Good afternoon, welcome to the Hansa Biopharma Quarter Two 2023 conference call. My name is Carla, and I will be the operator of today's call. If you'd like to register a question for the Q&A portion of the call, please press Star followed by one on your telephone keypad. When asking your question, please ensure your telephone is unmuted locally. To revoke a question, you can press Star followed by two. I would now like to pass the conference over to our host, Søren Tulstrup, to begin. Please go ahead when you're ready.
Thank you, operator. Good morning, good afternoon, and welcome to the Hansa Biopharma conference call to review second quarter 2023 results. I'm Søren Tulstrup, CEO of Hansa Biopharma. Joining me today is our Chief Commercial Officer and U.S. President, Matthew Shaulis, and our CFO, Donato Spota. Our Head of Investor Relations, Klaus Sindahl, is also with us. Today, we'll discuss the highlights and progress we made during the second quarter of 2023 and review our near-term milestones. The presentation should take roughly 20 minutes, after which there will be an opportunity to ask questions during a Q&A session. Please turn to slide 2. Please allow me to draw your attention to the fact that we'll be making forward-looking statements during this presentation. You should therefore apply appropriate caution. Please turn to slide 3 and an overview of Q2 highlights.
I'm pleased with the solid performance in the second quarter. The launch of Idefirix in Europe continues to track well against the key launch metrics, and we've also seen good progress in our efforts to advance a valuable pipeline of drug candidates in all our four priority therapy areas. We delivered our best quarter yet when it comes to product sales as we continue to scale Idefirix in established markets with pricing and reimbursement secured. Our progress was further underscored by encouraging changes in the transplantation clinical community, including implementation of medical guidelines on a national level in key markets and a new desensitization program by Eurotransplant, targeting Idefirix eligible patients. Importantly, during the last year, we've secured positive reimbursement decisions in many key markets.
Most recently, in June, Idefirix was granted reimbursement in Belgium, where more than 1,100 patients are waiting for a kidney transplant and approximately 1 in 10 are classified as highly sensitized, with limited or no access to suitable donor organs. We're also pleased with the recent decision by the Australian Therapeutic Goods Administration to grant provisional approval for Idefirix in Australia as desensitization treatment in highly sensitized patients prior to kidney transplantation. This regulatory milestone marks the first time that Idefirix has been approved in kidney transplantation from both living and deceased donors. Matt will cover our commercial progress in more detail later during this presentation. On the clinical development side, we've continued to drive progress across our early and late-stage programs and franchises. In the U.S., during the second quarter, we exceeded our initial enrollment target in the pivotal ConfIdeS trial in kidney transplantation.
As previously communicated, we will continue to enroll patients and add more centers to accelerate randomization. In the autoimmune disease phase, we're excited about the launch of a new investigator-initiated phase 2 trial in ANCA-associated vasculitis. This new trial is an important step in developing imlifidase as a drug candidate in a new indication with very few treatment options available today. The trial will target 10 patients with pulmonary hemorrhage due to severe ANCA-associated vasculitis and will be led and sponsored by the Charité – Universitätsmedizin hospital in Berlin. Additionally, within autoimmune disease indications, our pivotal global phase 3 study in anti-GBM antibodies saw the first patient treated in May, as previously reported, and further patients have been enrolled since. The target is to get 50 patients enrolled at 30-40 sites across the U.S. and Europe.
In April, we announced a new gene therapy collaboration with Genethon to develop imlifidase as pretreatment to gene therapy in Krabbe disease patients with anti-AAV antibodies. Genethon is a pioneer in research and development of gene therapies for rare diseases. Through this collaboration, patients with Krabbe disease and preformed antibodies will be involved in a study where imlifidase is evaluated as a pretreatment prior to the administration of GNT-0003, Genethon's gene therapy candidate, which is currently being evaluated in a pivotal clinical study in France, Italy, and the Netherlands, and has received PRIME status from EMA. This research and development collaboration is further testimony to our commitment in gene therapy and to bringing valuable therapeutic options to patients with unmet medical needs. With this overview, I will now hand over the call to Matt Shaulis, who will walk us through our commercial progress in more detail. Matt, please.
Please turn to slide 4. Thank you, Søren. Slide 4 illustrates where we are in our commercial journey as we scale Idefirix as a new way of allowing transplantation while transforming the desensitization landscape. As Søren stated in the beginning of the presentation, we've recently seen solid commercial performance and progress on our key launch metrics, including our best quarter yet of product sales. While we're pleased with this most recent quarter, based on unpredictability and organ allocation, we do anticipate seeing volatility in sales from month to month and quarter to quarter.
