Establishment Labs Holdings Inc. (NASDAQ:ESTA) Q3 2022 Earnings Call Transcript

Anthony Petrone: Appreciate that all. I’ll hop in queue. Thanks.

Operator: Our next question comes from Josh Jennings with Cowen. Please proceed with your question.

Josh Jennings: Hi, good afternoon. Thanks for taking the questions and congrats on another strong quarter. Wanted to just ask a follow up on the U.S. FDA approval process. Just, more of a structural question about the modular submission process; once you have the first three modules submitted and the clinical module is the last module that you will submit, and then kick off the PMA review time. So we assume that those first three models have been reviewed fully by the FDA and you will only receive questions on the clinical data package, or is this €“ is it a start from scratch where the FDA could come back and ask questions about the first three modules as well?

Juan Jose Chacon-Quiros: Thanks Josh. And this process is continuous and they can always ask questions, and we have had questions from different modules at different times. I think the FDA is having a situation in which they have to deal with a lot of things at the same time. So what we are seeing is them trying to get all of these things done. So we actually appreciate of a lot the fact that they’re moving on all three modules. So we expect that to continue and we expect to submit our fourth module and this way get going with the final process of the PMA.

Josh Jennings: Understood. Thanks. And then just one follow-up on just, thinking about the U.S. commercial effort and build out of the sales infrastructure may not be ready to talk about that. But any high level kind of clues on the strategy there or any timing about when, when you’ll be ready to share the commercial strategy for the U.S.? Thanks for taking the questions.

Juan Jose Chacon-Quiros: Yes. On that one, we actually started when we hired Heather Brennan as the Head of our U.S. market. And then furthermore, when we’ve been adding other people to create the structure necessary for our US launch. What we have not done yet is begin hiring know commercial people because we are cognizant of the process that we are undertaking with the FDA. We will continue to work towards the launch? You saw us in Boston at the plastic surgery meeting and, we hosted a symposium for plastic surgeons and investigators. We had Dr. Robert Langer there speaking about his work on implant bio compatibility and that shows you that we are active, but we have to be mindful not to promote ahead of the approval of Motiva Implants?

Josh Jennings: Thank you.

Operator: Our next question comes on the line of George Sellers with Stephens. Please proceed with your question.

George Sellers: Thanks for taking the question and congrats on the quarter. You mentioned expectations for Mia commercialization to begin in Europe in the first half of 2023. So I just wanted to ask about any update on the MDD to MDR transition and the Annex 16 requirements and what you’re sort of incorporating as we think about that commercialization timeline?

Juan Jose Chacon-Quiros: Yes. Thanks George. We are moving on all fronts. The only thing that was pending was basically the publication of the Annex 16, which is expected to happen this month. Now that the common specifications have been approved by the European authorities, so with that we do plan to move ahead full steam and get going with the different areas that are necessary for C-mark of the tools, having had the approval for the implants a couple years ago. Now, we are also making progress in other markets. We are currently in Japan, taking this call because we are continued €“ continuing to work with our local partners here in Japan, local clinics towards the preparation of the launch. So it’s an exciting time. We are doing cases of Mia this week here in Japan. These are early experience cases, but it shows you how, you know, we continue to progress with Mia and we’re very happy about that.