces modest improvements in exercise<br>capacity compared to CRT (QRS>150ms) and BAT<br>0%<br>3%<br>2% 2%<br>7%<br>-1%<br>9%<br>19% 20%<br>-5%<br>0%<br>5%<br>10%<br>15%<br>20%<br> β-blockers SGLT2i ACE/ARB ARNI MRA Narrow QRS Intermediate<br>QRS<br>QRS >150 Barostim<br>GDMT CRT BAT<br>Sample size weighted average %<br>change in exercise capacity<br>n = number of studies<br>GDMT1<br>(n=29)<br>CRT1<br>(n=12)<br>% Improvement in exercise capacity versus control arm<br>Narrow QRS<br>BAT2,3<br>(n=2)<br>QRS > 150<br>/ LBBB
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13<br>Savarese G et al, Heart Failure Drug Treatment—Inertia, Titration, and Discontinuation (EVOLUTION HF), J Am Coll Cardiol HF. 2023; 11:1–14<br>Tolerance, titration and discontinuation of GDMT<br>Large proportions of the HF patient population remain<br>under target dose or have discontinued GDMT at 1 year
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14<br>US Heart Failure Sales Achieved with 6-Month Data<br>14 Territories Active Implanting Centers US HF Revenue<br>$175 $65 $140<br>$607<br>$1,258<br>$2,001<br>$2,468<br>$2,702<br>$2,928<br>$3,781<br>$4,901<br>$5,960<br>$0K<br>$1,000K<br>$2,000K<br>$3,000K<br>$4,000K<br>$5,000K<br>$6,000K<br>0<br>20<br>40<br>60<br>80<br>100<br>120<br>Q1 '20 Q2 '20 Q3 '20 Q4 '20 Q1 '21 Q2 '21 Q3 '21 Q4 '21 Q1 '22 Q2 '22 Q3 '22 Q4 '22
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BeAT-HF Summary of Key Evidence<br>Description<br>Composite CV Mortality and HF Morbidity Rate Ratio = 0.94<br>All-cause Mortality (death, LVAD, heart transplant) Hazard Ratio = 0.66<br>Hierarchical Win Ratio (CV mortality, HF morbidity, QOL) Win Ratio = 1.26<br>Related MANCE-free Rate<br>Major Adverse Neurologic and Cardiac Events<br>96.9%<br>Quality of Life – MLWHF<br>(6 / 12 / 24 Month)<br>-13 / -8 / -10<br>Exercise Capacity – 6MHW<br>(6 / 12 Month)<br>+55 / +44<br>Functional Status – NYHA Class % Improved<br>(6 / 12 / 24 Month)<br>30% / 32% / 27%<br>Long-term<br>Safety<br>Long-term<br>Symptom<br>Improvement<br>Favors CONTROL Favors BAT<br>70% 100%<br>+15 pts -15 pts<br>-60 m +60 m<br>85%<br>0 pts<br>0 m<br>-50% 0% +50%<br>Additional<br>Analyses<br>Primary<br>endpoint<br>2.0 1.0 0.1<br>2.0 1.0 0.1<br>0.1 1.0 2.0<br>15
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Conclusion<br>Totality of evidence indicates that BAT is<br>a safe, effective and durable treatment for<br>patients with heart failure with reduced<br>ejection fraction<br>16
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17<br>The post-market phase of BeAT-HF confirmed the long-term durability of safety and symptomatic improvements,<br>and the sustainability of the extent of the improvements.<br>The reduction of all-cause death, LVAD and heart<br>transplant is meaningful (34% reduction, nominal p-value<br>0.054).<br>The pre-specified hierarchical composite endpoint was well<br>balanced, and demonstrated meaningful benefit (Win ratio<br>= 1.26, nominal p-value=0.04), stable over multiple<br>sensitivity analyses.<br>Key takeaways<br>Barostim is currently FDA-approved for the improvement<br>of heart failure symptoms based on the pre-market phase<br>of BeAT-HF at 6 months.
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18<br>One or more manuscripts will be written by the executive steering committee for submission<br>to peer-reviewed journals.<br>A collaborative effort between CVRx, FDA and key academic institutions will continue analyzing<br>the impact of COVID on heart-failure clinical trials, particularly on BeAT-HF.<br>Next steps<br>The PMA-Supplement Clinical report has been submitted to FDA on 6/5/23, to seek an<br>expansion of the labeling, commensurate with the recommendation of the Executive Steering<br>Committee of BeAT-HF. We agree with the committee that the totality of evidence, despite a<br>potential impact of COVID, supports the use of Barostim as a treatment for heart failure.
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19<br>US Heart Failure Sales Growth Continues<br>Territories Active Implanting Centers US HF Revenue<br>$175 $65 $140 $607<br>$1,258<br>$2,001<br>$2,468<br>$2,702<br>$2,928<br>$3,781<br>$4,901<br>$5,960<br>$6,786<br>$0K<br>$1,000K<br>$2,000K<br>$3,000K<br>$4,000K<br>$5,000K<br>$6,000K<br>$7,000K<br>0<br>20<br>40<br>60<br>80<br>100<br>120<br>140<br>160<br>Q1 '20 Q2 '20 Q3 '20 Q4 '20 Q1 '21 Q2 '21 Q3 '21 Q4 '21 Q1 '22 Q2 '22 Q3 '22 Q4 '22 Q1 '23
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20<br>Highlights<br>Financial Results<br>Q1 '21 Q2 '21 Q3 '21 Q4 '21 Q1 '22 Q2 '22 Q3 '22 Q4 '22 Q1 '23<br>OUS $1,248 $1,018 $823 $800 $1,018 $1,094 $1,146 $1,190 $1,037<br>US Legacy $354 $104 $104 $156 $130 $156 $139 $26 $156<br>US HF $1,258 $2,001 $2,468 $2,702 $2,928 $3,781 $4,901 $5,960 $6,786<br>$0<br>$1,000<br>$2,000<br>$3,000<br>$4,000<br>$5,000<br>$6,000<br>$7,000<br>$8,000<br>Revenue ($, thousands)<br>$6.2m<br>$5.0m<br>$4.1m<br>$3.7m<br>$3.4m<br>$3.1m<br>$2.9m<br>$7.2m<br>Q1 2023<br> • Revenue:$8.0M<br> • US HF Revenue: $6.8M (+132%)<br> • US HF ASP: $30.2K<br> • Gross Margin: 83%<br> • 3/31 Cash: $103M<br>Apr/May – Momentum Continues<br>Full Year 2022<br> • Revenue: $22.5M<br> • US HF Revenue: $17.6M (+108%)<br> • US HF ASP: $29.9K<br> • Gross Margin: 78%<br>20<br>$8.0m
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21<br> • For the full year of 2023, we expect:<br> • Total revenue between $35.5 million and $38.0 million;<br> • Gross margin between 80% and 83%;<br> • Operating expenses between $76.0 million and $80.0 million<br> • For the second quarter of 2023, we expect total revenue<br>between $8.2 million and $8.8 million<br>2023 Guidance as of April 27, 2023
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Questions?
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