Executive Summary

Q4 revenue was $7.8M (+14% y/y), capping record FY24 revenue of $31.4M (+31% y/y); Q4 gross margin was 61% and FY24 gross margin was 61% .
2025 revenue guidance introduced at $36–$41M (+15% to +31% y/y), with growth drivers including OR navigation (3.0 software), Prism laser expansion to 1.5T, and GLP preclinical services scale-up; timing of GLP ramp is the biggest swing factor in the guide range .
Operating discipline continues: debt fully repaid; cash/cash equivalents $20.1M at year-end; 2024 operational cash burn reduced 35% to $9.0M; management reiterated a disciplined spend approach in 2025 .
Strategic execution accelerated: 25 new global center activations in 2024 (6 in Q4), ~3x historic pace; company framing next phase “Fast. Forward.” to extend leadership in neuro drug delivery and expand OR/laser footprint .

What Went Well and What Went Wrong

What Went Well

Sustained top-line growth with improving margins: Q4 revenue +14% y/y to $7.8M; gross margin 61% (vs 59% prior-year Q4) driven by volume and lower costs post-manufacturing transition .
Network and platform expansion: 25 new global centers in 2024 (six in Q4), broadening capacity for drug delivery and device procedures; CEO emphasizes new “Fast. Forward.” phase to scale commercial readiness .
Clean balance sheet and lower burn: full early repayment of $10M convertible note; FY24 operational cash burn cut by 35% to $9.0M; period-end cash/cash equivalents $20.1M .
- Quote: “2024 represented the strongest financial and strategic performance in our history including more than 30% revenue growth, and a 35% reduction in operational cash burn.” — CEO Joe Burnett .

What Went Wrong

Mixed Q/Q trajectory and operating expense pressure: Q4 revenue of $7.8M was below Q3’s $8.1M; Q4 operating expenses rose to $10.4M (driven by personnel, R&D, regulatory fees) .
Biologics services softness within Q4 mix: Biologics & Drug Delivery revenue was up just 4% y/y to $4.2M as service revenue declined due to fewer preclinical studies; offset by strong biologics product demand .
Slight data inconsistency on burn: Press release cites Q4 operational cash burn of $1.2M, whereas CFO commentary referenced $1.4M; management signaled ongoing disciplined spend but no full-year 2025 burn guidance yet .

Financial Results

Revenue and Gross Margin: Last Three Quarters

Metric	Q2 2024	Q3 2024	Q4 2024
Revenue ($USD Millions)	$7.9	$8.1	$7.8
Gross Margin (%)	63%	60%	61%

Notes: Q4 revenue +14% y/y; gross margin improved vs prior-year Q4 (59%→61%) .

Segment Revenue Mix by Quarter

Segment ($USD Millions)	Q2 2024	Q3 2024	Q4 2024
Biologics & Drug Delivery	$4.3	$4.4	$4.2
Neurosurgery Navigation & Therapy	$2.6	$2.9	$2.9
Capital Equipment & Software	$0.9	$0.8	$0.6
Total Revenue	$7.9	$8.1	$7.8

Segment callouts:

Q4 Biologics & Drug Delivery: +4% y/y to $4.2M; product revenue strength offset by fewer preclinical service studies .
Q4 Neurosurgery Navigation & Therapy: +43% y/y to $2.9M on new accounts, SmartFrame OR, and Prism .
Q4 Capital Equipment & Software: $0.6M vs $0.7M prior year .

KPIs and Operating Items

KPI/Metric	Q2 2024	Q3 2024	Q4 2024
New Centers Activated (quarter)	6 (cum 14 YTD)	5 (cum >20 YTD)	6 (25 in FY24)
Cash & Cash Equivalents (period-end, $M)	$32.8	$21.6	$20.1
Debt Outstanding (period-end)	Repaid $10.1M on 8/26; none outstanding	None	None
Operational Cash Burn (quarter, $M)	$2.7	$1.2	$1.2 press release; $1.4 CFO (see note)
Operating Expenses (quarter, $M)	$9.7	n/a disclosed as total	$10.4

Note: Q4 operational cash burn discrepancy (press release $1.2M vs CFO $1.4M) .

EPS vs Estimates

The company does not report quarterly EPS in the press release; FY24 net loss per share was $(0.70) .
S&P Global quarterly consensus estimates were unavailable due to a temporary data limit; will update when available.

Guidance Changes

Metric	Period	Previous Guidance	Current Guidance	Change
Revenue ($M)	FY 2025	n/a	$36–$41	Initiated
Global Site Activations	2025	n/a	15–20 expected	Initiated
Gross Margin Path	Multi-year	n/a	Path to 70%+ at scale (longer-term target)	Reiterated trajectory
Operational Cash Burn	2025	n/a	No specific guide; disciplined approach	Commentary only

Management noted the 2025 revenue range is most sensitive to the timing of GLP capacity going live (mid-to-late 2025) .

