CVRx Reports Second Quarter 2024 Financial and Operating Results
CVRx, Inc. (NASDAQ: CVRX) reported strong Q2 2024 financial results, with total revenue reaching $11.8 million, a 24% increase year-over-year. U.S. Heart Failure revenue grew 27% to $10.5 million. The company expanded its active implanting centers in the U.S. by 35% compared to Q2 2023. CVRx appointed new executives, including a Chief Revenue Officer, to strengthen its leadership team. Despite revenue growth, the company reported a net loss of $14.0 million, or $0.65 per share. CVRx updated its full-year 2024 guidance, projecting total revenue between $50.0 million and $53.0 million. The company remains focused on expanding therapy awareness, strengthening clinical evidence, and improving patient access for its Barostim technology.
CVRx, Inc. (NASDAQ: CVRX) ha riportato forti risultati finanziari per il secondo trimestre del 2024, con ricavi totali che hanno raggiunto 11,8 milioni di dollari, un aumento del 24% rispetto all' anno precedente. I ricavi per insufficienza cardiaca negli Stati Uniti sono aumentati del 27% a 10,5 milioni di dollari. L'azienda ha ampliato i suoi centri di impianto attivi negli Stati Uniti del 35% rispetto al secondo trimestre del 2023. CVRx ha nominato nuovi dirigenti, tra cui un Chief Revenue Officer, per rafforzare il proprio team di leadership. Nonostante la crescita dei ricavi, l'azienda ha riportato una perdita netta di 14,0 milioni di dollari, pari a 0,65 dollari per azione. CVRx ha aggiornato le sue previsioni per l'intero anno 2024, prevedendo ricavi totali compresi tra 50,0 milioni di dollari e 53,0 milioni di dollari. L'azienda rimane focalizzata sull'espansione della consapevolezza della terapia, il rafforzamento delle prove cliniche e il miglioramento dell'accesso dei pazienti alla sua tecnologia Barostim.
CVRx, Inc. (NASDAQ: CVRX) reportó sólidos resultados financieros para el segundo trimestre de 2024, con ingresos totales que alcanzaron 11.8 millones de dólares, un incremento del 24% interanual. Los ingresos por insuficiencia cardíaca en EE. UU. crecieron un 27% alcanzando 10.5 millones de dólares. La compañía amplió su número de centros de implantación activos en EE. UU. en un 35% en comparación con el segundo trimestre de 2023. CVRx nombró a nuevos ejecutivos, incluyendo un Director de Ingresos, para fortalecer su equipo de liderazgo. A pesar del crecimiento en los ingresos, la compañía reportó una pérdida neta de 14.0 millones de dólares, o 0.65 dólares por acción. CVRx actualizó su guía para el año completo 2024, proyectando ingresos totales entre 50.0 millones de dólares y 53.0 millones de dólares. La compañía sigue enfocada en aumentar la conciencia sobre la terapia, fortalecer la evidencia clínica y mejorar el acceso de los pacientes a su tecnología Barostim.
CVRx, Inc. (NASDAQ: CVRX)는 2024년 2분기 강력한 재무 실적을 보고했으며, 총 수익이 1,180만 달러에 이르러 전년 대비 24% 증가했습니다. 미국의 심부전 수익이 27% 증가하여 1,050만 달러로 증가했습니다. 회사는 2023년 2분기 대비 미국 내 활성 이식 센터를 35% 확장했습니다. CVRx는 새로운 경영진을 임명했으며, 수익 책임자도 포함되어 있으며, 이는 리더십 팀을 강화하기 위함입니다. 수익은 증가했지만, 회사는 1,400만 달러의 순손실을 보고했으며, 이는 주당 0.65달러에 해당합니다. CVRx는 2024년 전체 연도 예상치를 업데이트하여 총 수익을 5,000만 달러에서 5,300만 달러 사이로 예측하고 있습니다. 회사는 Barostim 기술에 대한 치료 인식을 확대하고, 임상 증거를 강화하며, 환자의 접근성을 개선하는 데 집중하고 있습니다.
