Revenue Performance - Revenue for the three months ended September 30, 2025, was $14.7 million, an increase of $1.3 million, or 10%, compared to the same period in 2024[86] - Revenue for the nine months ended September 30, 2025, was $40.6 million, an increase of $4.7 million, or 13%, compared to the same period in 2024[99] - Revenue generated in the U.S. was $36.9 million for the nine months ended September 30, 2025, an increase of $4.1 million, or 13%, over the prior year[100] - Revenue generated in Europe was $3.7 million for the nine months ended September 30, 2025, a $0.5 million increase, or 17%, compared to the same period in 2024[101] Gross Profit and Margins - Gross profit increased to $12.8 million for the three months ended September 30, 2025, a rise of $1.6 million, or 15%, with a gross margin of 87% compared to 83% in the prior year[91] - Gross profit for the nine months ended September 30, 2025, was $34.5 million, reflecting a $4.3 million increase, or 14%, over the prior year[103] Operating Expenses - Total operating expenses for the three months ended September 30, 2025, were $25.0 million, an increase of $0.9 million, or 4%, compared to the same period in 2024[85] - SG&A expenses decreased by $4.6 million, or 6%, to $66.5 million for the nine months ended September 30, 2025, primarily due to a decrease in non-cash stock-based compensation[107] Research and Development - Research and development expenses rose to $3.1 million, an increase of $0.6 million, or 26%, primarily due to higher compensation and consulting costs[92] Net Loss - Net loss for the nine months ended September 30, 2025, was $41.4 million, a decrease of $7.9 million, or 16%, compared to the net loss of $49.3 million in the same period in 2024[111] - The company anticipates continued net losses in the coming years due to planned investments in commercialization efforts[72] Cash and Financing - The company had cash and cash equivalents of $85.1 million as of September 30, 2025, down from $105.9 million at the end of 2024[111] - Cash used in operating activities for the nine months ended September 30, 2025, was $30.4 million, slightly lower than $31.1 million in the same period in 2024[118] - The company issued 543,462 shares of common stock under the ATM offering for gross proceeds of $9.5 million during the nine months ended September 30, 2025[113] - Interest expense increased by $1.5 million for the nine months ended September 30, 2025, driven by higher levels of borrowings under the Loan Agreement[108] Market Expansion and Strategy - U.S. sales accounted for $13.5 million, reflecting a 10% increase, driven by growth in the heart failure business and expansion into new sales territories[87] - The company had 250 active implanting centers in the U.S. as of September 30, 2025, up from 208 in the previous year[88] - The company plans to expand its U.S. commercial organization and increase awareness among physicians and patients to drive future revenue growth[77] Regulatory and Economic Factors - The Centers for Medicare & Medicaid Services released new Category I CPT codes for Barostim, expected to improve reimbursement predictability starting January 1, 2026[73] - Inflationary factors may adversely affect operating results, with potential impacts on gross margin and operating expenses if product selling prices do not increase accordingly[129] - Revenue and operating expenses incurred outside the U.S. are subject to foreign currency exchange rate fluctuations, particularly with the Euro, but realized gains and losses have not been material to financial statements[128] - The company is exposed to interest rate risk primarily related to cash equivalents and debt under the Loan Agreement, with no current plans to use financial derivatives[127]

Group 1 - The article does not provide any specific content related to a company or industry [1]

分组1 - CVRx reported a quarterly loss of $0.49 per share, slightly better than the Zacks Consensus Estimate of a loss of $0.50, and an improvement from a loss of $0.57 per share a year ago, indicating an earnings surprise of +2.00% [1] - The company generated revenues of $14.69 million for the quarter ended September 2025, exceeding the Zacks Consensus Estimate by 3.33%, and showing an increase from $13.37 million in the same quarter last year [2] - CVRx has surpassed consensus revenue estimates four times over the last four quarters, indicating a positive trend in revenue performance [2] 分组2 - The stock has underperformed, losing about 21.2% since the beginning of the year, while the S&P 500 has gained 15.1%, raising questions about the stock's future performance [3] - The current consensus EPS estimate for the upcoming quarter is -$0.41 on revenues of $15.99 million, and for the current fiscal year, it is -$2.00 on revenues of $56.13 million [7] - The Zacks Industry Rank for Medical - Instruments is in the top 37% of over 250 Zacks industries, suggesting that the industry outlook is favorable and could positively impact stock performance [8]

CVRx (NasdaqGS:CVRX) Q3 2025 Earnings Call November 05, 2025 04:30 PM ET Speaker1Greetings and welcome to the CVRx Third Quarter 2025 earnings conference call. At this time, all participants are in a listen-only mode. A brief question-and-answer session will follow the formal presentation. If anyone should require operator assistance during the conference, please press star zero on your telephone keypad. As a reminder, this conference is being recorded. It is now my pleasure to introduce your host, Mike Wal ...

Exhibit 99.1 CVRx Reports Third Quarter 2025 Financial and Operating Results MINNEAPOLIS, November 5, 2025 (GLOBE NEWSWIRE) -- CVRx, Inc. (NASDAQ: CVRX) ("CVRx"), a commercial-stage medical device company focused on developing, manufacturing and commercializing innovative neuromodulation solutions for patients with cardiovascular diseases, today announced its financial and operating results for the third quarter of 2025. Recent Highlights "We're pleased with the solid progress we made in the third quarter a ...

MINNEAPOLIS, Nov. 05, 2025 (GLOBE NEWSWIRE) -- CVRx, Inc. (NASDAQ: CVRX) ("CVRx"), a commercial-stage medical device company focused on developing, manufacturing and commercializing innovative neuromodulation solutions for patients with cardiovascular diseases, today announced its financial and operating results for the third quarter of 2025. Recent Highlights Total revenue for the third quarter 2025 was $14.7 million, an increase of 10% over the prior year quarterU.S. revenue for the third quarter of 2025 ...

MINNEAPOLIS, Nov. 04, 2025 (GLOBE NEWSWIRE) -- CVRx, Inc. (NASDAQ: CVRX) ("CVRx"), a commercial-stage medical device company focused on developing, manufacturing and commercializing innovative neuromodulation solutions for patients with cardiovascular diseases, today announced that the management team will present at the Jefferies Global Healthcare Conference in London on Tuesday, Nov. 18, 2025. The Company is scheduled to present at 8:00 a.m. (GMT) / 4:00 a.m. (ET) the same day via webcast. A live audio we ...

Core Insights - CVRx, Inc. plans to release its third quarter 2025 financial and operating results on November 5, 2025, after market close [1] - A conference call will be held at 4:30 p.m. 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]

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)