That being said, as discussed back in the first quarter, we expect an even better second half of the year, as key markets, such as the U.K. and Germany, are expected to contribute, given the recent market access obtained, changes to the Eurotransplant allocation system, as well as Hansa securing a number of clinic-level agreements. In Europe. We've now secured market access in 13 countries, including the five largest markets and the recent positive reimbursement decision in Belgium. Our progress is also underscored by encouraging changes in the transplantation clinical community, where we, in recent months, have seen medical guidelines and recommendations implemented on a national level in a number of key European markets, including the U.K., Finland, France, Belgium, and the Netherlands.
These medical guidelines and recommendations are incorporated on the back of the ESOT guidelines published in Transplant International last fall, which helped the transplantation community in shaping the framework for management pathway for highly sensitized kidney transplantation patients. Another example is the ESOT-engaged Delphi Consensus Working Group, which recently released findings in a poster presentation at ATC in San Diego. Not only does the working group include the role of imlifidase for desensitized patients, it also provides viewpoints on important elements of managing patient complexity in desensitization, such as antibody removal strategies, induction and maintenance immunosuppression, and patient monitoring. As mentioned, back in June, a group of Hansa representatives from R&D, Medical, and Commercial attended the American Transplant Congress 2023 in San Diego.
The ATC is the joint annual meeting of the American Society of Transplant Surgeons and the American Society of Transplantation, with more than 5,000 transplant professionals, including physicians, scientists, nurses, pharmacists, and allied health professionals attending, representing more than 50 countries. This year, more than 500 oral presentations and 1,200 poster sessions were scheduled in five days. For Hansa, this was a key opportunity to interact with experts and stakeholders from the clinical research community, gather insights on clinical management of highly sensitized patients, and further raise awareness of our U.S. ConfIdeS trial among KOLs, while at the same time promoting Hansa's reputation and share of voice as a promising biotech company, driving innovation in the field of kidney transplantation. Lastly, our post-approval study continues to enroll according to plan. The post-approval study will support full marketing authorization in Europe.
The post-approval study will help generating valuable patient experience among the up to 25 clinics as we build the foundation for Idefirix to become a new standard of care in desensitization treatment for highly sensitized kidney transplant patients. Please turn to slide 5 in a review of our ongoing clinical programs. The end of June, Eurotransplant initiated a new desensitization program for imlifidase-eligible patients as a pilot in the Acceptable Mismatch Program. Eurotransplant is an international nonprofit organization that acts as a mediator between donor hospitals and transplant centers among its member states, which today includes countries in the Benelux zone, Germany, and select Eastern European countries, such as Hungary and Croatia. The Eurotransplant network has facilitated organ allocation in a deceased donor setting and cross-border exchanges for more than 50 years, the network has one overarching ambition: to ensure best possible match for patients.
Today, patients with a high level of donor-specific antibodies are eligible for a special priority list within the Acceptable Mismatch program. The list still precludes HLA-incompatible patients who are immunologically compromised because of their HLA profile to a deceased donor, leaving them with basically no hope to be transplanted. 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 3 years in the Acceptable Mismatch program, donor below 65 years of age, and preferable negative T-cell cross-match towards acceptable antigens for the desensitization program.
We're very excited about the prospects of the new Eurotransplant program, which will provide opportunities for important clinical experience using Idefirix to treat highly sensitive patients and potentially lead to improved outcomes for hundreds of Idefirix-eligible patients in the Eurotransplant zone. Please turn to slide 6. Last week, Idefirix received provisional approval in Australia as a desensitization treatment in highly sensitized patients prior to kidney transplantation. Importantly, the decision from the Australian Therapeutic Goods Administration represents the first regulatory body in the world to approve the use of Idefirix in transplants from both living and deceased donors, which helps ensure comprehensive access for highly sensitized patients in Australia to this important therapy. With nearly 21% of kidney transplant candidates in Australia considered highly sensitized with a CPRA of 95% or higher, the approval of Idefirix represents an important innovation in kidney transplantation care for patients and clinicians.
In 2021, 875 kidney transplantations were performed in Australia, with 24% coming from living donors and 76% from deceased donors. Full approval in Australia will require submission to the TGA of further safety and efficacy data from studies that are currently underway, like the U.S. ConfIdeS trial and the post-approval study in Europe, while a decision on market access is expected sometime in the second half of 2023. Please turn to slide 7. With regard to our pivotal U.S. ConfIdeS trial in kidney transplantation, we exceeded our initial enrollment target during the second quarter. We'll continue to enroll more patients, as previously guided, to accelerate randomization. As of today, we've enrolled 76 kidney transplant patients at 14 sites. We'll continue to add centers with a goal of approximately 20 or more to accelerate randomization of 64 patients.
