CVRx Reports Third Quarter 2025 Financial and Operating Results
CVRx (NASDAQ: CVRX) reported third-quarter 2025 results: revenue $14.7M (+10% YoY) with U.S. revenue $13.5M (+10% YoY) and 250 active U.S. implanting centers. Gross profit was $12.8M (+15% YoY) and gross margin 87% (up from 83%). Net loss narrowed slightly to $12.9M (−$0.2M) or $0.49 per share. Cash and cash equivalents totaled $85.1M. CMS finalized Category I CPT coding, which management cites as improving patient access and reducing adoption barriers. Full‑year 2025 guidance was updated to $55.6M–$56.6M revenue, 85%–86% gross margin, and $98M–$99M operating expenses. The company expects Q4 2025 revenue of $15.0M–$16.0M.
CVRx (NASDAQ: CVRX) ha riportato i risultati del terzo trimestre 2025: fatturato di 14,7 milioni di dollari (+10% YoY) con fatturato negli Stati Uniti di 13,5 milioni di dollari (+10% YoY) e 250 centri statunitensi attivi di impianto. Il margine lordo è stato 12,8 milioni di dollari (+15% YoY) e margine lordo dell'87% (in rialzo dall'83%). La perdita netta è leggermente diminuita a 12,9 milioni di dollari (−0,2 milioni) o 0,49 dollari per azione. Le disponibilità liquide sono ammontate a 85,1 milioni di dollari. CMS ha finalizzato la codifica CPT di Categoria I, che la direzione ritiene migliori l’accesso dei pazienti e riduca le barriere all’adozione. Le previsioni per l'intero 2025 sono state aggiornate a fatturato tra 55,6 e 56,6 milioni di dollari, margine lordo tra l'85% e l'86%, e spese operative tra 98 e 99 milioni di dollari. L'azienda prevede un fatturato nel quarto trimestre 2025 tra 15,0 e 16,0 milioni di dollari.
CVRx (NASDAQ: CVRX) reportó resultados del tercer trimestre de 2025: ingresos de 14,7 millones de dólares (+10% interanual) con ingresos en EE. UU. de 13,5 millones de dólares (+10% interanual) y 250 centros activos de implantación en EE. UU.. La ganancia bruta fue de 12,8 millones de dólares (+15% interanual) y margen bruto del 87% (sube desde el 83%). La pérdida neta se redujo ligeramente a 12,9 millones de dólares (−0,2 millones) o 0,49 dólares por acción. Efectivo y equivalentes totalizaron 85,1 millones de dólares. CMS finalizó la codificación CPT de Categoría I, que la dirección cita como una mejora en el acceso de los pacientes y una reducción de las barreras de adopción. Las perspectivas para todo 2025 se actualizaron a ingresos de 55,6–56,6 millones de dólares, margen bruto del 85%–86%, y gastos operativos de 98–99 millones de dólares. La compañía espera ingresos en el cuarto trimestre de 2025 de 15,0–16,0 millones de dólares.
CVRx(나스닥: CVRX)은 2025년 3분기 실적을 발표했다: 매출 1470만 달러 (+전년동기 대비 10%) with 미국 매출 1350만 달러 (+전년동기 대비 10%) 및 미국 내 250개의 활성 이식 센터. 총이익은 1280만 달러 (+전년동기 대비 15%)이며 총이익률 87% (83%에서 상승). 순손실은 약간 축소되어 1290만 달러 (−230만 달러) 또는 주당 0.49달러로 기록. 현금 및 현금성 자산은 8510만 달러로 집계. CMS가 카테고리 I CPT 코딩을 최종 확정했고, 이는management에 따르면 환자 접근성 향상과 채택 장벽 감소에 기여한다고 한다. 2025년 연간 가이던스는 매출 5560만–5660만 달러, 총이익률 85%–86%, 그리고 영업비용 9800만–9900만 달러로 업데이트되었다. 회사는 2025년 4분기 매출을 1500만–1600만 달러로 기대한다.
CVRx (NASDAQ: CVRX) a publié les résultats du troisième trimestre 2025: chiffre d'affaires 14,7 millions de dollars (+10% en glissement annuel) with un chiffre d'affaires américain de 13,5 millions de dollars (+10% en glissement annuel) et 250 centres d'implantation américains actifs. Le bénéfice brut s'est élevé à 12,8 millions de dollars (+15% YoY) et la marge brute est de 87% (contre 83%). La perte nette s'est légèrement réduite à 12,9 millions de dollars (−0,2 million) ou 0,49 dollar par action. La trésorerie et équivalents s'élevait à 85,1 millions de dollars. CMS a finalisé le codage CPT de catégorie I, que la direction estime améliorer l'accès des patients et réduire les barrières à l'adoption. Les prévisions pour l'ensemble de 2025 ont été révisées à un chiffre d'affaires de 55,6–56,6 millions de dollars, une marge brute de 85%–86%, et des dépenses d'exploitation de 98–99 millions de dollars. La société prévoit un chiffre d'affaires au 4e trimestre 2025 de 15,0–16,0 millions de dollars.
