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

And next up is Hansa Biopharma, and we will be joined by speaker, Klaus Sindahl, Head of Investor Relations.

Good morning, and thank you so much for your interest in Hansa Biopharma. Can you hear me?

Yes, absolutely. So please go ahead.

Okay. Yes. Yes. So my name is Klaus Sindahl, and I'm Head of Investor Relations here at Hansa. And I'm very excited to come here and present Hansa to this orphan drug event. So before I continue, I just need to briefly show you this slide on our forward-looking statements. So Hansa Biopharma has now progressed into a commercial stage biopharmaceutical company, and we have a broad clinical pipeline in transplantation and in autoimmune diseases. We are more than 110 employees, and we are based out of Lund, but we also have operations in Europe and the U.S. We currently have a market cap of around SEK 7 billion. Since most of you are fairly familiar with Hansa, I will not spend a lot of time on talking about who we are, but rather, I will talk about our recent development. And as you can see from this slide, we have had a very eventful year over the past 12 months with triple validation of our technology platform, first and foremost, of course, with the conditional approval in kidney transplantation. And then secondly, we also had a positive data readout in anti-GBM, which is the first indication outside of transplantation. And then thirdly, we also entered into a partnership into gene therapy with Sarepta Therapeutics in 2 indications. So very, very eventful year. And this year has also started quite well as we end the first quarter have continued to see clear progress with the first commercial sales of Idefirix recorded in the first quarter. And as I said before, it's essentially transforming the company into a commercial stage company. Also, I want to highlight that we recently entered into a preclinical collaboration with argenx. A collaboration, which is set up to explore the potential of combining imlifidase, so our technology with efgartigimod and argenx FcRn inhibitor. These 2 technologies would complement each other very well. So we are testing that preclinically. Lastly, our commercial activities in transplantations are also underway as planned, and we expect to get the first national reimbursement here in the second or third quarter this year. A key part of that reimbursement process is to do these healthcare technology assessments, which needs to be conducted to evaluate the health economic impact of using Idefirix. And this was actually done in Sweden, very recently with the TLV report very -- with a very favorable outcome supporting the use of Idefirix. We are, of course, very pleased with that. If we should spend just a minute on talking about our technology. So the foundation of Hansa is built on this unique IgG antibody-cleaving enzyme, which comes from a human pathogen, bacterium called Streptococcus pyogenes. And this enzyme has a very clear mode of action, as you can see on the slide, where it's essentially from a 15-minute infusion in 2 to 6 hours actually inactivates the IgG level or approach below detectable level. And then you create as a 7-day window where you basically can enable transplantation in highly sensitized patients as we are doing now. Imlifidase is a great product. It's a great technology. It's specific to IgG and all subclasses of IgG and nothing else. However, there is one issue since it comes from a human pathogen, it's immunogenic. So it can only be used for acute treatment. It cannot be used for relapses, so continuous treatment in acute diseases. So we are not developing it for chronic treatment. We are only focused on acute treatment. We have, however, a second-generation technology called NiceR, where we potentially can enable that space, and that's also acute space. But as depicted here on this slide, we are currently focused on 3 spaces. So transplantation and post transplantation, and this is here where we got the first approval in, in in Europe. And we're also looking into potential dealing with rejection episodes after transplantation, which is occurring in roughly 10% of all transplantations. And then below, you can see that we are also in 2 autoimmune diseases in anti-GBM and Guillain-Barré syndrome, 2 indications outside transplantation I'll get back to in a moment. And then we have entered this partnership with Sarepta, as I told you, initially in limb-girdle and Duchenne muscular dystrophy. That's still preclinical, however. This slide depicts our business model or our value creation model, if you like. And if you look to the left, we have our growth engine. So this is our enzyme platform. And as we develop new enzymes or develop new drugs from enzymes throughout the value chain, we would like to control -- or control key elements in the value chain. And as we approach commercialization, we have 2 different paths. So one is to go through our own commercial infrastructure. We will do that in transplantation and autoimmune diseases because it makes sense. It's a very targeted audience, and we have the in-house capabilities to do so. Whereas in gene therapy and in oncology, we would actually approach the market through a partner, just like we have done now with Sarepta. So 2 different approaches on the strategy. As I said initially, we are now a commercial stage biopharmaceutical company. We have recognized the first sales and our launch activities are underway as planned. The first pricing, the initial pharmacy pricing levels have now been published in 7 markets, including the Nordics, Benelux, Germany and U.K. So we have seen clear progress as well as supply chains are now being established for the initial distribution to these leading transplantation