FIREBRICK PHARMA LTD (FRE) - Indonesia’s Approval Signals A Commercial Turning Point For Firebrick Pharma

A product can be ready for the world and still be held back by one thing: how regulators choose to classify it. We sit down again with Dr Peter Molloy, Executive Chairman of Firebrick Pharma, to unpack the company’s shift from R&D to commercial execution and why a single regulatory milestone in Indonesia changes the scale of the Nasodine opportunity.

Peter walks us through the origin story that starts with Betadine and leads to Nasodine, a povidone-iodine nasal spray designed to target the viral cause of the common cold using a topical antiseptic approach. We dig into why povidone-iodine remains compelling after decades of use, how low concentrations can still be potent, and why the “no resistance” profile matters when consumers are surrounded by symptom-only OTC options. Just as importantly, we talk about the practical reality for ASX health companies: Australia’s TGA can treat products like Nasodine as a drug, while markets such as Singapore may treat it as an antiseptic, dramatically changing time, cost, and pathway to market.

From there, the conversation turns to growth: Indonesia’s approval and its 60 to 65 million middle and upper-middle class consumers, the Philippines as the next potential major approval, and plans to broaden the Nasodine product range. We also cover the business model behind the strategy, including licensing partnerships that reduce manufacturing and marketing burden, recent capital raising, cash burn, and what “runway” looks like in a tough funding environment. If you’re following Firebrick Pharma, Nasodine, or healthcare commercialisation in Southeast Asia, this is the roadmap and the reality check.

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Transcript

Andrew Musgrave

Welcome again to ASX Briefs. And today we're joined again by Dr. Peter Molloy, the Executive Chairman of Firebrick Pharmer Limited, to discuss a transformational period for the company following major regulatory and financial milestones. Peter, thanks for joining me again and welcome back to the ASX Briefs Podcast.

Peter Molloy

Great to be here. Thanks, Andrew.

Andrew Musgrave

Now Peter, it's been a while since we last spoke, but for those new to the Firebrick story, can you just provide a brief overview of the company and your lead product, Nasodine?

Peter Molloy

Yeah, sure thing. It's a company we started, Stephen Goodall and I started in 2012. But it's impossible to tell the Firebrick story properly without telling the story of Betadine, which was the original inspiration for what we're doing. Early in my pharmaceutical career, in fact, was my first pharmaceutical job. I worked for a company in Adelaide called Faulding, a great company. And they managed to get the license from the US owners of the Betadine brand. They managed to get the license for the Australian distribution rights. And I was lucky enough to be the the product manager that was given a job of managing it. And the original, yeah, the original patent on the active ingredient, which is called povidone-iodine, expired in 1976. And it was really just being marketed in most countries as a hospital antiseptic. But I saw the opportunity to create an OTC franchise around it, and over several years launched a number of products, most successful of which was the Betadine Sore Throat Gargle. Now, just for historical context, Faulding lost the Betadine license after they were acquired by Mayne, I think in about 2001, and then it was given to Sanofi Aventis, so it's been through a few hands, and is now owned by iNova, at least in Australia and Southeast Asia. So, it's been through a few hands. It's no longer, and Faulding doesn't exist anymore, at least not in its original form. But in the 1980s, we built a very valuable OTC franchise led by this uh very successful product, Betadine Sore Throat Gargle, which now sells in Australia between supermarkets and pharmacy, I think around 2 million units. So, it's that's an incredibly successful product. What I realized was that after I left Faulding, there were a lot of ideas on the table for other products that we could have developed with povidone-iodine for consumer use and for use by doctors and hospitals. And there was really no new development that was done. Hasn't been any new development done on Betadine since about the 1990s. And I thought we should really look at seriously exploiting these opportunities, and fundamentally, that's why we set up Firebrick Pharma in 2012 with the primary purpose of developing a povidone-iodine nasal spray as the world's first effective treatment for the common cold, the first common cold treatment that actually targets the viral cause. But we had other products in mind as well that I saw as opportunities for povidone-iodine. So that was the genesis of Firebrick, and the rationale for a povidone-iodine nasal spray was that povidone-iodine is well known, it's been around for 40 or 50 years just in Australia. It's very safe. With the gargle, there have been about a hundred million sore throats treated just in Australia by our estimate, and it kills all the viruses that cause the same viruses that cause sore throats also cause colds, and it kills all those viruses. And there's no potential for resistance. Most importantly, it's quite safe to use in the nose at a low concentration, a much lower concentration than you use as a hospital antiseptic. But it has this unique chemistry whereby even at low concentrations, it's still very potent as an antimicrobial and kills all viruses, including all the ones that cause sore throats and all the ones that cause not just colds and flu, but all the pandemic strains. So, you can, you know, it's easy to get excited about a povidone-iodine nasal spray. And we decided that if we can develop this, it would be a fantastic breakthrough and first real treatment for the common cold. So that's why we set up Firebrick, and over the subsequent five or six years, we completed all the development of the nasal spray. So, we now have a fully developed product, it's gone through commercial scale manufacturing in Australia, but also in the US and in the Philippines. We're also manufacturing it there, and it's on the market in several markets, and there'll be a lot more over the next few years. So, we really have migrated from being an RD focused company to a commercial company. And in 2015, our first patent was granted, and in 2016 we filed the global trademark Nasodine. So that's how Firebrick was started.

