CVRx (CVRX) FY Conference Summary Company Overview - **Company**: CVRx - **Industry**: Medical Devices, specifically focusing on neuromodulation therapy for cardiovascular diseases - **Annual Total Addressable Market (TAM)**: $2.2 billion with a well-defined patient population and limited competition [2][6] Key Points and Arguments Heart Failure Market - Heart failure is a significant health issue in the U.S., leading to approximately 1 million hospital discharges, 1.3 million emergency room visits, and $70 billion in annual spending by the end of the decade [3] - Current treatment options include guideline-directed medical therapy (quad therapy), but only 1% of patients reach the maximum tolerated dose, and 40% discontinue at least one medication within the first year [4] - The existing therapies have minimal impact on quality of life, with patients expressing a desire for symptom improvement over longevity [5][6] Barostim Therapy - Barostim therapy targets the "walking wounded" heart failure patients who are symptomatic despite optimal medical therapy [6] - The Heart Failure Society of America has acknowledged the need for device therapy after three to six months of optimal medical therapy [6] - Clinical data from the BEAT HF trial shows Barostim therapy provides significant improvements in quality of life, exercise capacity, and a 68% improvement in NYHA functional class [10] - A real-world study indicated an 85% reduction in hospitalizations post-implantation of Barostim [11] Go-to-Market Strategy - The company is focusing on optimizing its sales strategy, which includes building a world-class sales organization and addressing barriers to therapy adoption [12] - 41% of the sales force has been newly hired in the past year, which has caused some disruption but is expected to stabilize [13][18] - Recent reimbursement developments include achieving a permanent inpatient payment of $43,000 for the procedure, which aligns inpatient and outpatient payments [14][15] Financial Performance and Guidance - Q2 showed a 15% year-over-year growth in heart failure revenue, with guidance narrowed to $55-$57 million for the year [17][23] - The company has $95 million in cash, sufficient for at least three years of operations, with no immediate need for additional capital [42][43] - Gross margins are currently around 84%, with potential for improvement as production capacity increases [45][46] Clinical Trials and FDA Interaction - Ongoing discussions with the FDA regarding trial design for indication expansion, with an expected timeline of 5-7 years for trial completion [38][40] - The estimated cost of the trial is between $20-$25 million, which is manageable within the current financial framework [43] Additional Important Insights - The company is adapting its market segmentation strategy to include tier three and four accounts, recognizing potential in previously overlooked centers [26][28] - Advocacy efforts for a level six reimbursement code are ongoing, with a potential increase in reimbursement rates anticipated [33][34] - The company is focused on executing its plans and expects to see benefits from recent changes as it moves into the next fiscal year [47]

[Cautionary Note on Forward-Looking Statements and Summary Risk Factors](index=3&type=section&id=Cautionary%20Note%20on%20Forward-Looking%20Statements%20and%20Summary%20Risk%20Factors) This section cautions on forward-looking statements and summarizes key risks, including significant losses and Barostim dependence - The company has a history of **significant losses** and expects them to continue, with no assurance of achieving or sustaining profitability[10](index=10&type=chunk) - CVRx is highly dependent on its **single product, Barostim**, and its failure to increase market acceptance in the U.S. would negatively impact business, liquidity, and results of operations[10](index=10&type=chunk) - Key risks include **intense competition**, dependence on **third-party manufacturers and suppliers**, potential **product liability claims**, and the need to retain key executives and obtain long-term clinical data[11](index=11&type=chunk) [Part I — Financial Information](index=6&type=section&id=Part%20I%20%E2%80%94%20Financial%20Information) [Item 1. Financial Statements](index=6&type=section&id=Item%201.%20Financial%20Statements) This section presents unaudited condensed consolidated financial statements, including balance sheets, income statements, equity, cash flows, and explanatory notes [Condensed Consolidated Balance Sheets](index=6&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) Total assets decreased from **$133.4 million** to **$119.6 million**, driven by reduced cash, while total stockholders' equity declined from **$71.1 million** to **$57.9 million** Key Balance Sheet Metrics | Metric | Dec 31, 2024 (in thousands) | Jun 30, 2025 (in thousands) | Change (in thousands) | | :-------------------------- | :-------------------------- | :-------------------------- | :-------------------- | | Cash and cash equivalents | $105,933 | $95,025 | $(10,908) | | Total current assets | $129,813 | $116,145 | $(13,668) | | Total assets | $133,414 | $119,564 | $(13,850) | | Total current liabilities | $10,762 | $9,689 | $(1,073) | | Total liabilities | $62,359 | $61,630 | $(729) | | Total stockholders' equity | $71,055 | $57,934 | $(13,121) | [Condensed Consolidated Statements of Operations and Comprehensive Loss](index=7&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) Revenue and gross profit increased for both periods, but net loss varied, influenced by operating expenses and a significant SG&A decrease for the six-month period Key Operations Metrics | Metric (in thousands) | 3 Months Ended Jun 30, 2025 | 3 Months Ended Jun 30, 2024 | YoY Change ($) | YoY Change (%) | | :-------------------- | :-------------------------- | :-------------------------- | :------------- | :------------- | | Revenue | $13,589 | $11,807 | $1,782 | 15% | | Gross profit | $11,450 | $9,907 | $1,543 | 16% | | Net loss | $(14,736) | $(14,029) | $(707) | 5% | | Metric (in thousands) | 6 Months Ended Jun 30, 2025 | 6 Months Ended Jun 30, 2024 | YoY Change ($) | YoY Change (%) | | :-------------------- | :-------------------------- | :-------------------------- | :------------- | :------------- | | Revenue | $25,937 | $22,577 | $3,360 | 15% | | Gross profit | $21,762 | $19,062 | $2,700 | 14% | | Net loss | $(28,502) | $(36,215) | $7,713 | (21)% | - Net loss per share (basic and diluted) improved from **$(0.65)** to **$(0.57)** for the three months ended June 30, 2025, and from **$(1.69)** to **$(1.10)** for the six months ended June 30, 2025[15](index=15&type=chunk) [Condensed Consolidated Statements of Stockholders' Equity](index=8&type=section&id=Condensed%20Consolidated%20Statements%20of%20Stockholders'%20Equity) Stockholders' equity decreased from **$71.1 million** to **$57.9 million**, primarily due to net loss, partially offset by stock option exercises and common stock issuance Key Equity Metrics | Metric (in thousands) | Dec 31, 2024 | Jun 30, 2025 | Change | | :-------------------- | :----------- | :----------- | :----- | | Common stock | $253 | $261 | $8 | | Additional paid-in capital | $608,354 | $623,724 | $15,370 | | Accumulated deficit | $(537,346) | $(565,848) | $(28,502) | | Total stockholders' equity | $71,055 | $57,934 | $(13,121) | - The number of issued and outstanding common shares increased from **25,324,684** at December 31, 2024, to **26,145,951** at June 30, 2025[17](index=17&type=chunk) [Condensed Consolidated Statements of Cash Flows](index=9&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) Operating and investing activities used cash, while financing activities significantly increased to **$10.0 million** from common stock issuance, resulting in a **$10.9 million** net cash decrease Key Cash Flow Metrics | Cash Flow Activity (in thousands) | 6 Months Ended Jun 30, 2025 | 6 Months Ended Jun 30, 2024 | YoY Change | | :-------------------------------- | :-------------------------- | :-------------------------- | :--------- | | Net cash used in operating activities | $(20,703) | $(20,726) | $23 | | Net cash used in investing activities | $(217) | $(1,272) | $1,055 | | Net cash provided by financing activities | $10,007 | $1,834 | $8,173 | | Net change in cash and cash equivalents | $(10,908) | $(20,169) | $9,261 | | Cash and cash equivalents at end of period | $95,025 | $70,400 | $24,625 | - Cash provided by financing activities in H1 **2025** was significantly boosted by **$9.2 million** from the issuance of common stock through an ATM offering[19](index=19&type=chunk) [Notes to Condensed Consolidated Financial Statements](index=10&type=section&id=Notes%20to%20Condensed%20Consolidated%20Financial%20Statements) These notes provide essential context and detail for the condensed consolidated financial statements, covering the company's business, accounting policies, and specific financial line items [1. Business organization](index=10&type=section&id=1.