Thank you very much. Good afternoon, good morning, everybody, and welcome to the Hansa Biopharma conference call to review the Q1 results for 2026.

I'm Renée Aguiar-Lucander, CEO for Hansa Biopharma, and joining me today is Evan Ballantyne, Chief Financial Officer; Richard Philipson, Chief Medical Officer; and Maria Törnsén, Chief Operating Officer and President of the US. Please, next slide, please.

Please allow me to draw your attention to the fact that we'll be making forward-looking statements during the presentation. You should therefore apply appropriate caution.

Next slide, please. This is the agenda for today's call, and these are the people, as I just mentioned, who will be covering the different sections.

Next slide, please. Let me start by taking you through an overview of the quarter.

As I mentioned in the Q4 report, we expected Q1 to be impacted by the significant number of initiatives which we rolled out during the quarter, which I'll cover in some more detail later in the presentation. This is indeed also what we observed, with revenues amounting to 34.6 million Swedish crowns, slightly above Q3 of 2025.

We know that there will continue to be significant variability between quarters, and I do not expect this to change over the medium term due to the structural issues related to organ allocation in Europe. During the quarter, we raised $30 million in a convertible note, significantly extending our runway.

We also paid down the NovaQuest debt by almost $15 million in January, as per the restructuring agreement, and we now do not have another payment due until the middle of 2027. We also spent significant time and resources during the quarter compiling the briefing pack to the FDA related to GBS, which we submitted in early April.

We're very excited about the fact that our abstract of the ConfIdeS study was accepted for oral presentation at ATC in June. In the quarter, we continued to build out our US leadership team, and also initiated our BLA review with the FDA.

Next slide, please. In December of 2025, we announced the leadership change of the European commercial organization and initiated a significant reorganization, in combination with the rollout of new system support and ways of working.

We believe that this was necessary in order to be appropriately prepared for the rollout of the significant amount of data which we'll be able to share with the physician and patient community starting in Q2 and continuing for the remainder of 2026. I want to thank all of my colleagues in the commercial organization for their leadership, collaboration, and ability to adapt quickly, as we all know that change is not easy, and especially not when it comes in high concentration over a short period of time.

However, we have achieved a lot over the last three months, and we can now start to see some of the benefits, though it will still take a couple of months for everything to truly get bedded down. Next page, please.

I am not planning to provide any detailed guidance for this year, but I would like to share some fundamental components which we will leverage to successfully navigate 2026. One year into my CEO role at Hansa, I'm glad to announce, and I'm sure that the organization is happy to hear, that the changes which were necessary to stabilize the business and position it for growth have more or less been completed.

This included the restructuring and reduction in force, the renegotiation of the debt facility, raising of equity capital to ensure sufficient runway to read out key clinical data and obtain a potential US approval, strengthening the internal expertise and experience required to successfully build an international sustainable life science business, clarifying and focused the pipeline strategy, and last, but certainly not least, review, reorganize, and adapt the European commercial organization to improve transparency, performance, and ensure the effective delivery of key clinical data to the physician and patient community. I believe that the company now is well positioned to benefit from the key events coming up this year, and we look forward to sharing them with you as the year progresses.

Q1 was, as I've said in my report, a transition quarter, but there's no new or different information fundamentally impacting our market, and we have no reason to believe that the performance was primarily impacted by the many changes that we rolled out during the quarter. We're also encouraged by the strong start to Q2, which we hope is the beginning of a consistent trend of improvement, which should be further strengthened by the data coming out in Q2.

With this, I will hand over to Maria, who will provide some more details on several of these topics.

Thank you very much, Renée. Next slide, please.

Let me first turn your attention to the European and international markets. In Europe, Idefirix has maintained a unique position since launch.

There is no other approved therapy on the European market which can do what Idefirix does: enabling a life-saving kidney transplant for highly sensitized patients. Across Europe, there are up to 11,000 highly sensitized patients waiting for a kidney transplant today.

These patients need to navigate the complexities of finding an organ, and in some cases, that can take up to 12 years. In Europe, we launched with very limited data from only Phase 2 studies, and over the years, we have built on that clinical experience and now have over 200 patients treated with Idefirix in Europe.

2026 is a very exciting year for our European business, as we will finally gain access to additional clinical data which we know European KOLs are eagerly awaiting. Our Phase 2 data was published last year, and in 2026, we look forward to releasing additional data from our US Phase 3 study, ConfIdeS, and most importantly, from our European Phase 3 trial, PAES.

This data will allow us not only to communicate additional data to European transplant centers, but it will also enable us to seek full approval in Europe. In addition, we know that European KOLs are anticipating publishing their own real-world evidence, and we look forward to seeing this data published.

Next slide, please. Our Q1 performance was, as Renée mentioned, impacted by the changes we made to our European business.

We made those changes as we felt they would be necessary to drive growth in the second half of this year and in future years. Our Q1 product sales was 33.9 million SEK.