Andrew Musgrave

Okay, and you've just announced a major regulatory milestone in Indonesia. So, can you walk us through the significance of this approval?

Peter Molloy

What we look for in markets for Nasodine are markets where the regulatory hurdles aren't unduly burdensome. Now I have to say that Australia has extremely high hurdles for a product like Nasodine, it treats, the TGA treats Nasodine as a drug, even though it works as a topical antiseptic. It doesn't work inside the body to any extent from an efficacy perspective, but it's treated as a drug. And once the clinical evidentiary requirements of a new drug are applied to a topical antiseptic, it becomes very, very difficult to get approval, and we have not succeeded in getting approval yet in Australia. And we face the same problem in other markets that have very high hurdles on new products, like Europe and in the US, if we wanted to market this as an OTC treatment for the common cold. But there are other markets that don't have those same hurdles and, in our view, adopt a more common-sense approach. The first one that we pursued was Singapore, which is a sophisticated market that has a strong pharmaceutical basis, strong pharmaceutical industry, and regards Nasodine as an antiseptic. In fact, we did not need approval in Singapore to market the product, other than to get HSA's, that's the equivalent of TGA, HSA's approval for consumer advertising. So, it was very easy, and that was one of the first markets we uh we launched in. Indonesia was a little more challenging. We needed to actually file for approval with the uh the Indonesian health authorities, and we succeeded. We succeeded actually in June last year, but because of our negotiations with the partner there who was acting as our regulatory agent, it took us until early this year before we could announce that approval. It's approved in Indonesia just like in Singapore as an antiseptic. It's also available in Fiji on that same basis. Now you might say, well, why is Fiji even on our list? It's such a small market. It's because a doctor from Fiji approached us and said, we would love to have this product. This product is a no-brainer. We want this product. I'll help you get it on the market in Fiji. And she did. So that's why it's in Fiji. So, we're looking at opportunistic markets where we can where we can introduce it. Now, Indonesia is extremely important as a value inflection event for Firebrick, and that's because it's a market of 280 million people, it is the largest by population market in Southeast Asia. And you might say that, well, not everybody in Indonesia can afford a product like Nasodine, and that's true. But if you look at the middle and upper middle-class statistics on Indonesia, there are about 60 or 65 million people, and it's growing in Indonesia who are classified as middle and upper middle class who can afford this product. It will sell a little cheaper in Indonesia than it does in Singapore, and I think we can consider that whole 60 to 65 million people as our addressable market. That compares with Singapore, where there are six million people, and only three and a half million are considered middle and upper middle class. So, Indonesia is a real market, it's the largest market in Southeast Asia, and it's an important target market for us. And I have to also say, while we're on the topic of large markets in Southeast Asia, we're currently seeking approval for Nasodine, again as an antiseptic, in the Philippines. And we expect that approval to come through this year. And the Philippines is important because it's the second largest market in Southeast Asia. So, between the Philippines and Indonesia, we've got two major events happening, hopefully this year, in the case of the Philippines, and it's already happened in the case of Indonesia. Two the two largest markets in Southeast Asia will allow the marketing of Nasodine. And between them, they represent something like 40 or 50 times the size of our current market there, which is Singapore. So, in many respects, Andrew, I sort of think of Singapore as a bit of a pilot market for us that's helped us test out the story, talk to doctors, and figure out what sticks in terms of the story and what particular indications people are using it for. We've also come to realize that the consumer market is the largest opportunity, but the most difficult because of all the products that are currently available for the common cold. But this is a product with many opportunities beyond consumer common coal treatment. And that's one of the realizations that we'll be taking into these other large markets as they come on board. So, yes, this is the Indonesian approval as a major event, and I hope that we'll see another major event this year, which is the approval in the Philippines.

