Oh, good afternoon, and welcome to this event with Hansa Biopharma. With me today, I have the head of IR, Claus Sindal, and I would like to welcome the audience as well. Just before we start this event, a couple of practical issues. You are more than welcome to pose questions during the presentation, and then I will forward them to Claus. And you post your questions on the right side of your screen. Secondly, the event will last around 30 minutes, including Q&A, so please be patient. With that said, I would like to welcome Claus. Welcome, Claus.
Thank you so much, Claus. I think I will like to start recapping what we communicated Thursday when we announced our Q1 results. I will go into presentation mode here. Hope you all can see my slides. For Q1, we have communicated that our market access and our commercialization efforts continue to progress as according to plan. For the first quarter, we have secured market access in Spain, which will then complete market access in the five largest markets in Europe, which is roughly two-thirds of all transplantations or equivalent to 15,000 transplantations annually. This is, of course, a great achievement. We are very happy to see it landed.
The first quarter, we have also seen the first repeat business of Idefirix in select markets and select clinics, which is also a great testimony to our new transformative therapy and that things are actually going according to plan. Some of you may have seen that there's also been published patient stories with the first patients. We have had stories from the Netherlands, from the Erasmus Medical Center. We've also had a story from Spain, quite extraordinary, with a 50-year-old patient who had been 38 years on dialysis, who was transplanted successfully with the use of imlifidase and is now good, doing good.
Then thirdly, we also had a patient case from Padova in Italy, with the first patient, with a lady who has also been on dialysis for a number of years and was in no position to find a matched compatible kidney. So that's all great progress. For the first quarter, we have recorded SEK 24 million of revenue, whereof SEK 14 million came or stems from product sales, and I can get back to that later on in the presentation. I also wanted to highlight that we have expanded our commercialization partnership with Medison Pharma to also now cover the Baltics.
As some of you may remember, 15 months ago, we announced the collaboration with Medison the first time, which initially covered Israel and select Eastern European markets, including Poland and Czech Republic. We've actually now also received market access, so we are working right now with the clinics in those markets to identify patients and have the first patients treated in those markets. If we look at our pipeline, we have seen good advances in our phase II program with Guillain-Barré syndrome. This is the second acute autoimmune indications Hansa is looking into. Anti-GBM disease is the first indication which has advanced into phase III.
But for Guillain-Barré syndrome, we have now completed enrollment in 30 patients, and as communicated, we plan to announce first high-level data in the second half of the year. Those data points will mainly be focused around safety and tolerability, whereas the full data set, which is expected to be announced in 2024, will be on efficacy to the IGOS database in the Netherlands, where you are comparing efficacy with a registry. From that, you will determine on a path forward for a potential phase III study to be run. It was also great to see that our second-generation enzyme, which goes under the umbrella NiceR, with the lead molecule HNSA-5487, has now progressed into a clinical study.
So this is the first time we have moved into the clinic, and we have started a clinical study in phase I with our next-generation enzymes in healthy volunteers. For some of you who have been following the Hansa story for a number of years, you know that this will potentially open up a complete new space for Hansa, as we can allow for potential repeat treatment, opening up a completely new indication universe, such as relapsing autoimmune diseases and gene therapy. The limitations with our first-generation enzyme, imlifidase, is that it comes from a human pathogen, a Streptococcus pyogenes, which actually makes the body recognize the enzyme.
So it can only be used once, in some cases two, but that's not what we are developing that enzyme for. The second generation is where you are pursuing a path for multiple dosing. Then it's also great to see that we are close to have enrolled all patients in the U.S. ConfIdeS study. So we had 62 out of 64 patients enrolled as per first quarter. We are, however, going to over-enroll this study and add more centers. Actually, we are increasing the number of centers from 13 today, up to 20 in the U.S.
This is because we have seen strong interest in the U.S. from clinics to participate in our trial, but also due to the fact that we want to accelerate randomization, which is the next inflection point here. Randomization will not happen until a patient has actually been offered an organ. In order to increase that rate, which we actually cannot control at all, we want to enroll more patients with the purpose to complete randomization by the end of this year. As I started out by saying, revenue came in at 24 million SEK, which is slightly below consensus, but still in line with our expectations.
