Good afternoon, everyone. I think we're ready to start here. Hope you all enjoyed the investing in R&D healthcare companies panel. This is the last session of presentations for the conference. We hope you've enjoyed it so far. So to kick us off with this session of presentations, we have Medexus Pharmaceuticals. And please give a big round of applause for Ken, CEO of Medexus. Thank you.
Thank you very much. Thank you, Scotty. I just want to thank Bloom Burton for the opportunity to present Medexus here today. Medexus is a publicly traded company under the TSX, under the symbol MDP, and the OTC QX in the U.S. So if I can get the slides here. There we go. So we're a publicly traded company. Our disclosure terms are on our website at medexus.com. There's lots of investor information there. So please feel free to go and see that or reach out to us. So let's start with Medexus. Medexus is a commercial stage pharma company with about $108 million in revenue. We report in U.S. dollars. We've got a commercial platform built out across both U.S. and Canada. About 75% of our revenue does come from the U.S. We produce positive EBITDA.
We've got a really significant catalyst coming in a product in our pipeline called Treosulfan, which we think can more than double the revenue that the company has. So really, when you think about our company, think about a commercial play that has got a broad portfolio of products, a steady base of business with a strong catalyst coming in the near future. So the business model is really quite straightforward. Clearly, organic growth of existing portfolio is really important. We've got 17 products within the two territories, U.S. and Canada. Those 17 products have got a strong gross margin in the 60% range. And we're seeing applying our commercial expertise to grow those products and that revenue to produce a good return. We acquire our products through business development. So we don't do any true R&D.
We are licensing and acquiring products in those two territories, in particular therapeutic areas that we find of interest. We're trying to leverage that commercial infrastructure in those therapeutic areas with a broader portfolio, which obviously creates a bigger return as we go forward. If you do look at our statements, you will see an R&D line. That's really more or less product development where we're expanding label. There was a good recent example where we added a pediatric indication to our Ixinity drug, and that was recently approved by the FDA. We don't do any true R&D, but we will do some work to expand label to improve the commercial profitability of those products. This is the product portfolio. I think the important thing to take away from this is that we do have a high degree of focus.
We've selected certain therapeutic areas where we think we can apply our commercial infrastructure, where we think we can add commercial products and build the portfolio. One of the most important areas that we're in is hematology or HemOnc, where we have Ixinity as a Factor IX product for hemophilia B and a pipeline product called Treosulfan, which I'll spend some more time on later because it's really the most important pipeline product that we have within our portfolio. In addition to that, we have products in rheumatology where we have Rasuvo and Metoject and basically the same product on both sides of the border, just different branding. Rare disease, we have a product called Gleolan, which is for the treatment of glioblastoma tumors, the most common type of cancerous brain tumor.
Then finally, we have a bit of an outlier, which is the allergy dermatology business in Canada. It was a legacy business that's performed extremely well, produces a solid return for us, and we're looking to expand that business in Canada. A focus of therapeutic effort and seeking to build the portfolio in those therapeutic areas, which leverages the infrastructure that's already in place. As I mentioned, the commercial platform exists in both the U.S. and Canada. We've got teams that are fully built out. Salespeople are all our own. And we are preparing them for launch of new products, and particularly Treosulfan coming soon, we expect in the U.S. and already in market in Canada. It's really important that this commercial platform be in place because this is really where we get our leverage.
As we add products to this platform, obviously at a 60% or better gross margin, a lot of that drops to the bottom line because we don't have to build out full sales teams as we go forward. Ixinity is one of the lead products within our portfolio. This is a product for Hemophilia B, a rare disease. It's 4,000-5,000 people in all of the U.S., about 700 people in Canada. It's a rare disease. It replaces Factor IX, which is the factor that's missing from their blood and allows these people to live completely normal lives as long as they have access to our product. So this product we acquired from Aptevo a few years ago. We've been successfully growing this product.
We ran a clinical study to demonstrate its utility in pediatrics that was filed with the FDA and last month was approved by the FDA and now being added to our label. It's a really important addition, not because pediatrics is going to be a huge market opportunity, because this being a rare disease, there's only a few new children diagnosed per year. But what this does allow us to do is have an even footing with the other Factor IX products that exist in the marketplace. And that gives us the opportunity to contract. And so if we're able to contract because we can supply the product to all patients, that puts us in a much better position. So as we go forward, we think that will become a more important portion of our business. Rasuvo is a product in the rheumatology area.
This is kind of a legacy product that we've had. We launched it behind a competitive product. We passed them and dominated this particular therapeutic area. We've got about an 80% market share. It's very mature at this stage. We've got most of our business locked up in contracts. So that continues on very, very nicely. The recent bump, kind of the funny bump you see there, that's related to a shortage of methotrexate. There have been worldwide shortages of methotrexate that haven't affected us. And as a result, we've gotten a nice bump in revenue for Rasuvo and for Metoject, which is the same product in Canada. Gleolan, as I mentioned, is another product in rare disease. This is for glioblastoma tumors, the most common form of cancerous brain tumor. This kind of revolutionizes how these tumors are treated.
