CVRx — Third Quarter 2026 Earnings Summary

Financial Performance:

• Total revenue for the three months ended September 30, 2026, was $13.8 million, a decrease of $0.9 million (6%) compared to $14.7 million in the same period in 2025.
• U.S. revenue was $13.0 million, a decrease of $0.5 million (4%) year-over-year; U.S. revenue units totaled 412 in 2026 versus 420 in 2025.
• Europe revenue was $0.9 million, a decrease of $0.3 million (27%) year-over-year; total revenue units in Europe decreased to 38 in 2026 from 50 in 2025.
• Gross profit was $12.0 million, a decrease of $0.8 million (6%) year-over-year; gross margin remained at 87% for both the current and prior year periods.
• Research and development expenses decreased $0.5 million (16%) to $2.7 million, driven by lower headcount and consulting expenses.
• Selling, general, and administrative (SG&A) expenses increased $0.5 million (2%) to $22.4 million, primarily due to increases in legal, travel, and consulting expenses, partially offset by a decrease in advertising.
• Interest expense increased $0.1 million year-over-year due to higher borrowings under the term loan agreement with Innovatus Capital Partners.
• Net loss was $14.2 million ($0.52 per share) for the quarter, compared to a net loss of $12.9 million ($0.49 per share) in the prior year period.
• Cash and cash equivalents were $58.7 million as of September 30, 2026, down from $75.7 million as of December 31, 2025.
• Net cash used in operating and investing activities was $11.0 million for the quarter, compared to $10.0 million in the prior year period.
• Long-term debt increased to $58.7 million as of September 30, 2026, from $49.5 million as of December 31, 2025.

Guidance and Future Outlook:

• Full-year 2026 total revenue guidance was lowered to between $56.0 million and $57.0 million, down from the prior guidance of $58.0 million to $60.0 million.
• Full-year 2026 gross margin guidance remains between 86% and 87%.
• Full-year 2026 operating expenses are expected to be between $99 million and $101 million.
• Fourth quarter 2026 total revenue is expected to be between $11.7 million and $12.7 million.
• The company is executing cost reduction actions, including reductions in non-commercial functions and pulling back on marketing and R&D projects not expected to impact revenue.

Business Segments and Product Lines:

• Active implanting centers in the U.S. increased to 262 as of September 30, 2026, from 250 as of September 30, 2025.
• The number of U.S. sales territories increased to 56 as of September 30, 2026, from 50 in the prior year period.
• The number of sales territories in Europe remained unchanged at five.
• A second major Medicare Advantage provider issued a coverage policy for Barostim effective July 17, 2026, covering the current FDA-approved indication and BENEFIT-HF patients; these two policies represent approximately 21% of Medicare Advantage enrollment.
• The company presented late-breaking REBALANCE Registry data at the Heart Failure Society of America (HFSA) Annual Scientific Meeting 2026, evaluating 435 patients across 45 U.S. centers.
• Real-world evidence regarding patients with heart failure with mildly reduced ejection fraction (HFmrEF) was presented at HFSA.

Market and Competitive Landscape:

• Revenue decreases in the U.S. were attributed to lower sales force productivity and prolonged challenges with one of the company's largest payers.
• Higher-than-usual implants by centers with existing units occurred in the quarter, partially offset by a larger annual purchase expected in the fourth quarter.
• The company noted a dependence on a single product, Barostim, and highlighted risks regarding competitors developing safer, more effective, or less costly products.

Risks and Challenges:

• The company faces risks related to the ability to continue demonstrating the merits of Barostim to physicians and patients.
• There are risks associated with third-party payors failing to provide adequate coverage and reimbursement.
• The company cites risks regarding product liability claims, future lawsuits to protect intellectual property, and dependence on third-party manufacturers and suppliers.
• Forward-looking statements highlight risks related to enrollment in the BENEFIT-HF clinical trial and the resulting impact on the addressable market.

Management Commentary and Tone:

• Kevin Hykes, President and CEO, stated the company remains encouraged by progress on strategic initiatives, including the expansion of Medicare Advantage coverage and clinical evidence released at HFSA.
• Management expressed confidence in the ability to bring the therapy to more heart failure patients with new coverage policies, BENEFIT-HF enrollment, and continued focus on commercial execution.
• The tone acknowledged that "there is more work ahead" while highlighting disciplined cost management and investment in sales and reimbursement teams.

Other Key Points:

• John Landry was appointed Chief Financial Officer effective November 6, 2026, succeeding Jared Oasheim.
• Pursuant to Nasdaq Listing Rule 5635(c)(4), Mr. Landry will receive an inducement grant on November 9, 2026, consisting of stock options for 186,447 shares and restricted stock units for 41,433 shares.
• The stock options vest 25% on the first annual anniversary and then in equal monthly installments over the subsequent three years; RSUs vest 25% on each annual anniversary.
• The company reported a net loss per share of $1.55 for the nine months ended September 30, 2026, compared to $1.59 in the prior year period.
• Total revenue for the nine months ended September 30, 2026, was $44.3 million, an increase from $40.6 million in the same period in 2025.