CVRx, Inc. (NASDAQ: CVRX) a annoncé de solides résultats financiers pour le deuxième trimestre 2024, avec un chiffre d'affaires total atteignant 11,8 millions de dollars, soit une augmentation de 24 % par rapport à l'année précédente. Les revenus liés à l'insuffisance cardiaque aux États-Unis ont augmenté de 27 % pour atteindre 10,5 millions de dollars. La société a élargi de 35 % le nombre de ses centres d'implantation actifs aux États-Unis par rapport au deuxième trimestre 2023. CVRx a nommé de nouveaux dirigeants, y compris un directeur des revenus, afin de renforcer son équipe de direction. Malgré la croissance des revenus, la société a enregistré une perte nette de 14,0 millions de dollars, soit 0,65 dollar par action. CVRx a mis à jour ses prévisions pour l'année complète 2024, projetant des revenus totaux compris entre 50,0 millions de dollars et 53,0 millions de dollars. L'entreprise reste concentrée sur l'expansion de la sensibilisation à la thérapie, le renforcement des preuves cliniques et l'amélioration de l'accès des patients à sa technologie Barostim.
CVRx, Inc. (NASDAQ: CVRX) berichtete über solide finanzielle Ergebnisse im zweiten Quartal 2024, mit einem Gesamtumsatz von 11,8 Millionen Dollar, was einem Anstieg von 24 % im Jahresvergleich entspricht. Der Umsatz aus Herzinsuffizienz in den USA wuchs um 27 % auf 10,5 Millionen Dollar. Das Unternehmen erweiterte seine aktiven Implantationszentren in den USA im Vergleich zum zweiten Quartal 2023 um 35 %. CVRx ernannte neue Führungskräfte, einschließlich eines Chief Revenue Officer, um sein Führungsteam zu stärken. Trotz des Umsatzwachstums meldete das Unternehmen einen Nettoverlust von 14,0 Millionen Dollar oder 0,65 Dollar pro Aktie. CVRx aktualisierte seine Jahresprognose für 2024 und erwartet einen Gesamtumsatz zwischen 50,0 Millionen Dollar und 53,0 Millionen Dollar. Das Unternehmen bleibt darauf konzentriert, das Bewusstsein für die Therapie zu erweitern, die klinischen Beweise zu stärken und den Zugang der Patienten zu seiner Barostim-Technologie zu verbessern.
- Total revenue increased 24% year-over-year to $11.8 million in Q2 2024
- U.S. Heart Failure revenue grew 27% to $10.5 million
- Active implanting centers in the U.S. increased by 35% compared to Q2 2023
- Gross profit increased 24% to $9.9 million with a stable gross margin of 84%
- Number of sales territories in the U.S. increased by three to a total of 42
- Strengthened executive team with key appointments to drive market development
- Net loss increased to $14.0 million in Q2 2024 from $11.6 million in Q2 2023
- SG&A expenses increased 28% to $21.1 million
- Revenue generated in Europe decreased by 6% to $1.1 million
- Cash and cash equivalents decreased to $70.4 million as of June 30, 2024
Insights
CVRx's Q2 2024 results demonstrate solid growth, particularly in the U.S. Heart Failure (HF) segment. The 24% year-over-year revenue increase to
Key financial metrics to note:
- Gross margin remained stable at
84% , indicating consistent production efficiency. - R&D expenses decreased by
16% , which could be a concern if it impacts future innovation. - SG&A expenses increased by
28% , primarily due to increased headcount and stock-based compensation. This investment in sales and marketing could drive future growth but also impacts profitability in the short term. - Net loss widened to
$14.0 million ($0.65 per share) from$11.6 million ($0.56 per share) in Q2 2023. - Cash position of
$70.4 million provides runway for continued growth initiatives.
The company's updated guidance for 2024, with expected revenue between
CVRx's Barostim technology represents an innovative approach to treating heart failure through neuromodulation. The 35% increase in active implanting centers to 189 in the U.S. indicates growing acceptance among healthcare providers. This expansion is important for market penetration and suggests increasing confidence in the technology's efficacy.
