Hansa Biopharma AB (publ) (HNSA) Earnings Call Transcript & Summary

[Foreign Language] Erik Penser Bank's Bolagsdag. Now [Foreign Language] Klaus Sindahl for Hansa Biopharma. So [Foreign Language].

Yes. [Foreign Language] I hope it's okay I'll do the presentation in English, even though you can ask questions to me afterwards in Swedish. I'm happy to answer those. But thank you so much for inviting me to this Erik Penser Bolagsdag. I'm very much looking forward to present Hansa for you. Before I start, I just need to show you this forward-looking statement. So you, of course, need to discount whatever I say. Yes, Hansa Biopharma, for those who are new to the case, I just want you to understand where we are today. It's a fully commercial-stage biopharmaceutical company based out of Lund. We are roughly 130 employees today. Actually, it's a good organization now, I mean, commercial-stage, et cetera. So we are now building our team across R&D and commercial. And it's a very experienced team. I mean we have, on average, 20 years of experience in the life science sector. So a good qualified team. We have a technology which has now been validated in 3 different indication areas. First and foremost, of course, with the regulatory approval obtained 18 months ago in highly sensitized kidney transplant patients. And then secondly, in the first autoimmune indication. So the first indication outside of transplantation, which is a disease called anti-GBM. It's an ultra-rare disease but very interesting, and I'll get back to it. And actually, we released a press release yesterday on Journal of American Society of Nephrology, which actually validated or wrote about the data we have come out with. And then thirdly, we have also validation in gene therapy. It's a fairly new space to us, but we have, nevertheless, already 2 partnerships here with Sarepta Therapeutics and AskBio, which was -- the latter one was announced here in the beginning of January. And here, the idea is that imlifidase, our lead compound, will help the gene therapy companies in inactivating the neutralizing antibodies, which prevents a large proportion of the patients to be treated with the gene therapies. So very, very exciting area where we are doing preclinical studies right now. We have a broad pipeline in transplantation and in autoimmune diseases and also a preclinic pipeline with these programs in gene therapy. From a market capitalization point of view, our current market cap is around SEK 3 billion, and we have financed into 2023 with the current cash in hand and with the projected expenses. We're listed here in Stockholm, and we have roughly 18,000 shareholders. As I started with, we have many milestones which have been achieved over the last 15 to 18 months, first and foremost, as I said, initially with the regulatory approval. And now we're actually seeing good progress in what is actually the enabler to get to these transplantation clinics because we have actually now secured pricing and reimbursement in the first 5 countries, and we have ongoing process in 14 countries. So beyond Sweden, which was the first country, we also have The Netherlands. We have Greece, Finland on a hospital basis. And then we also -- last Friday, we obtained early access in France. And France is actually the largest market within transplantation. So very, very interesting. But beyond that, we have had to -- or we have actually had 3 partnerships established over the last year. First with argenx in combination therapies, where you -- the idea here is to combine efgartigimod in FcRn for maintenance therapy with our imlifidase for acute treatment to enable more therapeutic areas. Very, very interesting. Then we have also done a collaboration in kidney transplantation with Medison Pharma, covering a number of Eastern European countries and Israel. And then, as I said initially, AskBio, a new collaboration in gene therapy. If I should go a step back and talk about our lead compound, imlifidase, it stems from bacteria, human pathogens, Streptococcus pyogenes. And what it does is it's very fast and effectively cleaves IgG, which is 80% of the human immune system. And it does that in 2 steps. And from a 15-minute infusion, you could see 2 to 6 hours afterwards that your IgG level is below detectable levels. So very, very effective enzyme. And as you see here on the right-hand side of the graph, the IgG level goes down very fast, and then it will stay down for up to 7 days. And this is the window where it's relevant for enabling kidney transplantation or if you want to knock down IgG in context of an autoimmune disease where the immune system starts to attack the body's own organs. And then it gradually will start to come back again. And this compound has immense applicability across a number of different indication areas. We have depicted 4 areas on this slide here to the left-hand side. So transplantation, pre and post, as I said, first indication now approved in kidney. But there are also other relevant areas, such as lung and heart, and also after transplantation to avoid these rejection episodes. Then left-hand corner, we have acute autoimmune diseases. We have 2 programs there, GBS and anti-GBM, where the body for -- or the immune system for various reasons start to attack the organs, as I said before. And very encouraging data from anti-GBM. Then 3 programs, preclinical programs, in gene therapy with AskBio and Sarepta. We're looking into Duchenne muscular dystrophy, limb-girdle muscular dystrophy and more recently, Pompe disease. And then fourthly, we have also started to explore oncology within hematopoietic stem cell transplantation, which is actually a quite interesting area on the side of kidney transplantation. And then to the right-hand side, we have our next generation of enzymes, which can be used in more chronic indications where you can deal with flares, reoccurring flares. Just a few words on our business model. To the left-hand side, you see here our growth platform. Here, we are developing new