The performance was mainly driven by France and our international markets. We do not believe this performance is a reflection of Idefirix's potential, but rather a short-term impact based on the decisions we made.

We have in previous calls talked about the challenges we have faced in Germany with the pause of the Eurotransplant program, and in the region of Catalonia, Spain, with regional reimbursement. I'm very pleased to report that our targeted efforts have resulted in positive changes.

In Germany, the KOLs have submitted new consensus recommendations for publication in an international journal. These recommendations, which will enable German transplant centers to transplant patients within the ETKAS program, where the majority of highly sensitized patients are listed, have been rolled out to German transplant centers in a webinar, and we anticipate the recommendations will be published in mid-2026.

In Spain, we secured reimbursement in the region of Catalonia after months of targeted efforts. The new reimbursement pathway went into effect as of April 1st, and post-Q1 close, we have seen our first sale in Catalonia with this new reimbursement pathway.

Catalonia is a very important region for Idefirix. In our PAES trial, 1/3 of all enrolled patients came from three centers in the Catalonia region.

As such, we have significant clinical experience already, and we anticipate this region will be a strong contributor to future sales. In addition to these positive accomplishments, we have also made targeted investments in new systems and activities to drive further growth of Idefirix in the coming years.

Let's now turn our attention to the US market. Next slide.

We are excited about the potential of bringing imlifidase to the US market. Today, there are approximately 15,000 highly sensitized patients on the waitlist for a kidney transplant in the US, and 7,000 of those have a cPRA over 98%, making it very difficult to find a matching organ.

For the patients with the highest cPRA, they may never receive an organ offer, or have to wait over seven years before they can have a transplant. Unfortunately, approximately 10,000 patients die or become too sick to transplant while waiting, and a higher proportion of those patients are highly sensitized.

This is where imlifidase can play an important role in reducing the wait time and enabling more patients to have access to a life-changing transplant. Next slide, please.

We have recently conducted several market research projects in the US, which all confirmed the unmet needs for patients and the potential place for imlifidase in their treatment journey. Today, there are no approved treatments for the desensitization of highly sensitized kidney transplant patients, and the off-label treatments used are not seen as great options for patients.

The burden of dialysis is also very real. Patients who wait for a kidney transplant need to undergo dialysis three times a week for several hours each time.

That creates an extreme burden on the patient, impacting the patient's quality of life, and also contributing to significant costs for the healthcare system. When preparing for a potential launch in the US, we know that we need to engage with several stakeholders within the transplant centers: from surgeons, to transplant coordinators, pharmacists, and HLA directors.

In particular, the HLA director will play an important role with imlifidase, as they are responsible for the delisting protocols and managing the antigen profile of the patient. P&T approval will be critical to ensure access at hospital level, and in our initial research, financial decision-makers and clinical experts believe imlifidase will gain P&T approval given the strong clinical profile of imlifidase.

Finally, we believe our initial launch drivers and uptake will likely come from centers with prior clinical experience of imlifidase and from high-volume kidney transplant centers. Let's turn to the next slide and look at our launch preparations.

Our launch preparations are in full motion, and we are focusing our efforts on two critical areas: site of care strategy and market access. As I mentioned the previous slide, we believe our initial uptake will come from centers with clinical experience and from centers who are performing high volume of kidney transplants.

We are therefore focusing our efforts on the top 100 centers initially in the US. Those centers represent approximately 80% of the volume, and among those centers, we have 25 ConfIdeS centers, who are accounting for 25% of the volume.

These centers have clinical experience, which we believe will be a differentiating factor compared to the European launch, where we only had two centers with clinical experience prior to European approval. Our market access activities have been focused on completing our market research and gaining a better understanding of transplant centers' financials.

The majority of transplants are paid by Medicare, and in particular those patients who are waiting for a long time for a transplant tend to a large extent have Medicare insurance. When speaking with financial decision-makers in the transplant centers, they all recognize the significant burden for these patients and the strong value proposition of imlifidase.

Our efforts are focused on enabling speed of access at launch and breadth of adoption across multiple transplant centers. As mentioned in previous calls, we know that NTAP, New Technology Add-on Payment, and outlier payments will be important for transplant center economics, and prior CAR-T launches are good launch analogs that we are using to model our center engagements.

Finally, we have also focused on identifying our distribution partner and other aspects of the supply chain to ensure we can deliver the product to the US shortly after approval. Other activities in the quarter have been focused on building out our US team, with a particular focus on market access and medical affairs.

Our full commercial build is expected in Q4, shortly before PDUFA. Our medical team are focused on engaging with KOLs and transplant center stakeholders at medical conferences, and we are in particular looking forward to the American Transplant Congress in Boston in June, where we will present our full ConfIdeS data, have a Hansa symposium, and other KOL engagements.

