Core Insights - CVRx, Inc. is a commercial-stage medical device company focused on innovative neuromodulation solutions for cardiovascular diseases [3] - The management team will present at the 44th Annual J.P. Morgan Healthcare Conference on January 14, 2026, at 3:45 p.m. (PT) [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] - Barostim 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] Event Information - A live webcast of the J.P. Morgan Healthcare Conference presentation will be available at ir.cvrx.com, with an archived version accessible for a limited time [2]

Summary of CVRx Conference Call Company Overview - **Company**: CVRx - **Industry**: Medical Technology (Med Tech) Key Points and Arguments Financial Guidance and Sales Performance - The company is guiding for an incremental revenue increase of only $1 million in Q4, compared to over $2 million in the same period last year, indicating a conservative approach to forecasting [1][2] - Sequential growth has been approximately 8%-10% since a business reset earlier in the year, which involved a deeper transformation of the sales force [2][3] Sales Force Transformation - The sales force has undergone significant changes, with many new hires coming from established companies like Abbott and J&J, focusing on a more systematic approach to therapy adoption [4][5] - The productivity of new sales representatives is expected to ramp up over a period of 6 to 12 months, depending on their prior experience and the territories they inherit [10] Revenue Targets and Cash Flow - Each sales representative is targeted to generate approximately $1.8 million in annual revenue, with the current average territory producing about $1 million [11][12] - The company aims to achieve cash flow break-even by increasing the productivity of existing territories and adding new ones [19][20] Market Adoption Barriers - The company identifies three main barriers to therapy adoption: awareness among clinicians, the need for more clinical evidence, and reimbursement issues [34] - The company is investing in new randomized controlled trials (RCTs) to generate additional evidence and address these barriers [34][50] Clinical Trials and Evidence Generation - A new RCT is planned with 2,500 randomized patients, which is expected to take 4-6 years to enroll and follow up, with an estimated cost of $20 million-$30 million [50][53] - The trial aims to expand the indication for the therapy, potentially tripling the total addressable market (TAM) [51] Reimbursement Landscape - The company has successfully secured permanent inpatient reimbursement rates, increasing from $17,000 to $45,000, and is working towards a permanent level six code for outpatient procedures [108][110] - The transition from Category III to Category I codes is expected to improve prior authorization processes and reduce friction in therapy adoption [112][113] Gross Margin and Cash Position - The gross margin in Q3 was reported at 87%, with expectations to maintain margins in the 85%-86% range moving forward [116] - The company has $85 million in cash, with a burn rate of $10 million per quarter, indicating at least three years of cash runway [118] Competitive Landscape - The company does not view competitors like Impulse Dynamics as direct threats, emphasizing that both companies can coexist and grow within the same market [106][107] - The recent approval and reimbursement updates for competitors are seen as potentially beneficial for the overall market [101][104] Additional Important Insights - The company is focused on deepening relationships with high-potential accounts, with only 20% of accounts currently performing at least one implant per month [92] - The company is actively working to improve the productivity of its sales force and the adoption rates within existing accounts [93][96]

Core Insights - CVRx, Inc. is a commercial-stage medical device company focused on innovative neuromodulation solutions for cardiovascular diseases [3] - The management team will participate in a fireside chat at the Piper Sandler 37th Annual Healthcare Conference on December 3, 2025 [1] - The Barostim™ device is the first FDA-approved 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 use in heart failure patients in the U.S., as well as CE Mark approval for heart failure and resistant hypertension in the European Economic Area [3] Event Details - The fireside chat is scheduled for December 3, 2025, at 2:00 p.m. (ET) and will be available via webcast on the company's investor relations page [1][2]