enzymes. And as we develop the enzymes and take them through the value chain, it's our intention to go to the market with our own commercial infrastructure in transplantation and autoimmune diseases because the landscape for our clinics is rather focused, and we can actually address that with our own commercial organization. When it comes to gene therapy and oncology, we want to address it through partnerships like we have done now with AskBio and Sarepta. So a very, very clear model and also where we illustrate that we can actually take up the majority of the value within transplantation and also on indications. Our first approved drug, Idefirix, as it's called commercially, is targeted or is labeled for highly sensitized patients who are incompatible to a disease donor. And highly sensitized patients in general are patients with too high levels of antibodies: can be due to pregnancies, can be due to blood transfusions or previous transplantations. And this group of patients have very limited access to new organs in the systems because of this high level of antibodies. And this is what we now can address with Idefirix/imlifidase. So it's actually -- even though it's 10% to 15% of the wait list, it's actually a fairly large patient population, if you look at it overall. So across U.S. and Europe, we have roughly 170,000 patients on the wait list. And as I said, 10% to 15% is equivalent to 25,000 patients in total. Of course, not all of them will be treated with imlifidase, but I mean, they have to wait very many years to wait for an organ. 50,000 transplantations are being carried out across the U.S. and Europe, as you see here, to markets which are roughly similar in size. And we have initially only labeled for deceased donor transplantation. So if you look at it, in theory, it would mean that around 5,000, 6,000 patients would be relevant for imlifidase with the current indication or label. Just a few words on the commercial launch process. Because we're actually starting out building the foundation with the leading transplantation centers, it's very important that the first clinics generate positive experience. Imlifidase was only tested in 5 clinics in 46 patients. So we are building a plane, like flying it, right? Because we need to expand the usage through good experience, focusing on the leading centers who have experience within digitalization. We also need to establish medical guidelines, protocols, et cetera. So it's very important that we do this in a careful manner. Also, we need to do a post-approval study because it's a conditional approval only based on Phase II data. So it will take a couple of years before we will start to see more exponential growth. But once we have obtained full approval in Europe and also in the U.S., which is set to be in 2024, as it looks right now, we should see much more exponential growth. And on top of that, we're also working on partnerships in rest of the world, like the Medison agreement we did end of last year. So people or investors need to have a bit of patience, look at the foundation we are building for repeat business chocka. And then after a couple of years, when we have obtained pricing and reimbursement, we have established a good foundation for the business, we should, as I said, see more exponential growth. And then in a third wave, we look at potential label expansion into living donor transplantation into other solid organs such as heart and lung and also these post-transplantation episodes. So here, we will enable new growth pockets. So this is how we envision the growth journey just in this area. Then we have other areas, of course. But just for people to understand, we're building the groundwork for imlifidase. This slide illustrates where we are currently with our market access processes. And as you can see, we are quite active. Now we have process going on in 14 countries. And if you focus on the countries with the dark blue, it's where we have obtained now pricing and reimbursement. And I mean, this is a great validation with early access in France. I mean this compound costs just shy of EUR 300,000 or SEK 3 million for one treatment, right? But it actually resonates very well with the value proposition because the alternative today is dialysis, which costs SEK 750,000 a year for these patients. And they -- I mean, they are getting treated every second day, 3, 4 hours, where they are getting these antibodies washed out of the blood. And I mean, they can't work, et cetera. So you can make sure that these patients get back to a real life and even work. So pricing reimbursement obtained now in Sweden, Netherlands and Greece, Finland on a hospital basis; and then as I said, early access in France, which is the largest market, actually. And we expect additional of the EU top 5 markets to be processed very soon. So -- and these markets make up 15,000 transplants a year. So it's not insignificant. This is my last slide. I just wanted to highlight that even though we've talked a lot about the kidney transplantation opportunity because it's near term, it's where we have our current commercialization focus, we actually have a unique platform not only from a technology point of view with imlifidase but also from a more commercial point of view as we actually can expand into so many different indication areas where this technology is relevant. I mean IgG-mediated disease makes up a lot of the indications in autoimmune disease, transplantation, gene therapy and oncology, right? So we actually have programs in each of these franchises as we call it. And given the good data, which was announced yesterday or published in the peer-reviewed journal from American Society of Nephrology, I mean, we're really building the foundation for a great company here. And also, beyond imlifidase, we're looking at next generation of enzymes. We are looking at a combination with argenx, et cetera. So we are only scratching the surface with this technology. So with this, I will hand back the word to the moderator, Ludvig.

