My name is Ken d'Entremont. I'm the CEO of Medexus Pharmaceuticals. Let's start with what is Medexus. What's our mission? What's our purpose? Medexus is really a pharma company that's literally trying to save lives. We've got some very significant products that are in the rare disease orphan drug space that have very improved outcomes for some very serious diseases. Literally saving lives for those patients that we treat. There's lots of information on our company at medexus.com, including our forward-looking statements. This is an overview of who we are. We're basically a company that has about $100 million in revenue today. These are all U.S. dollars. We have about 15 products in the market in both the U.S. and Canada. Those are the two territories where we participate. We've had a nice, strong, steady growth over many years. About 63% of our revenue currently comes out of the U.S.
Management has got a significant degree of ownership. Really importantly, we've got this very significant catalyst in a product called GRAFAPEX that we have literally just launched. That will transform the company from something that does around $100 million in revenue and produces about $20 million of positive EBITDA to a company that produces more like $250 million or $300 million of revenue at a better gross margin. A very, very significant catalyst that we're in the process of executing. We're interested in three particular therapeutic areas. One is hematology/oncology, where GRAFAPEX resides. We have a few different products in that particular therapeutic area. That's where most of the growth will come from. We also participate in allergy/dermatology, where we have a few products. Finally, in autoimmune disease, where we have a mature product but a pipeline coming to fill in. Our business model is really quite straightforward.
We're not drug developers. We're not spending a lot of money on developing these drugs. We are really commercial operators. We're looking to acquire licensed drugs that we can get registered in the U.S. and Canada and drive to peak sales and repeat. The infrastructure is all in place. That's really what we're looking to leverage as we add products to our portfolio. The business model is really quite simple. We're very, very focused on organic growth of existing portfolio and pipeline products. We acquire all of that through business development. It's either licensing or M&A that have built these 15 products plus pipeline products. We will continue to do that in order to grow the company into the future. We do a little bit of product development, and that is typically improving the label of existing drugs. There's not a lot of R&D risk in this company.
It's really just focused on commercial risk. We mitigate the commercial risk by selecting good assets that we can drive to peak sales. This is the infrastructure that we have built. As I mentioned earlier, we have got complete teams already built out in both the U.S. and Canada, and these teams can obviously support a lot more product. As we're adding products to the portfolio in the therapeutic areas where we already participate, that creates a lot of leverage. GRAFAPEX, for instance, which is the newest product, it's at an 80% gross margin, and we had a relatively minor increase in commercial spending to support that product. Clearly, it's very accretive very fast. That's really the beauty of our business model, is that once we have the base established and are producing positive net income and EBITDA, then as we grow, that makes a very meaningful number going forward.
The catalyst that we have in our portfolio is this product. It's called GRAFAPEX in the U.S., or triosulfan is its generic name. It has the potential to do over $100 million in revenue, obviously more than doubling what we currently do in our portfolio. This is a product for allogeneic stem cell transplantation. Basically, it's a very positive way to treat some leukemias that are absolutely devastating, like AML and MDS, where there's virtually 100% mortality at five years. A stem cell transplant for these patients can replace the immune system, and it can result in very, very good outcomes, basically give them a new opportunity at life. What our drug does is it conditions the bone marrow prior to that transplant, so we're called a conditioning agent. That's what we do. This product was approved by the FDA in January of this year.
We launched it in February, and the commercial outcomes so far have been very, very positive. We're seeing solid uptake by hospitals. We're seeing very positive formulary decisions by P&T committees. We're seeing commercial payers put it onto their formularies. The uptake has been really good. Most recently, we got an MTAP approval, so new technology for Medicare patients. These are really difficult approvals to get. There were only 13 applications last year. Only five were approved. We were one of the five. What that does is give about a $21,000 reimbursement for these patients. A really, really serious opportunity for us to grow. The drug has orphan drug designation, so it has seven years of exclusivity going forward. We feel really confident in the outlook for the drug because it's been well researched, been launched in many countries, including Canada, where we launched it ourselves.
Trecondyv, or triosulfan in Canada, has had a really, really significant uptake. At this point in time, we have a 56% share of pediatric transplants and a 10% share of adult transplants. I'll point out that this is before we got reimbursement for this drug in Canada. Reimbursement in Canada happened several months ago. We would expect to see this trend accelerate as we go forward. This bodes very, very well for GRAFAPEX in the U.S. because we've had this experience in Canada. The other thing that gives us a high degree of confidence is the clinical data. The phase III study showed a 30% improvement in overall mortality. 30% is a massive improvement in survival. We've done a retrospective study in one of the key hospitals in a real-world situation that showed that we had 56% less chance of all-cause mortality at two years.
Very significant improvement in outcomes, literally saving patients' lives. As a result, we think this drug will become standard of care. In Europe, where it's been launched for several years now, it's attained between a 25% and a 65% market share. Clearly, we've got a lot of upside in this drug. Our $100 million forecast that we're putting out, that's a 25% or a 35% share in the U.S. Clearly, there is lots of upside for this drug. That's not the only drug we have in our portfolio. We have another drug in hematology, which is called IXINITY. This is for hemophilia B, another rare disease orphan drug indication. This particular drug basically replaces what is missing from the patient's blood. With our drug, they can live a completely normal life. It's a rather rare indication, hemophilia B. There's about 4,000 - 5,000 patients in the U.S. with this disease.
