MiMedx Group, Inc. (NASDAQ:MDXG) Q4 2022 Earnings Call Transcript

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Pete Carlson: Anthony, it’s Pete. And I think you’re hitting on a good point there, and I’ll speak a little bit personally. But this is a view we talk about internally, which is as all the companies that are in the space are required to meet regulatory burden that includes things like obtaining a tissue research or reference group letter of clarification that your product is 361 and going through the associated FDA inspection, we do think there are companies that will not want to make the effort to meet those burdens. And so yes, we do think there could be some companies that might drop out of the market. When that starts happening? It’s hard to tell. But the TRG requirement is sitting in front of proposals with some LCVs. As you know, we have that for our sheet products, our core EPIFIX line, and that’s 90% of our portfolio in the private office setting.

So we’re — we feel comfortable there. But you are — I do think you’ve hit a good point where the regulatory burden as it becomes more concrete, there will be some products and that’s a potential tailwind for ourselves.

Joe Capper: So Pete, we do grow in this segment, right? We grow in this segment today. We just don’t grow as fast as we do in other segments. So when price is not the issue, when we’re competing on clinical efficacy, we win. And to the extent that we level this playing field, we will win more often. So to Pete’s point, it will equate to some upside for us. It’s hard to quantify that because, again, you have to take into account that some of this may affect the overutilization.

Pete Carlson: Yes, I agree with that.

Operator: And our next question comes from Carl Byrnes with Northland Capital Markets.

Carl Byrnes: Thanks again for the follow-up question. Pete, you touched on this with respect to the turn and licensing program. Can you just remind us when the PDUFA action date is on FleX AM, which is the bovine collagen powder product? And then also unrelated but quasi related, any comments or thoughts in terms of potential tuck-under acquisitions that could augment the Wound & Surgical segment as well?

Pete Carlson: Carl, I’ll start with your first question and let Joe talked about the second. There’s no date to reference relative to approval or receiving approval from the FDA on the 510(k) submission from Turn — or by Turn for the Flex product. It’s the normal back and forth with the regulator asking questions. So we don’t have any time frame to share.

Joe Capper: Yes. As far as adjacency, it’s too soon to start talking publicly about. I think the most important message to you guys is it’s a focus point. We’ve formalized the planning process, and we’ve put a core group together within the Company. So really, it’s laying the groundwork.

Operator: And we have reached the end of the question-and-answer session. I’ll now turn the call back over to the CEO, Joe Capper for closing remarks.

Joe Capper: Thanks, operator. Thank you, everybody, for your questions and for your interest in the Company. We look forward to talking to you in a few months. That concludes today’s call. Thanks again.

Operator: And this concludes today’s conference, and you may disconnect your lines at this time. Thank you for your participation.

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