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Establishment Labs (NASDAQ:ESTA) reported first-quarter 2026 revenue of $59.9 million and adjusted EBITDA of $1.2 million, marking what Chief Executive Officer Peter Caldini described as “a strong start to the year.” Revenue increased 45% versus the prior-year period, and the company posted its third consecutive quarter of positive adjusted EBITDA.

Caldini said the U.S. business “continued to outperform” with revenue of $19.6 million, up 216% year over year and 13.3% sequentially, despite what management called a seasonally light quarter for breast augmentation and reconstruction. Outside the U.S., the company delivered about 15% growth, and its minimally invasive platform generated $9.1 million in quarterly revenue.

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Gross margin improved 350 basis points to 70.7% from 67.2% in the first quarter of 2025. CFO Sandra Harris attributed the expansion primarily to “the increasing contribution of our higher margin U.S. business,” as well as the growing impact of the minimally invasive platform, which she said carries higher average selling prices and margins.

SG&A expense rose to $43.6 million from $39.7 million a year earlier, driven by variable costs tied to higher sales—“including freight”—foreign exchange impacts, and continued investment in the U.S. business, Harris said. Excluding a one-time item, adjusted SG&A was $41.0 million, or 68.4% of revenue, which Harris said represented about 50 basis points of leverage year over year. R&D spending was $5.2 million, consistent with prior quarters.

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Management emphasized accelerating U.S. adoption as a key driver. Harris noted that U.S. revenue represented 32.7% of total revenue in the quarter, up from 26.8% in the fourth quarter of 2025 and 15% in the first quarter of 2025. Caldini said the company recently surpassed 1,700 accounts in the U.S. and is seeing increased adoption from higher-volume surgeons, with “30% increase in average orders since the end of Q4.” On the call, he clarified that the order-growth comment was specific to the U.S.

Establishment Labs officially launched its minimally invasive platform in the U.S. in March, led by Preservé. Caldini said demand was strong enough that, after initially training surgeons at the company’s Costa Rica campus, Establishment Labs began training in the U.S. as well to accelerate certification. The company certified more than 260 U.S. surgeons by the end of the first quarter, exceeding its prior goal of training 200 by the end of 2026, he said.

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Caldini also pointed to early patient data from a survey of 94 Preservé patients three months post-surgery, reporting that 98% said they experienced minimal disruption to daily life and 95% said they were satisfied or extremely satisfied with results. He added that 15% of surveyed patients were new to the category and had not considered breast augmentation until learning about Preservé, while 84% said they were willing to pay a premium for the procedure’s benefits and 99% said they would choose it again.

In response to analyst questions, Caldini said the U.S. growth is still primarily driven by base Motiva implant adoption and utilization within accounts, while adding that Preservé is expected to be a significant growth driver over time. He also said that in markets outside the U.S. where both Mia and Preservé are available, the two procedures have been “very complementary,” with Mia positioned as a more premium, more restrictive offering and Preservé described as more “day-to-day” and lower-priced than Mia. Caldini said Preservé has helped bring in new accounts in some of the company’s direct markets in Western Europe, and he expects a similar trend could develop in the U.S. as the launch progresses.

Caldini highlighted several planned growth drivers, including expansion into U.S. breast reconstruction, which he said is “equal in size to the breast augmentation market.” He said the company submitted Motiva implants to the FDA for approval in primary and revision breast reconstruction in December 2025 and is progressing through the review process. Harris later said the company has made “no assumptions” about timing of FDA approval for reconstruction in its outlook.

On product timing, Caldini said the company has had discussions with the FDA regarding approval requirements for the Motiva Ergonomix2 implant, but he does not see it as “a significant driver for us until probably around 2028.” Mia is not yet available in the U.S., while Preservé has recently been introduced domestically.

Following first-quarter performance, management raised full-year 2026 revenue guidance to $266.5 million to $268.5 million, up from $264 million to $266 million. Harris said the updated range implies approximately 26% to 27% growth over 2025. The company expects its business outside the U.S. to grow in the single digits, while the U.S. is expected to exceed 30% of total revenue for the year, up from about 22% last year.

For the minimally invasive business, Harris said first-quarter revenue of $9.1 million came in above expectations, and the company now expects minimally invasive revenue to exceed $35 million in 2026, up from its prior $30 million outlook. The company expects full-year gross margin of 71.2% to 72.2%, operating expenses of $195 million to $200 million, and adjusted EBITDA to be positive in each quarter of 2026. Harris added that the company expects second-quarter EBITDA to be approximately double first-quarter levels, even as operating expenses remain elevated due to U.S. investment.

Cash and financing were also a focus. Harris said cash decreased $7.5 million during the quarter to $68.1 million, primarily due to investments in the U.S. market. Caldini said the company refinanced its credit facility and expects to reach cash flow positive in the second half of the year, while Harris said the company has “enough cash on hand to reach cash flow positive” and has “no needs or plans to do any type of equity financing.”

Harris outlined expected near-term cash usage in the second quarter, including a final $4.7 million payment related to the Benelux acquisition, the timing of short-term incentive payouts, and continued U.S. commercial investments, partially offset by $6 million of proceeds from the recent debt refinancing. She also said the refinancing introduced PIK interest, which she expects to benefit cash performance in the back half of the year, describing “PIK interest of more than $5 million per quarter.”

In response to a question on the new debt agreement, Harris said the facility increased from $225 million to $265 million drawn and carries an 8.75% interest rate, with the ability to use PIK. She characterized the net impact as “neutral to slightly up” when considering increased availability of funds, the lower interest rate, and use of PIK.

Addressing macro conditions, Caldini said the company has not seen an impact on global procedure demand so far, though it is monitoring the environment. He noted the Middle East represents about 5% of total sales, and the company had no orders from the region in the first quarter but had orders in the system for the second quarter. Harris added that the company is seeing “some initial surcharges on outbound freight” but said it has been able to navigate those costs while holding margins; she also said silicone volumes are locked in under contract through year-end.

Separately, Harris said the company believes it is well-positioned to qualify for inclusion in Russell indices based on current market capitalization, noting that April 30 marked the Russell reconstitution rank date, with final membership to be confirmed in the coming months.

Establishment Labs Holdings Inc is a global medical technology company specializing in the design, development and manufacture of silicone gel breast implants for aesthetic and reconstructive surgery. The company's proprietary portfolio is built around patient-focused safety, customization and innovation, offering solutions intended to enhance surgical outcomes and support clinical traceability.

The company's flagship products fall under the Motiva® brand, which includes a range of ergonomic and round breast implants featuring SilkSurface® texturing and an embedded Q Inside® Safety microtransponder for unique implant identification.

The article "Establishment Labs Q1 Earnings Call Highlights" was originally published by MarketBeat.