Finally, across the US organization, we are focused on our site of care strategy. As I mentioned earlier, in each transplant center, there are multiple stakeholders we need to engage with, from market access, to medical affairs and commercial, to ensure we have a successful launch.

We have developed a strong strategy for how to engage these centers to ensure we know the stakeholders and can best support the incorporation of imlifidase into their treatment workflow once approved. With that, I will hand it over to our Chief Medical Officer, Richard Philipson, for an overview of our pipeline.

Richard?

Thanks, Maria. Next slide, please.

I'd like to start by discussing study 20-HMedIdes-19, which we refer to as the Post-Authorisation Efficacy and Safety study, or the PAES study. As indicated by the name of the study, this is a post-approval commitment to the European regulatory authority following the conditional approval of imlifidase in Europe in 2020.

Next slide. The primary objective of the study is to determine the one-year graft failure-free survival in highly sensitized kidney transplant patients pretreated with imlifidase to turn a positive crossmatch against a deceased donor into a negative crossmatch.

Secondary objectives include the evaluation of renal function, patient survival, and graft survival up to one year after transplantation. Of course, safety is also one of the secondary objectives of the study.

Next slide. Here, we provide an overview of the design of the study.

Starting at the top of the schematic, patients enrolled in the imlifidase treatment group were highly sensitized with the highest unmet medical need based on the local kidney allocation system. Patients underwent a delisting step at prescreening to increase the likelihood of receiving a donor organ offer.

When an organ offer was received, if the patient was crossmatch positive to the organ, then the patient proceeded to treatment with imlifidase and transplantation, subject to meeting required eligibility criteria and converting from crossmatch positive to crossmatch negative. It was planned to enroll 50 patients into this treatment group.

Moving down the schematic, there are two non-comparative reference groups. It's important to note that patients were not randomized to these reference groups, and there are no statistical comparisons made between the imlifidase treatment group and the reference groups.

Furthermore, patients in these two reference cohorts had different baseline characteristics when compared with the imlifidase treatment group. The non-comparative concurrent reference group comprises 50 to 100 contemporaneous kidney transplant patients enrolled at the same sites at approximately the same time as patients enrolled in the imlifidase treatment group.

These patients were not sensitized and had a negative crossmatch to the deceased donor organ offer. The rationale for inclusion of this reference group is to understand outcomes at the same sites when undertaking matched kidney transplants.

Finally, the non-comparative historical reference group comprises 100 kidney transplanted patients randomly selected from a patient registry from 2010 onwards. Selection of patients was performed by the registry administrators and was completed prior to the start of the enrollment of the main study.

Patients in this cohort were sensitized, but to a lesser degree than patients in the imlifidase treatment group, and were crossmatch negative to the donor organ offer. Again, to emphasize, the primary objective, to determine the one-year graft failure-free survival in highly sensitized kidney transplant patients, applies to the imlifidase treatment group only.

Next slide. In this slide, we summarize the treatment schedule for patients enrolled in the imlifidase treatment group.

Following the prescreening and screening steps, patients meeting eligibility requirements and with a positive crossmatch to a donor organ offer were treated with imlifidase. Prior to administration of imlifidase, all patients received premedication in the usual way with intravenous methylprednisolone and an antihistamine.

A second dose of imlifidase could be administered within 24 hours if crossmatch conversion was not achieved after the first dose, which is in keeping with other imlifidase trials. Patients converting to a negative crossmatch were transplanted and then immediately went on to receive standard post-transplant immunosuppressive treatment comprising tacrolimus, mycophenolate mofetil, and corticosteroids.

Transplanted patients also received rabbit anti-thymocyte globulin on day five, rituximab on day seven, and IVIG on day nine to 10. Next slide.

The study enrolled the first patient in May 2022. There have been 22 participating sites in a total of 11 countries in the EU and UK, and we expect database lock next month.

Next slide. Now moving on to discuss Hansa's plans for its next generation IgG-cleaving enzyme, HNSA-5487, which I'll hereafter refer to as 5487.

This is a rapidly-acting IgG-cleaving endopeptidase. It is highly specific IgG-degrading enzyme that cleaves all human subclasses of IgG, whether free or bound to antigen or cell membranes, and no substrate other than IgG has been identified.

Next slide. First, I'd like to provide a brief overview of Guillain-Barré syndrome, or GBS.

This is a rare, rapidly progressive, monophasic, immune-mediated neuropathy where the immune system attacks peripheral nerves, often following a viral or bacterial infection. The disease affects 1 to 2 in 100,000 people annually, with approximately 3,500 to 7,000 cases annually in the US.

There are also seasonal and geographical variations in the disease prevalence. GBS is characterized by rapid onset muscle weakness, tingling, and numbness, typically starting in the legs and moving symmetrically upward.

Symptoms can escalate to paralysis, breathing difficulties requiring assisted ventilation, and consequent immediate hospitalization. GBS is an antibody-mediated disorder in which complement-fixing IgG antibodies directed against gangliosides play a key role in the pathogenesis.