%20Business%20organization) CVRx, a medical device company, markets Barostim for heart failure and hypertension, expecting continued operating losses and negative cash flows - The company markets Barostim, a medical device for heart failure and resistant hypertension, primarily in the U.S. and Europe[21](index=21&type=chunk) - Management expects continued operating losses and negative cash flows in the foreseeable future, with no assurance of achieving profitability or positive cash flows[22](index=22&type=chunk) [2. Summary of significant accounting policies](index=10&type=section&id=2.%20Summary%20of%20significant%20accounting%20policies) Unaudited financial statements are prepared under U.S. GAAP, consolidating CVRx and its subsidiary, with an extended transition period for new accounting standards - The company is an emerging growth company and has elected to use the extended transition period for complying with new or revised financial accounting standards[25](index=25&type=chunk) - Revenue is recognized when a customer obtains control of promised goods or services, typically at the point of delivery, with payment terms generally between **30** and **90** days[32](index=32&type=chunk) - Stock-based compensation expense is recognized based on the grant date fair value of awards, using the Black-Scholes model for stock options and ESPP purchase rights, and closing stock price for RSUs[33](index=33&type=chunk)[52](index=52&type=chunk) [3. Selected balance sheet information](index=12&type=section&id=3.%20Selected%20balance%20sheet%20information) This section details inventory, property and equipment, and accrued expenses, showing slight decreases in all categories, particularly in accrued bonuses and 401(k) match Inventory Breakdown | Inventory (in thousands) | Jun 30, 2025 | Dec 31, 2024 | | :----------------------- | :----------- | :----------- | | Raw material | $7,698 | $6,857 | | Work-in-process | $230 | $353 | | Finished goods | $3,792 | $4,897 | | Total Inventory | $11,720 | $12,107 | Accrued Expenses Breakdown | Accrued Expenses (in thousands) | Jun 30, 2025 | Dec 31, 2024 | | :------------------------------ | :----------- | :----------- | | Bonuses | $2,515 | $3,621 | | 401(k) match | $637 | $1,106 | | Total Accrued Expenses | $6,657 | $8,180 | [4. Debt](index=13&type=section&id=4.%20Debt) CVRx has **$50.0 million** in outstanding Term Loans with Innovatus Life Sciences, bearing a floating interest rate, with compliance to all covenants as of June 30, 2025 - CVRx has **$50.0 million** in outstanding Term Loans as of June 30, 2025, under a Loan Agreement with Innovatus Life Sciences Fund I, LP[37](index=37&type=chunk) - The Term Loans bear a floating interest rate and have principal maturities of **$16.7 million** in **2027** and **$33.3 million** in **2028**[37](index=37&type=chunk)[38](index=38&type=chunk) - The company was in compliance with all debt covenants as of June 30, 2025[37](index=37&type=chunk) [5. Leases](index=14&type=section&id=5.%20Leases) CVRx leases its Minneapolis offices and manufacturing facility, expanding space in May 2025, with total operating lease liabilities of **$1.152 million** as of June 30, 2025 - CVRx expanded its existing office space by **3,678** square feet in May **2025**, with the lease term running concurrently with the existing lease until August **31**, **2028**[39](index=39&type=chunk) Lease Metrics Summary | Lease Metric (in thousands) | Jun 30, 2025 | Dec 31, 2024 | | :-------------------------- | :----------- | :----------- | | Operating lease right-of-use asset | $1,048 | $1,069 | | Total operating lease liabilities | $1,152 | $1,159 | - Operating cash outflows from the lease were **$0.3 million** for both the six months ended June 30, 2025, and 2024[40](index=40&type=chunk) [6. Stockholders' equity](index=14&type=section&id=6.%20Stockholders'%20equity) This section details common stock warrants and the ATM offering, under which **543,462 shares** were issued for **$9.5 million**, with **$6.7 million** remaining capacity [Common Stock Warrants](index=14&type=section&id=Common%20Stock%20Warrants) - As of June 30, 2025, **103,349** common stock warrants were exercisable at a weighted average exercise price of **$12.92** per share[41](index=41&type=chunk) - Johnson & Johnson Innovation – JJDC, Inc. exercised **607,725** common stock warrants for **604,000** shares via net exercise during the six months ended June 30, 2024[41](index=41&type=chunk) [At-the-Market ("ATM") Offering](index=16&type=section&id=At-the-Market%20(%22ATM%22)%20Offering) - CVRx issued **543,462** shares of common stock for gross proceeds of **$9.5 million** under its ATM offering during the six months ended June 30, 2025[43](index=43&type=chunk) - The company has approximately **$6.7 million** of additional capacity remaining under its **$50.0 million** ATM offering[43](index=43&type=chunk) [7. Stock-based compensation](index=16&type=section&id=7.%20Stock-based%20compensation) CVRx operates under stock incentive plans, with increased stock options and RSU grants, and a significant decrease in six-month stock-based compensation due to a prior-year modification expense [Summary of plans and activity](index=16&type=section&id=Summary%20of%20plans%20and%20activity) - The **2021** Equity Incentive Plan automatically increased by **1,266,234** shares on January **1**, **2025**, with **1,392,926** shares available for future issuance as of June 30, 2025[45](index=45&type=chunk) [Stock Options](index=16&type=section&id=Stock%20Options) Stock Option Activity Summary | Stock Option Activity | Dec 31, 2024 | Jun 30, 2025 | | :-------------------- | :----------- | :----------- | | Balance of Options | 5,550,419 | 6,025,124 | | Granted | N/A | 926,572 | | Cancelled / Forfeited | N/A | (246,004) | | Exercised | N/A | (205,863) | | Weighted Average Exercise Price | $11.81 | $12.06 | - Unrecognized compensation expense for stock options was **$23.2 million** as of June 30, 2025, to be recognized over approximately **2.7** years[48](index=48&type=chunk) [Restricted Stock Units](index=17&type=section&id=Restricted%20Stock%20Units) RSU Activity Summary | RSU Activity | Dec 31, 2024 | Jun 30, 2025 | | :----------- | :----------- | :----------- | | Unvested Balance | 0 | 335,658 | | Granted | N/A | 340,078 | | Forfeited | N/A | (4,420) | | Weighted Average Grant Date Fair Value | N/A | $12.85 | - Unrecognized compensation expense for RSUs was **$4.0 million** as of June 30, 2025, to be recognized over approximately **3.7** years[49](index=49&type=chunk) [Employee Stock Purchase Plan](index=17&type=section&id=Employee%20Stock%20Purchase%20Plan) - For the six months ended June 30, 2025, **71,942** shares were purchased under the ESPP for **$0.4 million** in employee contributions[51](index=51&type=chunk) - As of January **1**, **2025**, an additional **253,246** shares were reserved for issuance under the ESPP, with **814,111** shares available as of June 30, 2025[51](index=51&type=chunk) [Stock-based compensation expense](index=18&type=section&id=Stock-based%20compensation%20expense) Stock-based Compensation Expense Summary | Stock-based Compensation Expense (in thousands) | 3 Months Ended Jun 30, 2025 | 3 Months Ended Jun 30, 2024 | 6 Months Ended Jun 30, 2025 | 6 Months Ended Jun 30, 2024 | | :-------------------------------------------- | :-------------------------- | :-------------------------- | :-------------------------- | :-------------------------- | | Options | $2,596 | $2,485 | $4,810 | $13,513 | | RSUs | $265 | $0 | $357 | $0 | | Employee Stock Purchase Plan | $55 | $59 | $204 | $172 | | Total | $2,916 | $2,544 | $5,371 | $13,685 | - The significant decrease in stock-based compensation expense for the six months ended June 30, 2025, compared to 2024, was primarily due to an **$8.4 million** non-cash expense recognized in H1 **2024** related to the modification of stock options for the former CEO's retirement[54](index=54&type=chunk)[110](index=110&type=chunk) [8. Income taxes](index=19&type=section&id=8.