Hey, thanks so much. Really pleased to join the group this morning, and really appreciate the interest in Hansa Biopharma.
So please go ahead and do your presentation, and I will be back for the Q&A.
Wonderful. All right, as mentioned, I serve in a capacity here at Hansa as Chief Commercial Officer and US President. Really excited to join the group here at Carlsquare Life Sciences for this great event. Why don't we go to the next slide, which, of course, is our disclaimer. I need to briefly show this slide with our forward-looking statements, and then we can jump right into Hansa Biopharma. Today, we're a commercial stage biopharmaceutical company based out of Lund in the southern part of Sweden, where we're enjoying a little bit of light snowfall today, but we have operations in Europe and in the U.S. as well.
Idefirix, or imlifidase, is our first approved drug in Europe for highly sensitized patients in kidney transplantation, but the compound actually has a potentially broad applicability as a pipeline in a product. We have a broad pipeline with 7 ongoing programs in clinical development, and a technology which now has been validated across three therapeutic areas. First, approval and market access across 13 markets in kidney transplantation, including the Big Five, and Australia. Secondly, we've had positive data readout in anti-GBM, which was published in the Journal of the American Society of Nephrology, and then thirdly, in gene therapy, through 3 partnerships with Sarepta, AskBio, and most recently, Généthon.
Over the recent years, we've established a high-performance organization across R&D and commercial with a highly qualified team with deep industry experiences averaging 20 years or more in the life sciences industry. Today, Hansa has a market cap of just around $150 million, and we're listed here in Sweden on the Nasdaq exchange in Stockholm with more than 20,000 shareholders. The company is financed into 2025. Why don't we go to the next slide, and we'll talk a little bit more about imlifidase, you know, a novel approach with a rapid onset of action to eliminate IgG. The foundation of the company builds on a unique IgG antibody cleaving enzyme, which comes from a human pathogen, a bacterium, which no doubt many of you are familiar with, Streptococcus pyogenes.
The enzyme has a very clear mode of action since it cleaves IgG and all subtypes of IgG in the human serum, very fast, and very effectively. So basically, after a fifteen-minute infusion, you've reduced close to all IgG in your body to below detectable level in the course of a two- to six-hour timeframe. Inactivation of IgG antibodies can be very relevant in situations such as acute autoimmune diseases, where the immune system goes off track, and attacks, self-tissue, or transplantation situations, where there's not necessarily a perfect fit between the recipient and the donated organ. The IgG level then stays down, up to seven days before it gradually starts to bounce back to normal levels.
The seven-day window is where you can carry through a transplantation or treat patients with acute autoimmune diseases, and hence, because of this unique clinical profile, the broad applicability of the agent. Why don't we go to the next slide, where, you know, we can talk through some of the key drivers for the molecule? and essentially, what this does is enable treatment of patients that previously did not have viable options, and it's important to bear in mind that PLEX, IVIG, or B-cell depletion, which previously have been used within transplantation, are really not recognized as a standard of care.
They're not recognized within guidelines, and they're not approved from a regulatory standpoint, and all of this is fully aligned with the scientific view that they don't completely remove IgG antibodies. You can see, as the slide outlines, that because of this lack of complete removal, there remains a significant unmet need within the market. You know, plasmapheresis might remove things from circulation, IVIG may replace you know, the pathogenic antibodies, and B-cell depletion may lower those levels, but there still remain other sources of IgG within the body with each of those modalities. And essentially, Idefirix addresses this lack of complete removal of IgG, and essentially has become a paradigm shift in desensitization treatment across the ecosystem.
Obviously, what we recognize too, is that the early experiences in introducing this new treatment which is in the guidelines, this new treatment, which has been regulatory approved, unlike those other treatment options, early successes are gonna lead ultimately to long-term uptake. So why don't we go to the next slide, and we can talk a little bit more about some of those main factors. I think one of the first things to bear in mind is that that Idefirix is the first and only drug approved in Europe for desensitization of these important, highly sensitized patients. It's based on four phase II studies, proving 100% efficacy and a good safety profile.
It succeeded in receiving this conditional approval in Europe, and our initial label allows for kidney transplantation in a very targeted population of highly sensitized patients, those that are not compatible against an available deceased donor, and therefore are unlikely to be transplanted with the current allocation systems. The reasons for incompatibility are things like previous transplantations, pregnancies, and blood transfusions, all situations that occur fairly commonly and lead to a substantial patient need. The highly sensitized segment is illustrated in the orange box in the upper-right corner and represents about 10%-15% of the kidney transplant patients on the wait list. Around a hundred and seventy thousand patients across the U.S. and EU are on wait lists currently, waiting for a kidney.
