Executive Summary

Q4 2024 revenue was $44.5M, up 41% year over year, with gross margin expanding to 68.5%; adjusted EBITDA loss improved to $13.1M from $17.4M YoY, driven by U.S. launch mix and cost actions .
U.S. Motiva launch posted $3.3M in Q4 revenue and strong early KPIs (650 accounts onboarded, 88% reorder rate), with Q1 2025 U.S. revenue targeted at ~$5.5M; total 2025 U.S. revenue guidance is “at least” $35M .
2025 revenue guidance reaffirmed at $205–$210M (OUS $170–$175M, U.S. $35M); underlying gross margin expected to be +200–300 bps; company targets EBITDA-positive in H2 2025 and cash-flow positive in 2026 .
Key stock catalysts: continued U.S. ramp (orders/day acceleration), Preservé launch (Brazil) and pipeline clarity (Ergonomix2/Mia, reconstruction indication), plus potential celebrity partnership driving awareness; currency headwinds and LatAm softness remain watch points .

What Went Well and What Went Wrong

What Went Well

U.S. Motiva launch exceeded expectations with rapid adoption: 650 accounts onboarded, 450 ordering, 88% reorder rate; orders/day grew from 32 (Nov) to ~90 (Feb), supporting confidence to meet or exceed $35M U.S. revenue in 2025 .
Gross margin expanded to 68.5% (vs. 65.2% LY), driven by higher production volumes, decommissioning of the B15 site, and early U.S. sales contribution; mgmt sees further improvement as U.S. ramps .
Operating discipline: YoY OpEx down ~$12.5M in 2024 despite U.S. buildout; adjusted EBITDA loss improved QoQ/YoY, with H2 2025 targeted for first EBITDA-positive quarter .

“Please remember that breast augmentation is seasonal… We are on pace to have one of the best launches in the history of the aesthetics industry.” — CEO Juan José Chacón-Quirós .
“Our gross profit… was positively impacted by higher production volumes, the decommissioning of our B15 manufacturing site and the early contribution of sales in the U.S.” — CFO Rajbir Denhoy .

What Went Wrong

Net loss widened sequentially to $(34.5)M in Q4 (from $(16.7)M in Q3), reflecting higher interest and other expenses; diluted EPS was $(1.19) vs $(0.59) in Q3 and $(0.79) in Q4’23 .
Currency headwinds reduced sales by ~2 percentage points in Q4; 2025 reported OUS sales expected to be negatively impacted by ~$2–$3M .
LatAm remains weak; mgmt does not expect growth from LatAm in 2025, though deterioration appears to have stabilized in Q4 .

Financial Results

Metric	Q4 2023	Q2 2024	Q3 2024	Q4 2024
Revenue ($USD Millions)	$31.560	$44.117	$40.227	$44.514
Gross Profit ($USD Millions)	$20.585	$28.936	$25.717	$30.492
Gross Margin %	65.2%	65.6%	63.9%	68.5%
Total Operating Expenses ($USD Millions)	$42.700	$38.280	$38.856	$49.162
SG&A ($USD Millions)	$36.880	$32.792	$34.055	$44.018
R&D ($USD Millions)	$5.820	$5.488	$4.801	$5.144
Loss from Operations ($USD Millions)	$(22.115)	$(9.344)	$(13.139)	$(18.670)
Net Loss ($USD Millions)	$(20.542)	$(17.181)	$(16.682)	$(34.531)
Diluted EPS ($USD)	$(0.79)	$(0.62)	$(0.59)	$(1.19)
Adjusted EBITDA ($USD Millions)	$(17.399)	$(4.334)	$(7.017)	$(13.135)
Cash and Equivalents ($USD Millions)	$40.035	$54.600	$39.697	$90.347

Segment/Geography mix (Q4 2024):

Region	Mix %	Notes
Europe/Middle East/Africa	~38%	Demand uneven; EMEA flat despite macro pressure
Asia Pacific	~35%	Recovering from H2’23 downturn
Latin America	~18%	Weak; stabilized in Q4
North America	~9%	Includes $3.3M U.S. Motiva revenue

KPIs (launch and operations):

KPI	Value	Period/Context
U.S. Motiva revenue	$3.3M	Q4 2024
U.S. accounts onboarded	>650	As of late Feb 2025
Accounts ordering	450	As of late Feb 2025
Reorder rate	88%	As of late Feb 2025
Orders/day	32 (Nov), 60 (Dec), 70 (Jan), ~90 (Feb)	U.S. ramp cadence
Sales reps (U.S.)	40 active, selective adds possible	2025 plan
Orders since launch	>5,000	Through Feb 2025
Flora reconstruction VAC centers (U.S.)	35 completed; 32 ordered	Adoption traction

Estimates vs Actuals

Wall Street consensus (S&P Global) for Q4 2024 revenue and EPS was unavailable at the time of analysis due to SPGI rate limits. Values retrieved from S&P Global were unavailable; please refer to your S&P Global access for consensus benchmarks.*

Guidance Changes

Metric	Period	Previous Guidance	Current Guidance	Change
Total Revenue	FY 2025	$205–$210M (reaffirmed)	$205–$210M	Maintained
U.S. Revenue	FY 2025	“Expected to exceed $35M” (Q3 commentary)	At least $35M	Maintained (conservative framing)
OUS Revenue	FY 2025	NA	~$170–$175M; FX headwind ~$2–$3M	New detail
Gross Margin	FY 2025	NA	+200–300 bps underlying	New detail
OpEx (Total)	FY 2025	NA	~$45–$46M per quarter; ~$6–$7M noncash	New detail
EBITDA	FY 2025	NA	EBITDA-positive in H2 2025	New detail
Cash Flow	FY 2026	NA	Cash-flow positive	New detail
U.S. Revenue (Q1)	Q1 2025	NA	~$5.5M	New detail

