CVRx, Inc. Reports Quarterly Results for the Period Ended March 31, 2025

Overview

We are a commercial-stage medical device company focused on developing, manufacturing, and commercializing innovative and minimally invasive neuromodulation solutions for patients with cardiovascular disease. Our proprietary platform technology, Barostim, is designed to leverage the power of the brain and nervous system to address the imbalance of the Autonomic Nervous System, which causes Heart Failure with reduced Ejection Fraction (HFrEF) and other cardiovascular diseases. Barostim is the first and only commercially available neuromodulation device indicated to improve symptoms for patients with HFrEF.

Since our inception, our activities have consisted primarily of developing Barostim Therapy, conducting clinical studies, and filing for regulatory approvals. Our ability to generate significant revenue and become profitable will depend on our ability to continue to successfully commercialize Barostim and any product enhancements we may advance in the future. We expect to derive future revenue by expanding our dedicated sales force and increasing awareness of Barostim among payers, physicians, and patients.

Factors affecting our performance

Key factors impacting our business and results include:

• Growing and supporting our U.S. commercial organization
• Promoting awareness among physicians, hospitals, and patients to accelerate Barostim adoption
• Continuing to develop and disseminate clinical evidence supporting the benefits of Barostim
• Raising awareness among payers to build upon reimbursement for Barostim
• Investing in research and development to foster innovation
• Leveraging our manufacturing capacity to further improve gross margins

Components of results of operations

Revenue Our revenue is primarily generated from sales of Barostim in the U.S. and Europe. We expect U.S. sales to continue accounting for the majority of our revenue as we expand our sales force and increase awareness among physicians, patients, and payers.

Cost of goods sold and gross margin Cost of goods sold consists of component costs, manufacturing overhead, and distribution expenses. Gross margin is affected by factors like average selling price, product mix, and production volumes. We expect gross margin to improve over time as we increase direct sales and production.

Research and development expenses R&D expenses include costs associated with product development, clinical trials, and regulatory activities. We expect R&D expenses to increase as we continue enhancing Barostim.

Selling, general and administrative expenses SG&A expenses consist primarily of personnel costs, marketing, and other administrative expenses. We expect SG&A to increase in absolute dollars as we expand our commercial organization, but decrease as a percentage of revenue.

Results of operations

For the three months ended March 31, 2025, revenue increased 15% to $12.3 million compared to the prior year period, driven by 14% growth in U.S. HF revenue. Gross margin was 84%, down slightly from 85% in the prior year.

R&D expenses decreased 18% to $2.5 million, while SG&A expenses decreased 25% to $21.2 million, primarily due to lower stock-based compensation.

Net loss improved 38% to $13.8 million, reflecting the revenue growth and expense management.

Liquidity and capital resources

As of March 31, 2025, we had $102.7 million in cash and cash equivalents. We have incurred significant losses since inception and anticipate continued losses in the near-term as we invest in our commercial infrastructure and R&D.

In October 2022, we entered into a $50 million loan agreement to support our operations. We also have an at-the-market equity offering program that provides additional financial flexibility.

We believe our existing cash resources and cash from operations will be sufficient to meet our forecasted requirements for at least the next three years. However, we may seek additional financing through equity or debt if needed to execute or accelerate our growth strategies.