CVRx Reports Third Quarter 2024 Financial and Operating Results
CVRx reported strong Q3 2024 results with total revenue of $13.4 million, up 27% year-over-year. U.S. Heart Failure revenue reached $12.2 million, increasing 30%. Active implanting centers grew to 208, up 31%. The company achieved significant milestones including Barostim's reassignment to MS-DRG 276, increasing hospital payments from $17,000-$23,000 to approximately $43,000, and securing Category I CPT codes effective January 2026. However, net loss widened to $13.1 million ($0.57 per share) compared to $9.0 million in Q3 2023. The company narrowed its 2024 revenue guidance to $50.5-$51.5 million.
CVRx ha riportato risultati solidi per il terzo trimestre del 2024, con un fatturato totale di 13,4 milioni di dollari, in aumento del 27% rispetto all'anno precedente. I ricavi per l'insufficienza cardiaca negli Stati Uniti hanno raggiunto 12,2 milioni di dollari, aumentando del 30%. I centri di impianto attivi sono cresciuti fino a 208, con un incremento del 31%. L'azienda ha raggiunto traguardi significativi, tra cui il riesame di Barostim per l'MS-DRG 276, che ha aumentato i pagamenti ospedalieri da $17.000-$23.000 a circa $43.000, e ha ottenuto codici CPT di Categoria I, efficaci da gennaio 2026. Tuttavia, la perdita netta è aumentata a 13,1 milioni di dollari (0,57 dollari per azione) rispetto ai 9,0 milioni di dollari nel terzo trimestre del 2023. L'azienda ha ristretto le previsioni di fatturato per il 2024 a 50,5-51,5 milioni di dollari.
CVRx reportó resultados sólidos en el tercer trimestre de 2024, con ingresos totales de 13,4 millones de dólares, un aumento del 27% en comparación con el año anterior. Los ingresos por insuficiencia cardíaca en EE. UU. alcanzaron 12,2 millones de dólares, incrementándose en un 30%. Los centros de implantación activos crecieron a 208, un aumento del 31%. La compañía logró hitos significativos, incluyendo la reasignación de Barostim a MS-DRG 276, que aumentó los pagos hospitalarios de $17,000-$23,000 a aproximadamente $43,000, y asegurando códigos CPT de Categoría I que entrarán en vigor en enero de 2026. Sin embargo, la pérdida neta se amplió a 13,1 millones de dólares (0,57 dólares por acción) en comparación con 9,0 millones de dólares en el tercer trimestre de 2023. La compañía ha reducido su guía de ingresos para 2024 a 50,5-51,5 millones de dólares.
CVRx는 2024년 3분기에 총 1340만 달러의 강력한 실적을 보고했으며, 이는 전년 대비 27% 증가한 수치입니다. 미국의 심부전 관련 수익은 1220만 달러에 도달하여 30% 증가했습니다. 적극적인 임플란트 센터 수는 208개로 31% 증가했습니다. 회사는 병원 지급금을 $17,000-$23,000에서 약 $43,000으로 늘리기 위한 Barostim의 MS-DRG 276 재배정과 2026년 1월 발효되는 제1범주 CPT 코드 확보를 포함해 중요한 이정표를 달성했습니다. 그러나 순손실은 2023년 3분기 900만 달러에 비해 1310만 달러 (주당 0.57달러)로 확대되었습니다. 회사는 2024년 매출 가이드를 5050만-5150만 달러로 좁혔습니다.
CVRx a rapporté des résultats solides pour le troisième trimestre 2024, avec un chiffre d'affaires total de 13,4 millions de dollars, en hausse de 27 % par rapport à l'année précédente. Les revenus liés à l'insuffisance cardiaque aux États-Unis ont atteint 12,2 millions de dollars, en augmentation de 30 %. Le nombre de centres d'implantation actifs a atteint 208, soit une hausse de 31 %. L'entreprise a atteint des jalons importants, y compris la réattribution de Barostim à MS-DRG 276, augmentant les paiements hospitaliers de 17 000 à 23 000 dollars à environ 43 000 dollars, et a obtenu des codes CPT de catégorie I qui entreront en vigueur en janvier 2026. Cependant, la perte nette s'est élargie à 13,1 millions de dollars (0,57 dollar par action) par rapport à 9,0 millions de dollars au troisième trimestre 2023. L'entreprise a resserré ses prévisions de revenus pour 2024 à 50,5-51,5 millions de dollars.