Earnings Call Themes & Trends

Topic	Previous Mentions (Q-2: Q2 2024)	Previous Mentions (Q-1: Q3 2024)	Current Period (Q4 2024)	Trend
U.S. Motiva launch	FDA PMA preapproval finished; approval expected soon	FDA approval received; rapid onboarding; target 40 reps; expect >$35M U.S. in 2025	$3.3M U.S. Q4; 650 accounts; orders/day accelerating; Q1 U.S. ~$5.5M	Strong positive ramp
Gross margin drivers	GM 65.6% on mix/ASP	GM 63.9%; mix/FX headwinds	GM 68.5%; B15 closure + U.S. mix; more improvement expected	Improving
Cost actions/OpEx	OpEx down vs LY; adj. EBITDA improved	OpEx reduced; adj. EBITDA materially improved	2024 OpEx down ~$12.5M YoY; H2’25 EBITDA-positive target	Structural leverage building
OUS macro	Sequential recovery; guidance intact	Guidance reset; Brazil weakness; currency/mix	Mid-single-digit OUS growth; LatAm weak but stabilizing; FX headwind $2–$3M	Gradual recovery with FX headwinds
China distribution	NA	Distributor set-up; financing expected	$50M financing for distributor; H1 reorders light, H2 pickup	Investment supports H2 sell-out
Pipeline (Mia/Preservé/Ergonomix2)	Mia accelerating; PMA progress	U.S. launch; pipeline highlighted	Preservé launched in Brazil; Ergonomix2 submissions; Mia revenue guide $8–$10M (2025)	New product tailwinds
Supply chain/capacity	NA	NA	Third shift added post-FDA; no lingering supply constraints	Capacity secured
GLP-1 tailwind	NA	NA	Expect multi-year augmentation tailwind from GLP-1-induced changes	Emerging positive driver

Management Commentary

“The approval of Motiva implants in the United States was a watershed moment… we should be able to meet and even exceed our $35 million guidance for the U.S. in 2025.” — CEO Juan José Chacón‑Quirós .
“Gross profit… positively impacted by higher production volumes, the decommissioning of our B15 manufacturing site and the early contribution of sales in the U.S. We expect this number to continue to improve…” — CFO Rajbir Denhoy .
“We are targeting our first positive EBITDA quarter this year as well as turning cash flow positive next year.” — CEO Juan José Chacón‑Quirós .
“As of last Friday, we have over 650 accounts fully onboarded and 450 have already placed orders with 88% reordering… Momentum is building.” — CEO Juan José Chacón‑Quirós .
“Preservé… launched in Brazil… we have already received many orders for hundreds of systems at a price point more than double our most common SKUs in Brazil.” — CEO Juan José Chacón‑Quirós .

Q&A Highlights

U.S. ramp metrics: mgmt emphasized conservative $5.5M Q1 U.S. despite strong orders/day trajectory; reiterated $35M U.S. revenue guide excludes any new approvals (e.g., Ergonomix2) .
OUS macro backdrop: LatAm likely flat in 2025, EMEA/APAC recovering; guidance excludes upside from new products/approvals .
OpEx trajectory: U.S. commercial infrastructure built; ~stable run-rate with selective rep additions; leverage expected as top line scales .
Pipeline/regulatory: Ergonomix2 submissions (tools for Preservé); reconstruction indication submission in 2025 targeting 2026 approval; Mia expected $8–$10M 2025 revenue .
Supply: capacity expanded with third shift; no lingering constraints expected .

Estimates Context

S&P Global Wall Street consensus estimates for Q4 2024 revenue/EPS were unavailable at time of analysis due to API rate limits. Values retrieved from S&P Global were unavailable; please consult your S&P Global platform for consensus benchmarks.*
Qualitatively, U.S. KPIs and orders/day strength suggest potential upward pressure on U.S. sell-side revenue assumptions (mgmt: “meet and even exceed” $35M), while currency headwinds and LatAm softness may temper OUS expectations .

Key Takeaways for Investors

U.S. launch momentum is the core near-term driver: accelerating orders/day, high reorder rates, and conservative initial guidance point to potential upside in 2025 U.S. revenue contribution .
Margin mix shift and cost actions create operating leverage: GM uplift from U.S. pricing and B15 closure, with OpEx discipline targeting H2’25 EBITDA-positive and 2026 cash-flow positive .
Pipeline adds optionality: Preservé commercialization (Brazil), Mia ($8–$10M 2025), and Ergonomix2 submissions underpin multi-year growth beyond core implants .
Watch FX and LatAm: FX headwind ($2–$3M) and LatAm weakness likely offset some OUS recovery; China reorders skewed to H2’25 post distributor sell-in .
Near-term catalysts: additional U.S. account onboarding, potential celebrity partnership, major surgeon conferences, continued positive gross margin prints as U.S. mix grows .
Liquidity improved: $90.3M cash at year-end plus a $25M credit tranche available (~$115M accessible) supports U.S. ramp and inventory build .
Tactical setup: into Q1/Q2, monitor U.S. revenue realization vs ~$5.5M Q1 target and margin cadence; any update on Ergonomix2/Mia U.S. pathway would be incremental to the bull case .

Estimates unavailable via S&P Global at time of analysis due to rate limits; please reference S&P Global for current consensus data.

ESTABLISHMENT LABS HOLDINGS INC. (ESTA)·Q4 2024 Earnings Summary