Andrew Musgrave

Now, you've mentioned plans to expand the Nasodine range to up to four products from a regulatory standpoint, will these new products, like Nasodine throat spray, require entirely new submissions in each market, or can they leverage the existing approvals for the nasal spray?

Peter Molloy

You know, again, it depends on the market. In Singapore, the throat spray is simply an antiseptic and doesn't require approval, so it was easy for us to put it on the market there and similarly to make it available in Fiji. In Indonesia, there is a throat spray already, there's a Betadine throat spray available there, and we will probably track as a follow-on product to that in terms of a regulatory point of view, but we will need to probably file for regulatory approval there to get that on the market. So, it depends on the market. In the case of Singapore, it's very easy. These products are considered antiseptics and therefore don't require HSA approval before they're marketed. In other countries, individual approvals are required for each new product. So, it's a horses for courses situation. But we're expecting to announce at least one additional, one third, a third addition to the Nasodine range this year, and possibly a fourth will be coming through. So that will give us a full portfolio of products to offer to licensees in these markets and a great platform for creating value as a company going forward.

Andrew Musgrave

And turning to the financials, the company recently secured $1.5 million via replacement in a very difficult market, and you've just released your quarterly results. So, can you comment on your cash burn and how long these funds will last?

Peter Molloy

Yeah, let me talk about the cash burn first. We're very good at managing a cash burn, I have to say. Over the last year, 18 months, we've brought it right under control. And because of our model, our licensing model where we structure them such that our licensees are responsible for, wherever possible, responsible for manufacturing and or marketing costs, we don't have to fund the burden of those. So that allows us to keep to a core cost base which is relatively modest. We're burning, I've said in the past, we're burning about 600,000 a quarter. That increased in the March quarter because we had some one-off regulatory costs associated with activities in specific markets, and we had recruitment costs for our new non-executive director and our new head of business development and licensing, who is a going to be a key employee for us as we seek to expand the number of markets that we're in to about 10 countries over the next two or three years. So, apart from those one-off costs in March, I expect that by the June quarter and thereafter we'll can we go back to around 600, 650 a quarter in terms of burn. One 1.5 million that we raised in probably, in my experience, one of the toughest markets I've ever seen for capital raising. But we were encouraged to proceed. We had a very good, very good broker on board, Spark Plus out of Singapore. They did a great job for us, and I'm very pleased with what they delivered. We raised essentially what our capacity was at our current price, and so we fulfilled all the requirements of the capital raising in doing so. But what I would like to see going forward is that we get our share price up so that within our capacity we can raise more funds. What we've raised in this case will give us about a 12-month runway as of today, about 12 months, which is good. And clearly, we'll hopefully see our revenues grow and our costs remaining stable, and that's a pretty good recipe for ultimately becoming profitable.

Andrew Musgrave

Okay, Peter, now just to wrap things up, as you look ahead, what are some of the key milestone’s shareholders should be looking out for over the next 12 months?

Peter Molloy

Let me just backtrack a little bit and say that the last two years have been a turnaround period where we've pivoted towards commercialization. And in that context, 2026 is a most important year for us because it's the year where we deliver on approvals in the two largest markets in Southeast Asia and start marketing in both of those markets, I hope, before the end of 2026. So, it's going to be an important inflection year for us. We're going to announce hopefully a partner in Indonesia to commence marketing and approval in the Philippines, where we already have a very strong partner in place who also is a substantial shareholder in our company and is has commitment not just in terms of marketing but in investment in the company, which leads to a very potent alignment of motivations. So, approval in the Philippines is going to be a huge event for us this year. The announcement of additional products coming through in our pipeline. I think the market will be amazed at what we're developing there. And so, I think that'll be very positive. And I hope that we'll see approval in at least one other market in the region or elsewhere this year. So, this is a year of rapid growth in terms of outcomes, and beyond that, I think we're going to see enormous growth in the value of the company. You know, I look at our valuation, Andrew, and we're valued at the moment about 15 million, and you know, I could easily see it at 10 times that valuation, and I hope that we can deliver on that.

Andrew Musgrave

Okay, Peter. Well, it's been great to have you on the podcast again, so thanks for your time, and we look forward to further updates from Firebrick Pharma in the upcoming months. 
 
 Peter Molloy

Thank you. 
 
 Andrew Musgrave

 That concludes this episode of ASX Briefs. Don't forget to subscribe, and we look forward to catching you on our next episode.