The increasing number of centers will also help build valuable clinical experience in desensitization of these highly sensitized patients among KOLs in preparation for our planned launch in the U.S. market. Completion of study enrollment is expected shortly, while randomization should be completed by the end of the second half of 2023, as previously guided. With this, I will hand it back to Søren for continuing the update on our clinical programs.
Thank you, Matt. Please turn to slide 8. As we announced yesterday, a new investigator-initiated phase 2 study in ANCA-associated vasculitis has been started. This is the first study evaluating imlifidase in this patient population and is an important step forward in broadening the development of our technology platform and pipeline of drug candidates for rare immunologic diseases and conditions. In fact, ANCA-associated vasculitis will be the third program in the autoimmune disease space in clinical development for our lead antibody-cleaving enzyme molecule, imlifidase. As you will recall, we have existing clinical studies in both anti-GBM disease and the Guillain-Barré Syndrome. ANCA-associated vasculitis is a group of rare autoimmune conditions that affect approximately three patients in 100,000 people annually across Europe and the US, of which between 8% and 36% are estimated to have acute respiratory distress syndrome due to pulmonary hemorrhage.
The disease is characterized by the presence of IgG anti-neutrophil cytoplasmic antibodies directed against antigens expressed by the neutrophils, a type of white blood cells in the body's immune system. The presence of ANCA antibodies against neutrophils causes blood vessels damage that can affect multiple organs, most frequently the lungs and kidneys, where it leads to rapidly deteriorating organ function. In 25% of patients, the damage done leads to end-stage renal disease and sometimes also causes pulmonary hemorrhage in the lungs and respiratory failure. The new study, which is led by Dr. Adrian Schreiber and Dr. Philipp Enghard at Charité – Universitätsmedizin Berlin, is a single center, single-arm, phase 2 trial in 10 patients with severe ANCA-associated vasculitis and acute respiratory distress syndrome due to pulmonary hemorrhage.
Patients will be treated with imlifidase on top of standard of care, which consists of standard immunosuppression and intensive supportive care, with the primary objective to assess efficacy and safety in the treatment of patients for pulmonary hemorrhage due to severe ANCA-associated vasculitis. We look forward to the results from this study in yet another autoimmune disease and are excited about the potential for imlifidase to help even more patients suffering from serious autoimmune diseases and conditions. Please turn to slide 9 and a review of our ongoing clinical programs. At the end of May, we announced that the first patient was dosed with imlifidase in a global pivotal phase 3 trial in anti-GBM disease. The phase 3 program, which targets 50 patients at 30-40 centers, is the first and currently the only pivotal randomized trial in anti-GBM disease, a condition with significant unmet medical needs.
The primary objective of the study is to assess the superior effect of imlifidase in combination with standard of care versus standard of care alone, consisting of a combination of immunosuppressants, steroids, and plasma exchange. The performance of the treatment will be assessed through the evaluation of renal function at 6 months, as measured by filtration rate and need of dialysis. The safety profile and efficacy on pulmonary symptoms and health-related quality of life aspects will be explored. As of today, 4 patients have been enrolled, and we have 12 active sites up and running across the U.S., U.K., and EU. Earlier this year, we announced completion of enrollment in our GBS phase 2 program. GBS is an acute autoimmune attack on the peripheral nervous system, which affects approximately 1 to 2 patients per 100,000 people annually.
Top-line data on safety, tolerability, and potentially the early effect in imlifidase-treated GBS patients is expected to be announced in the second half of this year. The full data from the GBS phase II study is expected in 2024, following a comparative efficacy analysis between the imlifidase-treated group of patients in the trial and the matched cohort from the IGOS database at the Erasmus MC in Rotterdam, in the Netherlands. We plan to publish the full data set from the AMR study in the second half of this year, as previously announced, following the positive top-line data announced in November of last year. Please turn to slide 10 and a summary overview of our pipeline. As you can see on this slide, we have successfully developed a broad and exciting pipeline, currently with 8 ongoing clinical programs across transplantation and autoimmune diseases.
As communicated back in April, we have initiated the clinical program with HNSA-5487, the lead molecule from our second-generation IgG antibody-cleaving enzyme program, NiceR. HNSA-5487 is an opportunity to substantially expand the number of potential indications for our antibody-cleaving enzyme platform, including in areas where more than one dose of an IgG-modulating enzyme is beneficial. The program is progressing according to plan. Enrollment in the phase 1 study in healthy volunteers was recently completed. Data analysis is now underway to evaluate relevant indications to pursue in clinical development. In gene therapy, our partner, Sarepta, presented data during this year's American Society of Gene & Cell Therapy Conference, which was hosted mid-May in L.A.