Thank you, Klaus, for a good presentation. So in the presentation, you showed us this commercialization process in Europe divided into 3 phases. So can you give us a high-level guidance on when we can expect you to enter the next phase, so to say?

Yes. I mean as I also said during the presentation, it will probably take us a few years to land these pricing reimbursements, which is, I mean, very critical to get access into the markets, right? But then on top, we need to increase awareness around imlifidase, I mean, work with patient organizations to continue to focus on this unmet medical need. We need to establish medical guidelines. We are -- that's also in the works, right? We need to do a lot of different things to build this foundation, right? So it will probably take a couple of years before we have seen repeat business at the center level and where we start to see more exponential growth. And then in the next wave, we will also get the U.S. approval. We'll probably build on the EMA approval to expand into new geographies, could be Australia, Canada, Brazil and whatnot, through partnerships, right? So I mean, it's really around doing the work in the right manner and in the right -- with the right pace. So we -- I mean, we only have one shot at goal, right? So we need to do it in a diligent manner.

Right. Right. And as you said, you got this reimbursement feedback, the positive one from France under the early access program, which is initially valid for 1 year. Can we expect this to be like further than 1 year after this? Or what happens after this first year, so to say?

It's a really good question. So the early access is actually great that we have already achieved that. The full reimbursement process is normally between 12 and 18 months in France. And of course, that's where we eventually want to go. So that's still ongoing. So hopefully -- I mean, at the time when the early access expires, we are ready to go into the full reimbursement, right? And I mean, it could, in theory, also be extended for a few months, if that's needed. But of course, it's important that we see good experience with the clinics, they see patients being transplanted and good outcome afterwards so -- through this monitoring phase. And I mean, then, this should be a good opportunity to achieve full pricing and reimbursement, yes.

Yes. So you expect that like right after, maybe this...

Yes. I mean it could take a few months afterwards, but yes.

Yes. Perfect. And as you mentioned, this is only based on a Phase II study, this approval, and you need to conduct a Phase III study. When can we expect this to start? And can you provide some kind of guideline on how many patients and...

Yes. Absolutely. So first of all, I would like to emphasize, it's very unique to get approval -- conditional approval based on Phase II. I mean we had 46 patients, but all were transplanted. And normally, these patients would not be able to go through a transplantation because of their high level of antibodies. But we showed that with 100% efficacy and with a great safety profile. So now we are going to conduct post-approval, saw the need to do that. And that's going to be done in 50 patients across roughly 20, 25 centers. And we will carry that out in some of the existing markets, as usual, but also in new markets to broaden out the experience with the drug. So it's very natural. And this is, of course, also one of the reasons for this S-shaped launch curve, as we talked about, because you need to handle that in parallel with the commercial launch process.

Right. Right. Perfect. And if we move out from the kidney transplant area and we look at other solid organ transplants, what is the plan here? Are you planning on initiating Phase II studies here soon? Or are you awaiting more data from -- or more feedback on the kidney transplant area before doing so?

Yes. I think for the time being, we want to stay focused. But I mean, as you mentioned, heart and lung, I mean, those are really, really interesting opportunities longer term. But right now, I mean, it's about handling the commercial launch and what we have in the pipeline, stay focused so we'll do that successfully. But it's clear that we want to expand both geographically into new areas, but also, as we talked about, in -- with the label into living donor transplantation, I mean, kids, et cetera. I mean -- so that's natural, right, follow-ups; and then AMR for rejection episodes, I mean, before we really get into heart and lung. But yes, it's definitely interesting opportunities.

Yes. And you decided that you will add some centers to this phase -- or these Phase II studies in GBS and AMR. How is the patient recruitment going there? Are you seeing some positive effects on these added centers?

Yes. Absolutely. So it was a decision we took last fall given the pandemic and how things looked that we wanted to add more centers to accelerate the enrollment. And actually, if you look at AMR, we are at 26 patients currently out of 30. So we are very close to completing the enrollment in that study. GBS, however, has been impacted a bit by COVID, not the least because a number of our centers are based in France. And also, on top of that, we have seen a lack of IVIg, which is part of the protocol. So we have we've seen a slight setback here, but we will update our guidance to the GBS here in April when we announce our Q1 results. But I mean, it should pick up again, and we should see good traction, but we are very excited about that we can close AMR very soon.

Great. I had some more questions, but I think we can prioritize this because we got some from the web. Will the anti-GBM Phase III study commence this year? If so, which quarter do you believe we will see the first enrollment?

Yes. Absolutely. I mean that's our guidance to initiate the anti-GBM study in roughly 50 patients in at least 25 centers. It could also be 30 or even more centers. It's an ultra-rare disease. It's only 1.5 patients out of 1 million. So you need many centers to recruit patients here. And we have guided that we will initiate the study across U.S. and Europe this year. And we have -- I mean, now we have the go ahead with both EMA and FDA. But we don't guide per quarter. I mean it doesn't make much sense. I mean -- but just that we established the Phase III studies is great now that -- also because it's the first indication outside of transplantation, obviously.

Yes. Great. And someone is asking about the -- some other international markets, such as U.S., China and Japan. And U.S., you all already addressed. But China and Japan, do you see any...

Yes. Those markets are actually quite different. I mean it's normal that you do studies in U.S. and in Europe, and then other markets are building on that data. That's pretty much the standard in -- when it comes to new compounds. Those markets are very interesting. In Japan, there is a difference compared to the European market that it's mainly living donor transplantations. So we currently don't have a label for that. We only have for deceased, which is roughly 75% -- 70% of all transplantations today, right? So it's probably a bit further out. China is a good opportunity. But here, it's also about finding a trusted, credible partner in China, I mean, to potentially pursue that strategy. But it's definitely something we are looking into. Also, as I said, Australia, Canada, could be other markets.

Yes. Perfect. Great. Now we're running out of time. So thank you very much, Klaus. Nice to have you here.

Thanks very much for your interest.