%20Income%20taxes) CVRx recorded a nominal income tax benefit, maintaining a full valuation allowance against deferred tax assets due to cumulative net losses, and is evaluating the OBBBA's impact - CVRx maintains a full valuation allowance against all deferred tax assets due to its cumulative net loss position[55](index=55&type=chunk) - As of December **31**, **2024**, the company had federal NOLs of approximately **$429.7 million** and federal tax credit carryforwards of **$10.2 million**[56](index=56&type=chunk) - The company is evaluating the potential impact of the One Big Beautiful Bill Act (OBBBA), enacted in July **2025**, on its financial statements, which includes provisions for R&D cost capitalization and international tax framework modifications[58](index=58&type=chunk)[59](index=59&type=chunk) [9. Loss Per Share](index=21&type=section&id=9.%20Loss%20Per%20Share) Basic and diluted net loss per share improved for both periods, with potentially dilutive securities excluded from EPS calculation due to their anti-dilutive effect Loss Per Share Summary | Metric | 3 Months Ended Jun 30, 2025 | 3 Months Ended Jun 30, 2024 | 6 Months Ended Jun 30, 2025 | 6 Months Ended Jun 30, 2024 | | :-------------------------------- | :-------------------------- | :-------------------------- | :-------------------------- | :-------------------------- | | Net loss per share, basic and diluted | $(0.57) | $(0.65) | $(1.10) | $(1.69) | | Weighted-average common shares outstanding | 26,071,316 | 21,628,542 | 25,974,229 | 21,430,276 | - Potentially dilutive securities, totaling **6,464,131** shares as of June 30, 2025, were excluded from diluted EPS calculation due to their anti-dilutive effect[60](index=60&type=chunk) [10. Commitments and contingencies](index=21&type=section&id=10.%20Commitments%20and%20contingencies) No material contingent liabilities were identified as of June 30, 2025, or December 31, 2024 - No material contingent liabilities were identified as of June 30, 2025, or December 31, 2024[61](index=61&type=chunk) [11. Employee benefit plans](index=21&type=section&id=11.%20Employee%20benefit%20plans) CVRx sponsors a 401(k) plan with matching contributions, incurring **$0.3 million** expense for each three-month period and **$0.6 million** for each six-month period - The company adopted a policy to match employee **401(k)** contributions starting January **1**, **2024**[62](index=62&type=chunk) 401(k) Matching Contributions Summary | 401(k) Matching Contributions (in millions) | 3 Months Ended Jun 30, 2025 | 3 Months Ended Jun 30, 2024 | 6 Months Ended Jun 30, 2025 | 6 Months Ended Jun 30, 2024 | | :---------------------------------------- | :-------------------------- | :-------------------------- | :-------------------------- | :-------------------------- | | Expense | $0.3 | $0.3 | $0.6 | $0.6 | [12. Segment, geographic information, and revenue disaggregation](index=23&type=section&id=12.%20Segment,%20geographic%20information,%20and%20revenue%20disaggregation) CVRx operates as a single segment, with performance evaluated by consolidated net loss and geographic revenue, primarily from U.S. sales where most assets are located - CVRx operates as a single reportable and operating segment[63](index=63&type=chunk) Revenue by Geography Summary | Revenue by Geography (in thousands) | 3 Months Ended Jun 30, 2025 | 3 Months Ended Jun 30, 2024 | 6 Months Ended Jun 30, 2025 | 6 Months Ended Jun 30, 2024 | | :---------------------------------- | :-------------------------- | :-------------------------- | :-------------------------- | :-------------------------- | | U.S. | $12,243 | $10,673 | $23,444 | $20,508 | | Other countries (Europe) | $1,346 | $1,134 | $2,493 | $2,069 | | Total Revenue | $13,589 | $11,807 | $25,937 | $22,577 | - Substantially all long-lived assets are located in the U.S[64](index=64&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=23&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses financial condition, operations, recent developments, performance factors, liquidity, capital resources, and critical accounting policies [Overview](index=23&type=section&id=Overview) CVRx commercializes Barostim for HFrEF, aiming to expand sales and secure reimbursement, anticipating continued net losses from commercialization investments - CVRx commercializes Barostim, the first and only neuromodulation device indicated to improve symptoms for patients with HFrEF, leveraging the Autonomic Nervous System[65](index=65&type=chunk) - The company's sales and marketing efforts target electrophysiologists, HF specialists, interventional and general cardiologists, and vascular surgeons, with hospitals as primary customers in the U.S[67](index=67&type=chunk)[68](index=68&type=chunk) - CVRx expects to continue incurring net losses for several years due to planned investments in commercialization efforts, which may require additional funding[73](index=73&type=chunk) [Recent Developments](index=25&type=section&id=Recent%20Developments) CMS proposed new Category I CPT codes for Barostim in 2026 MPFS and retained it under New Technology APC 1580 with a **$45,000** outpatient rate in 2026 OPPS - CMS proposed new Category I CPT codes for Barostim implant and follow-up services in the **2026** MPFS, aiming to eliminate automatic denials and improve prior authorization predictability[74](index=74&type=chunk) - CMS proposed to retain the Barostim implant procedure under New Technology APC **1580** in the **2026** OPPS, with an associated outpatient payment rate of approximately **$45,000**[75](index=75&type=chunk) - The final rules for both MPFS and OPPS are expected in November **2025** and will take effect on January **1**, **2026**[74](index=74&type=chunk)[75](index=75&type=chunk) [Factors affecting our performance](index=27&type=section&id=Factors%20affecting%20our%20performance) Performance is influenced by U.S. revenue growth, gross margin fluctuations, increasing R&D and SG&A expenses, debt-related interest expense, and nominal income tax due to valuation allowances [Revenue](index=27&type=section&id=Revenue) U.S. sales are expected to drive the majority of revenue, fueled by increased awareness, sales force expansion, and potential Barostim labeling expansion - U.S. sales are expected to continue accounting for the majority of revenue, driven by increased awareness, sales force expansion, and potential expanded labeling for Barostim[77](index=77&type=chunk) - European revenue fluctuates based on average selling price, channel mix, and foreign currency exchange rates[78](index=78&type=chunk) [Cost of goods sold and gross margin](index=27&type=section&id=Cost%20of%20goods%20sold%20and%20gross%20margin) Cost of goods sold will rise with revenue, while gross margin is affected by average sale price, product mix, and manufacturing overhead efficiency - Cost of goods sold is expected to increase with revenue growth, while gross margin is influenced by average sale price, full system vs. individual IPG sales, and manufacturing overhead alignment with production volume[79](index=79&type=chunk)[80](index=80&type=chunk) - Gross margin benefits from increased direct sales and production volumes but may fluctuate with new products and manufacturing changes[80](index=80&type=chunk)[81](index=81&type=chunk)[82](index=82&type=chunk) [Research and development expenses](index=29&type=section&id=Research%20and%20development%20expenses) R&D expenses are projected to increase as the company continues developing Barostim enhancements - R&D expenses are expected to increase in absolute dollars as the company continues to develop enhancements to Barostim[83](index=83&type=chunk) [Selling, general and administrative expenses](index=29&type=section&id=Selling,%20general%20and%20administrative%20expenses) SG&A expenses are expected to increase in absolute dollars due to expanding U.S. sales force and international commercial organization - SG&A expenses are expected to increase in absolute dollars due to the expansion of the direct sales force and commercial organization in the U.S. and international presence[85](index=85&type=chunk) - SG&A expenses are expected to decrease as a percentage of revenue as revenue grows[85](index=85&type=chunk) [Interest expense](index=29&type=section&id=Interest%20expense) Interest expense comprises debt interest and amortization of associated financing costs - Interest expense consists of interest