Earnings Call Themes & Trends

Topic	Previous Mentions (Q2 2024)	Previous Mentions (Q3 2024)	Current Period (Q4 2024)	Trend
Cell & Gene Therapy pipeline / expedited FDA pathways	7 partnered programs with Fast Track/RMAT/Priority Review; expanding preclinical/clinical services; GLP readiness in 2025	Continued emphasis on 7 expedited programs; strategic agreements incl. milestones/royalties; GLP readiness late 2025	Potential approvals in next ~2 years; scale-up GLP capability 2H25; extended long-term partner agreements	Strengthening
OR navigation (SmartFrame OR)	Full market release; VAC processes underway; initial traction	6–7 OR accounts; many VACs in process; significant same-store upside	3.0 software FDA-cleared; early cases with sub-mm accuracy; not dependent on third-party nav	Accelerating
Prism Laser Therapy	3T approved; working toward 1.5T in 2025; anchor bolt accessory cleared	Ongoing adoption; more evaluations/VAC approvals	Plan to secure 1.5T labeling 2H25; background imaging transfer in Prism 3.0 to fit existing workflows	Broadening TAM
GLP Preclinical Services	GLP-ready this year; first GLP studies in 2025	Confident in demand; GLP capability targeted later 2025	GLP timing is key guide swing factor; meaningful 2026 revenue ramp	Execution gating 2025
Gross margin trajectory	63% in Q2; manufacturing transition benefits	60% in Q3; outlook to 70%+ at scale	61% in Q4; reiterates path with scale	Stable to improving
Global footprint	Tracking to 100 sites in 2025	>20 YTD; expect 100 by 1H25 if pace continues	25 new centers in 2024; targeted 15–20 more in 2025; pursuing Japan/Canada/Asia approvals	Expanding

Management Commentary

Strategic posture: “We enter the Fast. Forward. phase… extend our lead in cell and gene therapy delivery… evolve our portfolio to fast, simple, predictable workflows… expand our global installed base” — CEO Joe Burnett .
2025 product roadmap: ClearPoint 3.0 OR software (FDA cleared), Prism 3.0 features, 1.5T Prism labeling targeted 2H25, Velocity Alpha MR conditional drill submitted — “meaningfully reduce procedure times” .
Guidance drivers: “The largest driver… being the timing of our preclinical GLP expansion and what months those services become available” .
Financial discipline: “Our operational cash burn decreased to $9 million in 2024, a 35% reduction versus 2023… we remain committed to effectively and carefully managing our operating expenses” — CFO Danilo D’Alessandro .

Q&A Highlights

Expedited review impact: Simplified clinical strategies and fewer patients can “fast forward” timelines; 1% treatment penetration in expedited indications implies ~$250M incremental revenue at >70% GM at current ASPs (illustrative) .
Network scale: Targeting 200–250 capable U.S. hospitals long-term; next 3 years aim to reach 150 global activated centers .
Operating spend: No 2025 burn guide; case-by-case investments, with focus on growing revenue faster than opex .
2025 guide range: High end driven by earlier GLP capacity, stronger device disposables; capital likely flatter after a strong 2024 .
OR expansion traction: Only a handful of 2024 activations were OR-driven; expect higher contribution in 2025+ with 3.0 software removing third-party nav dependency .

Estimates Context

Q4 2024 consensus (revenue, EPS): S&P Global data unavailable at time of writing due to temporary data limits; will update comparison vs. Street when accessible.
Implications for estimates: 2025 revenue guide ($36–$41M) suggests +15% to +31% y/y; midpoint implies sustained double-digit growth with GLP timing the key variable, likely prompting Street models to flex GLP services start date and device disposable growth assumptions .

Key Takeaways for Investors

2025 setup: New OR software, Prism 1.5T label pursuit, and MR drill launch broaden addressable market and drive same-store growth; watch for VAC approvals and OR-driven activation mix shift .
GLP timing is the swing factor: Earlier GLP capacity (2H25) skews revenue toward the high end of guidance; later timing pushes contribution into 2026 .
Durable device momentum: Neurosurgery Navigation & Therapy grew 43% y/y in Q4; continued traction from SmartFrame OR and Prism supports margin scale .
Biologics product pull-through: Q4 mix showed softer services but strong product demand as partners progress; longer-term milestone/royalty frameworks diversify revenue .
Cash and capital flexibility: Debt-free with $20.1M cash at FY-end and sharply lower burn; management remains disciplined on spend pacing .
Near-term catalysts: Additional OR/prism installs and procedures, regulatory progress toward Prism 1.5T, adeor drill clearance, GLP facility updates, bio-pharma partner trial initiations and potential milestone receipts .

Appendix: Additional Full-Year Data

FY24 revenue $31.4M (+31%); product revenue $18.6M (+76%); operating loss $(19.7)M; net loss $(18.9)M; EPS $(0.70); cash/cash equivalents $20.1M .

Citations:

Q4/FY press release and financials:
Q4 earnings call transcript:
Q3 earnings call transcript:
Q2 earnings call transcript:
Debt repayment PR/8-K:

S&P Global estimates note: Quarterly consensus estimates for Q4 2024 were unavailable at time of writing due to temporary data limits; values will be updated once accessible.

ClearPoint Neuro, Inc. (CLPT)·Q4 2024 Earnings Summary