Disease progression is typically rapid, reaching a nadir within four weeks in most patients, with many attaining maximal weakness within two weeks. Although many patients recover from the acute phase, long-term morbidity is common, and approximately 20% of patients remain unable to walk independently at six months.

Current standard of care treatments include intravenous immunoglobulin, or IVIG, infusions, or plasma exchange, in addition to supportive care such as respiratory support and management of complications such as infection and thrombosis. It's estimated that approximately 25% of patients require mechanical ventilation for days to months following the acute autoimmune attack.

Next slide. Experience with imlifidase, our first-generation IgG-cleaving enzyme, followed by IVIG, provides relevant clinical precedent for the proposed 5487 development in GBS.

Specifically, a Phase 2 single-arm, open-label clinical trial has previously evaluated imlifidase followed by IVIG in patients with GBS enrolled within 12 days of symptom onset and followed for 12 months after imlifidase treatment. In this study, a single dose of 0.25 milligrams per kilogram of imlifidase rapidly cleaved IgG in 28 out of 30 patients.

At a group level, treatment with imlifidase followed by IVIG led to early improvement of the patients' functional status. The median time to walking independently was 16 days.

Most patients improved markedly in motor function early after imlifidase treatment. By one week after imlifidase dosing, 37% of patients were able to walk independently.

At four weeks after treatment with imlifidase, 52% of patients were able to walk independently, and 33% were able to run. Next slide.

Results from the imlifidase Phase 2 trial in GBS have been compared to patient data from an external prospective cohort treated with IVIG, known as the International Guillain-Barré Syndrome Outcome Study, or IGOS. The figure in the slide presents an unadjusted comparison of muscle strength as measured by MRC sum scores between the imlifidase treatment group and the reference cohort, demonstrating the rapid improvement in the imlifidase-treated patients.

Further, a matching-adjusted indirect treatment comparison, or MAIC, has been performed. The MAIC confirmed that the patients treated with imlifidase and IVIG walked independently, that is, a GBS disability score of less than two, 43 days earlier than those in the IGOS cohort treated with IVIG alone.

In the same MAIC analysis, the median number of days required for patients to improve one grade in the GBS disability score was six days for patients treated with imlifidase and IVIG, compared to 31 days for patients treated with IVIG alone, and this difference was statistically significant with a p-value of 0.002. Next slide.

Now turning to the current status of the program. A first-in-human study in healthy participants has been completed.

In this study, it was shown that circulating IgG was efficiently and rapidly reduced by a single dose of 5487 by more than 95% within a few hours. There was a positive correlation between dose and duration of reduced IgG levels, where a higher dose resulted in a longer duration of effect.

In other words, there was a clear dose-response relationship. There was also a significantly reduced anti-drug antibody, or ADA, response when compared with imlifidase, and the treatment was at least as efficacious as imlifidase in reducing total IgG levels.

Furthermore, 5487 was shown to be safe and well tolerated across all tested doses, and no serious or severe adverse events were reported from the trial. Based on these data and the clinical experience with imlifidase in GBS, a clinical development program for 5487 in GBS has been designed and submitted to FDA in the form of a briefing document.

A response to this submission is expected in May. Based on the current plan, the clinical phase of the development program will start by the end of this year.

I'd now like to hand over to Hansa's Chief Financial Officer, Evan Ballantyne.

Thank you, Richard. Q1 sales performance.

Total revenue for Q1 2026 was 34.6 million SEK, representing a 48% decrease compared to Q1 2025 of 66.3 million SEK. Product sales for Q1 2026 were 33.9 million SEK, also representing a 48% decrease as compared to Q1 2025.

We continue to see fluctuation in our quarter-over-quarter performance, and quarterly volatility reflects the unpredictability of the organ allocation market. Next slide, please.

For Q1 2026, SG&A expenses totaled approximately 106 million SEK, and were essentially flat compared to Q4 2025 of 102 million SEK. Compared to Q1 2025, SG&A expense of 76 million SEK were 29.6 million SEK higher.

This variance was driven by non-cash LTIP expense of 6.1 million SEK, fees associated with securing the convertible note of almost 10 million SEK, investments in commercial activities associated with the US launch, and improvements in the company's quality systems. R&D expense in Q1 2026 totaled approximately 57 million SEK, and were 11%, or 7 million SEK, favorable compared to Q1 2024.

The decrease in R&D expenses was primarily driven by the wind-down in clinical trial activities and restructuring actions taken in 2025. In Q1, the loss from operations was 143 million SEK, compared to 125 million SEK in the prior quarter, Q4 2025.

Next slide, please. Headcount for the period totaled 122, compared to 138 in Q1 2025.

Headcount was essentially flat compared to Q4 2025 of 125. Cash used in operations in Q1 2026 totaled 157 million SEK, compared to 152 million SEK in Q1 2025.

