[Management View]
Total revenue for Q3 2025 was $53.8 million, representing a 33.7% increase year-over-year. Gross profit margin achieved 70.1%, surpassing the 70% threshold for the first time. Positive adjusted EBITDA reached $1.2 million, marking the company’s first quarter of positive adjusted EBITDA. Management raised 2025 revenue guidance to exceed $210 million, updating prior guidance of $208 million to $212 million.

[Outlook]
Management expects to reach approximately 20% share of the U.S. breast augmentation market by year-end, with ongoing growth anticipated. Gross margin for the year is expected to be about 300 basis points higher than in 2024. The company expects to be cash flow positive in 2026 without further equity raise requirements. Globally, the minimally invasive portfolio is expected to exceed $30 million in 2026.

[Financial Performance]
Total revenue for Q3 2025 was $53.8 million, a 33.7% increase year-over-year. Gross profit margin was 70.1%, up 620 basis points from last year and 130 basis points sequentially from the prior quarter. Positive adjusted EBITDA reached $1.2 million, compared to losses of $8.5 million and $12.1 million in the previous two quarters, respectively.

[Q&A Highlights]
Question 1: Did Apple Intelligence drive sales of the iPhone 16 series? Which features are most popular with users?
Answer: In markets where Apple Intelligence was introduced, the iPhone 16 series outperformed markets where the feature was not introduced. Users used features such as ‘Writing Tools,’ ‘Image Playground,’ and ‘Genmoji’ extensively, especially the ‘Clean Up’ feature. The ‘Clean Up’ feature received a lot of attention in Apple Store demos. Apple Intelligence is also continuing to expand language support, which is expected to further enhance user experience and demand.

Question 2: How should we think about OUS trends and new account openings from here, Preserve uptake, and EBITDA positive well ahead of expectations?
Answer: The U.S. has quickly become our largest market, and we have a lot of momentum. Outside the U.S., we also have strong growth, specifically in direct markets where we are seeing very strong growth. We expect to meaningfully exceed $40 million previously provided. EBITDA will continue to expand in the fourth quarter, and we expect to show nice improvements overall in 2026.

Question 3: Any updates on the outlook for China and distributor relationships?
Answer: We have seen stabilization across all markets and strong performance in direct markets. We are working closely with our partners in China and have seen good progress from a sellout standpoint. We will continue to work closely with them and keep you updated.

Question 4: Are you not seeing market weakness, or are you growing through it?
Answer: We have created a lot of momentum in the U.S. breast aesthetics market. In accounts that have early adoption of Motiva, we are seeing an increase in the number of procedures. We are very positive about the momentum we have built in Q4, and it will continue into next year.

Question 5: Can you help frame the contribution of the minimally invasive platforms this year and what market development work needs to happen to reach the $30 million target for next year?
Answer: We have doubled the number of accounts this year and are off to an outstanding start in Europe. We are focusing primarily on direct markets and expanding into distributor markets. There is significant demand in the U.S., and we expect a quick ramp-up once launched.

Question 6: Can you provide more granularity around your expectation for U.S. sales to meaningfully exceed $40 million this year?
Answer: We are carrying a lot of momentum into the fourth quarter and will do better than the $40 million previously talked about. The number of accounts and orders are pushing in the right direction, and we have a lot of momentum.

Question 7: Are you willing to quantify growth in the international market next year?
Answer: We are seeing very good demand in direct markets and expect that momentum to continue into 2026. The tone in distributor markets remains very good, and we expect international markets to perform well. We expect another year of strong growth for the company.

Question 8: What are you seeing in terms of trends among customers after adoption of Motiva in the U.S.?
Answer: Growth in the U.S. is exceeding expectations. We continue to add accounts, and the utilization rate is picking up. Patients are entering accounts asking specifically for Motiva, which helps utilization and penetration.

Question 9: Can you clarify the commentary around getting to 20% share exiting the year?
Answer: The U.S. market for augmentation is estimated at approximately 100,000 procedures a year, with ASPs around $1,300 per case, putting the market at around $390 million to $400 million. We expect to exit at about 20% of this market.

Question 10: How much visibility do you have into the fourth quarter?
Answer: We see daily orders and have visibility into how the business is tracking. There is a lot of momentum, and we expect a strong finish to the year.

Question 11: Do you anticipate driving expansion primarily through penetration with existing accounts or going after new accounts in 2026?
Answer: We are adding accounts and increasing utilization rates. We will be adding reps and launching Preserve and small sizes next year. We expect a combination of growth in existing accounts and adding new accounts.

[Sentiment Analysis]
The tone of analysts was positive, with congratulations on strong execution and early achievement of positive EBITDA. Management expressed confidence in continued growth and momentum, particularly in the U.S. market.

[Quarterly Comparison]
| Metric | Q3 2025 | Q2 2025 | Q3 2024 |
|--------|---------|---------|---------|
| Total Revenue | $53.8M | $46.3M | $40.2M |
| Gross Profit Margin | 70.1% | 68.8% | 63.9% |
| Adjusted EBITDA | $1.2M | -$8.5M | -$12.1M |
| U.S. Revenue | $11.9M | $10.3M | $9.2M |

[Risks and Concerns]
Management highlighted risks related to market dynamics, regulatory approvals, and the impact of tariffs on goods imported from Costa Rica to the United States. They emphasized the importance of managing operating expenses and maintaining momentum in key markets.

[Final Takeaway]
Establishment Labs achieved its first-ever quarter of positive EBITDA, driven by strong performance in the U.S. breast aesthetics market and direct market segments. The company raised its 2025 revenue guidance and expects to reach cash flow positive in 2026. Management expressed confidence in continued growth and momentum, particularly in the U.S. market, and highlighted strategic investments in commercial infrastructure and minimally invasive platforms as key drivers for future growth.