Establishment Labs Holdings Inc. reported preliminary unaudited revenue of $64.0 million to $65.0 million for the fourth quarter of 2025, a jump from the $53.8 million recorded in the third quarter. The increase is largely driven by a 27% rise in U.S. Motiva implant sales, which now account for $17.0 million to $17.5 million of the quarterly top line, up from roughly $13.5 million in the prior quarter. The higher mix of U.S. commercial sales, combined with a stronger demand for the company’s flagship SmoothSilk‑surface implants, underpins the revenue lift.
The company’s full‑year 2025 guidance of $210.5 million to $211.5 million represents a 27% increase over 2024, aligning closely with the consensus estimate of $211.27 million. This growth is driven by the continued expansion of the U.S. commercial market, where Motiva implants have captured a growing share of the breast‑augmentation segment following FDA approval in September 2024. The guidance also reflects a modest uptick in international sales, which now contribute roughly 15% of total revenue, up from 12% in 2024.
Cash on hand at the end of the year is projected to be $75.5 million, an increase of $4.8 million from the $70.7 million reported at the close of Q3. The stronger cash position is a result of higher operating cash flow, driven by the company’s high gross margin—over 70% in Q3—and disciplined cost management that has kept operating expenses in line with revenue growth.
Management highlighted that the company continues to generate positive adjusted EBITDA and expects to become free‑cash‑flow positive later in 2026. The improvement in operating leverage is attributed to the scaling of the U.S. commercial business, which benefits from lower per‑unit manufacturing costs and higher average selling prices. CEO Peter Caldini noted that “we continue to have positive adjusted EBITDA, and our cash position reflects our success in managing and improving the business.” He added that the company is “expecting to turn free cash flow positive later this year, and our operating leverage will become very evident in 2026 and beyond.”
Analysts had projected Q4 revenue of $63.7 million; the company’s guidance of $64.0 million to $65.0 million represents a beat of up to $1.3 million, or roughly 2% above consensus. The full‑year guidance sits at the upper end of the prior range of $208 million to $212 million, signaling confidence in sustained demand and margin stability.
Market reaction to the announcement was tempered by investor focus on the timeline for achieving free‑cash‑flow positivity. While the record revenue and positive EBITDA were welcomed, analysts and investors expressed caution regarding the company’s path to profitability, noting that the free‑cash‑flow positive milestone is still projected for later in 2026. The mixed sentiment was further influenced by the company’s recent submission for FDA approval of Motiva implants for breast reconstruction, which, while expanding the addressable market, also introduces additional regulatory and reimbursement uncertainties.
The company’s gross margin of 70.1% in Q3 2025 underscores its pricing power and efficient operations. High margins are supported by the premium positioning of Motiva implants and the company’s ability to maintain a favorable mix of high‑margin U.S. commercial sales. The margin stability, coupled with the strong cash position, positions Establishment Labs to invest in research and development and to pursue additional regulatory approvals, such as the pending reconstruction indication.
In summary, Establishment Labs’ preliminary Q4 2025 results demonstrate robust revenue growth, a solid cash position, and a clear path toward free‑cash‑flow positivity. The company’s focus on scaling its U.S. commercial business, maintaining high margins, and expanding its product portfolio through regulatory approvals provides a strong foundation for continued growth in 2026 and beyond.
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