Hyperfine, Inc. (HYPR)·Q4 2024 Earnings Summary

Executive Summary

• Q4 2024 revenue was $2.32M, down 13% year over year from $2.69M due to longer U.S. hospital sales cycles and a heavier international mix that lowered ASPs; diluted EPS was -$0.14 vs. -$0.15 prior year .
• Management guided to H1 2025 revenue of ~$6M and FY 2025 growth of 20–30%; gross margin targeted at 47–52% and cash burn of $25–27M, positioning for a “tale of two halves” with catalysts in the back half (office launch, multiple hospital call points, international expansion) .
• The IAC issued updated MRI accreditation standards enabling CMS reimbursement for portable point-of-care brain MRI, unlocking the neurology office opportunity; pilots are underway with planned mid-2025 launch and Neuro PMR study .
• NVIDIA collaboration announced to accelerate AI image reconstruction and workflow decision support; management deferred specifics, but it is a potential sentiment catalyst tied to future technology .
• Wall Street consensus (S&P Global) was unavailable at time of retrieval, so beat/miss vs. estimates could not be assessed.*

What Went Well and What Went Wrong

What Went Well

• Progress toward diversified growth vectors: office setting accreditation (IAC) enables CMS reimbursement, expanding TAM and creating a new commercial channel; pilots show “seamless” accreditation and implementation .
• Strong technology roadmap: two AI-powered software releases planned in 2025; KOL feedback suggests image quality approaching conventional 1.5T MRI, expected to accelerate adoption and shorten learning curves .
• Operating discipline: FY 2024 gross margin expanded to 46% and cash burn fell 9% y/y; FYE cash/equivalents were $37.6M, with runway extended to end of 2026 after restructuring and financing .

What Went Wrong

• Q4 revenue decline and lower gross profit ($0.83M vs. $1.03M) driven by elongated U.S. hospital cycles and lower ASP from heavier international mix; U.S. field productivity variability prompted 50% territory leadership changes in December .
• FY 2024 revenue finished at $12.89M, below Q3 guidance of $14–$14.5M, reflecting late-year demand/mix dynamics despite Q3 record performance .
• Near-term uncertainty in grant-funded deals and macro capital allocation in hospitals tempers early 2025 visibility; management highlighted risks around tariffs (assumes no material impact) and NIH funding pressures in forward-looking statements .

Financial Results

Segment breakdown

KPIs

Note: ND = not disclosed in filings referenced.

Guidance Changes

Earnings Call Themes & Trends

Management Commentary

• “2025 will be a tale of two halves… by the end of the year, we expect to be actively selling into several sites of care in the hospital setting, neurology offices and into more international markets.” — Maria Sainz .
• “Our next-generation releases will bring a step function image quality improvement… images… like those obtained from conventional 1.5 Tesla MRI systems.” — Maria Sainz .
• “We are initiating total cash burn expectations… $25 million to $27 million for the full year 2025… and see our cash runway… to the end of 2026.” — Brett Hale .
• “Soft revenue [in Q4] was due to longer deal timing… and lower average selling price associated with a heavier mix of international deals.” — Brett Hale .
• “The new IAC guidelines… pave the way for the Swoop system to be available in neurology offices and clinics.” — Company statement .

Q&A Highlights

• NVIDIA collaboration: Analysts probed data sharing/specific deliverables; management reiterated future-tech nature and declined further detail, framing the PR as high-level and forward-looking .
• Capital cycles and grant funding: Hospitals’ capital processes are more protracted with multiple stakeholders; grant-funded deals show added uncertainty, supporting two-halves guidance framing .
• Mix and ASP durability: U.S. direct pricing raised; distributor-led OUS lowers ASP; quarterly ASP variability expected based on mix .
• Office expansion readiness: Accreditation pilots “seamless,” Neuro PMR study at Dent Institute and Texas Neurology to validate use cases; decision-making is faster in offices vs. hospitals .
• Sales force upgrade: Replaced ~50% of underperforming regions; rigorous training to position for back-half ramp alongside software upgrades .

Estimates Context

• S&P Global consensus EPS and revenue estimates for Q4 2024 were unavailable at the time of retrieval due to API request limits; as a result, we cannot assess beat/miss vs. Wall Street consensus at this time.*

Key Takeaways for Investors

• Near-term softness reflects elongated U.S. hospital cycles and heavier international mix; watch H1 2025 execution as revenue ~$6M sets the base for a back-half acceleration narrative .
• Structural catalysts are credible: IAC accreditation unlocks CMS-reimbursable office imaging; mid-2025 office launch and Neuro PMR should diversify revenue beyond critical care .
• Technology upgrades are central to adoption: planned 10th/11th-gen AI software with 1.5T-like image quality is a potential inflection driver; monitor FDA clearance timing (first by mid-2025) .
• Margin and cash discipline: GM guided 47–52% and cash burn $25–27M with runway extended to end-2026; if volume ramps, sustained >50% GM appears attainable per management commentary .
• International scale-up continues: CE/UKCA software approvals and 13 distributors position EMEA/Middle East/APAC expansion; India regulatory entry targeted H2 2025 .
• Risk watch: tariffs (assumed immaterial), grant funding uncertainty, and hospital capital constraints; mix-driven ASP variability may continue intra-quarter .
• Trading lens: potential catalysts include the 10th-gen software clearance, office launch updates, additional clinical data (ACTION PMR/CARE PMR), and NVIDIA collaboration milestones; narrative supports multiple expansion if execution lands in 2H 2025 .

*Estimates unavailable: values would be retrieved from S&P Global.