on debt and amortization of associated financing costs[86](index=86&type=chunk) [Other income, net](index=29&type=section&id=Other%20income,%20net) Other income, net, primarily includes interest income, partially offset by foreign currency exchange rate effects - Other income, net, primarily consists of interest income on interest-bearing accounts, partially offset by foreign currency exchange rate effects[87](index=87&type=chunk) [Benefit (provision) for income taxes](index=29&type=section&id=Benefit%20(provision)%20for%20income%20taxes) Income tax benefit/provision relates to foreign jurisdictions, with a full valuation allowance for deferred tax assets - Income tax benefit/provision is primarily related to foreign jurisdictions, with a full valuation allowance maintained for deferred tax assets[88](index=88&type=chunk) [Results of operations](index=30&type=section&id=Results%20of%20operations) This section details financial results for Q2 and H1 2025 vs 2024, highlighting revenue growth, gross profit increases, and changes in operating expenses and net loss [Three months ended June 30, 2025, compared to the three months ended June 30, 2024](index=30&type=section&id=Three%20months%20ended%20June%2030,%202025,%20compared%20to%20the%20three%20months%20ended%20June%2030,%202024) Three Months Ended June 30, 2025 vs 2024 | Metric (in thousands) | Jun 30, 2025 | Jun 30, 2024 | Change ($) | Change (%) | | :-------------------- | :----------- | :----------- | :--------- | :--------- | | Revenue | $13,589 | $11,807 | $1,782 | 15% | | Gross profit | $11,450 | $9,907 | $1,543 | 16% | | Gross margin | 84% | 84% | 0% | 0% | | R&D expenses | $2,469 | $2,765 | $(296) | (11)% | | SG&A expenses | $23,357 | $21,115 | $2,242 | 11% | | Net loss | $(14,736) | $(14,029) | $(707) | 5% | - U.S. revenue increased by **15%** to **$12.2 million**, driven by growth in the HF business, expansion into new sales territories (**47** vs **42**), new accounts, and increased awareness[91](index=91&type=chunk)[92](index=92&type=chunk)[93](index=93&type=chunk) - Active implanting centers grew from **189** to **240**[93](index=93&type=chunk) - European revenue increased by **19%** to **$1.3 million**, despite a decrease in total revenue units (**61** vs **63**) and a reduction in sales territories (**5** vs **6**)[91](index=91&type=chunk)[94](index=94&type=chunk) [Six months ended June 30, 2025, compared to the six months ended June 30, 2024](index=33&type=section&id=Six%20months%20ended%20June%2030,%202025,%20compared%20to%20the%20six%20months%20ended%20June%2030,%202024) Six Months Ended June 30, 2025 vs 2024 | Metric (in thousands) | Jun 30, 2025 | Jun 30, 2024 | Change ($) | Change (%) | | :-------------------- | :----------- | :----------- | :--------- | :--------- | | Revenue | $25,937 | $22,577 | $3,360 | 15% | | Gross profit | $21,762 | $19,062 | $2,700 | 14% | | Gross margin | 84% | 84% | 0% | 0% | | R&D expenses | $4,986 | $5,822 | $(836) | (14)% | | SG&A expenses | $44,589 | $49,445 | $(4,856) | (10)% | | Net loss | $(28,502) | $(36,215) | $7,713 | (21)% | - U.S. revenue increased by **14%** to **$23.4 million**, with HF revenue units growing from **658** to **740**[104](index=104&type=chunk)[105](index=105&type=chunk) - European revenue increased by **20%** to **$2.5 million**, with total revenue units increasing from **107** to **120**[104](index=104&type=chunk)[106](index=106&type=chunk) - The decrease in SG&A expenses for the six-month period was primarily due to an **$8.2 million** decrease in non-cash stock-based compensation expense, related to a one-time modification for the former CEO's retirement in Q1 **2024**[110](index=110&type=chunk) [Liquidity, capital resources and plan of operations](index=35&type=section&id=Liquidity,%20capital%20resources%20and%20plan%20of%20operations) CVRx incurred significant losses and negative cash flows, with cash decreasing to **$95.0 million**, but believes existing resources will cover requirements for at least three years - Cash and cash equivalents decreased from **$105.9 million** at December **31**, **2024**, to **$95.0 million** at June 30, 2025[114](index=114&type=chunk) - Net cash used in operating activities was **$20.7 million** for both the six months ended June 30, 2025, and 2024[114](index=114&type=chunk) - The company believes existing cash resources and cash from operations will be sufficient for operating liquidity, capital expenditures, and debt services for at least the next three years[118](index=118&type=chunk) [Cash flows](index=37&type=section&id=Cash%20flows) Net cash used in operating activities remained stable, investing cash use decreased, and financing cash provided increased substantially to **$10.0 million** from common stock issuance Key Cash Flow Metrics | Cash Flow Activity (in thousands) | 6 Months Ended Jun 30, 2025 | 6 Months Ended Jun 30, 2024 | | :-------------------------------- | :-------------------------- | :-------------------------- | | Operating activities | $(20,703) | $(20,726) | | Investing activities | $(217) | $(1,272) | | Financing activities | $10,007 | $1,834 | | Net change in cash and cash equivalents | $(10,908) | $(20,169) | - Net cash provided by financing activities in H1 **2025** was primarily driven by **$9.2 million** from the issuance of common stock via the ATM offering[126](index=126&type=chunk) [Contractual obligations and commitments](index=39&type=section&id=Contractual%20obligations%20and%20commitments) No material changes to contractual obligations were reported as of June 30, 2025, compared to the prior Annual Report on Form 10-K - No material changes to contractual obligations were reported as of June 30, 2025[128](index=128&type=chunk) [Critical accounting policies and estimates](index=39&type=section&id=Critical%20accounting%20policies%20and%20estimates) Critical accounting policies and estimates remain consistent with the prior Annual Report on Form 10-K - Critical accounting policies and estimates are unchanged from the previous Annual Report on Form 10-K[129](index=129&type=chunk) [JOBS Act accounting election](index=39&type=section&id=JOBS%20Act%20accounting%20election) As an emerging growth company, CVRx uses an extended transition period for new accounting standards, potentially affecting comparability - CVRx has elected to use the extended transition period under the JOBS Act for new accounting standards, potentially impacting comparability with other public companies[130](index=130&type=chunk) [Recent accounting pronouncements](index=39&type=section&id=Recent%20accounting%20pronouncements) Recent accounting pronouncements are discussed in Note 2 to the condensed consolidated financial statements - The FASB issued ASU **2023-09**, "Improvements to Income Tax Disclosures," effective for annual periods beginning after December **15**, **2024**, which CVRx is currently evaluating[34](index=34&type=chunk)[131](index=131&type=chunk) [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=41&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) Market risks include interest rate fluctuations on cash and debt, foreign currency exchange rate changes, and inflation affecting gross margins and operating expenses [Interest rate risk](index=41&type=section&id=Interest%20rate%20risk) Interest rate risk is limited to cash equivalents and floating-rate debt, with no use of financial derivatives - Interest rate risk is limited to cash equivalents and debt under the Loan Agreement, which bears a floating rate[132](index=132&type=chunk) - The company does not use financial derivatives[132](index=132&type=chunk) [Foreign currency exchange rate risk](index=41&type=section&id=Foreign%20currency%20exchange%20rate%20risk) Foreign currency exchange rate fluctuations, especially in the Euro, can impact international revenue and operating expenses - Foreign currency exchange rate fluctuations, particularly in the Euro, can impact revenue and operating expenses from international operations[133](index=133&type=chunk) - Foreign currency transaction gains and losses have not been material to date, and the company has not engaged in hedging transactions[133](index=133&type=chunk) [Inflation risk](index=41&type=section&id=Inflation%20risk) Inflation could adversely affect operating results if costs increase faster than product selling prices - Inflationary factors could adversely affect operating results if cost of goods sold and operating expenses increase more than product selling