CVRx Conference Call Summary Company Overview - **Company**: CVRx - **Industry**: Cardiovascular medical devices - **Product**: Barostim, a neuromodulation therapy for heart failure - **Annual Total Addressable Market (TAM)**: $2.2 billion [1][5] Key Points and Arguments Heart Failure Market - Heart failure leads to over 1 million hospitalizations, 1.3 million emergency room visits, and 8 million physician office visits in the U.S. annually, with spending projected to reach approximately $70 billion by the end of the decade [1] - Heart failure is a progressive disease with significant mortality rates, exceeding those of the top five cancers [1] Treatment Landscape - Current treatment involves quad therapy (four Class I drugs), but only 1% of patients reach therapeutic doses, and 40% discontinue at least one drug within the first year [3] - Patients express a preference for a higher quality of life over mere life extension [4] - Barostim targets the "forgotten middle" of heart failure patients, aiming to restore quality of life [4] Clinical Evidence and Efficacy - Barostim has shown a 68% improvement in New York Heart Class functional status and a 94% response rate among patients [10] - A real-world study indicated an 85% reduction in hospitalization rates post-implantation of Barostim [11] - The therapy operates by restoring signaling from baroreceptors to the brain, effectively reducing sympathetic tone and neurohormonal toxicity [8][9] Go-to-Market Strategy - CVRx is focusing on building a specialized sales organization and deepening adoption in targeted accounts rather than broad distribution [12][13] - The company has identified 300-400 centers in the U.S. with the highest potential for Barostim adoption based on patient volume and experience with similar devices [15][16] Barriers to Adoption - Key barriers include therapy awareness, clinical evidence, patient access, and reimbursement issues [18][19] - Significant outreach efforts are being made to educate referral physicians and advanced practice providers [20] Reimbursement Developments - Secured a permanent inpatient DRG reimbursement of $43,000 and an outpatient code at $45,000 [24] - Transitioning to a permanent category one procedural code on January 1, which will enhance payment certainty for surgeons and reduce prior authorization denials [25][26] Financial Performance - Reported Q3 revenue of $14.7 million, with guidance for Q4 revenue between $15 million and $16 million [27] - Gross margin reported at 87%, with a cash balance of $85 million [27] Additional Important Information - The therapy has a remarkable 97% freedom from complications during implantation [9] - The company is actively generating further clinical evidence to support the therapy's efficacy and safety [21][22][23]

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]

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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]

Financial Data and Key Metrics Changes - Revenue for Q3 2025 was $14.7 million, an increase of $1.3 million or 10% year-over-year [11] - Gross profit was $12.8 million, up $1.5 million or 15% year-over-year, with a gross margin increase to 87% from 83% [12][13] - Net loss was $12.9 million or $0.49 per share, compared to a net loss of $13.1 million or $0.57 per share in Q3 2024 [16] - Cash and cash equivalents stood at $85.1 million as of September 30, 2025 [16] Business Line Data and Key Metrics Changes - U.S. revenue was $13.5 million, a 10% increase, with 420 revenue units sold compared to 394 in Q3 2024 [11][12] - Active implanting centers in the U.S. increased to 250 from 240 in the previous quarter [11] - European revenue was $1.2 million, a 12% increase, but total revenue units decreased to 50 from 56 [12] Market Data and Key Metrics Changes - The company added 10 net new centers in Q3 2025, with over 20% of active implanting centers achieving three or more implants [4][5] - The average selling price (ASP) for the quarter was over $31,000, up from just below $30,000 in Q3 2024 [33] Company Strategy and Development Direction - The company is focused on building a world-class sales organization and expanding its commercial footprint [3][4] - Targeting high-potential centers for sustainable programs and implementing a best practice playbook for therapy adoption [4] - The transition to a Category One CPT code effective January 1, 2026, is expected to improve reimbursement predictability and support therapy adoption [6][9] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the sales team's productivity and the positive signals from payers [18] - The company anticipates mid-teens growth in 2026, with potential for higher growth rates in the mid-20% range by 2027 and beyond [22][36] - The management highlighted the importance of reimbursement advancements and clinical evidence in driving future growth [6][9] Other Important Information - R&D expenses increased by $0.6 million or 26% to $3.1 million, driven by higher compensation and consulting expenses [13] - The company plans to refresh its registration statement in connection with the filing of its Q3 10Q [17] Q&A Session Summary Question: Guidance and Sales Reps Productivity - Management noted that while Q3 results were strong, they are cautious about future guidance due to ongoing productivity ramp-up of new sales reps [20][21] Question: 2026 Growth Projections - Management is comfortable with mid-teens growth expectations for 2026, with potential for exceeding those expectations based on various factors [22][36] Question: Sales Force Productivity - Management indicated that while new reps are becoming productive, full productivity is still being developed, with a typical ramp-up period of 6-12 months [25][26] Question: Reimbursement Changes - The transition to Category One CPT code is expected to reduce prior authorization friction and improve approval rates [28][29] Question: Gross Margin Insights - The increase in gross margin was attributed to a mix of higher average selling prices and improved manufacturing efficiencies [32][33] Question: RCT Trial and Enrollment - The company is planning a significant randomized controlled trial with approximately 2,000 patients, which could expand the total addressable market [44][49] Question: Operating Expenses Management - Management expects operating expenses to grow at a lower rate than revenue, indicating operational leverage [63]