centers. And then secondly, we are also in close dialogue with the reimbursement authorities, national reimbursement authorities in a number of countries. And as a key part of that, we need to do this or they will do these health care technology assessments, and we had the first one in Sweden favoring imlifidase and actually even suggesting that as a cost-saving treatment towards the standard of care today, which is dialysis. So we are, of course, very pleased with that outcome. Then in parallel to the reimbursement process, we are also trying to see if we can access patients outside for key centers, so local access programs, and that's what we will continue on in parallel. So launching imlifidase or Idefirix, we are not doing it by a traditional down strategy where you're blasting out the product in a number of countries at the same time and you are focusing on the larger markets initially. We are rather focusing here on leading transplantation centers. So we have a center by seller focus, and we are initially focusing on countries where they have access to patients, early physicians, reimbursement and where they have adaptive legislative systems and allocation systems, so where the access to the markets is the easiest. Initially, we will be targeting very few centers, but leading centers to sort of create these centers as centers of reference for the further rollout. The second wave of our rollout will be the more complex markets in Europe, where that's not necessarily access today. It requires some more lead way to get into the markets. So we need to work around that, medical protocols, et cetera. We need to navigate allocation systems and legislation. And then thirdly, we are also targeting a third wave in rest of the world. So markets outside of Europe and U.S., we actually plan to have a partner strategy in markets where we can sort of build off the EMA approval. And it could be countries like Israel or Australia. And then the fourth wave is, of course, the U.S., where we are about to commence a new U.S. trial, which is, of course, subject still to approval on the protocol. But if everything goes as planned, we should be able to file a BLA by first half 2024. This is just a snapshot of our pipeline activities, and I'll just highlight the 3 clinical programs, so anti-GBM, AMR and GBS. So anti-GBM is actually where we had this positive data readout last fall, where we got essentially a proof of concept that the patients who got Imlifidase treatment, actually, 10 of these patients reached dialysis independence, which is a very, very good outcome because usually, you would see 2/3 of all patients progress into dialysis or even die. So very, very encouraging outcome. And now we are preparing for regulatory discussions with EMA and FDA on the path forward. AMR, acute episodes, rejection episodes after transplantation, very important projects, as I said, 10% lose their kidney after transplantation. We are now enrolling patients to this study, and we currently have 9 patients enrolled and expect to complete enrollment by the end of this year. Guillain-Barré, a very severe autoimmune disease where patients will end up in -- many patients will end up in respiratory support. It's a acute episode we need to deal with, and we believe we have a good fit with imlifidase. 8 patients have enrolled into the start out of 30, and we expect to complete enrollment towards the end of this year. With this line, I just wanted to depict other opportunities in the autoimmune space because it's actually very exciting. And as you see, anti-GBM and GBS are just a few opportunities. And this is actually a very interesting space because there's not a lot of approved treatment, especially not on the acute side of things. So of course, we believe this area holds significant potential. So we are very pleased with the first data route -- data readout in anti-GBM. Lastly, I also want to touch upon gene therapy. And in gene therapy, the issue is that a lot of patients are not eligible for treatment given that they have neutralizing antibodies, which prevents effective treatment with the gene therapy. So the idea here is that we can -- with imlifidase, we can inactivate the neutralizing antibodies and enable the gene therapy to work in these patients a really, really huge opportunity and where we initially have done a partnership now with Sarepta Therapeutics. It's still preclinical phase, but we have seen very encouraging data, which was published in Nature Medicine, not too long time ago, with very encouraging outcome in a mouse male and in monkeys, where we actually saw a transduction was enabled. And similar to autoimmune, the autoimmune space, we see very, very huge potential in gene therapy as all -- basically all gene therapies deal with this issue around neutralizing antibodies. So now we are in 2 indications, but the partnership with Sarepta is only exclusive when it comes to these 2 indications. So there are actually significant potential beyond that, and that's what we'll continue to pursue. We are in a number of dialogues with different parties at different stages. So very exciting field. And with this, I will conclude my presentation. As you see, we have a very exciting year going forward or a lot of milestones, we expect to move on with our second-generation enzyme NiceR, initiate IND-enabling tox studies. We expect to get the first reimbursement, national reimbursement agreement in place in the second or third quarter. And then we expect -- assuming the protocol will be approved for the U.S. study, we expect to dose the first patient in the second half of the year and then complete enrollment in our AMR and GBS study towards the end of this year. So with that, I will leave it back to the moderator.