So if we apply a 10%-15% metric on the wait list, it translates into about 17,000-25,000 relevant patients on those wait lists. Of course, organ availability is, however, still the limiting factor, so it's perhaps only one out of four that are being transplanted on an annual basis, which means that, in theory, the annual addressable patient population should be somewhere around 2,000-3,000 annually in Europe and the same in the US, and of course, we would then take a share of this market. You know, naturally, we look to have our initial uptake in those centers that have the infrastructure in order to, you know, address this complex immunologic patient type.
Of course, we've got to account for factors like comorbidities, risk of infection, age, other factors that further define the addressable patient population here. Maybe we could talk about a case study or two to really paint the picture here. The first case study you can see in the lower left-hand corner of the slide, a 51 year old, highly sensitized male patient who'd been on dialysis for four years, transplanted at the University Hospital in Vienna, following a graft loss twenty years after receiving a kidney from his father. Another example from Italy, a 43 year old, highly sensitized female kidney transplant patient transplanted at the University Hospital of Padua after being on dialysis for almost fourteen years and experiencing one graft loss.
You can see that these are patients that otherwise would not have great treatment options, but in this case, ultimately get a treatment that allows them to have a higher quality of life in a dialysis-free setting. Really substantial, you know, opportunity to address the unmet need here. Let's go to the next slide, and we'll talk a little bit about commercial excellence. You can see what we do is frame out the way that our sales cycle works in concert with the transplant cycle. You can start with the kind of upper right-hand corner of the transplant cycle, where you see organ identification. It's followed by a candidate being wait-listed for an organ. It's necessary to identify the transplant candidate from the wait list. A comprehensive patient profile is worked up for them.
They're then identified for treatment, and desensitization and transplantation happens next. Obviously, in parallel with that cycle for those patients, we're working in our sales and commercialization cycle, and this really resolves around four major themes: market access, clinical readiness of the centers to include imlifidase in their complex immunologic transplantation procedures, patient selection and treatment, and then finally, the organ allocation itself. So for our organization, the process starts really at the top of that orange circle, overcoming objections, communicating the benefit of the product, including the five-year survival endpoint in our long-term follow-up data.
Then moving really counterclockwise to the left to creating urgency to treat and positioning Idefirix as a strong treatment alternative, identifying the unmet needs for that patient population, working through and convincing the transplant center of the market access, facilitating their clinical readiness so that they're prepared to use Idefirix in their complex protocols, and then really syncing up the patient selection within the wait list of those patients that are at that center, and then as the organ gets allocated, utilization happens.
So, there's a lot of complexity here, but as I mentioned before, the team at Hansa has deep life sciences background, deep experiences in transplantation and immunology, and as a result, is the right group in order to drive success in this highly complex setting, where of course, you know, satisfying unmet need for patients is a really strong motivator. Why don't we go to the next slide, and you can see some elements of our S-shaped launch curve, and, you know, really, we're heading towards the end of the first phase of the curve.
The first phase has been focused around building the foundation for Idefirix to become a new standard of care in transplantation through generating those first early experiences in the leading hospitals, while securing market access and implementing new country-specific medical guidelines, while supporting better patient and organ access. I've been told that today, there's been very few, if any, options for this group of patients, as we outlined on an earlier slide, and as a result, this early phase of the curve is absolutely critical for these patients. We've now secured market access in 13 countries, including the Big Five, and started to see repeat business at a number of clinics. In addition to recent changes to the organ allocation systems, we'll support increased patient uptake going forward, as systems are now calibrated to allow for organs to be transferred to incompatible patients.
This is also the reason for us to believe in sales increase in the fourth quarter and the periods to come. Going forward, we expect more accelerated growth as we complete the post-approval trial in 50 patients. It's no secret that this is an overhang and, to a certain extent, competes with our commercial uptake. Secondly, we'll pursue expansion into new markets like Australia, where we recently obtained provisional approval, and we're very pleased to see that approval included living donor patients, and longer term, we may benefit from label expansion into other solid organs and living donor transplants in some of the core markets. Why don't we go to the next slide, and I'll double-click briefly on market access?