prices[134](index=134&type=chunk) [Credit risk](index=41&type=section&id=Credit%20risk) Cash and cash equivalents are held with financial institutions, with balances potentially exceeding insured limits - Cash and cash equivalents are held with financial institutions believed to have sufficient assets, but balances may exceed insured limits[135](index=135&type=chunk) [Item 4. Controls and Procedures](index=41&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded disclosure controls and procedures were effective as of June 30, 2025, with no material changes in internal control over financial reporting [Evaluation of disclosure controls and procedures](index=41&type=section&id=Evaluation%20of%20disclosure%20controls%20and%20procedures) - The CEO and CFO concluded that disclosure controls and procedures were effective as of June 30, 2025[136](index=136&type=chunk)[137](index=137&type=chunk) [Changes in internal control over financial reporting](index=43&type=section&id=Changes%20in%20internal%20control%20over%20financial%20reporting) - No material changes in internal control over financial reporting occurred during the quarter ended June 30, 2025[138](index=138&type=chunk) [Part II — Other Information](index=43&type=section&id=Part%20II%20%E2%80%94%20Other%20Information) [Item 1. Legal Proceedings](index=43&type=section&id=Item%201.%20Legal%20Proceedings) The company is not currently a party to any material legal proceedings - The company is not involved in any material legal proceedings[140](index=140&type=chunk) [Item 1A. Risk Factors](index=43&type=page&id=Item%201A.%20Risk%20Factors) This section updates risk factors, highlighting extensive foreign regulation; Barostim's EU MDR compliance was approved, but ongoing adherence is required to market products - Barostim's compliance with the EU Medical Device Regulation (MDR) was approved on April **9**, **2025**, following extensive updates to quality systems and technical file documentation[146](index=146&type=chunk) - The company must continue to submit updates for substantial changes and undergo annual audits to verify ongoing MDR compliance[146](index=146&type=chunk) - Failure to comply with foreign regulatory requirements, including those in the EEA, could result in enforcement actions and impair the ability to market products[146](index=146&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=45&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) No unregistered sales of equity securities or use of proceeds were reported - No unregistered sales of equity securities or use of proceeds were reported[147](index=147&type=chunk) [Item 3. Defaults Upon Senior Securities](index=45&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) No defaults upon senior securities were reported - No defaults upon senior securities were reported[148](index=148&type=chunk) [Item 4. Mine Safety Disclosures](index=45&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This item is not applicable to CVRx - Mine Safety Disclosures are not applicable to the registrant[149](index=149&type=chunk) [Item 5. Other Information](index=45&type=section&id=Item%205.%20Other%20Information) No Rule 10b5-1 or non-Rule 10b5-1 trading arrangements were adopted, modified, or terminated by directors or officers during Q2 2025 - No Rule **10b5-1** or non-Rule **10b5-1** trading arrangements were adopted, modified, or terminated by directors or officers during Q2 **2025**[150](index=150&type=chunk) [Item 6. Exhibits](index=46&type=section&id=Item%206.%20Exhibits) This section lists exhibits filed with the Form 10-Q, including corporate governance documents, a lease amendment, CEO/CFO certifications, and XBRL documents - Key exhibits include corporate governance documents (Certificate of Incorporation, By-Laws), a lease amendment, CEO/CFO certifications, and XBRL financial data files[153](index=153&type=chunk) [Signatures](index=47&type=section&id=Signatures) The report was signed by President and CEO Kevin Hykes and CFO Jared Oasheim on August 5, 2025 - The report was signed by the President and CEO, Kevin Hykes, and the CFO, Jared Oasheim, on August **5**, **2025**[156](index=156&type=chunk)

CVRx (CVRX -0.13%), a medical device innovator focused on heart failure therapy, released its second quarter 2025 earnings on August 4, 2025. The most important news was a Revenue (GAAP) increased to $13.6 million, up 15% year-over-year and above analyst expectations of $13.29 million (GAAP). The company also reported a net loss of $14.7 million, or $(0.57) per share (GAAP). While that loss widened slightly, the per-share figure (GAAP) improved due to an increased share count. The quarter reflected strong c ...

Company Performance - CVRx reported a quarterly loss of $0.57 per share, which was worse than the Zacks Consensus Estimate of a loss of $0.52, but an improvement from a loss of $0.65 per share a year ago, indicating a -9.62% earnings surprise [1] - The company posted revenues of $13.59 million for the quarter ended June 2025, surpassing the Zacks Consensus Estimate by 0.96% and showing an increase from $11.81 million in the same quarter last year [2] - Over the last four quarters, CVRx has surpassed consensus revenue estimates four times, but has only done so for EPS estimates once [2] Stock Performance - CVRx shares have declined approximately 40.3% since the beginning of the year, contrasting with the S&P 500's gain of 6.1% [3] - The current consensus EPS estimate for the upcoming quarter is -$0.47 on revenues of $14.54 million, and for the current fiscal year, it is -$1.97 on revenues of $56.54 million [7] Industry Outlook - The Medical - Instruments industry, to which CVRx belongs, is currently ranked in the bottom 37% of over 250 Zacks industries, suggesting potential challenges ahead [8] - The performance of CVRx's stock may be influenced by the overall outlook of the industry, as research indicates that the top 50% of Zacks-ranked industries outperform the bottom 50% by more than 2 to 1 [8]

Financial Data and Key Metrics Changes - Total revenue for Q2 2025 was $13.6 million, a 15% increase compared to the same quarter last year [5][18] - U.S. heart failure revenue was $12.2 million, also a 15% increase year-over-year [19] - Gross profit increased to $11.5 million, a 16% increase from the prior year [21] - Net loss for the quarter was $14.7 million, or $0.57 per share, compared to a net loss of $14 million, or $0.65 per share, in the prior year [23][24] Business Line Data and Key Metrics Changes - Heart failure revenue units in the U.S. increased to 3.87 million from 3.39 million year-over-year [19] - The number of active implanting centers in the U.S. rose to 240 from 227 at the end of Q1 2025 [6][20] - The number of sales territories in the U.S. increased to 47 from 45 at the end of Q1 2025 [6][20] - Revenue in Europe was $1.3 million, a 19% increase year-over-year, although total revenue units in Europe decreased to 61 from 63 [21] Market Data and Key Metrics Changes - The company expanded its U.S. sales territories and active implanting centers, indicating growth in market presence [6][20] - The reimbursement strategy is advancing, with CMS proposing to maintain the Barostim implant procedure payment at approximately $45,000 [12][13] Company Strategy and Development Direction - The company is focusing on sustainable Barostim programs and optimizing onboarding and training for new territory managers [8][11] - The strategy includes targeting Tier one and Tier two accounts while also exploring opportunities in Tier three and four accounts [10][11] - The company is committed to building clinical evidence and increasing awareness of Barostim through educational programs [15][16] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the direction of the business and the momentum being built, particularly in sales force stabilization and reimbursement improvements [26] - The company anticipates continued growth driven by strong fundamentals and a predictable therapy [26] - Management acknowledged ongoing challenges in changing medical practices but believes reimbursement improvements will significantly reduce friction [84][85] Other Important Information - The company appointed Brent Binkowski as Chief Operating Officer, effective August, to oversee research and development, operations, regulatory affairs, and quality [27] - The company narrowed its revenue guidance for the full year of 2025 to between $55 million and $57 million [25] Q&A Session Summary Question: Can