Investor Update

Apr 28, 2021

Slides

And next up is Hansa BioPharma, and we will be joined by speaker Claus 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. So my name is Claus Sindahl and I'm the Head of Investor Relations here at Hansa. And I'm very excited to come here and present Hansa to you at 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 lung, but we also have operations in Europe and The U. S. We currently have a market cap of around SEK 7,000,000,000. 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 developments. And as you can see from this slide, we have had a very eventful year over the past twelve 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 TBM, which is the first indication outside of transplantation. And then thirdly, we also entered into a partnership into gene therapy with Sarepta Therapeutics in two indications. So very, very eventful year. And this year has also started quite well as we, in the first quarter, have continued to see clear progress with the first commercial sales of Idafrix 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 mbifidase, so our technology, with efgartigimod, Argenx FcRn inhibitor. These two technologies would complement each other very well. So we are testing that preclinically. Lastly, our commercial activities and consultations 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 health care technology assessments, which needs to be conducted to evaluate the health economic impact of using iDRIX. And this was actually done in Sweden very recently with the TLB report with a very favorable outcome supporting the use of Idafrix. 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 IT antibody cleaving enzyme, which comes from a human pathogen, a bacterium called streptococcus pyogenes. And this enzyme has a very clear mode of action, as you can see here on the slide, where it's essentially from a fifteen minute infusion in two to six hours actually inactivates the IgG level or puts it below detectable level. And then you create a seven day window where you basically can enable transplantation in highly sensitized patients as we are doing now. Immunopidase is a great product. It's a great technology. It's specific to IgE and all subclasses of IgE 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 treatments. 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 NISA, 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 three spaces, so transplantation and post transplantation. And this is here where we got the first approval in kidney in Europe. And we also are looking into potential dealing with rejection episodes after transplantation, which is occurring in roughly ten percent of all transportations. And then below, you can see that we are also in two autoimmune diseases, an anti DPM and Guillain Barre syndrome, two indications outside transplantation I'll get back to in 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 two 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 two 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 seven 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 transportation 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 these or they will do these health care technology assessments, and we had the first one in Sweden favoring in vivo days and actually even suggesting it 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 parallel. Launching Invidaes or IDAFRIX, it's we're not doing it by a traditional dawn strategy where you are 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 transportation centers. So we have a center by center focus. And we are initially focusing on countries where they have access to patients, early decisions, 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, etcetera. You 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 partnering 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 of twenty twenty four. This is just a snapshot of our pipeline activities, and I will just highlight the three 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 lift less treatment, actually ten of these patients reached dialysis independent, which is a very, very good outcome because usually you would see two thirds 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 the path forward. AMR, acute episodes, rejection episodes after transplantation, very important project. As I said, ten percent lose their kidney after transplantation. We are now enrolling patients to this study, and we currently have nine patients enrolled and expect to complete enrollment by the end of this year. Guillain Barre, a very severe autoimmune disease where patients will end up in many patients will end up in respiratory support. It's acute episode we need to deal with, and and we believe we have a good fit within bifidacea. Eight patients have enrolled into the study out of 30, and we expect to complete enrollment towards the end of this year. With this slide, I just wanted to depict other opportunities in the autoimmune space because it's actually very exciting. And as you see, EntityPM 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're very pleased with the first 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 liable for treatment given that they have neutralizing antibodies which prevent effective treatment with the gene therapy. So the idea here is that we can, with imbipidase, we can inactivate the neutralizing antibodies and enable the gene therapy to work in these patients. So 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 model and in monkeys, where we actually saw 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 two indications, but the partnership with Sarepta is only exclusive when it comes to these two indications. So there are actually significant potential beyond that, 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, NISA, 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, Claus. Very exciting and efficient presentation. And my name is Johan Elijos. I will be guiding you for the Q and 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 recorded the first sales here in the first quarter. Given that these are high risk patients, etcetera, we are not envisioning to be very much granular on the patients and the clinics, etcetera. So beyond confirming that the first sale is from Germany, I would 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 syndicate anything on the pricing level and the clinical proposition? I mean, the pricing of Amlivadase now, it's out there in the markets, in seven markets, right, and the pricing is around just shy of €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 that we have put out. And so but of course, it's not a reimbursed price, we expect it to be around that level. Interesting. And when it comes to take up and the specialist center that presumably is in the first wave? Can you elaborate something about this? Of course, it's very early stage. But on the dynamics, are many of them going to wait and see for clinical outcome and evidence before It's clearly our intention to focus on leading transportation centers who have experience already in desensitization, 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, you know, to take patients in one by one. And and and and and then you should see the learning curve, you know, go in our favor. But but it's it's not our intention to to go out more broadly initially. Remember, the studies or the product got approved on four 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 experiences are generated and we see good outcomes, we should see it roll out faster in year three and onwards. And are we likely to get clinical sort of feedback and experience already, let's say, early next year or late this year or? I mean, since this is based on phase two data, the approval, it's 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, this Emblifidase is only approved in very few patients, right? It's fifty three patients with them 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. And just to give some examples, I think your presentation was very good. Gene therapy is one area which is massive, your mechanism of actions seems promising and neutralizing nabs. And 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 reflection, Hans Sepp, 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 tenfold the next capital injection as you've done previously? And how long will that take? No. Well, our only guidance on finance situation is that we are fully financed now. We have CHF 1,300,000,000.0 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, you know, very versatile, flexible platform with, you know, huge opportunities in many, many spaces. It's transplantation. 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 a 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. Let's see. But we're in a good spot, and we are looking forward to advance our programmes 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 Thank you.