As we always communicated, sales will, especially product sales, will remain volatile in this period as we are building the foundation for our technology, Idefirix, in the clinics. So in these initial years, it's not about volume, it's more about generating good, positive outcome, as we have talked about numerous times. And we are seeing that in the clinics, and that's then again, catering for repeat business and expanded use into new clinics. So we are right on that curve we have always talked about. What will actually be interesting here in the second half of the year is that we should see more tailwind from some of the major markets I just talked about initially.
So, in Germany, for instance, we expect to see a pickup in the second half of the year as the kidney allocation system is undergoing a change here in June, actually, which will allow for incompatible transplantations. So far, the kidney allocation system is built on algorithms for compatible patients, so this change will actually benefit us a lot because otherwise organs will not be allocated to the extent to our patients as it should. What we eventually want to see is, of course, equity, so all patients have equal access in the market to organs, whether they are compatible or non-compatible. Also, we have, as I mentioned before, we have secured market access in Italy and Spain very recently.
It typically takes six to nine months from market access until we see, you know, it implemented into the regions, into the hospitals. We are preparing the clinics to take on patients, and then patients should be identified. So it typically takes some months before we will see it materialize into commercial sales. But we are on the path to see it, and we expect sales this year to be back-end loaded. Our cash position end of the first quarter was roughly SEK 1.3 billion following the two financing events we did last year. First, we did a loan with NovaQuest, and secondly, we did a capital raise, where we attracted a number of international institutions to invest in Hansa.
The company is currently financed into 2025, which is of course critical in an environment like this. Finally, I also wanted to highlight that we have a new Chief Commercial Officer and U.S. President in Matt Shaulis. So Matt comes with a long experience from Pfizer and will not only take over the commercial responsibility for our rollout at Hansa, but also he will take on the position as U.S. President as we build and prepare for U.S. launch once the ConfIdeS study is clear, of course, and we get approval. I think with that, I will hand back to Claus, the moderator, for questions.
I don't see the point in going through all the slides here, but this is just the highlight from the Q1.
Of course, Claus. Thanks a lot for your presentation. And with that said, we open up for questions. So please post your questions on the right side of the screen, and I will forward them to Claus. So Claus, if we get back to Idefirix and Europe overall, there's a question here from Michael regarding your partnership with Medison. If you could update us on how the outcome is for the moment. Have you treated any patients with the partner so far, and-
Yeah. Thank you so much for the question. So typically, we don't disclose information where sales stems from. What we have said, however, is that we have reached market access. So back in August, we reached market access in Poland, and back in December, it was in Czech Republic. So those two markets are definitely on track. I can't disclose whether we have actually treated patients in those two geographies, but it's probably a bit too early for Czech Republic. However, Poland should actually be ready to deal with commercial patients, so I cannot rule out that it has happened, but usually, we don't disclose that granularity.
... You know, but fair enough, Claus. And then you mentioned you added two more markets during Q1, two more reimbursement markets. And if we dwell a little on Spain, because on one of your slides, you show that Spain is more or less same size as France, if I understand it right. And you also mentioned that, well, we will see the sales pick up. You feel quite confident about that, but as you mentioned here and other places before, you see some challenges in the system. You mentioned Germany here, fixing the allocation. How is it performing in other markets and especially in the bigger markets?
Yeah. So, in order to understand the dynamics, one has to understand how these allocation systems are set up. So, Eurotransplant, which is the biggest system in Europe, you also have Scandiatransplant, which is for the Nordics, is a system which mainly covers Benelux and the DACH region, so the German-speaking countries, as well as a number of Eastern European countries. And, as I mentioned, there are some calibrations, some changes, which these systems needs to undergo to allow for incompatible kidney transplantation because the systems as such... I mean, this is a disruptive technology. The systems as such, are not set up to allocate kidneys to this group of patients.