CVRx (NASDAQ: CVRX) hat die Ergebnisse des dritten Quartals 2025 gemeldet: Umsatz 14,7 Mio. USD (+10% YoY) mit US-Umsatz 13,5 Mio. USD (+10% YoY) und 250 aktiven US-Implantationszentren. Bruttogewinn lag bei 12,8 Mio. USD (+15% YoY) und Bruttomarge 87% (von 83% erhöht). Nettoverlust leicht auf 12,9 Mio. USD gesunken (−0,2 Mio.) oder 0,49 USD pro Aktie. Barverfügbarkeit und Äquivalente betrugen 85,1 Mio. USD. CMS hat die Kategorie-I-CPT-Codierung finalisiert, was das Management zufolge den Patientenzugang verbessert und Adoptionsbarrieren reduziert. Die Guidance für das Gesamtjahr 2025 wurde aktualisiert auf Umsatz 55,6–56,6 Mio. USD, Bruttomarge 85%–86% und Betriebsausgaben 98–99 Mio. USD. Das Unternehmen erwartet für Q4 2025 einen Umsatz von 15,0–16,0 Mio. USD.
CVRx (بورصة ناسداك: CVRX) أبلغت عن نتائج الربع الثالث من عام 2025: الإيرادات 14.7 مليون دولار (+10% سنوياً) مع إيرادات الولايات المتحدة 13.5 مليون دولار (+10% سنوياً) و250 مركزاً أمريكياً نشطاً لإجراء الزرع. الربح الإجمالي كان 12.8 مليون دولار (+15% سنوياً) وهامش الربح الإجمالي 87% (ارتفاع من 83%). صافي الخسارة تضاعف قليلاً إلى 12.9 مليون دولار (−0.2 مليون) أو 0.49 دولار للسهم. النقد وما يعادله بلغ 85.1 مليون دولار. أكدت CMS إتمام تصنيف CPT من الفئة I، ويذكر الإدارة أن ذلك سيحسن وصول المرضى ويقلل من حواجز الاعتماد. تم تحديث توجيهات السنة المالية 2025 لتصبح إيرادات 55.6–56.6 مليون دولار، هامش ربح إجمالي 85%–86%، ومصروفات تشغيل 98–99 مليون دولار. وتتوقع الشركة إيرادات في الربع الرابع من 2025 بـ 15.0–16.0 مليون دولار.
- Revenue +10% year-over-year to $14.7M
- U.S. revenue +10% year-over-year to $13.5M
- Gross margin expanded to 87% (from 83%)
- 250 active U.S. implanting centers (growth vs prior year)
- CMS finalized Category I CPT codes improving reimbursement
- Net loss $12.9M in Q3 2025
- Operating expenses guided higher to $98M–$99M for 2025
- Interest expense increased due to higher term loan borrowings
Insights
Revenue and margins rose; CMS coding upgrade and U.S. traction support adoption, while losses persist and operating spend guidance rose.
Sales increased to
Results still show a net loss of
Watchables: fourth-quarter revenue guidance of
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 of10% over the prior year quarter - U.S. revenue for the third quarter of 2025 was
$13.5 million , an increase of10% over the prior year quarter - Active implanting centers in the U.S. grew to 250, an increase of
20% since September 30, 2024 - CMS published the final rule to assign favorable physician fee payment levels in connection with the Category I CPT codes set to take effect in 2026
"We're pleased with the solid progress we made in the third quarter as we continue to execute and build momentum across the organization," said Kevin Hykes, President and Chief Executive Officer of CVRx. "Our revised commercial strategy continues to show positive results. The development of our territories is progressing nicely as our newest reps are becoming increasingly more productive, resulting in both higher Barostim implant volumes and the expansion of our customer base. We're also pleased that CMS finalized our transition to Category I CPT codes, both improving patient access and removing key adoption barriers. Our focus remains on positively impacting the lives of patients who suffer from heart failure, and we are well positioned to drive deeper adoption going forward.”
