Executive Summary

Record Q3 revenue of $3.64M (+56% y/y) and gross margin of 52%, marking the second consecutive quarter above 50% and reflecting strong execution across U.S. and international placements .
Guidance tightened and effectively raised at the midpoint: FY24 revenue $14.0–$14.5M; gross margin updated to 47–50%; cash burn lowered to $37–$40M. Management reiterated a cash runway into early 2026 and confidence in growth acceleration in 2H25 as catalysts mature .
Commercial momentum supported by 13 system placements in Q3 (balanced U.S./OUS) and continued ASP discipline; international contributions were healthy, and seasonality was less pronounced than expected .
Strategic catalysts building: CE approval for latest AI-powered software in Europe, and new IAC MRI standards enabling office accreditation and CMS reimbursement for portable MR brain exams—both supportive of site-of-care expansion in 2025+ .
Estimates comparison unavailable: S&P Global consensus data could not be retrieved at the time of this report; therefore, beat/miss vs Street not assessed (see Estimates Context) [GetEstimates error].

What Went Well and What Went Wrong

What Went Well

Record revenue and sustained gross margin expansion: Q3 revenue hit $3.64M (+56% y/y), gross margin reached 52% (from 48% y/y; sequentially ~270bps higher vs ~50% in Q2), supported by balanced U.S./OUS placements and disciplined costs .
Technology milestones advancing adoption: 9th-gen AI-powered software enabled faster scans without compromising image quality; management guided to a 10th-gen release in H1’25 with images “more like those obtained from conventional 1.5T MRI,” potentially accelerating adoption .
Expanding evidence and TAM: Alzheimer’s ARIA-E monitoring data presented at CTAD and AAIC; stroke data showed faster time-to-scan and comparable diagnostic performance; management cites >$6B U.S. TAM across hospitals and offices, supporting multi-site expansion strategy .

What Went Wrong

Continued losses and cash burn: Net loss was $10.33M in Q3 (EPS -$0.14); YTD cash burn of $30.2M remains elevated despite sequential improvements, reflecting early commercial scale and ongoing R&D investment .
ASP variability and mix headwinds: International distributor model supports growth but pressures ASP and near-term margin mix; management continues to balance growth with margin goals amid channel mix changes .
Seasonality/closing dynamics remain unpredictable: While Q3 avoided anticipated seasonality and saw deals pull forward, management highlighted lack of traditional capital-budget seasonality and deal timing variability, implying near-term forecasting complexity .

Financial Results

Metric	Q3 2023	Q2 2024	Q3 2024
Revenue ($USD Millions)	$2.33	$3.63	$3.64
Gross Profit ($USD Millions)	$1.12	$1.80	$1.91
Gross Margin (%)	48%	49.6%	52%
Net Loss ($USD Millions)	$10.76	$10.16	$10.33
Diluted EPS ($USD)	$(0.15)	$(0.14)	$(0.14)

Segment breakdown

Metric	Q3 2023	Q2 2024	Q3 2024
Device Sales ($USD Millions)	$1.73	$2.97	$3.03
Service Sales ($USD Millions)	$0.60	$0.66	$0.61

KPIs

KPI	Q1 2024	Q2 2024	Q3 2024
Systems Sold/Placed (#)	13	13	13
Gross Margin (%)	41.1%	49.6%	52%
Cash & Equivalents ($USD Millions, period-end)	$63.20	$53.81	$45.77
Cash Burn ($USD Millions)	$12.0 (Q1)	$9.4 (Q2)	$30.2 YTD

Guidance Changes

Metric	Period	Previous Guidance	Current Guidance	Change
Revenue ($USD Millions)	FY 2024	$13–$16 (Q2)	$14–$14.5 (Q3)	Raised/narrowed at midpoint
Gross Margin (%)	FY 2024	45–50 (Q2)	47–50 (Q3)	Raised low end; maintained high end
Cash Burn ($USD Millions)	FY 2024	~$40 (Q2)	$37–$40 (Q3)	Lowered range

Additional context: Q1 guidance initially set FY24 revenue at $12–$15M and GM at 45–50% with cash burn ~$40M, subsequently raised in Q2 and tightened/updated in Q3 .