I mentioned before that we've secured market access in 13 countries so far, including the Big Five: UK, Germany, Italy, and France, with early access, and also in Spain. These markets represent two-thirds of all kidney transplantation in Europe. There are about 15,000 transplantations on an annual basis. Idefirix has a price point of around 3 million SEK or about 300,000 EUR, subject to things like discounts and rebates, and this price point resonates well with the cost of dialysis, which is approximately $100,000 a year or about 1 million SEK per year, which is the alternative for these patients.
So while there certainly is a reasonable price point for Idefirix in the transplant setting, the number of years of living dialysis-free and reducing those costs to the healthcare system are very compelling when we engage with the payers, and this has been a real source of strength for the overall launch. Let's go to the next slide, and we'll talk about some key launch metrics. And to measure our progress, we're using this set of metrics which directly impact future adoption and sales as a new transformative therapy. They include market building, market access activities, patient identification, and transplant center readiness and use.
Let's talk about market-building activities, such as creation of Idefirix-specific guidelines, which have now been implemented on a national clinical practice framework in several countries, including the UK, France, Finland, Belgium, and the Netherlands. As I said, this provides a new clinical practice framework for healthcare professionals in the management pathway of these highly sensitized patients, and our medical teams are supporting further country level guideline development in additional markets. Second, securing market access is another key component of a launch. During the past ten months, we've secured pricing and reimbursement in such important markets as Spain, Italy, Belgium, and the Czech Republic, increasing the number of countries with full market access up to, as I mentioned before, 13.
Securing reimbursement at the national level in some countries is only a first step before moving on to a more local or regional level, such as in Spain and Italy, where we're currently making good progress on those regions. Thirdly, patient identification. Another factor not to forget is that Hansa is running a mandatory post-approval study in Europe in parallel with commercialization. We're roughly 1/3 into completion of the post-approval study, which is set out to complete in 50 patients by the end of 2025 . While in the short term, the study might affect commercial sales and patient uptake, the experience in implementing Idefirix into the clinical protocols in these centers is invaluable, and we think that this will benefit growth and uptake in the longer term. Fourth, our most important metrics relate to clinical readiness and use.
It all starts with the transplant center's ability to incorporate Idefirix into their treatment protocols for the highly sensitized patients, and we continue to see strong progress here. It's important to know that readiness is focused on essentially about fifty clinics that we've qualified as Idefirix ready. These centers are the ones that have the infrastructure necessary in order to take on these complex immunologic procedures. They have twenty-four-hour access to pathology labs, immunology labs. They have the resources and access for things like T-cell and B-cell depletion that are necessary in order to take on these challenging cases. But what's really important to note here is that the number of clinics who've treated patients commercially or through our post-approval efficacy study has grown to more than 22 centers.
This represents about 120% growth in the current year versus the prior year, with nine centers having experience with repeat usage across the clinical studies and also commercial. Why don't we go to slide 11 and talk a little bit more about the Eurotransplant program, which we know is gonna be set to really transform the desensitization across these important member countries. As of the end of June, Eurotransplant initiated a new program for imlifidase-eligible patients as a pilot in the Acceptable Mismatch program. Eurotransplant is an international non-profit organization. It acts as a mediator between donor hospitals and transplant centers among its member states, which today include the Benelux zone, Germany, select Eastern European countries such as Hungary and Croatia.
Today, patients with a high level of donor-specific antibodies are eligible for a special priority list within the Acceptable Mismatch program. However, the list still precludes the HLA-incompatible patients, which is the patient group that we target. With the new Eurotransplant desensitization program, the aim is to include 20 imlifidase-eligible patients who are incompatible to a deceased donor in a pilot program. Patients will be included based on certain criteria, such as minimal waiting time of three years in the AM program, donor being below 65 years of age, and preferably negative T-cell cross-match towards acceptable antigens for the desensitization program. We're really excited about the prospects of the new ET program.
It'll provide opportunities for important clinical experience, and we've seen an initial group of patients get identified for treatment, and we'll look forward to reporting back on success there. The program is gonna look at batches of these patients, and continue to evaluate the outcomes in them, which we anticipate should be consistent with what we've seen in our clinical studies that show important benefit conveyed to these patients. Next, let's talk a little bit about imlifidase and the role that it can play in complementing the US kidney allocation system. In the U.S., there is something known as the KAS, or Kidney Allocation System, and there are numerous factors that input into this.
Things like waiting time, age, previous transplantation, sensitivity level as expressed by CPRA score, the distance of the organ and the recipient, and the quality of the donor kidney, which uses a metric called KDPI. Essentially, KAS, or the Kidney Allocation System, gives patients points with regard to their level of sensitization, which is intended to increase the likelihood of finding a match for those sensitized patients. While this is important and necessary progress, it hasn't fully satisfied the need of these patients. Transplantation of highly sensitized patients has increased since the introduction of that KAS scoring, but thousands of those patients are still unlikely to find a match.
