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Hyperfine, Inc. (HYPR)·Q3 2025 Earnings Summary

Executive Summary

  • Q3 2025 revenue was $3.4M, up 27% sequentially, with record gross margin of 53.8% driven by a record average selling price of ~$361K; net loss was $11.0M or -$0.14 per share .
  • Year-over-year, revenue was below Q3 2024 ($3.64M) but margins improved (53.8% vs. 52.0%); EPS was unchanged at -$0.14 .
  • Management guided Q4 2025 revenue to $5–$6M and raised FY 2025 gross margin guidance to 49–51%; FY cash burn guidance increased to $29–$31M, with cash runway extended into 2H 2027 .
  • Catalysts: strong next-gen mix (63% of units), conversion of the U.S. hospital pipeline to next-gen, office launch momentum, CE/UKCA approvals for Optive AI, and French national procurement reference (UniHA) supporting adoption .

What Went Well and What Went Wrong

  • What Went Well

    • Record margin and pricing: “Gross margin…53.8%, a record…driven by increased average selling price” and ASP ~$361K on eight units sold .
    • Product-market fit: “Images produced by our next-generation system with Optiv AI approach those of conventional 1.5 T MRI scanners,” enabling mainstream adoption across hospital, office, and international markets .
    • International momentum: CE and UKCA approvals for Optive AI and reference in France’s largest public hospital procurement (UniHA) to facilitate nationwide purchases .

  • What Went Wrong

    • YoY revenue below prior year: Q3 2025 revenue of $3.4M vs. $3.64M in Q3 2024 despite margin gains .
    • Elevated cash burn outlook: FY 2025 total cash burn guidance raised to $29–$31M (from $27–$29M in Q2) to support inventory and commercialization .
    • Wider net loss vs. Q2: Q3 net loss was $11.0M vs. $9.2M in Q2, including a $2.3M non-cash change in fair value of warrant liabilities .

Financial Results

MetricQ3 2024Q1 2025Q2 2025Q3 2025
Revenue ($USD Millions)$3.64 $2.10 $2.70 $3.40
Gross Profit ($USD Millions)$1.91 $0.90 $1.30 $1.80
Gross Margin %52.0% 41.3% 49.3% 53.8%
Diluted EPS ($USD)-$0.14 -$0.12 -$0.12 -$0.14
Units Sold (#)N/A6 8 8

KPIs

KPIQ1 2025Q2 2025Q3 2025
Effective Device ASP ($USD)$254,000 N/A$361,000
% Next-Gen of Units SoldN/A17% 63%
Cash Burn (Excl. Financing, $USD Millions)$10.1 $8.1 $5.9
Cash & Equivalents ($USD Millions, period-end)$33.1 $25.4 $21.6

YoY snapshot

MetricQ3 2024Q3 2025
Revenue ($USD Millions)$3.64 $3.40
Gross Margin %52.0% 53.8%
Diluted EPS ($USD)-$0.14 -$0.14

Notes:

  • Q3 2025 EPS includes a $2.3M non-cash warrant liability fair value change .
  • ASP and next-gen mix underpin margin expansion .

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
Revenue ($USD Millions)Q4 2025N/A$5–$6 Initiated
Revenue ($USD Millions)FY 2025+10%–20% YoY $13–$14 Updated format
Gross Margin %FY 202547%–50% 49%–51% Raised
Total Cash Burn ($USD Millions)FY 2025$27–$29 $29–$31 Raised
Cash RunwayMulti-yearThrough 2026 Into 2H 2027 Extended

Earnings Call Themes & Trends

TopicPrevious Mentions (Q1 2025)Previous Mentions (Q2 2025)Current Period (Q3 2025)Trend
AI/technology initiativesPlanned next-gen software/system; image quality to approach 1.5T FDA clearance for next-gen subsystem and Optiv AI; accelerated manufacturing; strong market response “Images approach 1.5 T” confirmation; Optiv AI 10th-gen; upgrade planned Q1’26 Accelerating
Hospital pipeline/ROISales cycles lengthened (1–1.5 yrs) Pipeline converted to next-gen; early next-gen hospital sales Entire U.S. hospital pipeline converted; ROI 1–1.5 yrs; multi-site placements; IDN engagement Expanding
Office adoptionPilot sites IAC accredited; reimbursement process underway Pilot completed; full launch commenced; Neuro PMR enrollment ahead of plan Full commercial launch; segmentation pricing; partnership with NeuroNet; Neuro PMR completed enrollment, data expected early 2026 Building
Regulatory & internationalIndia approval expected; stroke triage evidence (ACTION PMR) Optiv AI available in Canada/Australia/NZ; EU launch expected 2025; next-gen OUS by end of 2026 CE/UKCA approvals; Optiv AI launch in 10 EU languages in Q4; France UniHA reference Strengthening
Macros/tariffsMonitoring tariffs; inventory sufficient; guidance assumes no material impact No updates beyond execution focus No new tariff commentary; focus on commercialization scaling Stable
Clinical studiesER/stroke triage (ACTION PMR); building ER evidence PRIME ER study initiated at Yale; office Neuro PMR enrollment accelerated PRIME >75 patients; PRISM PMR launched in OR; Alzheimer’s Care PMR ongoing Broadening