Basically, what it does is cause the cancerous tissue to fluoresce pink under blue light. So it makes it much easier for the neurosurgeon to identify what's cancer and what's not cancer. Clearly, when you're doing brain surgery, you need to be extremely cautious. You don't want to lose functionality for that patient. So having this marker available to determine what is cancer and what's not allows them to be a little more aggressive, do a more complete resection, which in turn then becomes better efficacy, longer survival for that patient. The reason we liked this product and licensed this a couple of years ago was that this is also in the same institutions where we're going to be launching Treosulfan. So it's an institutionally based product. Clearly, all these patients are being treated by the biggest cancer centers in the U.S. and Canada.
Those are the same centers where we'll be launching Treosulfan. So it gives us an opportunity to gain experience and access to those hospitals that we think will benefit us with Treosulfan. Rupall, as I mentioned, it's a bit of an outsider. Rupall is for seasonal allergies and hives. It's been an extremely good performer. You can see over the six or seven years it has been on the market is showing this very consistent linear growth on an annual basis. The funny peaks and valleys you see are related to the seasonality of allergies. Obviously, peaks starts in the spring, peaks in the summer, and then starts to wane in the fall. And so you see that cycle continue to repeat. This drug has been very, very successful for us. It will lose its data exclusivity next year.
And so we expect to replace this revenue with a product called terbinafine lacquer, which is a product for nail fungus. You've all heard the commercials about, "Geez, that's ugly. You should get that treated." No, there's nothing wrong. That's Bausch with Jublia. And that's about an $80 million product in Canada. So a really good market opportunity. This particular product, you don't have to use it as frequently. That product, you need to use every day for about a year. This product, after the initial use, it's once a week. So clearly, we think we'll get a very good share from that market for this product when it is approved, assuming it is approved. It's been filed with Health Canada, and we would expect to hear a decision before the loss of exclusivity of Rupall. And then this product would fall right into that portfolio for those people.
I think we've had a pretty good track record of deal execution. We've acquired a few products. Rasuvo and Ixinity are two good examples where we acquired these products for less than 1x revenue. So we're always trying to structure the economics for the partner in such a way it's based on our success. So if we're able to grow the product and hit targets, then they get their economics rather than putting all of the capital at risk upfront. We've successfully executed those types of deals several times now. And clearly, that's what we attempt to do. The pipeline for us is quite important. We've got this nice base of business that's fairly stable, about $100 million in revenue, producing good EBITDA. But we also have a very nice pipeline. And some of you will know this pipeline, Treosulfan being the most important part of it.
Treosulfan is a drug for conditioning of bone marrow prior to stem cell transplantation, basically a type of treatment for various bloodborne cancers and some other non-malignant diseases. So a very, very attractive area. So that drug has been approved in Canada. We did the registration, took six months, expedited review. Our partner, Medac from Germany, had some troubles in the U.S. where they got a CRL. And that was about two and a half years ago. And for that period of time, they've been working on correcting that CRL. It's just about to be resubmitted. And we think that ultimately this product will be approved for good reason. I think you'll see that common sense will prevail. This is a very efficacious drug and has a major advantage versus the product that is currently being used for this indication. In addition to that, we have Ixinity.
The pediatric indication now has been added. That happened last month. Gleolan, there is an additional indication coming for meningioma, which is a type of non-cancerous brain tumor. The drug basically does the same thing, causes the tumor to fluoresce so that the surgeon can do a good job and complete job taking it out. In the U.S., we have a product called triamcinolone hexacetonide, which is for juvenile idiopathic arthritis, obviously falls into the rheumatology portfolio. And then finally, in Canada, we have terbinafine, which is the nail lacquer for fungus. So a nice portfolio of pipeline products, the most important of which is Treosulfan, which I'm going to spend a little bit of time on. Treosulfan is a product that we licensed both Canada and U.S. several years ago. So we licensed this product.
It's an orphan drug, rare disease for conditioning bone marrow prior to stem cell transplantation. There's about 8,000 of these transplants that are done in the U.S. and is basically being linear growth for the last 15 years. The reason these things are done is that it's a possible curative outcome for people with leukemia. So obviously, very, very good outcomes. If these transplants work, they are cured of leukemia. It will also work for other non-malignant diseases. And we would expect to get a bunch of those off-label as well. We licensed this product in Canada. We then later licensed it for the U.S. We have a 7.5-year orphan drug exclusivity for this. And that period of time starts to tick after the registration. So we're not losing any of that exclusivity time in the interim as this file is being reviewed.
