Sign in
CI

CVRx, Inc. (CVRX)·Q3 2025 Earnings Summary

Executive Summary

  • Q3 2025 delivered 10% YoY revenue growth to $14.7M and a gross margin expansion to 87%; the company narrowed FY25 revenue guidance and raised the midpoint slightly, while materially lifting full-year gross margin guidance to 85–86% .
  • Results beat Wall Street consensus on revenue ($14.69M vs $14.16M*) and modestly on EPS (−$0.49 vs −$0.501*), while EBITDA was modestly worse than consensus (−$12.1M vs −$11.5M*) .
  • Commercial execution improved: active implanting centers rose to 250 (from 240 in Q2), U.S. revenue units increased to 420 (from 394 YoY), and reps showed broader contribution; management highlighted manufacturing efficiencies and ASPs as drivers of margin strength .
  • Reimbursement tailwinds are strengthening ahead of 2026: Category I CPT finalized and CMS maintained new-tech APC 1580 (~$45k outpatient payment); management sees these as catalysts for a 2026 growth re-acceleration to mid-teens .

What Went Well and What Went Wrong

  • What Went Well

    • “We grew revenue by double digits year over year and expanded our commercial footprint… newer reps are hitting their stride” — CEO Kevin Hykes .
    • Gross margin expanded to 87% on higher ASPs and lower cost per unit from manufacturing efficiencies .
    • Reimbursement progress: Category I CPT codes finalized and favorable physician fee levels; CMS maintained new-tech APC 1580 for outpatient procedures (~$45,000) .

  • What Went Wrong

    • EBITDA came in below consensus (actual −$12.1M vs −$11.5M*), with higher interest expense tied to term loan borrowings; SG&A slightly up YoY .
    • Q4 revenue guide implies slower sequential growth (~6% at midpoint) vs recent 8–10% sequential cadence, reflecting conservatism as rep productivity ramps .
    • R&D increased 26% YoY to $3.1M (compensation and consulting), reflecting investment needs ahead of potential RCT and portfolio initiatives .

Financial Results

MetricQ3 2024Q1 2025Q2 2025Q3 2025
Revenue ($USD Millions)$13.37 $12.30 $13.60 $14.69
Gross Margin (%)83% 84% 84% 87%
Net Loss ($USD Millions)$(13.10) $(13.80) $(14.00) $(12.87)
Net Loss per Share ($)$(0.57) $(0.53) $(0.57) $(0.49)
Q3 2025 vs EstimatesConsensus*Actual
Revenue ($USD Millions)$14.16*$14.69
Primary EPS ($)$(0.501)*$(0.49)
EBITDA ($USD Millions)$(11.51)*$(12.07)
  • Segment and KPI details
KPI (Q3 2025 unless noted)Value
U.S. Revenue ($USD Millions)$13.5
Europe Revenue ($USD Millions)$1.2
U.S. Revenue Units (YoY)420 vs 394
Europe Revenue Units (YoY)50 vs 56
Active Implanting Centers (U.S.)250 (vs 240 at Q2-end)
U.S. Sales Territories50 (up 3 in Q3)
Cash & Cash Equivalents$85.1M
Net Cash Used (Op + Investing)$10.0M

Note: Asterisks (*) indicate values retrieved from S&P Global.

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
Total Revenue ($USD Millions)FY 2025$55.0–$57.0 $55.6–$56.6 Narrowed range; midpoint slightly raised
Gross Margin (%)FY 202583–84% 85–86% Raised
Operating Expenses ($USD Millions)FY 2025$96–$98 $98–$99 Raised
Revenue ($USD Millions)Q4 2025$13.7–$14.7 $15.0–$16.0 Raised

Earnings Call Themes & Trends

TopicPrevious Mentions (Q1 & Q2)Current Period (Q3 2025)Trend
Sales force transformation & productivityQ1: Disruption from reorganization; 50% of TMs hired last 15 months; expect 3 territories/quarter going forward . Q2: Stabilization; activation resumed; targeted 3 territories/quarter .More reps contributing than ever; onboarding pace improving; territory count 50; active centers 250 .Improving productivity, broader contribution
Reimbursement (CPT/OPPS/APC)Q1: Category I CPT expected 2026; OPPS comment for Level 6; APC 1580 ~ $45k outpatient . Q2: Proposed 11 work RVUs; maintained APC 1580; awaiting final OPPS in Nov .Category I CPT finalized; continued strong MAC/commercial support; OPPS final pending; management expects reduced friction in 2026 .Positive tailwinds; increasing predictability
Gross margin driversQ2: 84% GM; pricing helped; expected similar in H2 .87% GM driven by ASP uplift (> $31k) and manufacturing efficiencies/lower unit costs .Structural improvement from cost efficiencies
Clinical evidence & RCTQ1: Planning pragmatic RCT (EF up to 50%, NT-proBNP up to 5,000); 1–2k patients, 100–150 centers . Q2: Continued FDA/CMS dialogue; evidence generation via real-world/ISR .IDE submitted mid-Oct; anticipating FDA feedback late Nov; targeting Category B IDE coverage; ~2,000 patients; 100+ centers .Advancing toward protocol agreement
Account strategy & tiersQ1/Q2: Focus on Tier 1/2; selective Tier 3/4 with champions; satellite-to-flagship pathways .Top accounts doing >10 implants per quarter; >20% of centers achieved ≥3 implants in Q3 .Deepening adoption in high-potential centers
Macro/tariffsQ1: Low tariff exposure; minimal macro impact expected .No change noted .Stable

