Establishment Labs Holdings Inc. (NASDAQ:ESTA) Q4 2022 Earnings Call Transcript

Page 5 of 5

Raj Denhoy: Yes, I think that’s the right way to think about it. I mean, as we’ve described here, right, in 2023, there’s just so many opportunities for us to support between the launch of Mia, preparation to the United States, the standing up of the new facility, moving into an operational capacity there. The early days in China, which, again, we’re using a distributor there, but there’re some efforts we’ll be supporting. And as we move into those initiatives, you’ll start to see the leverage flow out of them. But this year is a year where we’re investing. And as you get into ’24 and beyond, you should start to see that leverage materialize in our model.

Sam Eiber: Okay. Really helpful. And then maybe I can ask a follow-up here on the regulatory environment in the U.S. I guess, any updates on if you’re expecting an Ad Comm? How soon might you be able to figure that out? And is there even potential for a faster approval process considering you’ve had this modular submission process for a number of months now?

Juan Jose Chacon-Quiros: Yes, I think it’s a little bit early for that. And the most important thing is that we focus on the final stage of the regulatory process. I think as this unfolds, there may be opportunities, but I think we just have to keep ourselves to the proprietary of the trial and making sure that we answer every single question that comes our way from the FDA.

Sam Eiber: Okay. Really helpful. Thanks for taking the questions.

Operator: Thank you. There are no further questions at this time. I will hand the floor back over to Juan Jose Chacon-Quiros for closing remarks. Thank you.

Juan Jose Chacon-Quiros: Thank you for joining us on today’s call. We look forward to providing our next quarterly update in mid-May, and we wish everyone continued good health and happiness.

Operator: Thank you. This concludes today’s conference. All parties may disconnect. Have a great day.

Follow Establishment Labs Holdings Inc.

Page 5 of 5