CVRx meldete starke Ergebnisse für das dritte Quartal 2024 mit einem Gesamtumsatz von 13,4 Millionen Dollar, was einem Anstieg von 27 % im Vergleich zum Vorjahr entspricht. Die Einnahmen aus Herzinsuffizienz in den USA erreichten 12,2 Millionen Dollar und stiegen um 30 %. Die Anzahl aktiver Implantationszentren wuchs auf 208, was einem Anstieg von 31 % entspricht. Das Unternehmen erreichte bedeutende Meilensteine, darunter die Neuzuordnung von Barostim zu MS-DRG 276, was eine Erhöhung der Krankenhauszahlungen von $17,000-$23,000 auf etwa $43,000 zur Folge hatte, sowie die Sicherung von CPT-Codes der Kategorie I, die ab Januar 2026 in Kraft treten. Allerdings weitete sich der Nettoverlust auf 13,1 Millionen Dollar (0,57 Dollar pro Aktie) im Vergleich zu 9,0 Millionen Dollar im dritten Quartal 2023 aus. Das Unternehmen strAffte seine Umsatzprognose für 2024 auf 50,5-51,5 Millionen Dollar.
- Revenue growth of 27% YoY to $13.4 million
- U.S. Heart Failure revenue increased 30% to $12.2 million
- Active implanting centers grew 31% to 208
- Hospital reimbursement increased from $17-23K to $43K per procedure
- Secured Category I CPT codes for improved reimbursement
- Strong cash position of $100.2 million
- Gross margin maintained at 83%
- Net loss increased to $13.1 million from $9.0 million YoY
- SG&A expenses increased 38% to $21.6 million
- Cash burn of $10.4 million in Q3
- Operating expenses guidance increased to $100 million
- Revenue guidance narrowed downward to $50.5-$51.5 million
Insights
CVRx delivered solid Q3 2024 results with
Two key catalysts strengthen the growth outlook: 1) The MS-DRG 276 reassignment more than doubles hospital reimbursement to
The reimbursement developments mark a pivotal shift for Barostim's market adoption. The
The narrowed full-year revenue guidance of
MINNEAPOLIS, Oct. 29, 2024 (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 2024.
Recent Highlights
- Total revenue for the third quarter 2024 was
$13.4 million , an increase of27% over the prior year quarter - U.S. Heart Failure (HF) revenue for the third quarter of 2024 was
$12.2 million , an increase of30% over the prior year quarter - Active implanting centers in the U.S. were 208, an increase of
31% over the prior year quarter - Final Inpatient Prospective Payment System rule confirmed the reassignment of Barostim to MS-DRG 276, increasing payment to hospitals from approximately
$17,000 -$23,000 t o approximately$43,000 effective October 1, 2024 - The American Medical Association CPT® Editorial Panel accepted new Current Procedural Terminology (CPT) Category I codes for Barostim to treat the symptoms of heart failure, expected to take effect January 1, 2026
- New data published in JACC: Heart Failure demonstrated durable quality of life benefits of Barostim in heart failure patients with reduced ejection fraction
“We're thrilled with our continued strong performance in the third quarter, which reflects the growing adoption of Barostim therapy and the dedication of our team,” said Kevin Hykes, President and Chief Executive Officer of CVRx. "The recent favorable news regarding inpatient reimbursement and the Category 1 code, coupled with new long-term data demonstrating Barostim’s durable quality of life benefits, strengthens our position in the market. We remain focused on improving patient access, increasing education and awareness, and expanding our clinical evidence base. These developments, along with our strengthened leadership team and stabilized sales force reinforce our confidence in Barostim's potential to become standard of care for patients suffering from the debilitating symptoms of heart failure."
Third Quarter 2024 Financial and Operating Results
Revenue was
Revenue generated in the U.S. was
As of September 30, 2024, the Company had a total of 208 active implanting centers in the U.S., as compared to 189 as of June 30, 2024. 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 45 during the three months ended September 30, 2024.
Revenue generated in Europe was
Gross profit was
R&D expenses decreased
SG&A expenses increased
Interest expense increased
Other income, net decreased
Net loss was
As of September 30, 2024, cash and cash equivalents were
On September 30, 2024, the Company borrowed the remaining
For the three months ended September 30, 2024, the Company issued 2,358,775 shares of common stock for gross proceeds of
Final Inpatient Prospective Payment System Rule
In August 2024, the Company announced that the Centers for Medicare and Medicaid Services (CMS) has reassigned the Barostim implant procedure for the inpatient setting as part of the Medicare Hospital Inpatient Prospective Payment System (IPPS) final rule for CMS’ Fiscal Year 2025, which began on October 1, 2024. On that date, Barostim was reassigned to MS-DRG 276, which carries a national average payment of approximately
AMA Approves Category I CPT Codes for Barostim Therapy
The American Medical Association's CPT Editorial Panel approved new Category I codes for Barostim therapy, effective January 1, 2026. Led by the Society for Vascular Surgery with support from the American College of Cardiology, this advancement from Category III to Category I status reflects Barostim's growing adoption and established clinical evidence in treating heart failure symptoms. The new designation is expected to streamline reimbursement processes and expand access to this important therapy for heart failure patients.