Earnings Call Themes & Trends

Topic	Previous Mentions (Q-2 and Q-1)	Current Period (Q3)	Trend
AI/Technology initiatives	Q1 launched 8th-gen AI; positive DWI feedback; steady cadence of AI-powered releases . Q2: FDA cleared 9th-gen software; leading position on FDA’s AI/ML-enabled list .	Full rollout of 9th-gen; plan to obtain clearance and launch 10th-gen in H1’25; images “more like 1.5T” .	Accelerating
Alzheimer’s program (ARIA-E)	Q1: CARE PMR enrollment started; ARIA monitoring; workflow/value thesis .	AAIC/CTAD data: multiple ARIA-E cases with Swoop vs 3T; promising, cost-effective, workflow benefits .	Building evidence and funnel
Stroke program	Q1: ACTION PMR >100 patients; ED triage focus . Q2: Annals of Neurology publication; tissue clock concept .	European study: median time-to-scan 2.5h vs 27.7h; comparable performance to CT/high-field MRI .	Strengthening
International expansion	Q1: appointed EU distributors; OUS revenue mix increasing . Q2: distributor training; healthy contributions .	CE approval for latest software; broad EU distribution network; positioned for 2025 expansion .	Scaling
Regulatory/Accreditation	Q2: anticipated IAC standards; ACR safety manual update .	IAC standards now include portable point-of-care MR; enables office accreditation and CMS reimbursement .	Enabling office sites
Commercial metrics	Q1/Q2 placements steady at 13; margin profile improving .	Q3 placements 13; healthy U.S./OUS balance; GM 52% .	Steady volumes, rising margins
Seasonality/funding dynamics	Q2: expected summer seasonality; distributor mix .	Q3: little seasonality; purchases often via strategic/donor funds (not capex budgets) .	Less seasonal variability

Management Commentary

“The Hyperfine team delivered yet another strong quarter of financial performance across revenue growth, gross margin expansion, and disciplined cash management while executing against several important priorities in our plans to expand into new sites of care and internationally.” — Maria Sainz, CEO .
“The tenth generation software will bring a step-function image quality improvement... their assessment is that the images... are more like those obtained from conventional 1.5 Tesla MRI systems.” — Maria Sainz .
“We are narrowing our revenue outlook for the full year 2024 to a range of $14 million to $14.5 million... updating our gross margin to 47% to 50%... anticipate total cash burn to be $37 million to $40 million... cash runway into early 2026.” — Brett Hale, CFO .
“By the end of 2024, we expect the [IAC]... to issue updated MRI standards that include the use of portable point-of-care, ultra low-field brain MRI... exams with Swoop systems in those offices will be eligible to be covered by CMS.” — Maria Sainz ; subsequently confirmed by company press release .

Q&A Highlights

Placements and mix: 13 systems placed in Q3 with balanced U.S./OUS split; slight ASP improvement on mix .
Seasonality clarification: Limited traditional capex seasonality since purchases often funded by strategic/donor sources; Q3 saw deals close ahead of schedule .
Software upgrade cadence: Majority of U.S. accounts expected to have 9th-gen upgrade by year-end; 10th-gen targeted for H1’25 rollout pending clearance, with significant image quality gains .
European dynamics: Variation in MRI capacity and reimbursement frameworks across EU; strong clinician reception to Swoop; stroke data presented at ESNR highlighted time-to-scan advantages .

Estimates Context

S&P Global (Capital IQ) consensus estimates for Q3 2024 and Q4 2024 could not be retrieved due to an API limit at the time of request; as a result, we cannot assess beat/miss vs Street for revenue or EPS in this report [GetEstimates error].
Investors should note management’s own performance highlights (record revenue, sustained >50% GM) and updated guidance ranges as near-term anchors until consensus can be confirmed .

Key Takeaways for Investors

Sustained execution with improving unit economics: Two consecutive quarters above 50% GM and record revenue point to leverage as scale increases; SG&A trending lower y/y supports operating discipline .
2025 acceleration setup: H1’25 target for 10th-gen AI software with near-1.5T-like images plus validated stroke/Alzheimer’s use cases could materially shorten adoption curves and expand placements across EDs, clinics, and infusion centers .
Regulatory tailwinds: IAC standards now enabling office accreditation and CMS reimbursement for point-of-care MR brain exams opens a new site-of-care revenue stream (neurology offices) in 2H’25 and beyond .
International expansion: CE approval of latest software and broad EU distribution network position the company for European commercial scaling in 2025; expect incremental OUS growth with some ASP/margin mix effects .
Cash runway and guidance discipline: FY24 revenue narrowed to $14.0–$14.5M, GM updated to 47–50%, cash burn lowered to $37–$40M; runway into early 2026 reduces financing urgency near term, contingent on continued margin progress .
Trading implications: Near-term narrative supported by record results and guidance tightening; medium-term re-rating potential tied to verification of 10th-gen image quality in clinical practice and office accreditation commercialization traction in 2H’25 .
Monitoring checkpoints: Watch Q4 placements/mix, 10th-gen clearance timing, additional Alzheimer’s and stroke data readouts, EU order flow, and any updates to FY25 revenue/margin frameworks on subsequent calls .

Note: All financial and operational figures are sourced from company filings and earnings materials cited herein. Street consensus comparisons were not possible due to S&P Global data retrieval limitations at the time of analysis [GetEstimates error].

Hyperfine, Inc. (HYPR)·Q3 2024 Earnings Summary