In Q1 2026, cash and cash equivalents totaled 677 million SEK. On March 19th, 2026, the company entered into a US$30 million convertible note purchase agreement with Atai Capital Management.

The convertible note has a fixed rate of 3%, payable on a semi-annual basis in cash, beginning on September 15th, 2026, and a maturity date in March of 2031. This transaction extends Hansa's cash runway and strengthens the company's balance sheet in advance of the FDA approval and a subsequent US launch.

Now, I'd like to turn the presentation back to Renée for closing remarks and the Q&A portion of the call.

Thank you very much, Evan. Next slide, please.

In summary, we're looking forward to the continuation of this quarter as it brings many exciting updates for the company, and I'm proud to be able to sit here today and say that we're now operating from a strong and stable foundation with a clear roadmap ahead. We have a robust financial position with an extended runway and access to multiple future financing options should they be required in the future.

We are in full execution mode, and with a very experienced team in place, I look forward to the rest of the year with great excitement and enthusiasm. This includes the readout of the PAES study, with database lock expected next month; feedback from FDA regarding the GBS study design; presentation of the ConfIdeS Phase 3 data at ATC; a capital markets day with input and discussions from US and European KOLs covering ConfIdeS and PAES topline data, which we expect will be available by that time; and finally, in Q4, we plan to file for full approval with EMA of Idefirix, and look forward to the outcome of the PDUFA date in December.

Next slide, please. As I mentioned, we hope to share some of this information with you towards the end of this quarter at our Capital Markets Day, which will take place following the ATC conference in June, in New York.

It will also be possible to follow this event virtually, and a full agenda will follow. Next slide, please.

This concludes the presentation, and we can open up for questions. Next page, please.

Thank you.

thank you for taking my question. I wanted to ask on the US approval process.

How are the interactions with the FDA going so far, and have they signaled any key focus area or questions during the review of the BLA filing package so far?

I will take that question initially and then see if Richard has anything to add. I would say that the FDA BLA review process is going very well.

There's not been any kind of, I would say, odd or strange kind of questions or any kind of area from, for that matter, that would kind of be out of scope. I would say that it's really going quite well and kind of as expected.

I don't know, Richard, if you have anything to add.

No, I agree. Everything is going well.

It's going as expected, as Renée has said, and nothing untoward so far in our interactions, and we've been able to address any questions from the FDA so far.

Thank you. Makes sense.

Then, for EU sales, the 1Q impact, it makes sense. For the second quarter, you said that you had a strong start.

Any color on the ordering trend, center feedback that gives you confidence that sales will rebound?

I don't really want to get into any kind of very specific details on this, and I know better than to kind of assume that what has kind of started really well will necessarily be continuing in the same very, very positive manner going forward. I would say that we're very encouraged by what we've seen so far.

Obviously, it's kind of 20 days into the quarter, it's, again, it's not going to be able to kind of judge what the final kind of quarter outcome is going to be, but I do think that what we're seeing is a significantly different trend than what we saw in Q1.

Perfect. Thank you so much.

Hello?

Hello?

Oh.

Hello?

Hi, good morning. Thanks for taking the questions.

I guess, Renée, maybe as a follow-up on what you're seeing so far in the quarter, is this sort of a direct result to some of the changes you made in terms of the commercial organization? I'm also just curious, are they across all the regions, or is it again seeing strength in some of the core regions where we've seen pretty good use of imlifidase over the last few years, in particular France?

I'll have Maria provide any additional detail, but I would say that I think that it's a follow-on from the initiatives that we have launched. I think that that is clearly how we see it.

Again, we don't expect this to, we know it's going to take another couple of months for it to be fully kind of implemented, rolled out, but I do think that we have established better kind of transparency, more focus. We provided some system support, some investments, which I think are very important.

With regards to kind of the breadth, etc., I'll leave it to Maria to cover the general, just kind of brief trends that we're seeing today.

I would just echo what Renée said. We are very encouraged by the trends that we're seeing in the first 20, 22 days of the quarter.

It is not unique to one country. Without going into further details, we're seeing that across multiple markets.

I think, in particular, what I think is critical is what we have managed to accomplish in Spain, in the Catalonia region. As I mentioned, that region contributed to 1/3 of the enrollments in the PAES trial, and now that we've resolved the reimbursement there, as I mentioned earlier, we saw our first sale there, and I think that is a strong sort of indicator of that the actions that we have taken are starting to turn into results.

It will take, as we mentioned before, a few months for everything to settle, but we are seeing that what we are doing is starting to have an impact, and I think that is the most encouraging in this.

Great. Then just if I have a follow-up question for Richard in terms of the GBS program with 5487, I guess, do you intend that to be a registrational study?

Then also, just given the opportunity to redose, do you see clinical value in perhaps redosing patients, which is something that you weren't able to do with imlifidase in the original Phase 2 study? Thank you.

Okay. Thanks for the questions.