you walk us through the narrowed guidance and how it contemplates the ramp of new territory managers? - Management explained that the narrowed guidance reflects a slight adjustment and focuses on getting the new team productive as quickly as possible [30] Question: How do you measure the success of Tier three and four accounts? - Management clarified that they track data internally and provide it to reps as part of their playbook, helping them understand which accounts may be more receptive [32] Question: What are the expectations for the Salesforce reorganization and productivity ramp? - Management indicated that they expect to activate more territories and see productivity ramp up as new reps become more effective [38] Question: What are the implications of the gross margin guidance? - Management stated that the gross margin has been consistent and they expect to maintain similar numbers in Q3 and Q4 [42] Question: Can you elaborate on the reimbursement process and the transition to a category one code? - Management explained that the transition to a category one code will improve approval rates and predictability for procedures, moving away from the experimental status of category three [56][58] Question: What are the expected challenges for next year regarding adoption? - Management identified ongoing barriers related to reimbursement, awareness, and evidence generation as challenges that will persist [85]

Financial Data and Key Metrics Changes - Total revenue for Q2 2025 was $13.6 million, representing a 15% increase compared to the same quarter last year [4][18] - U.S. heart failure revenue was $12.2 million, also a 15% increase year-over-year [5][19] - Gross profit increased to $11.5 million, a 16% rise from the prior year [21] - Net loss for the quarter was $14.7 million, or $0.57 per share, compared to a net loss of $14 million, or $0.65 per share, in the prior year [23][24] Business Line Data and Key Metrics Changes - Heart failure revenue units in the U.S. increased from $3.39 million to $3.87 million year-over-year [19] - The number of active implanting centers in the U.S. rose to 240 from 227 at the end of Q1 2025 [5][20] - The number of sales territories in the U.S. increased to 47, up from 45 at the end of Q1 2025 [5][20] - Revenue generated in Europe was $1.3 million, a 19% increase year-over-year, despite a decrease in total revenue units [21] Market Data and Key Metrics Changes - The company is focusing on expanding its presence in Tier one and Tier two accounts while also exploring opportunities in Tier three and four accounts [8][10] - The sales force transformation is progressing, with over 35% of territory managers hired since January 1, 2025 [6][7] Company Strategy and Development Direction - The company is shifting focus from hiring to optimizing onboarding and training to increase productivity among new territory managers [7] - A refined approach to developing sustainable Barostim programs is showing positive results, targeting centers based on potential indicators [7][10] - The company is actively working on reimbursement strategies to reduce barriers to adoption for its therapy [11][12] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the direction of the business, highlighting the positive developments in reimbursement and clinical evidence [25] - The company anticipates continued growth as it moves towards making Barostim a standard of care for heart failure treatment [25] - Management acknowledged ongoing challenges in changing medical practices but believes reimbursement improvements will significantly aid adoption [85] Other Important Information - The company appointed Brent Binkowski as Chief Operating Officer, effective August 2025, to oversee research and development, operations, regulatory affairs, and quality [26] - The transition to Category one CPT codes in January 2026 is expected to enhance commercial efforts and improve prior authorization predictability [12] Q&A Session Summary Question: Can you walk us through the narrowed guidance and how it contemplates the ramp of new territory managers? - Management indicated that the narrowed guidance reflects a slight adjustment and focuses on getting new team members productive as quickly as possible [29] Question: How do you measure the success of Tier three and four accounts? - Management clarified that internal data tracking is used to guide reps on which accounts to target, rather than placing the burden on the reps themselves [31] Question: What is the expected ramp and cadence for the Salesforce reorganization? - Management expects to activate more territories quarterly and sees productivity ramping up as new hires become more effective [36] Question: Can you elaborate on the gross margin guidance? - Management stated that the gross margin has been consistent and does not anticipate significant changes in the second half of the year [40] Question: What are the expected challenges in the future? - Management identified ongoing barriers related to reimbursement, awareness, and evidence generation as challenges that will persist [85]

[Executive Summary & Recent Highlights](index=1&type=section&id=Executive%20Summary%20%26%20Recent%20Highlights) This section highlights robust Q2 2025 performance, including revenue growth, increased implant centers, and positive reimbursement updates [CEO Commentary](index=1&type=section&id=CEO%20Commentary) CVRx CEO Kevin Hykes reported robust Q2 2025 performance, driven by sales team transformation, Barostim program growth, and progress in clinical evidence and reimbursement, including CMS's proposal to retain Barostim in APC 1580 with appropriate payment - CVRx achieved robust performance in Q2 2025, with sustained business momentum[3](index=3&type=chunk) - Sales team transformation is progressing, establishing sustainable Barostim programs at high-potential centers[3](index=3&type=chunk) - CMS proposed retaining the Barostim implant procedure in APC 1580 with appropriate outpatient payment, strengthening reimbursement status[3](index=3&type=chunk) [Key Operational & Financial Highlights](index=1&type=section&id=Key%20Operational%20%26%20Financial%20Highlights) CVRx reported Q2 2025 total revenue of **$13.6 million**, a **15%** increase, with U.S. HF revenue also up **15%**, and active U.S. implanting centers growing to **240** Q2 2025 Key Financial and Operational Highlights | Metric | Q2 2025 | Q2 2024 | Change | Change Rate | Source | | :-------------------------------- | :--------- | :--------- | :----- | :---------- | :--- | | Total Revenue | $13.6 Million | $11.8 Million | +$1.8 Million | +15% | [4, 6] | | U.S. Heart Failure (HF) Revenue | $12.1 Million | $10.5 Million | +$1.6 Million | +15% | [5, 6] | | U.S. Active Implanting Centers | 240 | 189 (based on 27% growth) | +51 | +27% | [6, 7] | - CMS proposed retaining the Barostim implant procedure in New Technology APC 1580, with outpatient payment of approximately **$45,000** for 2026[6](index=6&type=chunk) - CMS proposed favorable physician fee payment levels related to Category I CPT codes[6](index=6&type=chunk) - Brent Binkowski was appointed as the newly created Chief Operating Officer[6](index=6&type=chunk) [Second Quarter 2025 Financial and Operating Results](index=1&type=section&id=Second%20Quarter%202025%20Financial%20and%20Operating%20Results) This section details CVRx's Q2 2025 financial performance, including revenue, operating expenses, net loss, and cash position [Revenue Performance](index=1&type=section&id=Revenue%20Performance) CVRx achieved **$13.6 million** in total revenue for Q2 2025, a **15%** year-over-year increase, driven by U.S. and European contributions Q2 2025 Total Revenue | Metric | Q2 2025 (Million USD) | Q2 2024 (Million USD) | Change (Million USD) | Growth Rate | | :--- | :-------------------- | :-------------------- | :------------------- | :---------- | | Total Revenue | 13.6 | 11.8 | 1.8 | 15% | [U.S. Revenue](index=1&type=section&id=U.S.