CVRx Q1 Earnings Call Highlights

Key Points

• CVRx topped first-quarter expectations with revenue of $14.8 million, up 20% year over year, driven mainly by a 22% increase in U.S. revenue from its Barostim heart failure business.
• Profitability metrics improved as gross margin expanded to 87% from 84% and net loss narrowed slightly to $13.1 million, while the company ended the quarter with $72.3 million in cash.
• Management highlighted reimbursement and clinical progress, including improved prior authorization rates under new Medicare Advantage rules and the first patient enrollment in the BENEFIT-HF trial, which could significantly expand Barostim’s addressable market if successful.

CVRx NASDAQ: CVRX reported first-quarter 2026 revenue of $14.8 million, up 20% from the prior-year period, as U.S. growth in its Barostim heart failure business helped the company exceed the high end of its guidance range, executives said on the company’s earnings call.

President and Chief Executive Officer Kevin Hykes said the quarter showed “early evidence” that investments made during 2025 are beginning to translate into results. Those efforts included strengthening the sales organization, refining the company’s go-to-market strategy, advancing reimbursement initiatives and securing approval for the BENEFIT-HF clinical trial.

“The Q1 reflects positive momentum across every part of our business,” Hykes said. “Our sales team is executing, the reimbursement environment is improving, and our clinical evidence program is advancing on schedule.”

U.S. Revenue Rises 22%

Chief Financial Officer Jared Oasheim said U.S. revenue was $13.7 million in the quarter, an increase of $2.5 million, or 22%, from the first quarter of 2025. U.S. revenue units totaled 429, compared with 359 in the prior-year period.

Oasheim attributed the U.S. gains primarily to continued growth in the heart failure business, including expansion into new sales territories and accounts, as well as increased physician and patient awareness of Barostim.

The company ended the quarter with 257 active implanting centers, up from 252 at the end of 2025. CVRx also had 56 U.S. sales territories at quarter-end, compared with 53 at the end of 2025 and 45 as of March 31, 2025.

European revenue was $1.1 million, down $27,000, or 2%, from a year earlier. Revenue units in Europe declined to 56 from 59, while the number of European sales territories remained at five.

Gross profit was $12.9 million, up 25% year over year, while gross margin improved to 87% from 84%. Oasheim said the increase reflected a higher average selling price and lower cost per unit, primarily due to improved manufacturing efficiencies.

Net Loss Narrows, Cash Position Remains at $72.3 Million

CVRx reported a first-quarter net loss of $13.1 million, or 50 cents per share, compared with a net loss of $13.8 million, or 53 cents per share, in the first quarter of 2025. The per-share results were based on 26.4 million weighted average shares outstanding in the latest quarter and 25.9 million a year earlier.

Research and development expenses increased 23% to $3.1 million, driven by higher consulting costs, compensation expenses and stock-based compensation, partially offset by lower clinical trial expenses. Selling, general and administrative expenses rose 3% to $22 million, primarily due to increased compensation and stock-based compensation, partly offset by lower consulting and advertising costs.

Interest expense increased by $94,000 to $1.6 million, which Oasheim said was driven by increased borrowings under the company’s term loan agreement with Innovatus Capital Partners. Other income, net, was $0.6 million, down from $1.1 million, primarily due to a lower cash balance.

As of March 31, CVRx had $72.3 million in cash and cash equivalents. Net cash used in operating and investing activities was $12.3 million, compared with $12.9 million in the prior-year period.

Prior Authorization Rates Improve, but March Softens

Hykes said the transition to Category I CPT codes, which took effect Jan. 1, represented “the most significant reimbursement advancement” in the company’s history. The 30-day Medicare Advantage prior authorization approval rate for submissions managed by CVRx’s in-house market access team was 46% in the first quarter, compared with 31% in 2024 and 44% in 2025.

Within the quarter, Hykes said the approval rate was 50% through the first two months before declining in March. He attributed the March softening to changes in the broader reimbursement environment affecting the medical device industry, rather than to a change in the clinical or coverage rationale for Barostim.

Hykes said new regulations requiring Medicare Advantage payers to respond to prior authorization requests within three or seven days, depending on urgency, led some payers to implement automated review processes beginning in late February. That resulted in more initial denials, often based on an experimental designation, even for therapies with Category I codes and clinical evidence.

“We believe that this is simply a timing issue and not a change to the ultimate approval rates because when our market access team appeals these decisions with additional clinical documentation, most of the initial denials are overturned successfully,” Hykes said.

During the question-and-answer portion of the call, Hykes said the company has begun using its own artificial intelligence tools to ensure prior authorization requests are complete and to respond to automated payer reviews. He said CVRx does not expect to expand its market access team to handle the increased initial denials.

BENEFIT-HF Trial Begins Enrollment

CVRx also highlighted progress on BENEFIT-HF, a randomized controlled trial evaluating Barostim in a broader heart failure population with ejection fraction up to 50% and NT-proBNP levels up to 5,000.

Hykes said CVRx activated the first trial site in the first quarter and enrolled its first patient last week. He said feedback from the heart failure community has been positive and that the trial is also generating engagement from centers interacting with CVRx for the first time.

If successful, Hykes said the trial could expand the company’s prevalence-based addressable market from approximately 339,000 patients to more than 980,000 patients, tripling the market opportunity to about $30 billion.

Oasheim said CVRx is being cautious about expectations for trial site activation in 2026. He said it could take 12 to 24 months to reach the target of 150 activated sites. In response to another analyst question, Oasheim said the company has described the trial timeline as five to seven years, including a two-year follow-up period after full enrollment.

Guidance Reiterated for 2026 Revenue

CVRx reiterated its full-year 2026 revenue guidance of $63 million to $67 million. The company now expects full-year gross margin of 85% to 87% and continues to expect operating expenses of $103 million to $107 million. For the second quarter, CVRx expects total revenue of $15.1 million to $16.1 million.

Oasheim said the company did not want to get ahead of itself by raising full-year revenue guidance after one quarter, despite the first-quarter outperformance. He said the guidance assumes prior authorization approval rates that are broadly consistent with 2025 levels, rather than assuming a benefit from Category I CPT codes.

“We’re really happy with the results of seeing that re-acceleration get back to 20% growth, but just don’t want to get ahead of ourselves by updating guide too early in the year,” Oasheim said.

About CVRx NASDAQ: CVRX

CVRx, Inc is a clinical-stage medical device company focused on developing a neuromodulation platform therapy for patients with cardiovascular disease. The company's flagship product, the Barostim™ system, delivers targeted electrical stimulation to the carotid baroreceptors with the goal of modulating the body's natural blood pressure control mechanisms. This minimally invasive, implantable therapy is designed to address unmet needs in individuals suffering from hypertension and heart failure.

The Barostim system is currently being evaluated in multiple clinical trials, including studies in resistant hypertension and advanced heart failure.

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