Thank you, Klaus. Very exciting and efficient presentation. And my name is Johan Unnerus. I will be guiding you for Q&A. And we can start off naturally with the sales, as you do actually have sales now. And I understand the initial part comes from Germany. Could you elaborate a bit on that?

Yes, I can confirm it's from Germany, and we are very pleased that we now have moved into commercial states that we have actually recognized or record the first sales here in the first quarter. Given that these are high-risk patients, et cetera, we are not envisioning to be very much granular on the patients and the clinics, et cetera. So beyond confirming that the first sale is from Germany, I will not go into more detail on the patients.

And this process of establishing reimbursement and the technical economic studies that are progressing, is it possible to indicate anything on the pricing level and the clinical proposition?

I mean, the pricing of imlifidase now it's out there in the market, in 7 markets, right? And the pricing is around just shy of EUR 300,000. And that price is based on the value the drug provides to the patient, the society, the healthcare systems, right? So we are actually very comfortable with that price level we have put out. And so -- but of course, it's not a reimbursed price, but we expect it to be around that level.

Interesting. And when it comes to take-up and these specialist centers that presumably is in the first wave. Can you elaborate something about this? Of course, it's very early stage, but on the dynamics, many of them going to wait and see for clinical outcome and evidence before taking up?

It's clearly our intention to focus on leading transplantation centers who have experience already in who are likely to become early adopters and centers of reference for others. So these leading centers are what we are focusing on initially. And it's important for us that we generate positive outcome in these patients. So expect them to take patients in one by one, and then you should see the learning curve go in our favor. But it's not our intention to go out more broadly initially. Remember, the studies -- the product got approved on 4 Phase II studies very, very unique. So it's a conditional approval. It's a paradigm shift. It's a new transformative technology. So we need to be very, very careful here in the initial phase of the rollout. But then as positive experience are generated, and we see good outcomes, we should see it roll out faster in year 3 and onwards.

And are we likely to get cleaner sort of feedback and experience already, let's say, out of next year or late this year or...?

I mean, since this is based on Phase II approval -- based on Phase II data, the approval, it's a conditional approval, as I said, we are doing a post-approval study in parallel, which would generate more of the same data, which would support -- remember, it's this -- imlifidase is only approved in very few patients, right? It's 53 patients who have been treated. So more data will come that we're doing this study in parallel.

Yes. Time is flying. But I want to touch on the strategic position and the perception of Hansa just to give some examples. I think your presentation was very good. Gene therapy is one area which is massive and your mechanism actions seems promising and neutralizing maps and perhaps when you -- if you can bring NiceR to the market, you can have more of a sustained recurring effect as well. To move on to my question or reflection, Hansa -- and many of investors might see as it's done now, - it's been a long journey, it's been a fantastic journey. You're out in the market. What's next? But you seem to have a sea of opportunities. And you get the sense that perhaps many investors are not really recognizing this. Can you tell tenfold the next capital injection as you've done previously? And how long will that take?

No. Well, our own guidance on finance situation is that we are fully financed now. We have EUR 1.3 billion on the books, and we are financed into 2023. So I'll not comment on that. But given the platform, I fully agree, this is a very versatile flexible platform with huge opportunities in many, many spaces. It's transportation, it's autoimmune diseases, it's gene therapy and even potentially oncology, right? So we see lots of opportunities, both with our first generation, but also with the potential second generation. And then we are also doing in between work now with argenx right? So we have -- we look at a bright future for Hansa.

Yes, you shouldn't underestimate, of course, the challenges and the risk, but you're now in a position where your candidate and mechanism of action is, if anything, is possibly too powerful.

Well, let's see. But we're in a good spot, and we are looking forward to advance our programs and more data readout and potentially also entering new fields.

Okay. Thank you very much again, and time is running out. So let's move on to the next presenter.

Thank you. Johan.

Thank you.