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Inspire Medical Systems, Inc. (INSP) Q4 2024 Earnings Summary

Executive Summary

  • Q4 2024 revenue rose 25% year over year to $239.7M, with diluted EPS at $1.15 and gross margin at 85.0% . Management highlighted this as the company’s first full year of profitability and reiterated strong momentum into 2025 .
  • FY 2025 guidance reaffirmed: revenue $940–$955M (+17–19% YoY), gross margin 84–86%, diluted EPS $2.10–$2.20; tax rate ~10%; diluted shares ~31M .
  • Inspire V limited market release underway; full 2025 launch contingent on inventory scale, with reimbursement alignment via CPT 64568 and no expected near‑term gross margin drag; Inspire V expected to be a tailwind to gross margin and capacity .
  • DOJ civil investigative demand received Jan 17 related to marketing, promotion and reimbursement practices; company will fully cooperate and does not anticipate interference with operations .
  • Cash generation improved: operating cash flow was $69.2M in Q4 (FY $130.2M), cash and investments ended FY at $516.5M; company executed a $75M accelerated share repurchase in Nov 2024 .

What Went Well and What Went Wrong

What Went Well

  • Strong top-line and profitability: Q4 revenue +25% YoY to $239.7M; operating income $31.9M; net income $35.2M; adjusted EBITDA $62.7M (26% margin) . CEO: “We are thrilled with our strong performance… delivering nearly $32 million in operating income and increasing diluted net income per share 135% year-over-year” .
  • Execution on Inspire V and SleepSync: limited Inspire V implants in Singapore and U.S., positive early feedback; SleepSync programmer fully launched in U.S., improving programming efficiency and data access . CFO: raised annual gross margin guidance to 84–86% and noted Inspire V is a tailwind .
  • Commercial scale and market development: added 72 U.S. centers (total 1,435) and 12 sales territories (total 335) in Q4; digital scheduling expanded to ~300 centers to streamline patient appointments .

What Went Wrong

  • Regulatory overhang: DOJ CID introduces uncertainty (scope, timing, potential costs). Management provided limited detail given early stage but does not expect operational interference .
  • Near-term earnings cadence: management expects negative EPS in Q1 2025 due to seasonality, with sequential improvement thereafter; implies limited near-term leverage despite full-year profitability trajectory .
  • Inspire V full launch timing gated by inventory scale; management emphasized avoiding start‑stop transitions between IV and V, requiring careful ramp of production capacity .

Financial Results

Sequential Performance (Q2→Q3→Q4 2024)

MetricQ2 2024Q3 2024Q4 2024
Revenue ($USD Millions)$195.9 $203.2 $239.7
Diluted EPS ($)$0.32 $0.60 $1.15
Gross Margin %84.8% 84.1% 85.0%

Year-over-Year Comparison (Q4 2023 → Q4 2024)

MetricQ4 2023Q4 2024
Revenue ($USD Millions)$192.5 $239.7
Diluted EPS ($)$0.49 $1.15
Gross Margin %85.4% 85.0%
Net Income ($USD Millions)$14.8 $35.2
Adjusted EBITDA ($USD Millions)$33.0 $62.7

Geographic Mix

MetricQ2 2024Q3 2024Q4 2024
U.S. Revenue ($USD Millions)$187.8 $195.8 $231.6
Outside U.S. Revenue ($USD Millions)$8.1 $7.4 $8.1

Operating KPIs

KPIQ2 2024Q3 2024Q4 2024
Active U.S. Centers1,316 1,371 1,435
U.S. Sales Territories310 323 335
Operating Cash Flow ($USD Millions)$52 $69.2

Balance Sheet Snapshot (FY End)

MetricDec 31, 2023Dec 31, 2024
Cash, Cash Equivalents & Investments ($USD Millions)$469.5 $516.5
Total Assets ($USD Millions)$676.8 $808.4
Total Equity ($USD Millions)$572.5 $689.7

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
Revenue ($USD Millions)FY 2025$940–$955 (initial Jan 13, 2025) $940–$955 (reaffirmed) Maintained
Gross Margin %FY 202584–86 Introduced; midpoint +100 bps vs prior year guide commentary
Diluted EPS ($)FY 2025$2.10–$2.20 Introduced
Tax Rate % (reported)FY 2025~10% Introduced (color)
Diluted Shares (Millions)FY 2025~31 Introduced (color)
Interest Income ($USD Millions)FY 2025$20 for the year ($5 per quarter) Introduced (color)
Centers/TerritoriesFY 2025Company historically guided centers; Q4 noted end of center guidance No longer guiding centers; will disclose territories and field clinical reps Discontinued center guidance