Third Quarter 2025 Financial and Operating Results
Revenue was
Revenue generated in the U.S. was
As of September 30, 2025, the Company had a total of 250 active implanting centers in the U.S., compared to 240 as of June 30, 2025. Active implanting centers are customers that have completed at least one commercial HF implant in the last 12 months. The number of sales territories in the U.S. increased by three to a total of 50 during the three months ended September 30, 2025.
Revenue generated in Europe was
Gross profit was
R&D expenses increased
SG&A expenses increased
Interest expense increased
Other income, net was
Net loss was
As of September 30, 2025, cash and cash equivalents were
Business Outlook
For the full year of 2025, the Company updated its guidance ranges and now expects:
- Total revenue between
$55.6 million and$56.6 million , compared to prior guidance of$55.0 million to$57.0 million ; - Gross margin between
85% and86% , compared to prior guidance of83% to84% ; - Operating expenses between
$98.0 million and$99.0 million , compared to prior guidance of$96.0 million to$98.0 million .
For the fourth quarter of 2025, the Company expects to report total revenue between
Webcast and Conference Call Information
The Company will host a conference call to review its results at 4:30 p.m. Eastern Time today. A live webcast of the investor conference call will be available online at the investor relations page of the Company’s website at ir.cvrx.com. To listen to the conference call on your telephone, please dial 1-877-704-4453 for U.S. callers, or 1-201-389-0920 for international callers, approximately ten minutes prior to the start time.
About CVRx, Inc.
CVRx is a commercial-stage medical device company focused on developing, manufacturing and commercializing innovative neuromodulation solutions for patients with cardiovascular diseases. Barostim™ is the first medical technology approved by FDA that uses neuromodulation to improve the symptoms of patients with heart failure. Barostim is an implantable device that delivers electrical pulses to baroreceptors located in the wall of the carotid artery. The therapy is designed to restore balance to the autonomic nervous system and thereby reduce the symptoms of heart failure. Barostim received the FDA Breakthrough Device designation and is FDA-approved for use in heart failure patients in the U.S. It has been certified as compliant with the EU Medical Device Regulation (MDR) and holds CE Mark approval for heart failure and resistant hypertension in the European Economic Area. To learn more about Barostim, visit www.cvrx.com.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements other than statements of historical facts are forward-looking statements, including statements regarding our future financial performance (including our financial guidance regarding full year and fourth quarter 2025 results), our anticipated growth strategies, anticipated trends in our industry, our business prospects and our opportunities. In some cases, you can identify forward-looking statements by terms such as “may,” “will,” “should,” “expect,” “plan,” “anticipate,” “could,” “outlook,” “guidance,” “intend,” “target,” “project,” “contemplate,” “believe,” “estimate,” “predict,” “potential” or “continue” or the negative of these terms or other similar expressions, although not all forward-looking statements contain these words.
The forward-looking statements in this press release are only predictions and are based largely on our current expectations and projections about future events and financial trends that we believe may affect our business, financial condition, and results of operations. These forward-looking statements speak only as of the date of this press release and are subject to a number of known and unknown risks, uncertainties and assumptions, including, but not limited to, our history of significant losses, which we expect to continue; our limited history operating as a commercial company and our dependence on a single product, Barostim; our limited commercial sales experience marketing and selling Barostim; our ability to continue demonstrating to physicians and patients the merits of our Barostim; any failure by third-party payors to provide adequate coverage and reimbursement for the use of Barostim; our competitors’ success in developing and marketing products that are safer, more effective, less costly, easier to use or otherwise more attractive than Barostim; any failure to receive access to hospitals; our dependence upon third-party manufacturers and suppliers, and in some cases a limited number of suppliers; a pandemic, epidemic or outbreak of an infectious disease in the U.S. or worldwide; product liability claims; future lawsuits to protect or enforce our intellectual property, which could be expensive, time consuming and ultimately unsuccessful; any failure to retain our key executives or recruit and hire new employees; impacts on adoption and regulatory approvals resulting from additional long-term clinical data about our product; and other important factors that could cause actual results, performance or achievements to differ materially from those that are found in “Part I, Item 1A. Risk Factors” in our Annual Report on Form 10-K for the year ended December 31, 2024 and “Part II, Item 1A. Risk Factors” in our Quarterly Report on Form 10-Q for the quarter ended June 30, 2025, as such factors may be updated from time to time in our other filings with the Securities and Exchange Commission. Except as required by applicable law, we do not plan to publicly update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise.
Investor Contact:
Mark Klausner or Mike Vallie
ICR Healthcare
443-213-0501
ir@cvrx.com
Media Contact:
Emily Meyers
CVRx, Inc.
