Company Interview / Orthocell's hopes to unlock a $1.6B market

OrthoCell’s (ASX:OCC) Paul Anderson shares that the company achieves a second consecutive quarter of record revenue, reaching $2 million, an 8% increase from the prior quarter.

The firm awaits US FDA approval, which could tap into a $1.6 billion market.

With approved products in major markets, Paul highlights the positive surgeon uptake and consistent outcomes.

OrthoCell (ASX:OCC) focuses on expanding its global footprint, with applications in Singapore and Brazil, alongside significant growth in the US market pending FDA clearance in 2025. Paul notes efforts to establish local infrastructure in the US, interacting with distributors and leading nerve surgeons. With over 2 years of funding available, OrthoCell’s growth strategy includes recruiting top talent to drive operations in the US.

Full unedited transcript below:

0:00

Well. MedTech firm Ortho Cell has reported a second consecutive quarter of record revenue reading, reaching $2 million, which is up nearly 8% from the previous quarter. The company is awaiting the US FDA approval for one of its products, which could potentially unlock a $1.6 billion market. That's US dollars. Let's get more on the details. Author cell's managing director, Paul Anderson, joins me now. Hey, Paul, we meet again.

0:31

Hi, Nadine. How are you? Very well. Thank you. All right. So, um. Yeah. Third consecutive session of gains. Talk to us about these second quarter results. Yeah. Look, this is a really exciting, uh, inflection point for our company. And certainly what we're now seeing is with products approved, um, in major markets and generating revenue, we're now really seeing that inflection point in revenue generation in the company. And really what this has shown is that there's really solid uptake of our products from surgeons in the market. Uh, this is reflected in, in consistent and predictable outcomes that we're providing. Uh, and so really this is at the end of, you know, ten years of really hard work. And now what we're seeing is this really important inflection point within the company.

1:20

Uh, so second consecutive record quarter as revenue exceeds $2 million. Um, where is the. Yeah, I just actually noticed that there's a pause in trading in your in your shares right now, effective at 3:04 p.m.. What's the news?

1:37

Uh, yeah. So we've had a regulatory approval, uh, come upon us just in the last little period. And so we've had to go into a trading halt. Um, um, uh, to, to cover that off. Okay, so clearly you can't tell me the details right now, so give us an update. Stay tuned for tomorrow. Yeah. All right, well, maybe we should be doing this tomorrow. So talk to me about I didn't realize. I didn't realize this was actually going to be happening during the interview. Yeah. No. That's okay. I'm. I'm very pleased to have you here to, uh, to get ahead of the news. Um, okay. So, um, where are you then? I can ask generally on your journey, you would have heard that I was just speaking with neurons, Don Pilsner. You know, they've been through the whole FDA process. They've partnered to get their their drug to commercialization. I know it's different for you, but still, I mean, we've got form here for listed companies achieving and kicking those goals with the FDA.

2:33

Yeah. So this is not our first FDA approval process that we're going through. Um, important to for investors to note that Australia, uh, our bone regeneration product, which is used in maxillofacial surgery and partnered with Bio Horizons, one of the larger dental companies, uh, that's approved in Australia, approved in Europe and approved in the US. Um, and so we understand how to interact with the FDA. We have significant experience on our board with Doctor Ravi Otani and Doctor Fiona Wood. A significant experience with dealing with the FDA. We've had our initial feedback from the FDA, and we're really confident that we're on track for our submission in December, and even more confident that we're on track for for approval of the product or clearance, as it's described in the US in March of 2025. So, you know, we're really setting ourselves now, this revenue is is really important to us. And the surgeon uptake is really important to us also. So the ability for us to take the learnings

3:32

from the Australian marketplace and then it apply those into the US, not just with the regulatory bodies, but now also with the surgeon connections that we're making and the key opinion leaders and centre of excellence, which are so important to the building of this technology in the US, is well underway. Okay. And so I know that the US is the focus right now, Um, but, you know, in your quarterly results you're talking about the global opportunity as well. So we've got Europe, we've got Japan, you know, we've got, um, Canada, Brazil, you know, the the total addressable market for these products is very large. So where is next in terms of gaining market share? Yeah. So at the same time, um, we are approved here in Australia. We are reimbursed here in Australia. So we're concentrating on on continuing to take market share and to build the revenue base for the company. Um, we're focused very heavily on the US in relationship to our FDI approval for our nerve repair, which will be a real game changer from a

4:32

revenue inflection point in the US as well. But at the same time as that, we're also really concentrating on increasing our, our, um, um, our footprint across the globe. And that includes, um, you know, a application for Remplir in Singapore, um, applications for Australia and went to the Brazilian market and already for Australia and soon to follow foreign player. So these are really important markets for us and they're really important commercial footprints for us to enable us to not only grow our revenue and gain penetration, but also to assist us in gaining assistance from a partnering perspective. Yeah, well, that's what I was going to ask. So for Remplir, have you made any advancements on finding a distribution partner in the United States?

5:18

Um, look, so absolutely, I mean, we've been working very strongly with, um, increasing local infrastructure that we're working to put into place. So we're building the team in the US right now, and as part of building that team is working with distributors and sub distributors to actually get some traction with our product upon um, uh, approval in the US, FDI. So that process is well down the pathway. And I've just returned from the US, uh, at a very large, um, plastic reconstructive, an orthopedic hand meeting where I've met with, you know, probably 15 of the of the, of the country's leading nerve surgeons. So, you know, we're well on that pathway to getting penetration to the US market upon approvals. Yeah. And you've got still quite a lot of cash at the bank. What are you going to do with it? Well, look, you know, that provides us with, with, you know, more than a two year runway. Um, we're funded through the FDA approval process. Uh, so that gives us great freedom to now to, you know, concentrate on that with a laser focus on the US market,

6:18

concentrating on tracking some really bright talent to the company to to drive that operation in the US. Um, and to, um, you know, to sit pretty really with, with 18 million in the bank, uh, ready to ready to rock and roll in the US. All right. So, um, look, I guess we will stay tuned for a further update coming through. Paul, thanks for joining us today.

6:41

It's my pleasure. And look, we're very excited about this inflection point. Uh, and really, you know, excited about the growth that sits ahead of us as a company.