We're still at a relatively early stage in terms of the overall clinical development plan. As I mentioned, we have submitted this to the FDA.

We are waiting for feedback from the FDA that we're going to receive next month. I think it would always be our sort of strong wish to be able to put in place a plan that gets us, gets us efficiently through to registration, let me put it like that.

We really need to get those comments back from the FDA before we really start sort of kind of explaining how we're going to do that. I think, I think redosing is an interesting component of a development program.

I think for GBS, we're very much focused on that acute treatment. It's an acute disease.

We don't necessarily see in, in, in that specific acute scenario a strong need for subsequent repeat dosing.

Great. Thank you very much.

Hi, team. This is Romy on for Suzanne.

Two questions. In Q1, Idefirix sales were particularly strong in France.

Just wondering if these were at the same level as in Q4 last year, and was France not impacted by the new initiatives? Secondly, are you able to expand on the multiple system and process initiatives in Europe?

Is it beyond regional authorization in Catalonia and the work that the German KOLs are doing? Thank you.

Sure. I will have Maria cover these questions.

Yes. Thank you for the questions.

First when it comes to France, I think France has since launch been a very strong contributor to the European sales, and we've talked about that in previous calls. We haven't gone into the details exactly what we're selling in each country, and I'm not going to do that, but I can say that we continue to see a strong growth in France.

That is attributed to the fact that we have many physicians in France that had early experience with the product. We also have the one center that participated in the Phase 2 trial.

Going back to what I mentioned before is that clinical experience is critical, and we have that early on in France, and that has sort of spread into many transplant centers in France. We also know, as an example, that France is about to publish some data from their real-world experience that we look forward to seeing when that gets published.

The sales trend in France continues, and that is very encouraging, and I think it proves that if you put the efforts behind the right type of educational initiatives and you get strong clinical experience, you'll see that growth in the product. Those are some of the things that we are putting in place for other markets as well.

To your second question on systems and processes, these are not just this sort of processes that you asked about in Catalonia and in Germany, but it's also things like CRM systems that we haven't had at Hansa historically. It is new dashboards that enables the teams to have greater insight into performance and numbers and opportunities.

It's sort of a broad cross-Europe systems. The other thing that we are doing is just trying to drive that clinical education, we have more pan-European webinars, educational sessions to really drive that clinical discussion and clinical experience, and spread some of that positive momentum that we're seeing in countries such as France, but also many, many other smaller countries in Europe.

Great, thank you. If I may, one more.

Just wondering what we can expect from the confirmatory PAES study, and what your thinking is on the impact of Idefirix sales?

I think in terms of what we can expect, obviously, we're going to report out kind of topline data, and I think Richard laid out kind of how the study is designed, and that's the data that we're going to share is kind of primary and kind of the topline data, as well as whatever kind of secondary information we might have at the time. As I'm sure you're aware, we are under MAR in Europe, and so we really have to kind of publish the data once we get it, and we don't always have all the actual kind of data at hand when we go out and have to report the actual kind of topline outcome.

In terms of kind of the impact, and I think following on to Maria's point, my personal view is that this will be very, very important. It will, as always, take a little bit of time to kind of get that information into the kind of hands and minds of kind of physicians and patients in Europe.

I do think that there's a lot of expectation, and people are waiting to kind of see that data because it is kind of a truly European-based kind of clinical experience that we're going to be able to see, which really, I don't think has really been the case previously. It's been very small amounts of clinical data that's kind of really has come from the European region.

I think that data together with ConfIdeS, together with the real-world data, I think all of this data is going to just bring additional kind of comfort. It's going to characterize kind of efficacy and safety of imlifidase and Idefirix.

I think it's always important in my view to really be able to share clinical outcomes with physicians, particularly in these kind of situations where there really hasn't been a way of treating these patients before. There isn't a lot of understanding, in some places, in terms of what do they do with these patients.

I think having as much kind of clinical information, data, as we can, I think will be very impactful in general.

Great, thank you so much.

Hey, team. Thanks for taking the questions.

Looking forward to the detailed ConfIdeS data at ATC in June. Was wondering if you could just help frame expectations for the detailed data, like what additional analyses can we expect to see, and will this include any additional patient follow-up beyond what was available at the topline?

Richard, do you want to take that?

Sure. We would anticipate a comprehensive description of the outcomes of the study at ATC, giving more detail around some of the other endpoints that were included in the study relating to outcomes such as antibody-mediated and cell-mediated rejection, anti-drug antibody responses, etc.

As well as some other efficacy endpoints, and also, of course, the safety outcomes of the study. There will not be any additional follow-up on those patients.

The cut of the data occurred last year, and there's been no further cuts of the data since then, we won't have any additional follow-up.

Got it. That makes sense.

