All right, good morning, everybody. Welcome to Room 104B. Speaking next, we have Medexus Pharmaceuticals and CEO Ken d'Entremont. He'll be speaking for around 20 minutes, and then we'll pass the mic around for some questions. We'll do a five-minute Q&A period after. Without further ado, Ken, take it away. Thank you.
Thank you very much. I want to thank Bloom Burton for the opportunity to present the company here today. Presentation will probably take me about 20 minutes, so I'll be happy to take any questions. I am here to present Medexus, a publicly traded company on the TSX. Lots of information on our website, including our statements, forward-looking statements. You can gather them there. You know, what is Medexus? Medexus, in its simplest terms, is a company that's trying to save lives, improve outcomes for some pretty serious diseases. We have built an organization, infrastructure throughout both the U.S. and Canada, and we are going about executing on that plan. As you look at the company today, we are about $113 million revenue last year. Everything I'll talk about is in US dollars except for our share price. $113 million in revenue.
We've got about 15 different products in both territories, so the risk is spread amongst many different products. We've got a really strong short-term catalyst in a product called Treosulfan, which I'll speak about in more detail in future slides. We've got about 60%-70% of our revenue currently coming out of the U.S. We are diversified between those two territories. The growth will largely come from the U.S. We would expect it to become 90/10 at some point in the future because a lot of the revenue growth is coming out of Treosulfan, now called Grafapex. Management owns about 10% of the company, so well aligned with shareholders. We're selling and commercializing products in some core therapeutic areas. The areas that we're interested in are these: hem/onc or hematology, oncology, allergy, dermatology, and autoimmune disease.
We have commercial assets in each of those therapeutic areas, and we have or are working on pipeline products for each of those therapeutic areas. The vision going forward is to continue to build all three of these areas with our current commercial products, as well as future licensing or M&A products in these areas. The plan to move forward is very, very clear. We're about executing on that vision now. The products that we sell are extremely complex. If we're getting into all the details of each therapeutic area where we participate, it would be a really complicated discussion. Our business model is dead simple. We are licensing and acquiring pharmaceutical products that treat really important diseases. We're getting them registered and then applying our commercial infrastructure to those products in Canada and the U.S. It's a really, really simple business model.
It's really driven on organic growth of multiple pharmaceutical products. Business development is how we acquire those products. It's either licensing or M&A that's bringing new product portfolio that fuels future growth. We're not doing any true R&D. That is not what we do, so there's no development risk in this business. What we are doing is going out and looking for licensing and M&A opportunities in the therapeutic areas that we're interested in in order to build portfolio and future revenue and net profit. We do a little bit of product development. When we do some work on our products, it's related to expanding the label. We will add a pediatric indication on IXINITY, for instance. Those are low-risk investments that give us good upside revenue potential in the future.
When you do look at our statements, you will see there is an R&D line. It's a very modest expense. That's what it's directed towards. As I mentioned earlier, we're very much focused on the U.S. and Canada. We've spent several years building up our organization to have the commercial infrastructure that can handle the products we have, but also future products that we expect to bring into the portfolio. That's really where the leverage is in this business. We've got roughly a 55%-60% gross margin on current portfolio. As we add new products like Treosulfan, which has an 80% gross margin, we're largely using all of the same infrastructure that's already in place. That gives us tremendous leverage to grow the return from this business. Clearly, having this commercial infrastructure is really, really important.
As we're adding products in the therapeutic areas that we're interested in, we're leveraging that infrastructure, and we don't have to build out whole new sales and organization teams. We're really using what is already in place, and that's really the important feature of this business, as I mentioned.
All right, good morning, everybody. Welcome to Room 104B. Speaking next, we have Medexus Pharmaceuticals and CEO Ken d'Entremont. He'll be speaking for around 20 minutes, and then we'll pass the mic around for some questions. We'll do a five-minute Q&A period after. Without further ado, Ken, take it away. Thank you.
Thank you very much. I want to thank Bloom Burton for the opportunity to present the company here today. Presentation will probably take me about 20 minutes, so I'll be happy to take any questions. I am here to present Medexus, a publicly traded company on the TSX. Lots of information on our website, including our statements, forward-looking statements. You can gather them there. You know, what is Medexus? Medexus, in its simplest terms, is a company that's trying to save lives, improve outcomes for some pretty serious diseases. We have built an organization, infrastructure throughout both the U.S. and Canada, and we are going about executing on that plan. As you look at the company today, we are about $113 million revenue last year. Everything I'll talk about is in US dollars except for our share price. $113 million in revenue.