This is the clinical data for Treosulfan. This gives you some insight as to why we think ultimately it will be approved. The slide on the left is a Kaplan-Meier curve showing either overall survival or event-free survival. I think this one is event-free. Overall survival basically shows exactly the same thing. That is showing basically a 26% improvement in overall survival for patients with AML and MDS, the most common types of leukemia. That's a massive increase in survival over a period of two years. This is long-term survival for these patients. The reason for that is it's just a much more efficacious drug. It has a much better side effect profile, doesn't lead to something called GVHD, graft-versus-host disease, which can be fatal for those patients. Clearly, a much, much better outcome.
The slide on the right is a summary of a pediatric trial. That pediatric trial showed similar results. That's a one-year survival curve. So you can see very, very high survival. In children, it's even more important to use our drug because it's efficacious, obviously, from demonstrated on the slide. But the side effect profile is much better. Side effects of the competitive product are organ toxicity. And in children, that means reproductive organ toxicity as well. And so it can lead to infertility in children. So you're able to cure them of their cancer, but you haven't left them with a great life in front of them. So clearly, our drug will give you better efficacy and doesn't have organ toxicity. And so it doesn't cause any issue with fertility. So a far better outcome. We've had this drug in Canada for the last two years.
The uptake in pediatrics was very rapid. We've got over a 59% market share in Canada already. We don't yet have reimbursement for the drug in Canada. It's a long process in Canada. Clearly, we are far advantaged versus everything else in the market. In the U.S., we think we'll get a similar type of uptake. Pediatrics is about 15% of the market. Clearly, we see rapid and early uptake in pediatrics and then strong uptake in adults over a period of time. This is our financial data. You can see we have nice, steady revenue growth. That has produced, I think, nine quarters of positive EBITDA. That has allowed us to generate cash, some cash last year, those of you who are following the story. We used to pay back a convertible debenture fully in cash, so zero dilution.
Then we replaced it with straight debt from a great debt partner in BMO at a very attractive rate for us. So now we go forward with a very clean balance sheet. This is the cap structure. We've got a relatively small number of shares outstanding. There's 24 million. So we took no dilution from that debenture. And now as we go forward with Treosulfan, clearly, the economics from Treosulfan will accrue to the 24 million shares outstanding, which is a fairly small number. And there is a fair bit of insider ownership. So as you think about the company, think of a built-out commercial platform, U.S. and Canada, stable course of business that we think is even on that being undervalued. And then you've got this catalyst, which is Treosulfan. Treosulfan will be filed this month, refiled.
We will announce when it's accepted for review. Then it will be a two to six-month review following that resubmission. So it could be as early as June for a decision, could be as late as October. So it's a really near-term catalyst that could have a very dramatic effect on our revenues and positive EBITDA. We've got the infrastructure largely in place for that. So any uptake that we get in Treo, we'll start to accrue very quickly. We've got other pipeline products that we do believe will come along as well, which are going to help us to further build the company. So that's Medexus. I'm happy to take any questions that you might have.
Hi, Ken. I was just wondering how comfortable you are with the debt level of the company at this point here.
Depending on the ratio that you're looking at, how do you see it and how do you think the market sees it?
It's a great question. I better have a good answer because our banker is sitting right here. So no, I think we set it up in such a way that we felt very comfortable with the repayment of it. It started out at $56.5. I think we're down to about $51 now. We've been paying it down over the course of just over a year that it's been in place and continue to continue. We expect to continue to do that. So the leverage ratio, I think, went from about three to 2.5-ish now. And we would expect to continue to pay it down.
What are expected peak sales on Treosulfan?
That's a great question.
So Busulfan, which is a competitive product, did $126 million at peak in the U.S. So we would expect to do something around that range. We obviously have far better efficacy than that competitive product and a far better side effect profile. So we do expect to get more off-label use. The two indications that are on label are AML and MDS, the two largest forms of leukemia. The competitive product only had a very small indication, limited indication. So we're far better there, far better in terms of the side effect profile. So we think we'll get those two large indications and be a real strong player there, but then get a fair share of off-label use also. Think of this market. This is 100+ institutions with the highest top-tier HemOncs in the country. So a very, very well-defined target who know the literature inside and out.
So this will be driven by the data. And in this case, the data is excellent. It has been launched in Western Europe for the last six or seven years. So there's lots of data that support what I just showed you in the pivotal study.
So I think you said there are 8,000 bone marrow transplants per year. So what portion of that would be on label versus off label, roughly?
Yeah, that's a great question. So let me see if I remember the data. AML and MDS probably are 40% of the total 8,000. So the rest will be off label. Pediatrics is about 15%. There's very little AML and MDS in pediatrics. So that will be an additional piece that we would expect to get. And then there's new data being generated annually for Treosulfan's use in other indications.
So clearly, our objective will be: let's start with AML and MDS. Let's start with pediatrics and then generate and expand the label in those other places.