Then with respect to the ongoing BLA review, and maybe as a follow-up to that point, Richard, can you just remind us, I guess, plans for submission of an additional cut of the data from ConfIdeS to FDA, I guess when that would take place, and then has there been any indication from FDA whether they would look to convene an advisory committee meeting to discuss the application? Thanks so much.

Okay. There won't be any further cuts of the data submitted to the FDA other than the standard 120-day safety update.

That's a standard part of any submission, so that will be submitted. We've had absolutely no indication of a requirement for an advisory committee.

Got it. That's helpful.

Thanks, guys. Looking forward to the presentation at ATC.

We are, too.

Hi, team. Thanks, and let me also offer my congrats on that late-breaker for ConfIdeS.

I was wondering, as we see data this summer from both the PAES and ConfIdeS, any key differences in the baseline of these patients, such as cPRA levels, or maybe differences in the post-treatment immunosuppressive regimens that we should keep in mind to help kind of compare and contextualize those data sets? Then, I realize it might be too early to discuss this, but I guess, any color on the labeled indication you're seeking in the US or discussions with the FDA around cPRA cutoff in the label at this point?

Thank you.

There are some differences in terms of kind of the patient profiles between the two studies, which I'll have Richard cover. We have not yet had any kind of interactions with the FDA with regards to the label.

Richard?

Can you hear me?

Yes, I can hear you now.

Okay. Thanks.

Essentially, in both the ConfIdeS study and the PAES study, patients enrolled into the study are highly sensitized. It is true to say that there are some minor differences in how that is defined, dependent on the country in which patients were enrolled in Europe, but overall, they can still be considered to be highly sensitized.

In general terms, the post-treatment immunosuppressive regimens used in Europe and the US were the same.

Thank you.

Hi, this is Georg from ABG. I have two questions.

First, a follow-up on France. I'm curious to whether there was any considerable contribution from lung transplants.

Secondly, in which particular regions do you expect particularly strong positive effects from the PAES data? Thank you.

Maria, do you want to take that?

Sure. When it comes to France, our contributions in Q1 was attributed to kidney transplant.

I'm not aware of a lung transplant as of yet in France. Could you repeat the second question, it was related to PAES?

Sure. I was wondering if you can elaborate on which particular regions you would expect a particularly strong positive effects from those data, for example, Catalonia with many patients included in the trial.

That is a great question, and I think, if you look back to how the product was launched in Europe, we only had two centers that had participated in the Phase 2 trial. Across Europe, there has been many physicians and transplant centers that have been waiting for additional data.

As Richard mentioned before, we have 22 centers that have participated, and they are one of the largest centers in Europe. I would say all of them are waiting for this data, and they've seen the product used in their clinic, but they're waiting for that pooled data of the 50 patients being rolled out.

I expect this to have a positive impact across all markets. I think for France, it will confirm what they already know.

They have a lot of experience in France, but we know that there are many markets where physicians have been waiting for this to see the outcomes of a larger trial with European patients. I think this will have a positive impact across all of the largest markets, the UK, but also some of the smaller markets where they're maybe one or two centers in each clinic.

That is why, as Renée mentioned before, having the PAES readout this year, more data from ConfIdeS in June, that is why we are very excited about the opportunity in front of us in Europe, because this is really what the physicians have been waiting for for a very long time.

Great, thank you.

You're welcome.

Hello, good afternoon. I had a follow-up question to one I asked at the last Q&A regarding your accounting definition of sales, namely how representative are your quarterly revenue figures of real-world use of Idefirix in actual transplantations?

Evan, do you want to take that question?

Yep. Sure.

We recognize revenue on the transfer of product from Hansa to a potential hospital. I think the revenue recognition reflects actual sales very well.

I was wondering, the transplantation could occur much later than the actual sales, how do actual transplantation track revenue?

Most of our customers pay us within pretty common terms of 30, 60, or 90 days once the product has been transferred, and some of our customers, a small portion, pay us based on transplantation. We break accounts receivable into two groups: groups that pay us on standard terms are current accounts receivable, and groups that pay us based on transplantation are categorized as non-current.

This is obviously an issue in terms of the fact that because they have to have the product available, because obviously by the time that they decide to delist a patient, the time period that will elapse between the act of delisting a patient and receiving an organ is completely unknown. That could be a couple of days, it could be a couple of weeks, can be a couple of months.

Obviously, once kind of the drug has been used, obviously it's generally replaced immediately by the hospital, but there isn't really a way of kind of having a 100% kind of immediate kind of connection, because you just have to have it accessible because the timelines are so short that this is not a drug that you can just kind of order once you actually have the organ in the clinic. Hopefully that addresses your question.

Thanks. That made it clear.

Thanks very much for fitting in my questions. I have a few if I may, but stop me if we're running out of time.

The first one is on Germany, the Eurotransplant, and maybe if you could say anything about what your expectations are for the guidelines, what they'll actually contain with respect to use of Idefirix, or perhaps what we should be watching for? Then a follow-on to that would be then what are your expectations in terms of the time to actually implementing any such changes?