Long-term Quality of Life Benefits of Barostim
In September 2024, the Company announced the publication of new data in the Journal of the American College of Cardiology: Heart Failure, detailing the durable improvements in Barostim patients out to 24-months in quality of life measures. The data demonstrated that patients receiving Barostim plus guideline-directed medical therapy reported feeling significantly better in a variety of physical and psychosocial measures compared to patients who received guideline-directed medical therapy alone. This publication builds on the data from the BeAT-HF trial published in 2024 in the European Journal of Heart Failure demonstrating the long-term sustained symptomatic benefits of Barostim in heart failure patients with reduced ejection fraction.
Business Outlook
For the full year of 2024, the Company expects:
- Total revenue between
$50.5 million and$51.5 million , narrowed from previously issued guidance of$50.0 million to$53.0 million ; - Gross margin between
83% and85% , unchanged from previously issued guidance; and - Operating expenses of approximately
$100 million , up from previously issued guidance of$95 million to$98 million .
For the fourth quarter of 2024, 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 also received the CE Mark 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 2024 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 demonstrate 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, 2023, 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:
Laura O’Neill
Finn Partners
402-499-8203
laura.oneill@finnpartners.com
| CVRx, INC. | |||||||
| Condensed Consolidated Balance Sheets | |||||||
| (In thousands, except share and per share data) | |||||||
| (Unaudited) | |||||||
| September 30, | December 31, | ||||||
| 2024 | 2023 | ||||||
| Assets | |||||||
| Current assets: | |||||||
| Cash and cash equivalents | $ | 100,161 | $ | 90,569 | |||
| Accounts receivable, net of allowances of | 9,033 | 7,551 | |||||
| Inventory | 11,892 | 10,983 | |||||
| Prepaid expenses and other current assets | 2,786 | 2,987 | |||||
| Total current assets | 123,872 | 112,090 | |||||
| Property and equipment, net | 2,631 | 1,763 | |||||
| Operating lease right-of-use asset | 1,144 | 1,349 | |||||
| Other non-current assets | 26 | 27 | |||||
| Total assets | $ | 127,673 | $ | 115,229 | |||
| Liabilities and Stockholders’ Equity | |||||||
| Current liabilities: | |||||||
| Accounts payable | $ | 3,276 | $ | 1,884 | |||
| Accrued expenses | 7,671 | 5,980 | |||||
| Total current liabilities | 10,947 | 7,864 | |||||
| Long-term debt | 49,214 | 29,222 | |||||
| Operating lease liability, non-current portion | 951 | 1,160 | |||||
| Other long-term liabilities | 1,378 | 1,036 | |||||
| Total liabilities | 62,490 | 39,282 | |||||
| Commitments and contingencies | |||||||
| Stockholders’ equity: | |||||||
| Common stock, | 242 | 209 | |||||
| Additional paid-in capital | 591,844 | 553,326 | |||||
| Accumulated deficit | (526,695 | ) | (477,381 | ) | |||
| Accumulated other comprehensive loss | (208 | ) | (207 | ) | |||
| Total stockholders’ equity | 65,183 | 75,947 | |||||
| Total liabilities and stockholders’ equity | $ | 127,673 | $ | 115,229 | |||
| 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, | ||||||||||||||
| 2024 | 2023 | 2024 | 2023 | ||||||||||||
| Revenue | $ | 13,373 | $ | 10,511 | $ | 35,950 | $ | 27,990 | |||||||
| Cost of goods sold | 2,248 | 1,691 | 5,763 | 4,536 | |||||||||||
| Gross profit | 11,125 | 8,820 | 30,187 | 23,454 | |||||||||||
| Operating expenses: | |||||||||||||||
| Research and development | 2,504 | 2,696 | 8,326 | 9,392 | |||||||||||
| Selling, general and administrative | 21,632 | 15,652 | 71,077 | 47,504 | |||||||||||
| Total operating expenses | 24,136 | 18,348 | 79,403 | 56,896 | |||||||||||
| Loss from operations | (13,011 | ) | (9,528 | ) | (49,216 | ) | (33,442 | ) | |||||||
| Interest expense | (958 | ) | (499 | ) | (2,877 | ) | (1,220 | ) | |||||||
| Other income, net | 917 | 1,056 | 2,905 | 2,734 | |||||||||||
| Loss before income taxes | (13,052 | ) | (8,971 | ) | (49,188 | ) | (31,928 | ) | |||||||
| Provision for income taxes | (47 | ) | (40 | ) | (126 | ) | (108 | ) | |||||||
| Net loss | (13,099 | ) | (9,011 | ) | (49,314 | ) | (32,036 | ) | |||||||
| Cumulative translation adjustment | 2 | (21 | ) | (1 | ) | (1 | ) | ||||||||
| Comprehensive loss | $ | (13,097 | ) | $ | (9,032 | ) | $ | (49,315 | ) | $ | (32,037 | ) | |||
| Net loss per share, basic and diluted | $ | (0.57 | ) | $ | (0.43 | ) | $ | (2.25 | ) | $ | (1.55 | ) | |||
| Weighted-average common shares used to compute net loss per share, basic and diluted | 22,783,337 | 20,801,350 | 21,884,588 | 20,730,024 | |||||||||||
FAQ
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