CVRx, Inc.

CVRx, Inc. Annual Report Summary (Fiscal Year Ended December 31, 2025)

This summary offers a clear, concise overview of CVRx, Inc.'s performance and strategic direction, directly from their latest annual report. It aims to provide investors with a solid understanding of the company's operations, financial health, and key considerations.

Company Overview: Innovating Heart Failure Treatment

CVRx, Inc. is a medical device company that develops and commercializes innovative solutions for patients suffering from heart failure. Its flagship product, Barostim, is a pioneering implantable neuromodulation device – a technology that uses electrical signals to modify nerve activity – designed to improve symptoms in heart failure patients.

Barostim uses Baroreflex Activation Therapy (BAT). It delivers mild electrical pulses to nerve endings (baroreceptors) in the carotid artery. These signals then travel to the brain, helping to rebalance the body's autonomic nervous system, which often malfunctions in chronic heart failure. This therapy complements traditional medical management.

Barostim achieved a significant milestone with its U.S. FDA Breakthrough Device designation and subsequent full FDA approval for heart failure patients. This highlights the FDA's belief that it offers a substantial clinical benefit over existing therapies. The company estimates the total addressable market for Barostim in heart failure is substantial, potentially reaching millions of patients worldwide.

Financial Performance (Fiscal Year Ended December 31, 2025)

For the fiscal year ended December 31, 2025, CVRx continued its commercial expansion. As a "smaller reporting company" and an "emerging growth company," CVRx benefits from certain scaled-down disclosure requirements. These designations also underscore the company's early stage of market penetration and its path towards profitability.

• Revenue Growth: CVRx reported total revenue of $50.3 million for FY2025, a significant 67% increase from $30.1 million in FY2024. Increased Barostim adoption in the U.S. market primarily drove this growth.
• Net Loss: Despite strong revenue growth, the company's net loss widened to ($82.5 million) for FY2025, up from ($70.2 million) in FY2024. This reflects substantial, ongoing investments in sales and marketing, research and development, and general administrative functions essential for commercial scale-up.
• Cash Position: As of December 31, 2025, CVRx held $120.7 million in cash and cash equivalents. Its operating activities consumed approximately $75 million in cash during FY2025.
• Market Capitalization: As of February 6, 2026, approximately 26.3 million shares of common stock were outstanding, resulting in a public market value of approximately $300 million for its outstanding shares.

Investor Note: CVRx has consistently incurred significant operating losses since its inception and expects this trend to continue for the foreseeable future. Achieving and maintaining profitability will heavily depend on Barostim's successful commercialization, market adoption, and efficient cost management. The company may need additional capital to fund future operations.

Management's Discussion and Analysis (MD&A) Highlights

Management highlights significant revenue growth in FY2025, primarily attributing it to the successful execution of its U.S. commercial strategy for Barostim. The 67% year-over-year revenue increase reflects growing physician adoption, an expanded direct sales force, and increased awareness within the cardiology community.

Despite this robust top-line growth, the company's net loss widened to ($82.5 million) from ($70.2 million) in the prior year. This wider loss directly results from strategic investments aimed at scaling the business. CVRx directed significant expenditures toward expanding its commercial infrastructure, including sales and marketing activities to drive Barostim adoption. It also continued research and development efforts to enhance the product and explore new indications. General and administrative expenses also rose to support the company's growth and public company operations. Management emphasizes these investments are critical for long-term market penetration and establishing Barostim as a standard of care for appropriate heart failure patients. The company expects to continue incurring operating losses for the foreseeable future as it prioritizes market expansion and commercialization.

Financial Health and Liquidity

As of December 31, 2025, CVRx held $120.7 million in cash and cash equivalents. During FY2025, the company used approximately $75 million in cash for its operating activities, reflecting ongoing investments in commercialization and R&D.

Historically, equity financings have been the company's primary source of liquidity. CVRx currently has no significant long-term debt obligations that would materially impact its liquidity.

Management believes its current cash and cash equivalents, combined with anticipated revenue growth, will fund its operations for at least the next 12 months. However, given its history of operating losses and continued investment needs, the company acknowledges it may require additional capital in the future to support further expansion, research and development, or other strategic initiatives. Its ability to raise additional capital, if needed, will depend on market conditions and the company's financial performance.

Competitive Position

CVRx operates in the highly competitive cardiovascular medical device market, which includes a wide range of heart failure therapies. The company's primary competitive advantage comes from its proprietary Barostim system. Barostim uses Baroreflex Activation Therapy (BAT), a unique neuromodulation approach for heart failure. This differentiates it from traditional drug treatments and other device-based therapies like cardiac resynchronization therapy (CRT) or left ventricular assist devices (LVADs).