The company's focus on strengthening clinical evidence is prudent. The appointment of Dr. Philip Adamson as Chief Medical Officer and Jennifer Englund as SVP of Global Clinical Research underscores CVRx's commitment to enhancing their clinical data. This strategy is vital in the medical device industry, where robust clinical evidence can drive adoption and potentially influence reimbursement decisions.
However, it's important to note that while the technology shows promise, long-term clinical outcomes and comparative effectiveness studies will be important for Barostim to become the standard of care in heart failure treatment. Investors should closely monitor upcoming clinical data and real-world evidence, as these will be key drivers for future growth and market acceptance.
CVRx's market strategy appears well-aligned with the growing demand for innovative heart failure treatments. The expansion to 42 sales territories in the U.S. and consistent presence in Europe with 6 territories demonstrate a focused approach to market penetration. The 27% growth in U.S. Heart Failure revenue suggests strong market traction.
The recent leadership appointments, particularly Robert John as Chief Revenue Officer and Bonnie Handke as SVP of Patient Access, Reimbursement and Healthcare Economics, indicate a strategic focus on market development and addressing key barriers to adoption. These hires could potentially accelerate market penetration and improve patient access to Barostim therapy.
However, the slight decrease in European revenue (down
The projected revenue growth for Q3 2024 (
MINNEAPOLIS, July 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 second quarter of 2024.
Recent Highlights
- Total revenue for the second quarter 2024 was
$11.8 million , an increase of24% over the prior year quarter - U.S. Heart Failure (HF) revenue for the second quarter of 2024 was
$10.5 million , an increase of27% over the prior year quarter - Active implanting centers in the U.S. were 189, an increase of
35% over the second quarter of 2023 - Hired new Chief Revenue Officer and completed expansion of executive leadership team
“We are pleased with our solid second quarter results, driven by another record quarter in our U.S. Heart Failure business. We remain extremely optimistic about the Barostim technology and our market opportunity. Our recent leadership appointments have significantly bolstered our executive team, positioning us well to address key market development priorities,” said Kevin Hykes, President and Chief Executive Officer of CVRx. “Our focus is on continuing to broaden therapy awareness, strengthen our clinical evidence, and improve patient access. With our innovative technology, expanding market presence, and the depth of expertise on our expanded leadership team, we're well-positioned to drive Barostim towards becoming standard of care, making a meaningful difference in the lives of those suffering from heart failure and other cardiovascular diseases.”
Second Quarter 2024 Financial and Operating Results
Revenue was
Revenue generated in the U.S. was
As of June 30, 2024, the Company had a total of 189 active implanting centers, as compared to 190 as of March 31, 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 42 during the three months ended June 30, 2024.
Revenue generated in Europe was
Gross profit was
R&D expenses decreased
SG&A expenses increased
Other income, net increased
Net loss was
As of June 30, 2024, cash and cash equivalents were
Leadership Team Expansion
During the quarter, the Company strengthened its executive team to drive market development priorities. Key appointments include Robert John as Chief Revenue Officer, bringing over 25 years of sales leadership experience in the medical device industry; Dr. Philip Adamson as Chief Medical Officer; Bonnie Handke as SVP of Patient Access, Reimbursement, and Healthcare Economics; Jennifer Englund as SVP of Global Clinical Research to enhance clinical evidence; and Tonya Austin as Chief Human Resources Officer. These strategic hires position CVRx to effectively address awareness, clinical, and patient access barriers as it drives Barostim towards becoming standard of care for heart failure.