%20Revenue) U.S. revenue reached **$12.2 million** in Q2 2025, a **15%** increase, primarily from heart failure (HF) implants, driven by sales expansion and increased awareness Q2 2025 U.S. Revenue Details | Metric | Q2 2025 | Q2 2024 | Change | Growth Rate | | :------------------- | :--------- | :--------- | :----- | :---------- | | U.S. Total Revenue | $12.2 Million | $10.6 Million | +$1.6 Million | +15% | | U.S. HF Revenue | $12.1 Million | $10.5 Million | +$1.6 Million | +15% | | U.S. HF Revenue Units | 387 | 339 | +48 | +14.2% | - U.S. revenue growth was primarily driven by new sales territory expansion, new customer acquisition, and increased physician and patient awareness of Barostim[5](index=5&type=chunk) [Europe Revenue](index=2&type=section&id=Europe%20Revenue) Europe revenue grew **19%** to **$1.3 million** in Q2 2025, despite a slight decrease in total implant units Q2 2025 Europe Revenue Details | Metric | Q2 2025 | Q2 2024 | Change (Million USD) | Growth Rate | | :------------------- | :--------- | :--------- | :------------------- | :---------- | | Europe Revenue | $1.3 Million | $1.1 Million | +$0.2 Million | +19% | | Europe Total Revenue Units | 61 | 63 | -2 | -3.2% | [Operating Expenses](index=2&type=section&id=Operating%20Expenses) Gross profit increased **16%** to **$11.5 million** with an **84%** margin, while R&D decreased **11%** and SG&A rose **11%** in Q2 2025 [Gross Profit & Margin](index=2&type=section&id=Gross%20Profit%20%26%20Margin) Gross profit for Q2 2025 increased **16%** to **$11.5 million**, maintaining an **84%** gross margin Q2 2025 Gross Profit and Margin | Metric | Q2 2025 | Q2 2024 | Change (Million USD) | Growth Rate | | :------- | :--------- | :--------- | :------------------- | :---------- | | Gross Profit | $11.5 Million | $9.9 Million | +$1.5 Million | +16% | | Gross Margin | 84% | 84% | 0% | 0% | [Research & Development](index=2&type=section&id=Research%20%26%20Development) R&D expenses decreased **11%** to **$2.5 million** in Q2 2025, primarily due to reduced compensation expenses Q2 2025 Research & Development Expenses | Metric | Q2 2025 | Q2 2024 | Change (Million USD) | Change Rate | | :------- | :--------- | :--------- | :------------------- | :---------- | | R&D Expenses | $2.5 Million | $2.8 Million | -$0.3 Million | -11% | - The decrease in R&D expenses was primarily driven by a **$0.3 million** reduction in compensation expenses[9](index=9&type=chunk) [Selling, General & Administrative](index=2&type=section&id=Selling%2C%20General%20%26%20Administrative) SG&A expenses increased **11%** to **$23.4 million** in Q2 2025, driven by higher compensation, travel, and stock-based compensation Q2 2025 SG&A Expenses | Metric | Q2 2025 | Q2 2024 | Change (Million USD) | Change Rate | | :------- | :--------- | :--------- | :------------------- | :---------- | | SG&A Expenses | $23.4 Million | $21.1 Million | +$2.2 Million | +11% | - The increase in SG&A expenses was primarily driven by a **$1.4 million** increase in compensation, an **$0.8 million** increase in travel expenses, and a **$0.4 million** increase in non-cash stock-based compensation, partially offset by a **$0.5 million** decrease in advertising expenses[10](index=10&type=chunk) [Other Income and Expenses](index=2&type=section&id=Other%20Income%20and%20Expenses) Interest expense increased by **$0.5 million** due to higher borrowings, while other net income rose by **$0.2 million** from interest on cash accounts in Q2 2025 Q2 2025 Other Income and Expenses | Metric | Q2 2025 (Million USD) | Q2 2024 (Million USD) | Change (Million USD) | | :----------- | :-------------------- | :-------------------- | :------------------- | | Interest Expense | 1.473 | 0.959 | +0.514 | | Other Income, Net | 1.110 | 0.944 | +0.166 | - The increase in interest expense was primarily driven by higher borrowing levels under the term loan agreement with Innovatus Capital Partners[11](index=11&type=chunk) - The increase in other net income was primarily driven by higher interest income from interest-bearing accounts[11](index=11&type=chunk) [Net Loss and EPS](index=2&type=section&id=Net%20Loss%20and%20EPS) Net loss for Q2 2025 expanded to **$14.7 million**, or **$0.57** per share, compared to a **$14.0 million** net loss, or **$0.65** per share, in the prior year Q2 2025 Net Loss and EPS | Metric | Q2 2025 | Q2 2024 | Change (Million USD) | | :--------------------------------- | :--------- | :--------- | :------------------- | | Net Loss | $14.7 Million | $14.0 Million | +$0.7 Million | | Net Loss Per Share | $0.57 | $0.65 | -$0.08 | | Weighted Average Shares Outstanding (Millions) | 26.1 | 21.6 | +4.5 | [Cash Position and Cash Flow](index=3&type=section&id=Cash%20Position%20and%20Cash%20Flow) Cash and cash equivalents stood at **$95.0 million** as of June 30, 2025, with net cash used in operating and investing activities decreasing to **$8.0 million** Q2 2025 Cash Position and Cash Flow | Metric | June 30, 2025 (Million USD) | June 30, 2024 (Million USD) | Change (Million USD) | | :--------------------------------- | :-------------------------- | :-------------------------- | :------------------- | | Cash and Cash Equivalents | $95.0 | $105.9 (December 31, 2024) | -$10.9 | | Net Cash Used in Operating and Investing Activities | $8.0 | $10.2 | -$2.2 | [Operational and Strategic Updates](index=2&type=section&id=Operational%20and%20Strategic%20Updates) This section covers growth in active implanting centers, positive reimbursement developments, and a key leadership appointment [Active Implanting Centers & Sales Territories](index=2&type=section&id=Active%20Implanting%20Centers%20%26%20Sales%20Territories) U.S. active implanting centers increased **27%** to **240**, and U.S. sales territories expanded to **47** as of June 30, 2025 Active Implanting Centers and Sales Territories | Metric | June 30, 2025 | June 30, 2024 | Change | Change Rate | | :------------------- | :------------ | :------------ | :----- | :---------- | | U.S. Active Implanting Centers | 240 | 189 (based on 27% growth) | +51 | +27% | | U.S. Sales Territories | 47 | 45 | +2 | +4.4% | | Europe Sales Territories | 5 | 5 | 0 | 0% | [Reimbursement Updates](index=3&type=section&id=Reimbursement%20Updates) CMS proposed retaining Barostim in New Technology APC 1580 with a **$45,000** outpatient payment for 2026, and Category I CPT codes are expected to improve predictability - CMS proposed retaining the Barostim implant procedure in New Technology APC 1580 for 2026, with outpatient payment of approximately **$45,000**[6](index=6&type=chunk)[14](index=14&type=chunk) - CMS is soliciting comments on establishing a Level 6 neurostimulator APC[14](index=14&type=chunk) - The transition to Category I CPT codes, effective January 2026, is expected to eliminate automatic denials and improve prior authorization predictability, with physician payment estimated at approximately **$550**[15](index=15&type=chunk) [Leadership Appointment](index=3&type=section&id=Leadership%20Appointment) Brent Binkowski was appointed Chief Operating Officer, joining in August to oversee R&D, operations, regulatory affairs, and quality functions - Brent Binkowski was appointed Chief Operating Officer and will join the company in August[6](index=6&type=chunk)[16](index=16&type=chunk) - He will be responsible for Research & Development, Operations, Regulatory Affairs, and Quality functions[16](index=16&type=chunk) - Binkowski brings over **20 years** of medical device leadership experience with expertise in implantable devices[16](index=16&type=chunk) [Business Outlook](index=3&type=section&id=Business%20Outlook) This section provides CVRx's updated full-year 2025 guidance and Q3 2025 revenue expectations [Full Year 2025 Guidance](index=3&type=section&id=Full%20Year%202025%20Guidance) CVRx narrowed its full-year 2025 guidance, projecting total revenue between **$55.0 million** and **$57.0 million**, gross margin of **83-84%**, and operating expenses of **$96.0 million** to **$98.0 million** Full Year 2025 Guidance | Metric | New Guidance | Old Guidance | | :----------- | :-------------------- | :-------------------- | | Total Revenue | $55.0 Million - $57.0 Million | $55.0 Million - $58.0 Million | | Gross Margin | 83% - 84% | - | | Operating Expenses | $96.0 Million - $98.0 Million | $95.0 Million - $98.0 Million | [Third Quarter 2025 Revenue Expectation](index=3&type=section&id=Third%20Quarter%202025%20Revenue%20Expectation) The company anticipates total revenue for the third quarter of 2025 to be between **$13.7 million** and **$14.7 million** Third Quarter 2025 Revenue Expectation | Metric | Expected Range | | :------- | :--------------- | | Total Revenue | $13.7 Million - $14.7 Million | [Company Information](index=4&type=section&id=Company%20Information) This section provides an overview of CVRx, its core product Barostim, forward-looking statements, and investor contacts [About CVRx, Inc.](index=4&type=section&id=About%20CVRx%2C%20Inc.) CVRx is a commercial-stage medical