So of course, it's great to see that the Eurotransplant system is now adapting to this change. They have also communicated that on their website. And that will definitely benefit our product sales already from the second half of the year. When it comes to Spain, this is probably the most efficient market we see. 90% of all patients in Spain comes from deceased organs. And one fifth of the transplantation relates to highly sensitized patients, or one fifth on the wait list. So of course, there's a large number of patients which are relevant for us in Spain. They have a very efficient system, as I said before.
So we expect Spain also to be beneficial for our patient uptake probably towards the end of this year, because as I said, it takes six to nine months. We have gotten reimbursement now on a national level, but it needs to be built into the regions and also to the hospitals. But what is actually good is that some of the first patient cases actually from the post-approval study has been published. The first case from Barcelona with this 54-year-old patient, as I mentioned earlier. France is another market where we got early access, and we have actually seen high high demand and for treatments. And that's really good.
It's a good example of how a system can adapt to a new technology. U.K., we have reached market access summer last year, so we should start to see that now, converted into commercial sales. We've secured agreements with the first few clinics, and that should pick up also in the second half of the year. What I wanted to say with this is that we are quite comfortable that we'll see product sales pick up in the second half of the year.
Thank you a lot for your answer, Claus. Yeah, it's important to understand these dynamics, because as I learned from talking with you several times, it's not a matter of you delivering or the feedback from the clinics, but actually this whole allocation system. So thanks a lot for that, for that explanation. If we jump a little to the gene therapy deals, there's a question coming in here. Are companies waiting for results from Sarepta phase one, or is it other questions that complicate further deals?
We continue to see very good interest for our technology in the gene therapy space. As we already have said and have highlighted on numerous occasions. I think some of them may be in a kind of waiting mode for potential new deals to occur. The Sarepta deal was signed back in 2022, in the summer, and we have, together with Sarepta, worked on generating the first preclinical evidence, the data, which now allows us to enter the clinic. I think some companies are probably in a bit of a waiting mode and want to see that data presented, how convincing is it, before they will potentially go through with a deal.
Also, it's worth to highlight that a number of these gene therapy companies have been struggling themselves. They have seen this numerous setbacks, which has also caused them to focus a lot on their own technology instead of doing potential partnerships. It's a lot about being first to market in the different indications. So we are like the extra topping on that, enabling the last few patients. So in the case with Sarepta and their Duchenne program, we can potentially enable 15% of their remaining patients who are suffering with these neutralizing antibodies. So this is, of course, what we will be focused on with our technology.
... Thanks a lot. Then, if we jump a little to GBS, your phase II program, you just completed enrolling a total of 30 patients.
Yeah.
And, are you still confident that you're able to present some kind of top-line data, second half of this year?
Absolutely. So this is what we have communicated on. We will highlight or we will present high level data, but as I also mentioned in my introduction, just around safety and tolerability. What is interesting with this study is that we are going to compare it against a registry with patients filed in the system at the Erasmus Center in the Netherlands. And this is, you know, end of the day, people are of course curious on the efficacy of the phase II program, and this is the data point to mainly focus on. Of course, safety and tolerability should also come in well. We know the mode of action with imlifidase.
It's previously been concluded as safe, but of course, you need to do it for this indication also. But the efficacy will mainly be highlighted in the control arm with this IGOS database, which we plan to announce in 2024.
Thanks a lot, then there's a little more personal question here, Claus, in the sense that some investors wonder why the board of directors don't do more insider buying when you and Søren do insider buying? I know it's a difficult question to answer.
Yeah, I think I have also responded to this on different occasions. I mean, end of the day, this is of course a personal decision, but in general, people should not get overexposed to certain cases. And I can tell for myself that, I mean, beyond, you know, your job, your salary, your... You also have short-term bonus schemes, and then, of course, you are participating in a long-term incentive program, right? So you are exposed to that. And of course, everyone wants to do good with the company and see the share price go up. But especially in these times, it's also about not putting all your eggs in one basket, right? I mean, there's no guarantee, especially not in a sector like biotech, right?