Business Outlook
For the full year of 2024, the Company now expects:
- Total revenue between
$50.0 million and$53.0 million ; - Gross margin between
83.0% and85.0% ; and - Operating expenses between
$95.0 million and$98.0 million , up from previously issued guidance of$92.0 million and$98.0 million
For the third 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 third 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 Westwicke
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) | ||||||||
| June 30, | December 31, | |||||||
| 2024 | 2023 | |||||||
| Assets | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 70,400 | $ | 90,569 | ||||
| Accounts receivable, net of allowances of | 8,606 | 7,551 | ||||||
| Inventory | 11,224 | 10,983 | ||||||
| Prepaid expenses and other current assets | 1,762 | 2,987 | ||||||
| Total current assets | 91,992 | 112,090 | ||||||
| Property and equipment, net | 2,763 | 1,763 | ||||||
| Operating lease right-of-use asset | 1,200 | 1,349 | ||||||
| Other non-current assets | 26 | 27 | ||||||
| Total assets | $ | 95,981 | $ | 115,229 | ||||
| Liabilities and Stockholders’ Equity | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 3,516 | $ | 1,884 | ||||
| Accrued expenses | 5,610 | 5,980 | ||||||
| Total current liabilities | 9,126 | 7,864 | ||||||
| Long-term debt | 29,319 | 29,222 | ||||||
| Operating lease liability, non-current portion | 1,023 | 1,160 | ||||||
| Other long-term liabilities | 1,265 | 1,036 | ||||||
| Total liabilities | 40,733 | 39,282 | ||||||
| Commitments and contingencies | ||||||||
| Stockholders’ equity: | ||||||||
| Common stock, | 217 | 209 | ||||||
| Additional paid-in capital | 568,837 | 553,326 | ||||||
| Accumulated deficit | (513,596 | ) | (477,381 | ) | ||||
| Accumulated other comprehensive loss | (210 | ) | (207 | ) | ||||
| Total stockholders’ equity | 55,248 | 75,947 | ||||||
| Total liabilities and stockholders’ equity | $ | 95,981 | $ | 115,229 | ||||
| CVRx, INC. Condensed Consolidated Statements of Operations and Comprehensive Loss (In thousands, except share and per share data) (Unaudited) | ||||||||||||||||
| Three months ended | Six months ended | |||||||||||||||
| June 30, | June 30, | |||||||||||||||
| 2024 | 2023 | 2024 | 2023 | |||||||||||||
| Revenue | $ | 11,807 | $ | 9,500 | $ | 22,577 | $ | 17,479 | ||||||||
| Cost of goods sold | 1,900 | 1,517 | 3,515 | 2,845 | ||||||||||||
| Gross profit | 9,907 | 7,983 | 19,062 | 14,634 | ||||||||||||
| Operating expenses: | ||||||||||||||||
| Research and development | 2,765 | 3,280 | 5,822 | 6,696 | ||||||||||||
| Selling, general and administrative | 21,115 | 16,455 | 49,445 | 31,852 | ||||||||||||
| Total operating expenses | 23,880 | 19,735 | 55,267 | 38,548 | ||||||||||||
| Loss from operations | (13,973 | ) | (11,752 | ) | (36,205 | ) | (23,914 | ) | ||||||||
| Interest expense | (959 | ) | (481 | ) | (1,919 | ) | (721 | ) | ||||||||
| Other income, net | 944 | 616 | 1,988 | 1,678 | ||||||||||||
| Loss before income taxes | (13,988 | ) | (11,617 | ) | (36,136 | ) | (22,957 | ) | ||||||||
| Provision for income taxes | (41 | ) | (34 | ) | (79 | ) | (68 | ) | ||||||||
| Net loss | (14,029 | ) | (11,651 | ) | (36,215 | ) | (23,025 | ) | ||||||||
| Cumulative translation adjustment | — | 17 | (3 | ) | 20 | |||||||||||
| Comprehensive loss | $ | (14,029 | ) | $ | (11,634 | ) | $ | (36,218 | ) | $ | (23,005 | ) | ||||
| Net loss per share, basic and diluted | $ | (0.65 | ) | $ | (0.56 | ) | $ | (1.69 | ) | $ | (1.11 | ) | ||||
| Weighted-average common shares used to compute net loss per share, basic and diluted | 21,628,542 | 20,711,850 | 21,430,276 | 20,702,589 | ||||||||||||
FAQ
What was CVRx's total revenue for Q2 2024?
How much did CVRx's U.S. Heart Failure revenue grow in Q2 2024?
What is CVRx's updated revenue guidance for full-year 2024?
How many active implanting centers did CVRx have in the U.S. as of Q2 2024?
What was CVRx's net loss per share for Q2 2024?