We've got about 15 different products in both territories, so the risk is spread amongst many different products. We've got a really strong short-term catalyst in a product called Treosulfan, which I'll speak about in more detail in future slides. We've got about 60%-70% of our revenue currently coming out of the U.S. We are diversified between those two territories. The growth will largely come from the U.S. We would expect it to become 90/10 at some point in the future because a lot of the revenue growth is coming out of Treosulfan, now called Grafapex. Management owns about 10% of the company, so well aligned with shareholders. We're selling and commercializing products in some core therapeutic areas. The areas that we're interested in are these: hem/onc or hematology, oncology, allergy, dermatology, and autoimmune disease.
We have commercial assets in each of those therapeutic areas, and we have or are working on pipeline products for each of those therapeutic areas. The vision going forward is to continue to build all three of these areas with our current commercial products, as well as future licensing or M&A products in these areas. The plan to move forward is very, very clear. We're about executing on that vision now. The products that we sell are extremely complex. If we're getting into all the details of each therapeutic area where we participate, it would be a really complicated discussion. Our business model is dead simple. We are licensing and acquiring pharmaceutical products that treat really important diseases. We're getting them registered and then applying our commercial infrastructure to those products in Canada and the U.S. It's a really, really simple business model.
It's really driven on organic growth of multiple pharmaceutical products. Business development is how we acquire those products. It's either licensing or M&A that's bringing new product portfolio that fuels future growth. We're not doing any true R&D. That is not what we do, so there's no development risk in this business. What we are doing is going out and looking for licensing and M&A opportunities in the therapeutic areas that we're interested in in order to build portfolio and future revenue and net profit. We do a little bit of product development. When we do some work on our products, it's related to expanding the label. We will add a pediatric indication on IXINITY, for instance. Those are low-risk investments that give us good upside revenue potential in the future.
When you do look at our statements, you will see there is an R&D line. It's a very modest expense. That's what it's directed towards. As I mentioned earlier, we're very much focused on the U.S. and Canada. We've spent several years building up our organization to have the commercial infrastructure that can handle the products we have, but also future products that we expect to bring into the portfolio. That's really where the leverage is in this business. We've got roughly a 55%-60% gross margin on current portfolio. As we add new products like a Treosulfan, which has an 80% gross margin, we're largely using all of the same infrastructure that's already in place. That gives us tremendous leverage to grow the return from this business. Clearly, having this commercial infrastructure is really, really important.
As we're adding products in the therapeutic areas that we're interested in, we're leveraging that infrastructure, and we don't have to build out whole new sales and organization teams. We're really using what is already in place, and that's really the important feature of this business. As I mentioned, we're focusing on very specific therapeutic areas: hem/onc, derm, autoimmune disease. These are therapeutic areas where you don't need big sales teams. We've got very, very focused resources in these therapeutic areas that deliver a really good return. These are very, very productive physicians or institutions. The real strong catalyst that we have is Treosulfan in the U.S. Those of you that have been following the story, you'll know that for many years we've been working on getting this product registered in the U.S. We have now successfully done that.
This is a tremendous catalyst for the company because it's such a good growth opportunity. Grafapex or Treosulfan, this is the first new conditioning agent in stem cell transplantation for decades. This is a really important innovation because it dramatically improves the outcomes for some really serious diseases, including certain forms of leukemia. Our drug, now being approved, we would expect is going to become the standard of care, which in the US is better than a $100 million revenue opportunity. Clearly, you know, this is a really strong growth driver for our company and can more than double our revenue at a gross margin that's better than our current blended gross margin. As I mentioned, this drug was approved in January. We began to commercialize it about a month later. The early returns are really positive.
We're seeing reimbursement happening both at the institutional level. We've got some of the key institutions who have put it onto their formularies. It's happening at the payer level, where we've got the second largest payer in all the U.S. has now put it on their formulary. That reimbursement piece is really important because that's the early driver of future revenue growth. That is happening, you know, exactly the way we had expected it to happen. In spite of all that, we are still getting physicians and hospitals who are using the drug even before reimbursement. When you see our results coming out in June for last quarter and then a few weeks following for the next quarter, you will see revenue from Treosulfan. Revenue is coming from Treosulfan by prior authorizations.
Basically, they're saying there's such a strong clinical need for this patient to have Treosulfan rather than the other products. They are giving them prior authorizations and access to the drug. That is a really positive development for us because it reinforces the need for the drug in the marketplace. We're really confident in the $100 million target, and that is for several reasons. First, Treosulfan has become the standard of care in any country where it's been launched. Clearly, we would expect that to happen in the U.S. We've experienced the same thing in Canada. As I mentioned, in Canada, we launched it several years ago, and the type of uptake that we're getting is really, really strong. You can see the type of growth that we got over the past fiscal year. I will remind you that that is prior to any reimbursement.