And it's not because people don't believe in it, it's just from a risk mitigation point of view that you need to ensure that, you know, you're not too exposed. But you have to ask the individuals for their motivation. I can only say for myself that I have invested a lot in the company because I'm a true believer of our technology.
That's a very straightforward question, you know, and you already invested with taking a role in Hansa. Well, of course, you get paid, but in that sense that of course there's different factors you should evaluate. But thanks a lot for answering the question. There's a question again about Idefirix and Europe. I think Claus already answered the question, but just once again, to be sure that everybody heard, is there a plan to educate transplantation doctors across E.U. regarding Idefirix? This investor thinks goes a little slow. I know you mentioned that last time. How can you speed up the process?
Yeah, but this is not about speeding up.
No.
This is about securing good outcome and that we're monitoring the patients. I mean, we go. I mean, this is on purpose. We go for one patient at a time because, I mean, do wrong. I mean, we have a conditional approval based on full phase II data. This is very unique that you get that. Normally, you would have to generate data from a full phase III study, which will take an awful lot of time. But of course, the downside is, if anything goes wrong here, I mean, we have a risk of potentially being withdrawn from the market, and this is a transformative therapy. I mean, it's also rather costly. It costs around EUR 300,000, right, per treatment.
Mm.
So we want to ensure that all cases go well, because we want to build this foundation. Also, remember, this is the exact same product which goes into other indications. So if you fast forward, I mean, you take on additional risk, which will also jeopardize this indication areas outside of transplantations. So we cannot, as a company, afford to do that. We need to do this right because we only have one shot at goal. So I really hope that investors can appreciate that. I know it's a lot about having patience for a case like Hansa, but there is so much potential in our technology that we want to ensure that we are getting the recognition in the medical society, so they will start to use the products over and over.
Because these customers are not returning, remember. I mean, once they are out, they are fixed.
Mm.
They are, I mean, we are giving them, especially these transplantation patients, we're giving them back their lives, right? So-
Mm.
Yeah.
Yeah, that's a very good answer to that question. Just maybe a final question here, and you're still welcome to post your questions. There's a final question here, regarding NiceR, you mentioned that before, or next generation Idefirix... Even though it's very early, could you try to elaborate a little on the perspectives for next generation cleavage technology in terms of indications, number of patients, market size, pricing, et cetera? Just to get an idea.
Yeah, that, that's a whole lot. So right now, we have just taken the compound, the first molecule into the clinic. And it's actually being tested now in healthy volunteers as we speak. So it's too early to give you an indication of, you know, which area we are pursuing. But once we have the data, we are probably, you know, also ready to announce which indication area we will pursue. But it's simply too early. We can just say that this has the potential to open up completely new spaces for Hansa, in relapsing autoimmune diseases, for instance, where you need this knockdown effect immediately, with an efficacy in effect, an effective and safe compound wise.
We are very excited about that. We finally can move it into the clinic, and it will be interesting once we can communicate on which path forwards and indication areas we can pursue.
Thanks a lot. Thanks a lot, Claus. I don't think we have further questions so far. So, with that said, first of all, I would like to thank the audience for all the good questions. And, you, Claus, thanks a lot for participating and answering all the good questions.
Yeah.
I really hope to see you soon. There's a lot of things going on this year, so I know we will see you soon. There's one question coming in here on the line. Sorry. Any comments to the decision from the Danish Medical Council a few weeks ago, not to recommend Idefirix due to pricing and lack of long-term data? Oh, that's a good question.
It's a bit similar to the Norway conversations we have had. This is not a final decision. I mean, now we have secured market access in the largest markets, and I mean, twelve countries in total.
Mm-hmm.
Of course, we want, you know, in the ideal world to secure all markets, but there are, of course, a few bumps on the way. I mean-
Mm
... well, that's what's best about additional data, evidence, long-term effects. But we have managed that in our conversations with countries, and I'm sure we will also do that eventually with Norway and Denmark. So it's also about having patience. And again, it's not a final decision. You have to go through these conversations and dialogues in different stages.
Mm-hmm. Thanks a lot, Claus. With that said, thanks a lot, everybody.