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CVRx, Inc. (CVRX)·Q4 2024 Earnings Summary

Executive Summary

  • Q4 revenue grew 36% year over year to $15.3M on strong U.S. Heart Failure adoption; gross margin was 83% (down ~200 bps YoY on higher cost per unit); net loss per share was $0.43 .
  • U.S. HF revenue rose 41% YoY to $14.3M on 457 revenue units, driven by more territories, new accounts, and rising physician/patient awareness; active implanting centers reached 223 (vs. 178 YE23) .
  • Reimbursement backdrop improved materially into 2025: inpatient DRG reassigned to ~$43k (effective Oct 1, 2024) and outpatient OPPS placement maintained at ~$45k for 2025, effectively equalizing settings and supporting access .
  • FY25 guidance maintained: revenue $63–$65M, gross margin 83–84%, OpEx $100–$104M; Q1’25 revenue guided to $14.5–$15.0M; management expects typical Q1 seasonality, then steady growth through 2025 .

What Went Well and What Went Wrong

  • What Went Well

    • U.S. HF growth accelerated: Q4 U.S. HF revenue +41% YoY to $14.3M on 457 units; sales territories expanded to 48 and active implanting centers to 223 .
    • Reimbursement milestones: CMS maintained outpatient payment at ~$45k for 2025 (OPPS APC 1580) and increased inpatient payment to ~$43k (DRG 276), equalizing settings and improving access .
    • Strategic focus and tone: “We capped off a very strong 2024… well‑positioned to drive the continued adoption of Barostim therapy,” CEO Kevin Hykes noted, citing a world‑class sales org and priority programs to deepen utilization and address adoption barriers .
  • What Went Wrong

    • Gross margin modestly compressed to 83% (vs. 85% LY) due to higher cost per unit, partially offset by volume leverage .
    • Operating intensity remained elevated: Q4 SG&A rose 19% YoY to $20.2M on headcount, stock‑based comp, and travel; FY24 OpEx reached $91.3M (included ~$8.4M one‑time CEO option mod in Q1’24) .
    • Europe mixed: Q4 Europe revenue flat at $1.0M with units down to 41 (from 52), and management trimmed 1 OUS territory amid spend discipline .

Financial Results

  • Income statement snapshot (company-reported)
MetricQ2 2024Q3 2024Q4 2024
Revenue ($M)$11.807 $13.373 $15.342
Gross Profit ($M)$9.907 $11.125 $12.771
Gross Margin (%)84% 83% 83%
Total OpEx ($M)$23.880 $24.136 $23.045
Loss from Operations ($M)$(13.973) $(13.011) $(10.274)
Net Loss/Share (basic & diluted)$(0.65) $(0.57) $(0.43)
Weighted Avg Shares (M)21.63 22.78 24.72
  • Q4 2024 vs Wall Street consensus

    • Consensus revenue and EPS from S&P Global were not retrievable at this time due to system limits; we cannot determine a beat/miss for Q4 2024. We attempted to fetch consensus for Q4 2024 and Q1 2025 but were unable to retrieve the data.
  • Segment and geography

Q4 2024 Segment DetailAmount/Units
U.S. Revenue ($M)$14.4
U.S. HF Revenue ($M)$14.3
U.S. HF Revenue Units457
Europe Revenue ($M)$1.0
Europe Units41
  • Segment trajectory (prior two quarters)
MetricQ2 2024Q3 2024Q4 2024
U.S. Revenue ($M)$10.7 $12.3 $14.4
U.S. HF Revenue ($M)$10.5 $12.2 $14.3
U.S. HF Units339 391 457
Europe Revenue ($M)$1.1 $1.1 $1.0
Europe Units63 56 41
  • KPIs and balance sheet
KPIQ2 2024Q3 2024Q4 2024
Active Implanting Centers (U.S.)189 208 223
U.S. Sales Territories42 45 48
Cash & Cash Equivalents ($M)$70.4 $100.2 $105.9
Long-term Debt ($M)$29.3 $49.2 $49.3

Why: Management attributes Q4 growth to territory expansion, new accounts, and increased physician/patient awareness; gross margin compression stemmed from higher cost per unit; SG&A growth reflects headcount and SBC; interest expense rose with higher term-loan borrowings .

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
Total RevenueFY 2025$63.0M–$65.0M (Jan 13, 2025) $63.0M–$65.0M (Feb 4, 2025) Maintained
Gross MarginFY 202583%–84% (Jan 13, 2025) 83%–84% (Feb 4, 2025) Maintained
Operating ExpensesFY 2025$100.0M–$104.0M (Jan 13, 2025) $100.0M–$104.0M (Feb 4, 2025) Maintained
Total RevenueQ1 2025$14.5M–$15.0M (Jan 13, 2025) $14.5M–$15.0M (Feb 4, 2025) Maintained

Call context: 2025 guidance assumes ASPs roughly consistent with 2024 (~$31k/device U.S. HF), high‑single‑digit to low‑double‑digit net new active centers per quarter, and utilization returning to Q4 levels after seasonal Q1 dip .

