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Hyperfine, Inc. (HYPR)·Q2 2024 Earnings Summary

Executive Summary

  • Record quarter: revenue $3.63M (+7.4% YoY, +10% QoQ) and record gross margin 49.6%; 13 commercial Swoop systems sold; balanced U.S./international mix .
  • FY24 revenue guidance raised to $13–$16M (from $12–$15M); gross margin guide maintained at 45–50%; cash burn guide maintained at ~$40M; cash runway reiterated into early 2026 .
  • Innovation and evidence catalysts: FDA clearance of 9th‑gen AI software reducing scan times; initial Alzheimer’s CARE PMR and stroke ACTION PMR data presented/published; international distributor build‑out (12 EU markets + India) .
  • Near‑term investment narrative: margin inflection and guidance raise vs. ongoing losses (Q2 net loss $10.16M; cash burn $9.4M) with management pointing to business acceleration starting 2H25 across Alzheimer’s clinics/offices, ED stroke, and international .

What Went Well and What Went Wrong

What Went Well

  • Record revenue and margins with a balanced U.S./international mix: “record quarter at $3.6 million” and record 50% gross margin; 13 systems sold in Q2 .
  • Product innovation: FDA cleared the 9th‑gen AI software, reducing scan times without sacrificing image quality; places HYPR among leaders on FDA’s AI/ML device list .
  • Clinical momentum: initial Alzheimer’s CARE PMR posters (AAIC) showed ARIA‑E detection at low field and strong morphometric agreement vs. high field; subset of ACTION PMR stroke study data published (Annals of Neurology) .

What Went Wrong

  • Continued losses and burn: Q2 net loss $10.16M (EPS $(0.14)); cash burn $9.4M; cash declined to $53.8M at quarter‑end .
  • Mix/seasonality watch‑outs: management expects some summer seasonality given higher international mix in 2H; mix pressure on ASPs was noted in prior quarter with heavier OUS sales .
  • Commercial conversion timing: strong interest from AAIC but “early to know how quickly… interest will funnel into orders,” pointing to Alzheimer’s revenue contribution starting 2H25 .

Financial Results

P&L Summary (USD Millions, except per‑share and %)

MetricQ2 2023Q1 2024Q2 2024
Revenue$3.381 $3.295 $3.631
Gross Profit$1.444 $1.354 $1.803
Gross Margin %42.7% 41.1% 49.6%
R&D Expense$5.331 $5.570 $5.959
Sales, Marketing, G&A$7.81 $6.43 $6.69
Net Loss$(10.637) $(9.848) $(10.156)
Diluted EPS$(0.15) $(0.14) $(0.14)

Revenue Mix

MetricQ2 2023Q1 2024Q2 2024
Device Revenue ($M)$2.810 $2.704 $2.970
Service Revenue ($M)$0.571 $0.591 $0.661

KPIs and Liquidity

KPIQ4 2023Q1 2024Q2 2024
Systems Sold (units)7 13 13
Liquidity/FlowQ1 2024Q2 2024
Cash & Cash Equivalents ($M)$63.204 $53.809
Cash Burn (Quarter, $M)$12.0 $9.4

Notes:

  • CFO also highlighted record 50% gross margin in Q2 and reiterated gross margin scalability over time .

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
RevenueFY 2024$12–$15M $13–$16M Raised
Gross Margin %FY 202445%–50% 45%–50% Maintained
Cash BurnFY 2024~$(40)M ~$(40)M Maintained
Cash RunwayCorporateInto early 2026 Into early 2026 Maintained

Management also noted the midpoint of FY24 revenue guidance implies ~31% YoY growth vs. 22% previously .