Rasuvo and Metoject are other products that we have in our portfolio. These are now kind of mature, but I show it because it kind of demonstrates what we've been able to do commercially. It shows that we've got about an 80% market share in this marketplace. We launched our product, beat a competitive product, and hold a very, very strong share. Very recently, the competitive product has now been removed from the market. We have additional upside as a result of that action. We do believe that Rasuvo in the U.S. has some growth potential, possibly. Another drug that we have that, again, we've commercialized very successfully is Rupall for allergy in Canada. We grew this drug dramatically over the years that we had it. It has now reached the end of its exclusivity period.
We would expect that it's going to decline, but it has been a successful commercial entity for us. It's really important in our business that we continue to build the portfolio because, as you well know, drugs have a defined life cycle. You want to keep adding more products into your portfolio to drive future growth. That's clearly why we keep building the portfolio. We also have a product called Nida, which is kind of an interesting product, which is for head lice, obviously the opposite of a rare disease or orphan drug indication, but something that has performed very successfully. The funny dip in the middle, that's during the COVID period where social distancing obviously had an impact on the transmission of lice. That has come back very, very strongly. Now there is a new regulatory change in Canada that will allow us to grow this drug fairly significantly.
I think what we have is a broad portfolio of products that have got good growth potential in them, in particular GRAFAPEX. How we achieve and how we brought those products in were all through business development. Each time we've done M&A, we've been able to do so very efficiently. Both Rasuvo and IXINITY, we purchased for less than one-time revenue. We used our capital really, really well. We tied the partner's economics to our success, our growth. That's obviously a far better way to do it. We've executed on that many, many times. Our financials are fairly straightforward. You can see we've had very nice growth. It kind of plateaued in the last few years as we were working on the registration of GRAFAPEX in the U.S. We would expect that that's going to accelerate very significantly. We've had many quarters of positive EBITDA.
We took a bit of a dip in the first quarter of launch of GRAFAPEX. We just released our results last night. Last quarter, we went to $3.4 million of EBITDA. We've already kind of hit the trough. As we go forward, we would expect this to grow. Nice, nice performance and fantastic growth opportunity. It's very clear that we're undervalued. We're trading at less than EV is less than one-time revenue. EV/adjusted EBITDA is 4.4. With the type of growth potential we have, we think this is a very, very good time for investors to get involved. Balance sheet is quite straightforward, about 32 million shares outstanding. Net debt is quite low. We've got good coverage from analysts, including Canaccord.
As you look at this company, I think what you should be looking at is, look, you've got a base of business that is significant and stable with a portfolio of new products coming, in particular GRAFAPEX, which is really going to accelerate growth at a better gross margin into the future. A really strong commercial platform that can drive this sort of uptake. I think we're in a really good position with the outcome of GRAFAPEX so far. We're seeing very, very significant growth. Now is a really good time to be involved in the company. I'm going to stop there and take any questions anybody might have. Yeah, please.
That's a pretty diverse set of products. What are you looking in licensing?
Great question. Typically, what we're looking for is in the three therapeutic areas where we participate: hematology, oncology, autoimmune disease, and allergy dermatology. Those are the therapeutic areas that we're interested in. We're looking for late-stage clinical development, late phase III or pre-registration. In a couple of instances, we took drugs that were already registered and sometimes launched, but we saw growth potential in them. We're looking for late stage. We're not taking a lot of development risk in our business.
You expect GRAFAPEX to turn cash flow positive. As that cash flows, what are your priorities for the company?
Yeah, that's a great question. GRAFAPEX is obviously performing really well. We did $3 million in revenue in the first quarter, so it's off to a really fast start. We expect that it will be accretive in the fourth calendar quarter, which is our fiscal Q3, the end of this calendar year. We expect it to become accretive. Obviously, as we go forward, GRAFAPEX is going to be a very, very significant driver of our growth. We'll be using that cash to find other products to build the portfolio. Our vision is to get much larger than $200 million or $300 million in revenue. We want to be $500+ in revenue.
Yeah. How did this happen that the time you were working to get that approval, there was an AD going on? You said that.
Yeah, no, it's a great question. Trecondyv, or triosulfan, in Canada got expedited review, six months it was on the market. In the U.S., it received the CRL the first time through. It took time to correct the CRL. We were highly confident it would be corrected. It was the partner who was doing that work. It wasn't us. We didn't have control of the registration file. It took some time. That was clearly our biggest opportunity. We were very, very focused on getting GRAFAPEX through the FDA. Now that has been achieved. We're looking to build our portfolio. We do have products in our portfolio in autoimmune disease. We have a product that we're developing. We have some licensing discussions late stage in the two other therapeutic areas.
There are a bunch of things that are near term that we would expect to add to our portfolio that will drive future growth. Great. I'll stop there. Thank you for your attention.