We see that despite the scoring, 2,500 patients with a CPRA score of 99 or above, and 3,500 patients with a CPRA between 98 and 99, still are in need of the ability to go to transplantation. We see that there's a clear unmet need in the US, despite some really admirable and good efforts. Why don't we go to the next slide? On this one, we can talk through essentially what can be done about this opportunity for highly sensitized patients that haven't been transplanted despite that prioritization on the wait list. This is where our pivotal US ConfIdeS trial in kidney transplantation comes into focus.
We'll continue to enroll additional patients, as we previously guided, and this study is set up to evaluate imlifidase as a potential disruptive therapy for highly sensitized patients waiting for a deceased donor kidney through the kidney allocation system. As we mentioned before, about two thousand five hundred highly sensitized patients in the U.S. with a CPRA score above ninety-nine and above fit into this category, and as the last slide mentioned, you know, continue to remain on the wait list. What we've learned since starting the study is that identifying and screening patients for the trial can take anywhere from weeks to several months. Unlike other trials that can progress once patients meet certain criteria, this trial is dependent on allocation of suitable organs to consented patients, a process that in the U.S. is managed by an independent third party.
Additionally, we see variability in the acceptance of those organs that are allocated based on the immunologic profile of both the donor and the recipient. We've acted on some of these early learnings to accelerate ConfIdeS. Comparing October 2023 year to date versus the full year of 2022, ConfIdeS has accelerated across some key metrics, including 30% higher consented patients, over 60% higher patients consented and waiting for organ allocation and randomization, and about 20% higher patient randomization. Furthermore, we've implemented measures to accelerate ConfIdeS. First, we're increasing the study sites, with nine additional centers initiated to bring our total to 25 centers geographically dispersed across the US for coverage of key population centers. Second, we've implemented a protocol amendment that will allow a greater portion of waiting recipients to be allocated and accept organs.
This is achieved by allowing a degree of antigen delisting that would otherwise preclude organ allocation and acceptance from taking place, and then finally, we've made some operational improvements in the study that provide for greater suitable patient identification, more support and guidance on treatment protocol implementation at study centers, and faster conversion of study centers from initial identification on to site activation. Despite these improvements, the allocation of organs to patients on the study and the acceptance of those organs based on immunologic patient and donor factors remain highly variable and difficult to predict. A total of 65 highly sensitized patients will be randomized in the trial, and as of today, we currently have approximately 95 patients that have been consented, and we've achieved more than half of the randomization target.
We expect to complete randomization by middle of 2024, and target the submission of the BLA in 2025, as per our recently updated guidance. Why don't we go to the next slide, and we'll close out by talking a little bit about the platform? Our antibody cleaving enzyme technology is truly a pipeline and a product targeting many opportunities across four therapeutic areas. In order to fully explore and harvest the potential from our technology platform, we've established four franchises in transplantation, autoimmune disease, oncology, and gene therapy, as illustrated. And as we advance, we'll start to target new orphan indication areas within spaces like HSCT in oncology. We think that this could be a meaningful step towards development of a new generation molecule that we think ultimately would have applicability in some of the larger autoimmune indications.
As you can see at the center of the illustration, we also have opportunities to advance our antibody cleaving enzyme technology beyond the first generation and enable repeat dosing in more chronic diseases. This is where that molecule, HNSA-5487, comes into play. And data from a phase one study will determine a first view on where we might go next. So we're looking for further data readouts, and then based on that, we'll have further perspective on the future of that exciting molecule. So with that, we'll conclude the talk and happily go to Q&A.
Thank you so much, Matt. First of all, when we talk about the ConfIdeS, the pivotal phase 3 study, can you elaborate a bit on the commercial uptake in the U.S. versus the EU?
Sure, sure, so I think that there are gonna be some notable distinctions between the approach to the U.S. market and the approach that we've had in the EU thus far. Let's start with where we are today. We currently have enrollment ongoing at numerous centers across the US with ConfIdeS, and we have a plan in place to get to 25 centers that would participate in the study. We think that the clinical experiences that those 25 centers will have in identifying patients on the wait list, and then incorporating imlifidase into their treatment protocols, is a very important initial step in spreading awareness, and ability to use imlifidase across centers in the U.S.