Earnings Call Themes & Trends

TopicPrevious Mentions (Q4’23, Q1’24)Current Period (Q2’24)Trend
AI/software cadence8th‑gen FDA clearance; next AI release targeted for late summer (Q1) 9th‑gen AI software FDA‑cleared; faster scan acquisition; leadership on FDA AI/ML list Accelerating
International expansionEarly distributor strategy communicated (Q4) Appointed distributors in 12 EU markets and India; healthy OUS contribution Expanding
Alzheimer’s CARE PMRStudy initiated; first patients scanned; prelim data expected by YE24 (Q1) Enrollment progressing; AAIC posters show ARIA‑E detection at low field and morphometry agreement Progressing
Stroke ACTION PMR>100 patients enrolled (Q4/Q1) Subset of study data published; “tissue clock” potential highlighted Advancing
Margins/ASPFY23 GM 43.1% posted (Q4) Q1 GM 41.1% with lower ASP due to OUS mix Record Q2 GM 49.6%; CFO targets >50% sustainable over time
Accreditation/regulatory—Targeting IAC accreditation for office settings by YE; ACR manual updated for low‑field point‑of‑care MRI Supportive

Management Commentary

  • “Our strong performance in 2024 continued in Q2 with a record quarter at $3.6 million in total revenue and a balanced mix of U.S. and international deals.” — CEO Maria Sainz .
  • “Gross profit... resulted in a record gross margin of 50%... We are raising our revenue outlook for the full year 2024 to a range of $13 million to $16 million... cash runway... into early 2026.” — CFO Brett Hale .
  • “FDA clearance of our ninth generation AI‑powered software marks a critical step forward... upgrade image quality and reduce acquisition times.” — CEO .
  • “We anticipate... placing Swoop systems in neurology clinics, infusion centers... commercially in the second half of 2025... stroke opportunity... EDs and hub‑and‑spoke networks... revenue contribution... second half of 2025.” — CEO .

Q&A Highlights

  • Guidance raise drivers: strength across both U.S. and international channels; robust U.S. pipeline in adult and pediatric hospitals supported confidence to raise FY24 revenue guide .
  • Alzheimer’s funnel: AAIC drove strong interest (300+ volunteers scanned on Swoop); too early to quantify; Alzheimer’s commercial contribution expected to begin 2H25 .
  • Upcoming catalysts: additional Alzheimer’s data expected at CTAD in late October (Madrid) from Washington University group .

Estimates Context

  • S&P Global consensus for Q2 2024 revenue and EPS was unavailable at time of analysis due to data access limits; therefore, we cannot present an estimates comparison for this quarter (Primary EPS Consensus Mean / Revenue Consensus Mean attempted but not returned). Values from S&P Global were unavailable at time of request.

Key Takeaways for Investors

  • Execution inflecting: record revenue and gross margin with disciplined opex; mix shift toward international is now a contributor rather than a drag, but watch summer seasonality .
  • 2024 outlook de‑risked at the top line (guide raised) while margin and burn guidance are reiterated; runway into early 2026 provides time to realize 2025 commercial catalysts .
  • Multi‑pronged 2025 growth setup: Alzheimer’s office/clinic adoption, ED stroke triage, and international expansion create incremental placement channels beyond current hospital beachheads .
  • Technology lead widening: rapid cadence of AI software clearances (9th‑gen) improving scan times and clinical fit; strengthens competitive positioning and potential margin leverage .
  • Clinical evidence building: early external data on ARIA detection and stroke “tissue clock” use cases bolster adoption narrative; more Alzheimer’s data expected near‑term (CTAD) .
  • Risk checks: path to scale still requires converting interest to orders (Alzheimer’s 2H25), managing ASP/mix with growing OUS sales, and sustaining margin gains amid small scale .
  • Trading setup: catalysts in the near term are primarily narrative (guidance raise, FDA/software, clinical read‑outs); fundamental revenue step‑ups more likely in 2H25 as new channels come online .

Appendix: Additional Business Highlights

  • Q2 sold 13 systems; device revenue $2.97M; service revenue $0.661M .
  • Six‑month 2024 revenue $6.93M (+15.1% YoY) and gross margin 45.6% vs. 43.2% in 1H23 .