CVRXMEDIUM SIGNALFINANCIAL10-K

CVRX significantly expanded its market opportunity assessment while burning through cash amid ongoing losses, though operational performance showed modest improvement.

The company increased its total addressable market estimate from $2.2 billion to $10.5 billion using a prevalence-based model while adding a separate $2.4 billion annual incidence-based opportunity, suggesting greater confidence in its Barostim therapy's commercial potential. However, the company burned through $30 million in cash while maintaining substantial operating losses, raising questions about runway and path to profitability despite improving operational metrics.

Comparing 2026-02-13 vs 2025-02-18View on EDGAR →
FINANCIAL ANALYSIS

CVRX showed mixed financial performance with gross profit growing modestly to $48.3 million and operating losses narrowing to $51.3 million, indicating improving operational efficiency. However, the company's cash position declined meaningfully from $105.9 million to $75.7 million while stockholders' equity fell to $39.3 million, reflecting continued cash burn amid ongoing losses. The overall picture suggests a company making operational progress but still requiring significant capital to reach profitability.

FINANCIAL STATEMENT CHANGES
Capital Expenditure
Cash Flow
-57.4%
$1.4M$580K

Capex reduced 57.4% — investment cycle winding down or capital discipline; may improve near-term free cash flow.

Stockholders Equity
Balance Sheet
-44.7%
$71.1M$39.3M

Equity declined sharply — large losses, buybacks, or write-downs reducing book value significantly.

Cash & Equivalents
Balance Sheet
-28.5%
$105.9M$75.7M

Cash decreased 28.5% — monitor burn rate and upcoming capital needs.

Current Liabilities
Balance Sheet
+23.7%
$10.8M$13.3M

Current liabilities rose 23.7% — increased short-term obligations, watch current ratio.

Current Assets
Balance Sheet
-21.7%
$129.8M$101.6M

Current assets declined 21.7% — monitor working capital adequacy and short-term liquidity.

Total Assets
Balance Sheet
-21.5%
$133.4M$104.8M

Total assets contracted 21.5% — asset sales, write-downs, or balance sheet optimization underway.

Accounts Receivable
Balance Sheet
+15.1%
$9.3M$10.7M

Receivables grew 15.1% — monitor days sales outstanding for collection efficiency.

Operating Income
P&L
+13.8%
-$59.5M-$51.3M

Operating income improving — cost discipline or growing revenue base absorbing fixed costs.

Gross Profit
P&L
+12.5%
$43.0M$48.3M

Gross profit expanding — improving pricing power or product mix shift toward higher-margin offerings.

Net Income
P&L
+11.1%
-$60.0M-$53.3M

Net income grew 11.1% — bottom-line growth signals improving overall business health.

LANGUAGE CHANGES
NEW — 2026-02-13
PRIOR — 2025-02-18
ADDED
As of February 6, 2026, there were 26,311,607 shares of the registrant s common stock, par value $0.01 per share outstanding.
We estimate our total market opportunity using both prevalence and incidence epidemiologic models in which prevalence reflects the total number of individuals indicated for therapy at a given time, while incidence captures the annual occurrence of new cases meeting the indication.
Based on these distinct models, we estimate that our prevalence-based market opportunity for HFrEF is $10.5 billion in the U.S.
Using an incidence-based model, we estimate an annual market opportunity of $2.4 billion in the U.S.
We currently believe, using a prevalence-based epidemiologic model, our market opportunity in the U.S.
We are investigating the benefits of Barostim in an expanded population of patients with HF with mildly Reduced Ejection Fraction ( HFmrEF ) and HFrEF with NT-proBNP 5,000 pg/mL in a large, multi-center, randomized controlled trial.
could increase to an estimated $30.5 billion or 983,000 patients using a prevalence-based epidemiologic model.
and European Union ( EU ) patient registries and other real world evidence ( RWE ) datasets, in order to evaluate and assess a comprehensive view of outcomes from HFrEF patients who have been implanted with Barostim.
We are continuing to invest in investigator-sponsored studies, driven by the strong interest of independent clinicians seeking to further validate the mechanisms underlying the device s benefits.
and Germany and through distributors in Austria, Spain, and other European countries.
REMOVED
As of February 11, 2025, there were 26,036,032 shares of the registrant s common stock, par value $0.01 per share outstanding.
We estimate that our annual market opportunity for HFrEF is $2.2 billion in the U.S.
and $2.8 billion in select European Markets (Germany, France, Italy, Spain, and the United Kingdom, or European Five ).
We currently believe our annual market opportunity in the U.S.
is an estimated $2.2 billion, or 76,000 patients, based on this new long-term safety and effectiveness data as well as our commercial experience and, as discussed below, the new reimbursement assignment for Barostim in 2025.
and Germany and through distributors in Austria, Spain, Italy, the Nordic region, and other European countries.
Our global sales and marketing team engages in sales efforts and promotional activities focused on electrophysiologists ( EPs ), HF specialists, interventional cardiologists, general cardiologists, and vascular surgeons.
Our primary activities include continuing to increase education and awareness among physicians, advanced practice providers and patients, develop a more robust portfolio of clinical evidence, and improve patient access to Barostim Therapy.
We generated revenue of $51.3 million, a gross margin of 84% and a net loss of $60.0 million for the year ended December 31, 2024, compared to revenue of $39.3 million, a gross margin of 84% and a net loss of $41.2 million for the year ended December 31, 2023.
Our accumulated deficit as of December 31, 2024 and 2023, was $537.3 million and $477.4 million, respectively.
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