This is quite different than in Europe, where we had only a phase two study in only two different European centers before the time that we got an approval, so simply completing the phase three study will put some of the progress in the U.S. market well ahead of where the European market was at the time of getting that approval.
Okay.
During this time phase, while we finish the clinical study, we'll also have ample opportunity for our medical affairs team to engage with those study sites, answer their questions, build their knowledge of imlifidase and this complex patient type, and we'll also do some extensive medical education initiatives at all of the right congresses and venues before the time of the launch. Another big distinction between the U.S. and Europe is that in the U.S., we'll have opportunities for pre-approval information exchange with major public and private payers before the time of the FDA approval. And we'll also have opportunities before and at the time of launch, to engage in pricing and contracting discussions with those payers.
This is quite different than the pricing and access work that is often done in Europe after the time that the indication is achieved. So we think that these are really important sort of milestones for you know, how overall market development will be shaped, and how we should be in a position to hit the ground running, at the time that we have the molecule available via a regulatory license.
Okay, thank you. And I do believe we have some questions in the audience. Please, go ahead.
Yes. You mentioned the Eurotransplant desensitization program. What would that mean for you in terms of commercialization?
Yeah, so I think that's a great question. For starters, the first thing that it means is, you know, going from the idea of treating highly sensitized patients in the Eurotransplant zone, and in particular, in a large market like Germany, from being, you know, sort of a concept that's been looked favorably upon to something that is actionable and has a program that supports it. So it's important to note that for the acceptable mismatch program, and then also for the pilot in desensitization, organs are allocated to those programs within Eurotransplant before organs get allocated to the other kinda larger parts of the overall network. So that's a principal distinction that we think is really helpful.
We also are very pleased that the desensitization program is essentially a sub-part of the overall acceptable mismatch program. It is for the incompatible patients that are within that acceptable mismatch program, and this means that very specific groups of patients have been identified by the program, and there are now discussions ongoing between the program and the centers to specifically identify some of those patients. So we believe that some initial numbers of patients have actually been identified and should be treated in the near term. We know that the pilot program is gonna periodically look at some of the patients with the longest wait times that have been identified for treatment after that treatment takes place. And then you know, evaluate the outcomes and adjust the program accordingly.
But in essence, it means going from good thinking about treating the highly sensitized patients to a program that's actually gonna identify and then treat them. And we think that this experience within the Eurotransplant footprint is also gonna then translate into experience in the centers and further utilization, you know, down the road on a broader commercial scale. But it's important to note that these patients that get treated through the protocol, they are also going to be commercial patients, right? This is not a clinical trial setting. This is a program that recognizes the benefit of the product in treating this patient type and will do just that.
Thank you. I think we can fit one more question in there. Do you have one in the audience?
Yes. So you have previously mentioned strong sales uptake in countries like France, and yeah, naturally, the budget systems in Europe can be quite varied, with health economics in the north and more budget-focused style in the south. So, how good would you say France is as a proxy for the ongoing commercialization in Europe in general?
Yeah, so we think that France is a pretty good strong proxy. And first of all, I think the main reason why it's a good general proxy is that even before looking at things like pricing and access, it's important to note that whether or not the underlying unmet need here is recognized. And in France, I think that the treating community and the transplant centers have recognized that there is an unmet need for the highly sensitized patient type, and this is the reason why they've identified patients on their wait lists. They've had initial experiences that now make them more experienced with the treatment protocols for this relatively complex patient type.
They're also following what outcomes they achieve with these patients and now identifying additional patients so that centers in France are now having repeat usage. The other side of this to look at is the pricing and access component of it. And whether a market is Northern European or it's Southern European, the patients that receive imlifidase typically are patients that would not otherwise be able to go to a transplant. And in all cases, Northern or Southern Europe, these patients then avoid dialysis, and for them that's a very important quality of life benefit. We are seeing from long-term follow-up related to our phase two studies that survival as an endpoint looks very good in this patient group.
And that drives the medical, you know, interest in treating this. But for the payers and for access, those same patients that are seeing that survival benefit are not undergoing dialysis, and the payer is not incurring the costs associated with that dialysis, you know, in these cases for many years. So the economics go well beyond a break even for the payer, and as a result, we think that those generalized conditions around the unmet need, and the cost avoidance for the payer, provide a good proxy for, frankly, all of the markets in Europe.
Thank you, Matt Shaulis, CCO and the US President at Hansa Biopharma. Thank you so much for your participation.
We really appreciate being included and look forward to future engagements.