Management Commentary

  • “Our refined approach to account targeting guides our expansion strategy, focusing on high-potential Tier One and Tier Two accounts… We added 10 net new centers this quarter and are seeing traction.” — Kevin Hykes .
  • “ASPs for the quarter were north of $31,000 on a worldwide basis… the bigger chunk that drove this improvement in Q3 margins was the cost per unit.” — Jared Oasheim .
  • “The Category One designation eliminates the experimental and investigational denials… we believe it will result in higher rates of approval and shorter times to those approvals for prior authorizations.” — Kevin Hykes .
  • “We are expecting to see a re-acceleration of growth… initially targeting the mid-teens for 2026.” — Jared Oasheim .

Q&A Highlights

  • Guidance cadence: Q4 midpoint implies ~6% sequential growth vs recent 8–10%; management kept conservatism until reps fully productive .
  • Margin durability: Mix of ASP uplift and cost efficiencies, with greater confidence in sustained cost improvements as volumes scale .
  • 2026 trajectory: Mid-teens growth targeted, with potential upside if Category I and payer processes reduce friction as expected .
  • RCT plan: ~2,000 patients, 100+ centers; seeking Category B IDE coverage; first patients potentially in H1 2026 subject to FDA/CMS approvals .
  • OpEx outlook: Q4 sequential step-down primarily in SG&A (seasonally lighter marketing/tradeshows) .

Estimates Context

  • Q3 2025 beats/misses: Revenue beat ($14.69M vs $14.16M*), EPS beat (−$0.49 vs −$0.501*), EBITDA miss (−$12.07M vs −$11.51M*). Street had 7 estimates for revenue/EPS .
  • Q4 2025: Company guide $15–$16M aligns with consensus midpoint ($15.50M*); EPS consensus −$0.444*; management signals continued sequential growth but remains prudent pending productivity ramps .
  • 2026 setup: Street modeling ~mid-teens revenue growth; management broadly comfortable aiming mid-teens, dependent on reimbursement and sales force maturation .
    Note: Asterisks (*) indicate values retrieved from S&P Global.

Key Takeaways for Investors

  • Revenue/margin quality improved: Structural manufacturing efficiencies and ASP support drove an 87% GM; watch sustainability into 2026 as volumes scale .
  • Commercial momentum building: Active centers reached 250; broader rep contribution and targeted Tier 1/2 focus indicate deepening adoption — a key driver of unit growth .
  • Reimbursement is a 2026 catalyst: Category I CPT and maintained APC 1580 should reduce prior auth friction and sustain hospital economics; monitor OPPS final rule and payer behavior .
  • Near-term prudence: Q4 guide is conservative vs recent cadence; look for sequential growth and SG&A moderation in Q4 .
  • RCT optionality: A large pragmatic trial could materially expand TAM (EF to 50%, NT-proBNP to 5,000) and raise profile; timing depends on FDA/CMS approvals .
  • Watch financing/interest expense: Higher term loan interest increased expense; cash of $85.1M provides runway to execute priorities .
  • Estimate revisions: Expect upward adjustments to GM assumptions for FY25 and potential fine-tuning of Q4 revenue/EPS; 2026 mid-teens growth looks increasingly attainable as Category I and payer dynamics take effect .

Appendix: Additional Details

  • Press release highlights and detailed financial statements embedded in 8-K (Ex. 99.1) confirm revenue $14.69M, GM 87%, net loss $(12.87)M, EPS $(0.49), cash $85.1M .
  • Prior quarter references: Q2 2025 revenue $13.6M, GM 84%, EPS $(0.57); Q1 2025 revenue $12.3M, GM 84%, EPS $(0.53) .

S&P Global disclaimer: All values marked with an asterisk (*) are retrieved from S&P Global analyst consensus estimates via GetEstimates.