Strong Top-Line Growth
Q1 2026 revenue of $59.9M, up 44.7% YoY (management rounded to 45%), with full-year guidance raised to $266.5M–$268.5M (≈26%–27% growth vs. 2025).
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The call communicated strong operational and commercial momentum led by a rapid U.S. launch, 45% YoY revenue growth in Q1, improving gross margin (70.7%) and a return to positive adjusted EBITDA. Key product innovations (minimally invasive platform) are driving adoption, surgeon and patient demand, and management raised full-year revenue guidance. Offsetting factors include elevated operating expenses, near-term cash usage and increased debt with PIK mechanics, plus some supply and geopolitical uncertainties. Overall, the positives around revenue acceleration, margin expansion, product differentiation and pathway to cash-flow positivity materially outweigh the risks discussed.
Management raised full‑year revenue guidance to $266.5–$268.5 million (up from $264–$266M), implying ~26–27% growth versus 2025, after a strong Q1: $59.9M revenue (+44.7% YoY), U.S. revenue $19.6M (32.7% of Q1, +216% YoY), minimally invasive (MIS) revenue $9.1M in Q1 and MIS now expected to exceed $35M in 2026 (prior MIS guide $30M), and adjusted EBITDA of $1.2M in Q1 (third consecutive quarter of positive adjusted EBITDA). Full‑year gross margin is guided to 71.2–72.2% (Q1 GM 70.7%, +350 bps YoY), operating expenses $195–$200M, and management expects adjusted EBITDA to be positive each quarter and to be cash‑flow positive in H2 2026; cash was $68.1M at quarter end (down $7.5M), Q2 cash usage will be higher (including a $4.7M Benelux payment) but Q2 EBITDA is expected to be roughly double Q1, U.S. revenue is expected to exceed 30% of total for the year (vs ~22% in 2025) while OUS growth is expected in the single digits. They also refinanced debt (availability up to $265M from $225M, 8.75% rate with PIK optionality) and highlighted PIK interest benefit of more than $5M per quarter supporting near‑term cash flow.
Q1 2026 revenue of $59.9M, up 44.7% YoY (management rounded to 45%), with full-year guidance raised to $266.5M–$268.5M (≈26%–27% growth vs. 2025).
U.S. revenue of $19.6M in Q1 (32.7% of total), up 216% YoY and +13.3% QoQ; U.S. expected to exceed 30% of total revenue for 2026 (vs ~22% in 2025). Company reported new weekly highs in U.S. order counts and a 30% increase in average orders since end of Q4.
Minimally invasive platform generated $9.1M in Q1; management raised 2026 guidance for this business to exceed $35M (up from prior $30M). More than 260 U.S. surgeons certified (surpassed plan of 200 for 2026 early). Preserve patient survey: 98% reported minimal disruption, 95% satisfied, 15% were new to category, 84% willing to pay a premium and 99% would choose the procedure again.
Gross margin expanded by 350 bps to 70.7% in Q1 2026 (from 67.2% in Q1 2025). Adjusted EBITDA positive $1.2M in Q1 versus loss of $12.1M in Q1 2025 — third consecutive quarter of positive adjusted EBITDA and company expects adjusted EBITDA positive each quarter in 2026.
Surpassed 1,700 accounts globally; 78% of surgeons report being asked for a brand by name and Motiva is requested 93% of the time in those instances. Company reported a 30% increase in average orders since end of Q4 and faster adoption by higher-volume surgeons.
FDA clinical trial and global post-market data show device-related complication rates at new industry lows (<1% capsular contracture and <1% claim rate from >49,000 warranties sold with 377 claims). Management contrasted this to competitor device-related complication rates up to ~20% in FDA trials.
Refinanced debt (increase in facility availability from $225M to $265M) with a lower stated rate (8.75%) and PIK option to support near-term cash; received ~$6M proceeds from refinancing in the quarter and management believes they have enough cash to reach cash flow positive in H2 2026 (cash on hand $68.1M at quarter end).
Submitted Motiva implants for U.S. FDA approval in breast reconstruction (Dec 2025) to expand addressable market; CE Mark for Zen temperature biosensing; ongoing pipeline items include Ergo2, GEM (gluteal augmentation), smaller sizes and Health Canada submission plans.
Good morning. Welcome to Establishment Labs First Quarter 2026 Earnings Call. [Operator Instructions] As a reminder, today's call is being recorded. I will now turn the call over to Malavika William, Global Head of Corporate Communications and Marketing. Please go ahead.
Thank you, operator, and thank you, everyone, for joining us. With me today is Peter Caldini, our Chief Executive Officer; and Sandra Harris, our Chief Financial Officer. Following our prepared remarks, we'll take your questions. Before we begin, I would like to remind you that comments made by management during this call will include forward-looking statements within the meaning of federal securities law. These include statements of Establishment Labs' financial outlook and the company's plans and timing for product development and sales. These forward-looking statements are based on management's current expectations and involve risks and uncertainties. For a discussion of the principal risk factors and uncertainties that may affect our performance or cause actual results to differ materially from these statements, I encourage you to review our most recent annual and quarterly reports on Form 10-K and Form 10-Q as well as other SEC filings, which are available on our website at establishmentlabs.com. I'd also like to remind you that our comments may include certain non-GAAP financial measures with respect to our performance, including, but not limited to, sales results, which can be stated on a constant currency basis or EBITDA, which we disclose on an adjusted EBITDA basis.
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