Reimbursement is just now happening in Canada, and we've gotten Ontario, Quebec, BC, a few other provinces have already put it on their formulary. All of that revenue growth was prior to reimbursement. These hospitals were paying for the drug out of their hospital budget. Clearly, now that we have governments fully reimbursing Treosulfan in Canada, we would expect to see that sales curve accelerate. The other very positive that we have is the market share in the two market segments, pediatric and adults. Pediatrics is a really important market segment in this space because that is a group that obviously is very susceptible to the toxicities of the old drugs. Our drug has got a very clean safety profile versus the drug it's replacing can actually cause infertility in the children that they're treating.
Obviously, a very bad outcome when you're trying to cure this child of a very fatal disease is to leave them infertile. Our drug does not do that. Clearly, that's a really important improvement in toxicities. The same concept can be applied to adults. Obviously, these are very ill people. They have leukemia and other really serious diseases. Organ toxicity is a real problem. Many of these patients have comorbidities. Obviously, having a drug that causes fewer toxicities gives them a better outcome. That's what the clinical trial was based on, where the Behlind study, you know, demonstrated a 26% improvement in overall survival at two years. Clearly, a very, very strong improvement in outcomes for these patients. We're experiencing the same thing in Canada. The other piece of information I think is really critical is this study here.
This is a real-world study. It was done at Princess Margaret Hospital here in the city, one of the top transplant centers in the world. They treated leukemia patients with Treosulfan, compared it to the legacy drug, and they determined that there was a 56% decrease in all-cause mortality. A really dramatic improvement in outcomes for these patients. Again, it's another indication that we feel that the U.S. market will adopt the drug readily. Treosulfan is an important driver of our revenue in the future. Our core business, which delivers $113 million in revenue, is made up of four or five different products, IXINITY being one of the largest. IXINITY is for hemophilia B, another rare disease orphan drug indication. There's only 4,000-5,000 patients in the U.S. with hemophilia B.
This drug basically replaces what's missing from their blood, allows them to have a completely normal life with access to our drug. This has been a very, very good performer for us, nice steady drug, had some ups and downs as we normalized the channel, if you've been following the story. Now we've got very, very consistent demand and ex-factory sales, which is delivering the returns that we expect. Rupall is another important product in our portfolio. This is a Canada-only product for allergy in the derm therapeutic area. We hope to expand in this area. We do have some licensing work that's happening now that would bring us other product opportunities for this space. You can see the type of strong upwards growth that we've had for this drug over many years.
It has recently been genericized, so we would expect that that would start to plateau and then slowly decline. There's a full anti-generic strategy in place, and so far that strategy is working extremely well for us. Rasuvo and Metoject are the lead products in our autoimmune space. These are now mature products. They are very, very stable. We have a very strong market share in the U.S., about an 80% market share, and we would expect that to be consistent as we go forward. We have another product that we're working on in this space that would drive future revenue should we successfully be able to develop it. Finally, Nyda is the one product that also is a partner with Rupall. In Canada, we have Nyda, which is for lice.
Obviously, the absolute opposite of rare disease orphan drug, but it's a bit of a legacy product that's performed extremely well. Obviously, we have continued to support that, and it has responded very nice following, obviously, the dip, which was the COVID period. As I mentioned at the very beginning, you know, clearly our business model is dependent on business development. We have to be able to successfully license and execute M&A deals, and we've done that consistently over the years. We've got two examples here where we purchase businesses for less than one-time revenue, and we tied the economics to the partner for successful revenue growth in the future. Obviously, that's a really good model for us because it takes a lot of the risk off of our balance sheet and puts it on future growth. A really, really important characteristic.
We would expect that, you know, our business development efforts will continue to execute these types of deals in order to build the portfolio. Now, if you look at our financial results, obviously we've had really nice steady revenue growth since we took this company public in 2018. You can see it had a bit of a plateau as we were waiting for Treosulfan to get approved in the U.S. We were not doing any deals. We were not doing any new licensing opportunities. We were waiting to get that approved. We now have that approved. We would expect that is going to start to accelerate from that base. If you look at the quarterly results, I think we are really proud of this and that we are showing really, really steady revenue and EBITDA.
I will point out that the last quarter that we showed, which is quarter ending December 31st, we had $30 million of revenue, which delivered 5.8 of EBITDA. Remember that 5.8 also included another $2 million that we spent on Treosulfan in anticipation of that commercialization. Had we not spent money on Treo, we would have had an EBITDA number of 7.8. Really, really strong base business that gives us support going forward. Finally, capital structure. Capital structure, I think, is pretty clean now, 32 million shares outstanding. At December 31st, we had debt of about $30 million. We did a capital raise of about $20 million in January. Net debt sits now at $10 million-$15 million, something in that range. A very, very manageable debt package with our friends from BMO.