Management Commentary

  • “We delivered revenue of $3.4 million, up 27% sequentially, and materially expanded gross margins to a record of nearly 54%, supported by a record average selling price of $361,000” .
  • “Observing clinicians note that the images produced by our next-generation system with Optiv AI approach those of conventional 1.5 T MRI scanners” .
  • “The device MSRP…is $550,000, roughly a 15% premium to the prior version…[with] significant average selling price uplift in the third quarter” .
  • “Hospitals’ return on investment assessments are showing 1 year–1.5 year break-even timelines versus 3–4 years typical for capital equipment” .
  • “We expect revenue in the fourth quarter of 2025 to be approximately $5 million–$6 million…[and] cash runway for the business lasting into the second half of 2027” .

Q&A Highlights

  • Pipeline/backlog composition: Three independently managed pipelines (U.S. hospital, U.S. office, international) with growing multi-unit deals and diversified geography; Q4 guide driven by conversion of next-gen hospital deals and office launch momentum .
  • Office penetration: Segmentation strategy (first-model + Optiv AI for smaller offices; next-gen for larger), NeuroNet partnership, completed Neuro PMR enrollment with data expected early 2026 .
  • International timelines: CE/UKCA approvals; 10 local language Optiv AI launch in Q4; French UniHA referral to expedite hospital purchases; next-gen system availability targeted OUS by end of 2026 .
  • 2026 outlook: Management deferred detailed commentary until after Q4, citing Q3 as launchpad and preference to guide in early 2026 .

Estimates Context

  • S&P Global consensus estimates were unavailable for HYPR for Q3 2025 and Q4 2025 (Revenue Consensus Mean, Primary EPS Consensus Mean, Target Price Consensus Mean, and counts returned no data) [Values retrieved from S&P Global].
  • Without consensus, we cannot assess beats/misses; focus shifts to company guidance ($5–$6M in Q4) and execution against the three-pipeline strategy .

Key Takeaways for Investors

  • Sequential momentum: Q3 revenue +27% QoQ with record margin 53.8% driven by next-gen mix and ASP; Q4 guide implies a significant step-up to $5–$6M, mid-point +60% QoQ and +137% YoY .
  • Margin trajectory: FY GM guidance raised to 49–51%; management expects >50% GM going forward as volumes and pricing scale—watch mix of next-gen units as a key lever .
  • Commercial inflection: Entire U.S. hospital pipeline converted to next-gen; office launch validated (IAC, reimbursement) with segmentation pricing; international lift from CE/UKCA and UniHA referencing—pipeline breadth reduces single-channel risk .
  • Cash and runway: $21.6M cash at 9/30 (excludes ~$20.1M gross proceeds on 10/16 offering); runway into 2H 2027 supports sustained commercialization—monitor cash burn as FY guidance increased to $29–$31M .
  • Risks: YoY revenue below Q3 2024 despite margin improvements; cash burn guidance higher; net loss widened due to non-cash warrant liability adjustment—watch operating leverage as volumes scale .
  • Near-term trading implications: Focus on Q4 bookings conversion (hospital + office), next-gen unit mix, and international language launch milestones (Optiv AI) as potential catalysts for revenue and margin upside .
  • Medium-term thesis: Sustained ASP/margin expansion from next-gen, diversified pipelines across sites of care, and evidence generation (PRIME, PRISM PMR, Neuro PMR) should support broader adoption and operating leverage through 2026 .

Sources Read in Full

  • Q3 2025 earnings call transcript (Nov 13, 2025) ; alternate transcript .
  • Preliminary Q3 2025 press release (Oct 15, 2025) .
  • Relevant press releases: CE/UKCA approval for Optive AI (Sep 2, 2025) ; PRISM PMR enrollment (Oct 21, 2025) ; PULSE platform launch (Oct 6, 2025) ; Pricing of $17.5M public offering (Oct 16, 2025) .
  • Prior quarters’ earnings call transcripts: Q2 2025 (Aug 13, 2025) ; Q1 2025 (May 13, 2025) .
  • Q3 2024 8-K (for YoY comparatives) .