763-416-2853
emeyers@cvrx.com
| CVRx, INC. Condensed Consolidated Balance Sheets (In thousands, except share and per share data) (Unaudited) | |||||||
| September 30, | December 31, | ||||||
| 2025 | 2024 | ||||||
| Assets | |||||||
| Current assets: | |||||||
| Cash and cash equivalents | $ | 85,124 | $ | 105,933 | |||
| Accounts receivable, net of allowances of | 8,209 | 9,268 | |||||
| Inventory | 11,394 | 12,107 | |||||
| Prepaid expenses and other current assets | 3,163 | 2,505 | |||||
| Total current assets | 107,890 | 129,813 | |||||
| Property and equipment, net | 2,446 | 2,505 | |||||
| Operating lease right-of-use asset | 963 | 1,069 | |||||
| Other non-current assets | 26 | 27 | |||||
| Total assets | $ | 111,325 | $ | 133,414 | |||
| Liabilities and Stockholders’ Equity | |||||||
| Current liabilities: | |||||||
| Accounts payable | $ | 3,628 | $ | 2,582 | |||
| Accrued expenses | 7,590 | 8,180 | |||||
| Total current liabilities | 11,218 | 10,762 | |||||
| Long-term debt | 49,453 | 49,273 | |||||
| Operating lease liability, non-current portion | 730 | 877 | |||||
| Other long-term liabilities | 1,870 | 1,447 | |||||
| Total liabilities | 63,271 | 62,359 | |||||
| Commitments and contingencies | |||||||
| Stockholders’ equity: | |||||||
| Common stock, | 262 | 253 | |||||
| Additional paid-in capital | 626,714 | 608,354 | |||||
| Accumulated deficit | (578,718 | ) | (537,346 | ) | |||
| Accumulated other comprehensive loss | (204 | ) | (206 | ) | |||
| Total stockholders’ equity | 48,054 | 71,055 | |||||
| Total liabilities and stockholders’ equity | $ | 111,325 | $ | 133,414 | |||
| CVRx, INC. Condensed Consolidated Statements of Operations and Comprehensive Loss (In thousands, except share and per share data) (Unaudited) | |||||||||||||||
| Three months ended | Nine months ended | ||||||||||||||
| September 30, | September 30, | ||||||||||||||
| 2025 | 2024 | 2025 | 2024 | ||||||||||||
| Revenue | $ | 14,690 | $ | 13,373 | $ | 40,627 | $ | 35,950 | |||||||
| Cost of goods sold | 1,937 | 2,248 | 6,112 | 5,763 | |||||||||||
| Gross profit | 12,753 | 11,125 | 34,515 | 30,187 | |||||||||||
| Operating expenses: | |||||||||||||||
| Research and development | 3,146 | 2,504 | 8,132 | 8,326 | |||||||||||
| Selling, general and administrative | 21,875 | 21,632 | 66,464 | 71,077 | |||||||||||
| Total operating expenses | 25,021 | 24,136 | 74,596 | 79,403 | |||||||||||
| Loss from operations | (12,268 | ) | (13,011 | ) | (40,081 | ) | (49,216 | ) | |||||||
| Interest expense | (1,480 | ) | (958 | ) | (4,410 | ) | (2,877 | ) | |||||||
| Other income, net | 875 | 917 | 3,108 | 2,905 | |||||||||||
| Loss before income taxes | (12,873 | ) | (13,052 | ) | (41,383 | ) | (49,188 | ) | |||||||
| Benefit (provision) for income taxes | 3 | (47 | ) | 11 | (126 | ) | |||||||||
| Net loss | (12,870 | ) | (13,099 | ) | (41,372 | ) | (49,314 | ) | |||||||
| Cumulative translation adjustment | (1 | ) | 2 | 2 | (1 | ) | |||||||||
| Comprehensive loss | $ | (12,871 | ) | $ | (13,097 | ) | $ | (41,370 | ) | $ | (49,315 | ) | |||
| Net loss per share, basic and diluted | $ | (0.49 | ) | $ | (0.57 | ) | $ | (1.59 | ) | $ | (2.25 | ) | |||
| Weighted-average common shares used to compute net loss per share, basic and diluted | 26,168,562 | 22,783,337 | 26,039,718 | 21,884,588 | |||||||||||
FAQ
What were CVRx (CVRX) third-quarter 2025 total and U.S. revenues?
How did CVRx's gross margin change in Q3 2025?
What is CVRx's updated full-year 2025 revenue guidance (CVRX)?
How many active U.S. implanting centers did CVRx report as of Sept. 30, 2025?
What did the CMS final rule mean for CVRx (CVRX) in 2026 coding?
What was CVRx's cash position and net loss for Q3 2025?