Really good analyst coverage, including David White from Bloom Burton here. We have good analyst coverage as well. That is really the story. You know, I think the key investment highlights for this business is that, look, you have a really good base business that is delivering very strong and reliable EBITDA. We have a very strong growth catalyst, which is Grafapex in the U.S., that has demonstrated really strong market performance everywhere it is being launched. Going forward, we have additional products in our pipeline that will fuel future growth into the future. We are very, very active in licensing and M&A now that Treosulfan has been approved. Obviously, that was a really important catalyst that we had to execute, and we have done so successfully. We are really back to business development, currently trading at a pretty significant discount to some of our peers.
We have a really strong balance sheet at this stage, stronger, strongest that we have ever had in the history of the company. You know, we are really confident about where we are and where we are going with this business and looking forward to continue to execute. That is the story. I am happy to take any questions that anybody might have.
Thank you. Thank you, Ken.
[audio distortion] free cash flow this year.
Free cash flow this year?
Yes.
We happen to have our CFO in the room, so I think I will pass it to him.
Our free cash flow very closely mirrors our EBITDA. You will see from the last trailing 12 months, it is at around $20 million. The $5 million-$6 million of EBITDA per quarter that we have kind of seen historically, that will dip as we launch them.
We've kind of guided towards that cost of about $4 million a quarter. You will see that drop sort of year- over- year in our free cash flow trend.
How much do your costs track towards the capex?
Brendan's basically saying that the cash flow tracks very closely to EBITDA, and so it's about $5 million per quarter. It's going to dip a little bit as we spend on Treosulfan, but then obviously as that starts to get traction later this year, you'll see it rebound pretty sharply.
[audio distortion] cost structure in Canada.
The cost structure in Canada, 70% of our revenues come in the U.S., so therefore 30% out of Canada. It's pretty evenly split in terms of our cost structure. Most of our corporate team is here in Canada, but we do have a commercial team in the U.S.
Can you talk about the size of the opportunity for Treosulfan, what the incremental gross margins are on that, and sort of where the total cost peaks out so we can sort of get an idea of what the incremental EBITDA is going to be from Trio?
Yeah, absolutely. So Trio obviously is a really key catalyst for us. Grafapex, brand name, will peak out at some place north of $100 million. The forecasting that we've done brings it in north of $100 million, and that's supported by one, uptake in all other markets. It's gotten very strong market share everywhere else it's been launched. We're seeing that type of uptake in Canada that would support that type of number. All the market research we've done with clinicians in the U.S. has supported that type of number. We're confident in the $100 million.
The gross margin is 80%, so it's a much stronger gross margin than our current blended gross margin, which is about 60%. We would expect to see margin appreciation as we go forward for the total company. The cost basis is what we've been guiding to. We're going to spend $3 million-$4 million per quarter on Trio alone, and that won't change over time. That'll be flat. You can see kind of where the breakeven is, and we expect to reach that point later this fiscal year.
I just want to make sure I understood correctly. You do expect on an ongoing basis, so beyond fiscal 2026, to be spending $3 million-$4 million marketing, et cetera, on Treosulfan over the next seven years that you have rights. Is that correct?
Yeah, it's correct.
Our assumption is that we will, we've built infrastructure to support Trio.
Yep.
That infrastructure is most of the cost. It's not all of the cost, but it's most. Clearly we need those people in the launch phase, which is the first three to five years. Following that period of time, we would expect that we'd have other products that we'll be launching and would use that same infrastructure. I think for our planning purposes, we just assume we keep those people in place. If that weren't to happen, then obviously we would be taking some of those costs out of the system.
Can you indicate how the rollout of Treosulfan, Grafapex has been? You started in late February, if I'm not mistaken, your fiscal year end is March 31st. Are you ahead?
Keep in mind that we're hearing about things three months later because of the fiscal year end. Could you address how sales are going currently?
Yeah. That's why we put the press release out, I guess, a few weeks ago, just to give everybody a bit of an update so we could speak to it. The rollout's going exactly as we would expect it, maybe a little bit better. We're seeing the reimbursement that we want to put in place happening faster. We're seeing prior authorizations happening. I think we said in the press release, 16 different hospitals had ordered the product as a prior authorization. Without reimbursement, that number has grown dramatically in the three weeks since we put the press release out. We're seeing that happen. There's market uptake.
In the financial results we'll put out end of June for the fiscal year, you will see some Trio revenue. We're booking Trio revenue now. It'll start to accelerate as reimbursement falls into place. That's the point at which we start to see really serious numbers.
Could you address one more thing, which is I know the focus is on Trio, but with regards to the business, are you actively looking for other drugs to market either in Canada or the United States?
Absolutely both. Yeah. Clearly business development is a really important part of our strategy. We have things in each therapeutic area that we would want to bring to market. There's a late-stage licensing deal that we're working on. Hopefully we've got the opportunity to talk about it in the near future.
Okay.
That's all the time we have for questions at this time. You can find Ken in the hallway. I'm sure he'd be happy to chat some more. Thank you, Ken.