Key aspects of CVRx's competitive position include:

• Unique Mechanism of Action: Barostim's non-drug, neuromodulation approach offers a distinct treatment option for patients who remain symptomatic despite optimal medical therapy.
• Regulatory Approvals: Its U.S. FDA Breakthrough Device designation and subsequent full FDA approval create a significant competitive barrier and validate the therapy's clinical benefit.
• Intellectual Property: The company's patent portfolio covers its technology, protecting its innovation and market position.
• Clinical Evidence: Ongoing and completed clinical trials provide growing evidence supporting Barostim's efficacy and safety.

However, CVRx faces competition from larger, well-established medical device companies with greater financial, sales, and marketing resources. These competitors may develop alternative or improved therapies, offer lower-cost solutions, or leverage their existing market presence and relationships with healthcare providers. Maintaining and enhancing its competitive position will depend on continued innovation, successful commercial execution, and effective physician and patient education.

Future Outlook and Strategic Priorities

CVRx's future success depends on executing a multi-faceted growth strategy. This strategy focuses on expanding Barostim's market presence and optimizing its commercial model:

• U.S. Market Penetration: Its primary focus is increasing Barostim adoption among cardiologists and electrophysiologists in the U.S. This involves expanding its direct sales force, enhancing physician training programs, and driving awareness through targeted marketing initiatives. The goal is to increase the number of active implanting centers and their average utilization.
• Reimbursement Optimization: CVRx actively works to secure and optimize reimbursement pathways with third-party payers, including private insurers and government programs like Medicare. Favorable and consistent reimbursement policies are critical for broader market access and physician adoption.
• Clinical Evidence Generation: The company continues generating long-term clinical data to further demonstrate Barostim's efficacy and safety. This includes ongoing post-market studies and potentially exploring new indications or patient populations where BAT could offer benefits.
• Operational Efficiency: As the company scales, improving manufacturing efficiency and supply chain resilience is crucial to enhance gross margins and manage operating expenses effectively.
• Potential Geographic Expansion: While the U.S. remains its primary focus, CVRx may explore strategic expansion into select international markets long-term, leveraging existing regulatory approvals in certain regions.

Key Risks & Challenges for Investors

Investing in CVRx carries several significant risks, typical for an early-commercial-stage medical device company:

• Continued Operating Losses and Need for Capital: The company has a history of losses and expects this trend to continue. There is no guarantee of achieving profitability. CVRx may need to raise additional capital through equity or debt financing, which could dilute existing shareholders or impose restrictive covenants.
• Heavy Reliance on Barostim: Barostim generates nearly all of CVRx's current revenue. Any issues with its efficacy, safety, market acceptance, or competition could severely impact the company's financial performance.
• Commercialization and Market Adoption: Despite FDA approval, widespread Barostim adoption requires significant effort to educate physicians, overcome resistance to new treatments (clinical inertia), and integrate the therapy into standard practice. Failure to accelerate adoption rates will hinder revenue growth.
• Reimbursement Uncertainty: Adequate and consistent reimbursement from third-party payers is critical. Changes in coverage policies, payment amounts, or delays in securing reimbursement could negatively affect sales and profitability.
• Intense Competition: The cardiovascular medical device market is highly competitive, with larger, well-established companies possessing greater financial and operational resources. Competitors may introduce alternative therapies, improve existing treatments, or offer lower-cost solutions.
• Supply Chain Dependencies: CVRx relies on third-party manufacturers for components and finished products. Supply chain disruptions, quality control issues, or increased costs from these suppliers could impact production, sales, and profit margins.
• Regulatory and Clinical Risks: While Barostim is approved, future regulatory requirements could change. Ongoing or future clinical studies might also yield unfavorable or inconclusive results, impacting market perception and adoption.
• Intellectual Property Protection: The company's success depends on its ability to protect its proprietary technology. Patent disputes, challenges to intellectual property, or an inability to obtain new patents could undermine its competitive advantage.
• Key Personnel Retention: CVRx's success highly depends on its ability to attract and retain key executives, sales personnel, and scientific talent. Losing key individuals could disrupt operations and strategic execution.
• General Economic and Healthcare Environment: Broader economic downturns, changes in healthcare policy, or unforeseen global events (e.g., pandemics) could negatively impact healthcare spending, patient access, and the company's operations.