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CVRx Reports Preliminary Fourth Quarter and Fiscal Year 2025 Financial Results and Issues Fiscal 2026 Guidance

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MINNEAPOLIS, Jan. 12, 2026 (GLOBE NEWSWIRE) -- CVRx, Inc. (NASDAQ: CVRX) ("CVRx"), a commercial-stag...

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AI Summary

CVRx anticipates revenue growth with Q4 2025 estimated at $15.9M-$16.1M and a strong 2026 outlook of $63M-$67M. The recent FDA approval for the BENEFIT-HF trial and the implementation of CPT codes enhancing reimbursement pave the way for increased product adoption. Focus on heart failure treatment and a stable balance sheet position the company for accelerated growth.

Sentiment Rationale

Historical trends show that regulatory approvals and revenue growth expectations often lead to stock price increases. Similar companies have experienced uplifts following FDA approvals, which bolstered adoption across the healthcare sector.

Trading Thesis

CVRx is a BUY with the upcoming favorable developments likely to boost revenue in 2026.

Market-Moving

  • FDA's approval of the BENEFIT-HF trial could increase investor confidence.
  • Implementation of Category I CPT codes supports future revenue stability.
  • The upcoming investor conference may provide positive sentiment for CVRX shares.
  • Expanded sales territories allow for greater market penetration and growth.

Key Facts

  • Q4 2025 revenue expected at $15.9M to $16.1M, 4%-5% YoY growth.
  • Full-year 2025 revenue forecasted between $56.5M and $56.7M, 10%-11% rise.
  • 2026 revenue guidance of $63M-$67M indicates 11%-18% growth.
  • Category I CPT codes effective January 1, boosting adoption potential.
  • FDA approved BENEFIT-HF trial design; CMS coverage application submitted.

Companies Mentioned

  • FDA (N/A): FDA's involvement is crucial for trial approvals.
  • CMS (N/A): Approval of coverage by CMS is vital for clinical trial funding.
  • Innovatus Capital Partners, LLC (N/A): Amendment of debt by Innovatus indicates strong financial support.

Corporate Developments

This news falls under 'Corporate Developments', highlighting strategic moves and financial forecasts that position CVRx for potential growth. The recent regulatory and financial improvements suggest strong forthcoming performance in the medical device market.

CVRx Reports Preliminary Fourth Quarter and Fiscal Year 2025 Financial Results and Issues Fiscal 2026 Guidance

MINNEAPOLIS, January 12, 2026 (GLOBE NEWSWIRE) -- CVRx, Inc. (NASDAQ: CVRX), a pioneer in developing innovative medical devices for cardiovascular diseases, has released its preliminary unaudited financial results for the fourth quarter and full year 2025, alongside guidance for fiscal 2026. The company expects significant revenue growth fueled by strategic advancements and favorable regulatory changes.

Financial Insights for Fourth Quarter and Full Year 2025

CVRx anticipates fourth quarter revenue ranging from $15.9 million to $16.1 million, marking a growth of approximately 4% to 5% compared to the same period in 2024. Full year 2025 revenue is projected to fall between $56.5 million and $56.7 million, reflecting a year-over-year increase of 10% to 11%.

Key highlights of CVRx's financial performance include:

  • Revenue Growth: Fourth quarter revenue planned at $15.9 million to $16.1 million.
  • Annual Revenue: Expected full-year revenue between $56.5 million and $56.7 million.
  • Active Implanting Centers: Total of 252 centers, up from 250 in September 2025.
  • Sales Territories: Increased to 53 territories in the U.S.
  • Cash Reserves: Cash and cash equivalents at $75.7 million.

Fiscal 2026 Revenue Guidance

Looking ahead, CVRx has provided ambitious guidance for fiscal year 2026. The company forecasts total revenue between $63 million and $67 million, which translates to a robust growth rate of 11% to 18%.

Additional expectations for 2026 include:

  • Gross Margin: Anticipated between 84% and 86%.
  • Operating Expenses: Estimated between $103 million and $107 million.
  • First Quarter 2026 Revenue: Expected revenue of $13.7 million to $14.7 million.

Strategic Growth Initiatives

Kevin Hykes, CEO of CVRx, expressed satisfaction with the company’s 2025 performance, stating, “We’re pleased with our execution in 2025 as we delivered solid results while making significant strategic progress.” He also noted the positive impact of the newly enacted Category I CPT codes, which enhance reimbursement opportunities and support commercial efforts.

The FDA's approval of the BENEFIT-HF trial design in November 2025 further positions CVRx for future growth. This study is set to evaluate the Barostim device's effects on heart failure outcomes, with plans to enroll 2,500 patients across up to 200 U.S. and German centers.

Debt Facility Amendment and Financial Stability

On January 9, 2026, CVRx amended its loan agreement with Innovatus Capital Partners, increasing its term loan by $50 million, bringing the total loan amount to up to $100 million. This financial maneuver is aimed at strengthening the company’s balance sheet:

  • The company borrowed an additional $10 million at closing, elevating total term loans to $60 million.
  • The amended term agreement has an interest rate of at least 9.40%, with an interest-only period extended by four years.
  • Loans mature in May 2031, secured by substantially all of CVRx's assets.

Upcoming Events

CVRx will present at the 44th Annual J.P. Morgan Healthcare Conference on January 14, 2026, at 3:45 p.m. Pacific Time. Stakeholders are invited to view the live audio webcast on the investor relations section of the CVRx website.

About CVRx, Inc.

CVRx, Inc. specializes in developing innovative neuromodulation solutions for patients with cardiovascular diseases. The Barostim™ device is the first FDA-approved technology using neuromodulation to alleviate heart failure symptoms. It works by delivering electrical pulses to baroreceptors in the carotid artery, aiming to balance the autonomic nervous system.

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