Earnings Call Themes & Trends

TopicPrevious Mentions (Q2 2024, Q3 2024)Current Period (Q4 2024)Trend
Reimbursement (OPPS/IPPS)Anticipated inpatient DRG increase; advocating OPPS outcome; later confirmed IPPS DRG ~$43k; OPPS process ongoing OPPS for 2025 maintained at APC 1580 (~$45k) and inpatient DRG reassigned to ~$43k; equalization supports access Positive, stabilized access
CPT Category I codesAMA accepted Category I CPT codes, effective Jan 1, 2026 Category I codes expected to streamline prior authorization and broaden access; RVUs visibility expected in July Structural tailwind building into 2026
Commercial execution, salesforceLeadership hires; focus on deeper adoption; fewer new centers near term Compensation redesigned to reward program depth; inclusive rollout; strong reception and retention Execution improving
Utilization per centerFocus shifting from new adds to deeper utilization Record units/center in Q4; targeting “North Star” accounts with multiple champions and implanters Utilization rising
EuropeStable to modest; spend calibrated One territory reduced; Europe revenue flat; continuing disciplined OUS investment Flat to cautious
Cash burn cadenceAdded liquidity (debt/ATM); flexibility to invest Seasonal cash burn step-up in Q1, then decline through year; FY25 burn expected lower YoY Improving trajectory

Management Commentary

  • “We capped off a very strong 2024… focused on three key strategic priorities to drive Barostim toward becoming the standard of care – building a world‑class sales organization, supporting the development of sustainable Barostim programs… and addressing barriers to adoption.” – Kevin Hykes, CEO .
  • “CMS maintained Barostim in the new technology APC 1580 for 2025… On an inpatient basis, we successfully secured the reassignment of Barostim to DRG 276… approximately $43,000… effectively equalized between inpatient and outpatient settings.” – Kevin Hykes .
  • “For 2025, we’re focused on 3 key strategic priorities… a new compensation structure that rewards the key elements of a successful program… targeting centers with the highest potential… and a steady cadence of publications and real‑world evidence.” – Kevin Hykes .

Q&A Highlights

  • 2025 guidance mechanics: Base ASP ~$31k in U.S. HF; net new centers high single digit to low double digit per quarter; utilization dips seasonally in Q1 then returns to Q4 levels .
  • OpEx framework: 2024 OpEx just over $102M included ~$8.4M one‑time option modification in Q1; 2025 OpEx growth concentrated in sales & marketing as territories expand ~3 per quarter .
  • Sales comp plan: Inclusive rollout with program‑related accelerators to deepen adoption (consistency, diversified referral sources, redundant surgical partners) and strong field reception .
  • Site‑of‑service: No material shift yet to inpatient post‑DRG change; will monitor CMS data; OUS territories reduced due to ROI .
  • “North Star” account construct: multiple HF prescribers, diversified referrers, multiple implanters, and admin partner; comp plan pays more where program elements exist .
  • Cash burn: Step-up in Q1 from bonuses/one‑timers; declining sequentially thereafter; 2025 annual burn expected down YoY .

Estimates Context

  • We attempted to pull S&P Global consensus EPS and revenue for Q4 2024 and Q1 2025 but the data were unavailable due to temporary request limits. As a result, we cannot definitively state beat/miss versus consensus for Q4 2024 at this time. We can update this section when access is restored.

Key Takeaways for Investors

  • Strong U.S. HF momentum with accelerating unit growth and record units per center in Q4 suggests deepening adoption as program‑focused selling takes hold .
  • Reimbursement tailwinds into 2025 are meaningful: OPPS maintained ($45k) and IPPS reassigned ($43k), reducing economic friction across sites of service and supporting volume scalability .
  • FY25 guide (23–27% growth) was reiterated; management expects Q1 seasonality then steady quarterly growth—watch utilization per center and net new AICs as leading indicators .
  • Operating leverage is progressing, but SG&A intensity remains elevated to build programs; monitor OpEx trajectory versus revenue as 48 territories ramp through 2025 .
  • Europe remains a modest contributor; disciplined OUS investment prioritizes ROI while U.S. drives growth .
  • Structural catalysts: Category I CPT codes (effective Jan 1, 2026) should streamline prior auth and broaden payer coverage; initial RVU view expected mid‑year 2025 .
  • Liquidity looks adequate (cash $105.9M) with debt in place; management expects lower FY25 cash burn; track progress against quarterly burn cadence .

Appendix: Source Documents (Q4 2024)

  • 8‑K and press release with full financials and 2025/Q1’25 guidance .
  • Q4 2024 earnings call transcript (prepared remarks and Q&A) .
  • Prior quarters for trend: Q3’24 release/transcript ; Q2’24 release/transcript .
  • Reimbursement updates: OPPS final rule (APC 1580) ; CPT Category I codes acceptance .
  • Additional RWE: post‑quarter conference (THT) real‑world data on reduced hospital utilization .