Earnings Call Themes & Trends

TopicQ2 2024 (Prev)Q3 2024 (Prev)Q4 2024 (Current)Trend
Inspire V (Gen 5) launch & reimbursementFDA approval; soft launch late 2024; pricing parity to Gen 4; GM accretive Coding plan to be finalized; old OPPS rates slightly up; full launch 2025 Limited US/Singapore implants; CPT 64568 appropriate; inventory ramp gating full launch; <5% of procedures in Q1; transition by year-end Progressing to broad launch in 2025
SleepSync, digital schedulingEarly launch; 200 centers using digital scheduling; +60% first-attempt appointment success ~250 centers using digital scheduling ~300 centers using digital scheduling; SleepSync fully launched; providers use own devices Scaling adoption
Utilization & capacityAim to increase sequentially; APPs to free ENT time Flat vs Q2; hurricanes/IV fluid shortage noted; expect seasonal cadence Expect negative EPS in Q1, sequential improvement thereafter Seasonal reset; sequential rebuild
Market access & payer policyPredictors to reduce DISE for low BMI; Medicare rates slight increase 2025 Medicare outpatient/ASC rates up; payer updates on expanded indications UHC DISE wording being discussed; payer updates continue; CPT 64568 utilized for V Ongoing updates
DOJ investigationCID received Jan 17; early stage; no expected interference New regulatory overhang
International expansionEU MDR certification; France reimbursement; OUS ~3–4% of WW revenue France and UK expected to contribute; OUS growth OUS to remain ~3–4% WW revenue in 2025 Stable low mix
GLP-1 dynamicsViewed complementary; claims data showed 1,500 dual claims; expected tailwind Complementary; awaiting label specifics; potential tailwinds On-label discussions ongoing; no tailwind yet observed; expect benefit over time Potential future tailwind

Management Commentary

  • “2024 was filled with many important milestones… and our first full year of profitability” .
  • “We are reiterating our full year 2025 revenue guidance of $940 million to $955 million… we expect diluted net income to be in the range of $2.10 to $2.20 per share” .
  • On Inspire V: “Respiratory sensing internal to the neurostimulator… eliminating the need to implant the pressure sensing lead… benefits include reduced surgical time and reduced production complexity and cost” .
  • On DOJ CID: “We intend to fully cooperate… We do not anticipate that the investigation will interfere with the important work we’re doing” .
  • EPS cadence: “We do not expect to be profitable in the first quarter, but then we’ll have sequential improvement thereafter” .

Q&A Highlights

  • EPS/Profitability cadence: Management expects negative EPS in Q1 2025 due to seasonality, with sequential improvement thereafter; comfortable with Street Q1 estimates .
  • Inspire V ramp and margin: Inspire V is a gross margin tailwind; limited launch now, inventory ramp gating full launch; reimbursement via CPT 64568 seen as appropriate; ASC economics improved with ~+$1,100 reimbursement vs prior settings .
  • International mix & interest income: OUS to remain ~3–4% of WW revenue in 2025; interest income guided to $20M for FY ($5M/quarter) .
  • Payer policy updates: UHC DISE language under discussion; broader move to reduce DISE for low BMI via PREDICTOR algorithm (e.g., BMI and neck circumference criteria) .
  • DOJ CID: Early stage; limited incremental detail; company confident in compliance programs .

Estimates Context

  • Wall Street consensus comparisons (EPS, revenue) via S&P Global were unavailable due to a temporary request limit; therefore formal beat/miss analysis vs consensus cannot be provided at this time. Management indicated comfort with Q1 estimates and reiterated FY 2025 guidance .

Key Takeaways for Investors

  • Q4 capped a pivotal year: 25% revenue growth, strong operating leverage, and first full-year profitability; momentum supported by broad center and territory expansion .
  • 2025 setup: Reaffirmed revenue growth (+17–19%), higher gross margin range, and EPS guidance imply continued scale despite Q1 seasonal reset; sequential improvement expected through the year .
  • Inspire V as a structural driver: Reduced OR time, simpler procedure, and gross margin tailwind should expand capacity and improve economics; full U.S. transition targeted by year-end pending inventory scale .
  • Execution focus: Scaling SleepSync and digital scheduling ameliorates bottlenecks in patient flow; continued payer engagement supports reduced DISE requirements for low BMI patients .
  • Regulatory watch: DOJ CID is an overhang but management does not expect operational impact; monitor disclosures for scope/timing/costs .
  • International stable but small: OUS likely remains ~3–4% of mix; U.S. dynamics and capacity are primary revenue drivers .
  • Capital allocation: Strong cash generation and completed $75M ASR provide flexibility; watch for opportunistic repurchases and investments to accelerate patient flow .

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