device company developing innovative neuromodulation solutions for cardiovascular disease patients, with Barostim™ as its FDA-approved core product - CVRx is a commercial-stage medical device company focused on providing innovative neuromodulation solutions for patients with cardiovascular diseases[20](index=20&type=chunk) - Barostim™ is the first FDA-approved medical technology to use neuromodulation to improve symptoms for heart failure patients[20](index=20&type=chunk) - Barostim delivers electrical impulses to baroreceptors in the carotid artery wall via an implantable device, aiming to restore autonomic nervous system balance and alleviate heart failure symptoms[20](index=20&type=chunk) [Forward-Looking Statements](index=4&type=section&id=Forward-Looking%20Statements) This press release contains forward-looking statements regarding future financial performance, growth strategies, and business prospects, subject to various known and unknown risks and uncertainties - This press release contains forward-looking statements as defined by the Private Securities Litigation Reform Act of 1995[21](index=21&type=chunk) - Forward-looking statements relate to future financial performance, growth strategies, industry trends, business prospects, and opportunities[21](index=21&type=chunk) - These statements are subject to known and unknown risks, uncertainties, and assumptions, including sustained losses, reliance on the single product Barostim, inadequate reimbursement coverage, competition, supply chain dependence, and regulatory approvals[22](index=22&type=chunk) [Investor Relations](index=5&type=section&id=Investor%20Relations) Contact information for investor and media relations is provided, including Mark Klausner, Mike Vallie, and Emily Meyers - Investor Contacts: Mark Klausner or Mike Vallie (ICR Healthcare), email: ir@cvrx.com, phone: 443-213-0501[23](index=23&type=chunk) - Media Contact: Emily Meyers (CVRx, Inc.), email: emeyers@cvrx.com, phone: 763-416-2853[23](index=23&type=chunk) [Financial Statements](index=6&type=section&id=Financial%20Statements) This section presents CVRx's condensed consolidated balance sheets and statements of operations and comprehensive loss for Q2 2025 [Condensed Consolidated Balance Sheets](index=6&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) As of June 30, 2025, total assets were **$119.564 million**, with cash and cash equivalents at **$95.025 million**, and total liabilities at **$61.630 million** Condensed Consolidated Balance Sheets (Selected, in Thousands of USD) | Metric | June 30, 2025 | December 31, 2024 | | :--------------------------------- | :------------- | :---------------- | | Cash and cash equivalents | 95,025 | 105,933 | | Total current assets | 116,145 | 129,813 | | Total assets | 119,564 | 133,414 | | Total current liabilities | 9,689 | 10,762 | | Long-term debt | 49,392 | 49,273 | | Total liabilities | 61,630 | 62,359 | | Total stockholders' equity | 57,934 | 71,055 | [Condensed Consolidated Statements of Operations and Comprehensive Loss](index=7&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) For Q2 2025, total revenue was **$13.589 million**, gross profit **$11.450 million**, operating loss **$14.376 million**, and net loss **$14.736 million**, or **$0.57** per share Condensed Consolidated Statements of Operations and Comprehensive Loss (Selected, in Thousands of USD) | Metric | Q2 2025 | Q2 2024 | H1 2025 | H1 2024 | | :--------------------------------- | :--------- | :--------- | :-------- | :-------- | | Revenue | 13,589 | 11,807 | 25,937 | 22,577 | | Cost of goods sold | 2,139 | 1,900 | 4,175 | 3,515 | | Gross profit | 11,450 | 9,907 | 21,762 | 19,062 | | Research and development expenses | 2,469 | 2,765 | 4,986 | 5,822 | | Selling, general and administrative expenses | 23,357 | 21,115 | 44,589 | 49,445 | | Operating loss | (14,376) | (13,973) | (27,813) | (36,205) | | Net loss | (14,736) | (14,029) | (28,502) | (36,215) | | Net loss per share (basic and diluted) | (0.57) | (0.65) | (1.10) | (1.69) |

Core Insights - CVRx, Inc. reported solid second quarter results for 2025, with a revenue increase of 15% year-over-year, reflecting strong business momentum and sales force transformation [3][4][9]. Financial Performance - Total revenue for Q2 2025 was $13.6 million, up from $11.8 million in Q2 2024, marking a $1.8 million increase [4][27]. - U.S. revenue was $12.2 million, also a 15% increase from $10.5 million in the same quarter last year [5][27]. - Heart Failure (HF) revenue in the U.S. reached $12.1 million, a 15% increase compared to $10.5 million in Q2 2024, with HF revenue units rising from 339 to 387 [5][9]. - European revenue was $1.3 million, a 19% increase from $1.1 million in Q2 2024, despite a slight decrease in revenue units from 63 to 61 [7][27]. - Gross profit for Q2 2025 was $11.5 million, a 16% increase from $9.9 million in Q2 2024, maintaining a gross margin of 84% [8][27]. - R&D expenses decreased by 11% to $2.5 million, while SG&A expenses increased by 11% to $23.4 million [8][9][10]. - The net loss for Q2 2025 was $14.7 million, or $0.57 per share, compared to a net loss of $14.0 million, or $0.65 per share, in Q2 2024 [12][27]. Operational Highlights - As of June 30, 2025, CVRx had 240 active implanting centers in the U.S., a 27% increase from 189 centers a year prior [6][9]. - The number of U.S. sales territories increased to 47, with two new territories added during the quarter [6][9]. - The company is advancing its clinical evidence strategy and strengthening its reimbursement position, with CMS proposing to keep Barostim in APC 1580 for 2026 [3][14]. Reimbursement Updates - CMS proposed to maintain the Barostim implant procedure in the New Technology APC 1580 for 2026, with an outpatient payment of approximately $45,000 [14][15]. - The transition to Category I CPT codes in January 2026 is expected to enhance reimbursement predictability and eliminate automatic denials associated with Category III codes [15]. Leadership Changes - Brent Binkowski has been appointed as the Chief Operating Officer, bringing over 20 years of experience in medical devices [16]. Business Outlook - For the full year of 2025, CVRx expects total revenue between $55.0 million and $57.0 million, with Q3 revenue projected between $13.7 million and $14.7 million [17][18].

Core Insights - CVRx, Inc. is a commercial-stage medical device company focused on innovative neuromodulation solutions for cardiovascular diseases [3] - The company will present at the Canaccord Genuity 45th Annual Growth Conference on August 12, 2025, at 3:00 PM Eastern Time [1] - Barostim™ is the first FDA-approved medical technology using neuromodulation to alleviate heart failure symptoms [3] Company Overview - CVRx specializes in developing, manufacturing, and commercializing neuromodulation solutions for patients with cardiovascular diseases [3] - Barostim is an implantable device that delivers electrical pulses to baroreceptors in the carotid artery, aimed at restoring balance to the autonomic nervous system [3] - The device has received FDA Breakthrough Device designation and is approved for heart failure patients in the U.S., as well as certified under EU Medical Device Regulation [3] Conference Details - A live audio webcast of the conference presentation will be available on the investor relations page of the company's website [2]

Core Insights - CVRx, Inc. plans to release its second quarter 2025 financial and operating results on August 4, 2025, after market close [1] - A conference call will be held at 4:30 PM Eastern Time on the same day to discuss the results [1] Company Overview - CVRx is a commercial-stage medical device company focused on developing, manufacturing, and commercializing innovative neuromodulation solutions for patients with cardiovascular diseases [3] - The company's flagship product, Barostim™, is the first FDA-approved medical technology that uses neuromodulation to alleviate symptoms in heart failure patients [3] - Barostim is an implantable device that delivers electrical pulses to baroreceptors in the carotid artery, aiming to restore balance to the autonomic nervous system and reduce heart failure symptoms [3] - The device has received FDA Breakthrough Device designation and is approved for use in heart failure patients in the U.S., as well as being compliant with EU Medical Device Regulation and holding CE Mark for heart failure and resistant hypertension in the European Economic Area [3]