Monogram Orthopaedics, Inc. (NASDAQ:MGRM) Q4 2023 Earnings Call Transcript

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They were concerned about this technology getting to market. Our average investor was 65 years old and actually cared about the technology. And any time we do any kind of communication, we’re inundated with e-mails from people who actually care about the technology. So, we have an audience that cares about the technology and is interested in more than just kind of maximizing to the very less penny returns. And as a management team, we have been thinking about, okay, well, maybe there’s an opportunity to — at these levels, give access to people who care about the technology kind of one more opportunity with hopefully a lot of accretive milestones. We’re going to talk about that more that’s in discussion, but just something to have in your minds as we continue moving forward.

So, I want to make sure that we keep getting to questions folks have. So, — okay, here we go. He’s going to why so much engineering, now I thought the product was submitted to FDA and kind of frozen until approval. So, Mark, we have not yet submitted to the FDA. In fact, the engineering on this product is largely done and has been for a long time, Kamran can speak to that. Right now, it’s just going through all of the testing that’s required for the submission. So, you have to prove to the FDA that your product is safe and effective. And that is not a trivial process. We’re making a lot of headway and we plan for that to be largely complete in the coming months. So, all of the engineering or the predominant engineering is on the mVision navigation, which is our novel navigation technology.

I think there’s been a lot of confusion and part of it is when we say 510(k), and I do see there’s some people who think we have been misleading about the timing of the clinical trial and so forth. We have never been misleading about the timing of the clinical trial. We’ve always said that we are discussing with the FDA. We are trying to determine whether or not clinical data would be needed and there was a lot of uncertainty around that. And in fact, we talk to regulatory consultants who still think — well, at this point, management has a strong feeling that we — it would be smart to have a clinical study with this embodiment. But it’s never a definitive. The FDA doesn’t give you definitive answers and the time it takes to get to a point of granular discussions is very time-consuming because every time you submit to the FDA for a response, it’s 60 days for them to get back to you.

So, you’re talking about a pretty tedious process. But–

Kamran Shamaei: If I can add Ben.

Benjamin Sexson: Yes. Sure.

Kamran Shamaei: Yes. So, if the question is why did engineer team is a big, I would say, the engineer team is actually relatively small compared to all the competitors that I’m aware of. We are actually order — at least one order of magnitude smaller in terms of size. But if the question was, why do we do so much engineering work because it really takes so much engineering work to get the surgical system of this scale to the market. And per Ben’s point, yes, no, we have not submitted to 510(k) through FDA yet.

Benjamin Sexson: Yes. So, we got a question here about analyst coverage, investor roadshows, strategic investors. So, we recently presented at the Canaccord Conference. A lot of it is kind of what I said, right, is institutional investors are not as inclined to take risk, right? They want to know what the budget is, what the milestones clearly are, what the timelines clearly are and so forth, right? So, we’re now getting to the point of having that very clearly defined for us. And we think that that’s going to be helpful for them. Now, what’s frustrating is the stock really kind of going down and becoming less attractive for fundraising. And so — we are not interested in diluting our shareholders. We really want folks who have been with the story with us a long time to thrive.

So, it’s a really delicate balance of trying to move the ball forward as far as you can, but obviously, derisking those milestones. So, what we have said is we think we’re in a good spot to get through the verification and validation. We think we’re in a good spot to submit 510(k). We think those are pretty accretive milestones, and then discussions are ongoing. Now, when it comes to the analyst coverage, that’s something that is difficult to control. We have talked to numerous investment banks, and we have retained investment banks. We did not like the deal flow so far that we were seeing, but hopefully, that improves as we kind of continue to move the ball forward. And generally speaking, initiating a relationship with an investment bank and working with them is helpful to analyst coverage.

So, the two are largely tied together. Okay. So, we got maybe — we’ll do five or 10 more minutes here. Any other questions for the team? Okay. This is a good one. So, I think this relates to the clinical trial, but it’s helpful to just talk about overseas. So, the — there’s a lot of synergy to the OUS clinical trial that we’re running. I — what we’ve said is we’ve identified the CRO. We’ve identified the distributor. We’ve identified the PIs. We know we will be using the — basically the mPress implant, cemented version of that. So, we think that we will be — require less inventory and that it will be kind of a lot more efficient to run a clinical trial OUS. So, for strategic reasons, it’s not helpful for us to say more. The Indian — when we talk about patients, right, there’s obviously a huge need in the United States, but Kamran and I had the opportunity to be in an operating room outside of the U.S., not too long ago.

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