Revenue Performance - Total revenue for Q3 2025 was $14.7 million, an increase of $1.3 million, or 10%, compared to Q3 2024[5] - U.S. revenue for Q3 2025 was $13.5 million, reflecting a 10% increase from the prior year, with 420 revenue units sold[6] - Revenue for the three months ended September 30, 2025, was $14,690 million, an increase from $13,373 million in the same period of 2024, representing a growth of 9.8%[26] - The company updated its full-year 2025 revenue guidance to between $55.6 million and $56.6 million[19] - For Q4 2025, the company expects total revenue between $15.0 million and $16.0 million[16] Profitability - Gross profit for Q3 2025 was $12.8 million, a 15% increase year-over-year, with a gross margin of 87%[10] - Gross profit for the nine months ended September 30, 2025, was $34,515 million, compared to $30,187 million for the same period in 2024, reflecting an increase of 14.4%[26] - The net loss for Q3 2025 was $12.9 million, or $0.49 per share, compared to a net loss of $13.1 million, or $0.57 per share, in Q3 2024[14] - The net loss for the three months ended September 30, 2025, was $12,870 million, slightly improved from a net loss of $13,099 million in the same period of 2024[26] - Net loss per share, basic and diluted, for the three months ended September 30, 2025, was $0.49, compared to $0.57 for the same period in 2024[26] Expenses - R&D expenses increased by $0.6 million, or 26%, to $3.1 million in Q3 2025[11] - Research and development expenses for the three months ended September 30, 2025, were $3,146 million, an increase from $2,504 million in 2024, marking a growth of 25.7%[26] - SG&A expenses rose by $0.2 million, or 1%, to $21.9 million in Q3 2025[12] - Selling, general and administrative expenses for the nine months ended September 30, 2025, totaled $66,464 million, down from $71,077 million in 2024, a decrease of 6.5%[26] - Total operating expenses for the three months ended September 30, 2025, were $25,021 million, up from $24,136 million in 2024, indicating a rise of 3.7%[26] Cash and Financial Position - Cash and cash equivalents as of September 30, 2025, were $85.1 million, with net cash used in operating and investing activities at $10.0 million[15] Other Financial Metrics - Interest expense for the three months ended September 30, 2025, was $1,480 million, compared to $958 million in the same period of 2024, representing an increase of 54.5%[26] - Other income for the nine months ended September 30, 2025, was $3,108 million, up from $2,905 million in 2024, reflecting a growth of 7%[26] - Active implanting centers in the U.S. grew to 250, a 20% increase since September 30, 2024[8] - The cumulative translation adjustment for the three months ended September 30, 2025, was $(1) million, compared to $2 million in the same period of 2024[26]

Core Insights - CVRx, Inc. reported a solid performance in Q3 2025, with a revenue increase of 10% year-over-year, reaching $14.7 million, driven by growth in the U.S. heart failure business and improved commercial strategies [4][10]. Financial Performance - Total revenue for Q3 2025 was $14.7 million, an increase of $1.3 million, or 10%, compared to Q3 2024 [4][10]. - U.S. revenue was $13.5 million, also reflecting a 10% increase from the previous year, with 420 revenue units sold compared to 394 in Q3 2024 [5][10]. - European revenue reached $1.2 million, a 12% increase from the prior year, although total revenue units decreased from 56 to 50 [7][10]. - Gross profit for Q3 2025 was $12.8 million, up 15% from $11.1 million in Q3 2024, with a gross margin improvement to 87% from 83% [8][10]. - R&D expenses rose by 26% to $3.1 million, driven by increased compensation and consulting costs [9][10]. - SG&A expenses increased slightly by 1% to $21.9 million, influenced by higher consulting and travel expenses [10][11]. - The net loss for Q3 2025 was $12.9 million, or $0.49 per share, compared to a net loss of $13.1 million, or $0.57 per share, in Q3 2024 [13][10]. Operational Highlights - The number of active implanting centers in the U.S. grew to 250, a 20% increase since September 2024, with the number of sales territories increasing to 50 [6][10]. - The company received favorable updates from CMS regarding the transition to Category I CPT codes, which is expected to enhance patient access and adoption of their products [3][10]. Business Outlook - For the full year of 2025, CVRx expects total revenue between $55.6 million and $56.6 million, with a gross margin between 85% and 86% [15][19]. - The company anticipates Q4 2025 revenue to be between $15.0 million and $16.0 million [15].