That's my first question. Thanks.

Maria, do you want to take that?

Sure. The consensus recommendations that have been put together in Germany have been written by all the major key opinion leaders in Germany.

They have rolled them out among the clinics on a webinar in March, and so they have the German version of those guidelines in their hands right now. They have submitted it in English to an international journal to be published, and we are not controlling the publication, but our expectations is probably mid of this year that we will see that publication in English.

In addition to the webinar that was held in March to discuss these new recommendations, our German team are also hosting different roundtables and KOL sessions with immunologists, with transplant surgeons, etc., to discuss the practicalities of these guidelines. The good news here is that all of the German KOLs are standing behind the guidelines.

They put their name behind those recommendations.

Are we to understand that it's basically to begin to reuse Idefirix in—

Yes. The guidelines are written keeping in mind the ETKAS program in Germany.

As we mentioned before, the priority program was paused by the German Bundesärztekammer. However, 2/3 of German highly sensitized patients are in the normal ETKAS program.

These consensus guidelines practically speaks about how to use Idefirix within that ETKAS program.

Great. Thanks.

Then,

yep.

No, go ahead.

No, sorry. I guess feel free to add, but otherwise, my second question would be on what are your expectations for how the PAES study data will look like?

That's the crystal ball question. I guess I'm happy to have Richard also weigh in on this, but I think at this point in time, there's been a lot of transplants taking place with this drug.

I think that what we've seen is a very, very consistent behavior of this drug. It is highly targeted.

We know what it does, we know that it works, and so I think my view is that we certainly don't expect any surprises from the PAES study at all. Obviously, we've not seen any part of any data, obviously we are kind of in the same place as you are in terms of we'd be very interested in seeing it.

Again, I feel very comfortable with all of the kind of clinical experience and what we've seen in other clinical trials and also obviously in real world. Again, I don't expect any surprises there.

Richard, I don't know if you have another crystal ball that you can look in?

I don't have a crystal ball, but I agree. I think we don't expect any surprises.

We were really pleased with the outcome of that study. As I've said answering a previous question, the patient populations are very similar in the ConfIdeS and the PAES study in terms of patients receiving imlifidase in the PAES study.

I think we haven't got a crystal ball, but agreeing with Renée, I really don't anticipate any surprises.

Great, thanks. Then if I could ask then a third question would be on Italy and Spain and the outlook there in terms of the rollouts across the remaining regions.

How do you see that progressing in terms of, let's say, the timeline?

Maria, do you want to take that?

Yes. Spain and Italy are obviously two of the important markets in Europe.

What I am observing are positive changes in those markets, both in terms of the rollout of reimbursement, which in both Italy and Spain is first on a national level, but then on a regional level, and we have made progress in all of the key regions, where the major transplant centers are. I'm also seeing more physicians sort of adjusting to delisting patients and understanding how to delist.

I'm also observing more utilization, meaning more centers that are starting to adopt the product post the sort of PAES trial enrollment finishing. I think those are sort of positive lead indicators.

Both Italian and Spanish physicians are obviously waiting for the data. They participated in the PAES trial.

I think that will be important as we get the data middle of this year, both from ConfIdeS full data, and also PAES. Part of our actions in both Italy and Spain is making sure that all of these centers that both participated in the PAES trial and did not, that they have access to this information.

I think that will confirm again the clinical confidence in the product. We are seeing positive momentum, I would say, in both markets, I'm sort of cautiously optimistic about the future in those markets.

Thanks so much. If it would be okay to squeeze in one last question, if you could explain a little bit more the CAR-T analog that you mentioned for the US.

That's it for me. Thank you.

Sure, happy to. Yes.

Imlifidase will be an inpatient drug in the US, meaning it's being used in the hospital setting, obviously as the patient is going through a major surgery. The CAR-Ts were also used inpatient, and that means that the way the products are paid and reimbursed is very similar.

The reimbursement pathway that they took when they launched will be very similar for imlifidase. Specifically, these drugs are covered by DRG codes as an inpatient drug.

When they launched, the DRG code, I think Renée will correct me, was very low, around $40,000, and the hospitals needed to apply for outlier payments. In addition, the manufacturers of those products applied for NTAP, New Technology Add-on Payment, to give that extra reimbursement to the hospitals.

Eventually, after a few years, they got their own assigned DRG code. When you think about how imlifidase will be used in the US, it will be inpatient, we will apply for NTAP, New Technology Add-on Payment, the hospitals will submit outlier payments to CMS.

That's why we say that the CAR-T launch and the uptake of the launch and how it was managed from an access and reimbursement perspective is a very good analog to look at if you want to sort of think about how the financials work for this inpatient drugs in the US.

Great. Thanks.

Thank you very much. Thank you very much for listening to this Q1 review, and we definitely look forward to our Q2 review, where we will have a lot of things happening between now and then.

Thank you again.