The data presented in non-human primates confirms the ability of imlifidase to remove antibodies towards AAVrh74, which supports the upcoming clinical study combining imlifidase with Sarepta Therapeutics' product, ELEVIDYS, previously known as SRP-9001. ELEVIDYS received U.S. FDA approval in June as a 1-time treatment in ambulatory pediatric patients, aged 4 to 5 years, suffering from Duchenne muscular dystrophy. In combination with imlifidase, additional treatment may potentially be enabled in up to 14% of patients who are currently suffering from 2 high titers of neutralizing antibodies against AAVrh74. With this overview, I will now hand over the call to Donato, who will walk us through a review of the financials for the second quarter and first half of 2023. Donato?
Thank you, Søren. Please turn to slide 11. Total revenue for the second quarter of 2023 amounted to SEK 36.7 million, including SEK 29.6 million in product sales and SEK 7.1 million in contract revenue, mainly from the agreement with Sarepta. For the first half of 2023, total revenue came in at SEK 60.8 million, including approximately SEK 44 million in product sales. The second quarter was our strongest product sales quarter so far, and we continue to expect sales to grow further in the second half of this year. As indicated by Matt, while we still anticipate quarter-on-quarter volatility to remain, we do expect sales for the remainder of the year and going forward to increase on the back of repeat business, implementation of new guidelines, additional countries being launched, and the new neuro transplant desensitization program targeting imlifidase-eligible patients.
Please turn to slide 12. Total SG&A expenses for the second quarter of 2023 amounted to SEK 129 million, compared to SEK 90 million for the second quarter of 2022. The increase reflects Hansa's broadened commercial activities and organizational expansion related to the launch of Idefirix in Europe and building our U.S. footprint. Further, inflation and devaluation of the Swedish krona against the euro and the US dollar are negatively impacting costs. For the half year, SG&A expenses increased to SEK 233 million versus SEK 171 million for the same period last year. Investments into R&D amounted to SEK 115 million for the second quarter 2023, which is a step up versus the recent quarters and reflects an increase of SEK 22 million compared to the second quarter of last year.
The increase is mainly driven by expanded pipeline activities, such as the ongoing pivotal phase 3 program in anti-GBM and the US ConfIdeS trial, as well as our clinical phase 1 trial and CMC development activities related to HNSA-5487, our lead molecule from the second generation enzyme program. R&D costs are also impacted by price adjustments due to inflation and the devaluation of Swedish krona. Looking at the full year 2023, we expect the operating expenses in the first half year to be indicative for the expected expenses in the second half of this year. Net loss amounted to SEK 251 million for the 2Q 2023, compared to SEK 170 million in the same period of last year.
For the half-year period, net loss stood at SEK 457 million, versus SEK 309 million for the same period last year. In addition to the increased investments in our operations, the increase in net loss versus last year periods is also driven by the amortized interest expenses related to our long-term loan. Notably, these interest expenses are non-cash expenses. Please turn to slide 13. Cash flow from operating activities amounted to minus SEK 182 million for the second quarter of 2023, compared to minus SEK 136 million for the second quarter a year ago. For the first half of 2023, operating cash flow was minus SEK 389 million, versus minus SEK 266 million in the first half year of 2022.
The increase over last year is mainly driven by the increase in operating expenses and the upfront payment of SEK 50 million we received early 2022 under the AskBio Agreement. Our cash position at the end of June was approximately SEK 1.1 billion, which is expected to provide a cash runway into 2025, as previously guided. I will now hand back the call to Søren for his final remarks.
Thank you, Donato. Please turn to slide 14. We're encouraged by the solid performance in the second quarter and a very eventful first half of 2023, with good progress in our pipeline across all our four franchises. Looking ahead, there are several milestones we must deliver on for the remainder of 2023 and the years to come... As highlighted earlier, we continue to see healthy interest among clinics to participate in our pivotal U.S. ConfIdeS trial, and we'll continue enrollment to accelerate randomization by adding new centers up to a total of 20 or more. Randomization is expected to complete in the second half of this year, as previously guided. In the second half of this year, we plan to announce the first high-level data readout in GBS, following the completion of enrollment at the end of March.
As discussed earlier, top-line data is expected later this year, with a full data set, including the outcome of the comparative efficacy analysis to an externally matched cohort from the IQVIA U.S. database, expected to be available in 2024. Additionally, we also expect to announce 5-year data from the long-term follow-up study in kidney transplantation. Data is expected to be announced in the second half of 2023, which is also the time we expect to publish the full data readout from the AMR Phase 2 trial. Finally, we're encouraged by the recent progress with Sarepta in gene therapy, following promising preclinical data with imlifidase in their Duchenne muscular dystrophy program. Together with our partner, Sarepta, we plan to commence a clinical study after the summer in a small group of DMD patients with preexisting IgG antibodies to Sarepta's newly approved gene therapy, ELEVIDYS. Now please turn to slide 15.
This concludes our presentation, and we would now like to open the call for questions. Operator, please begin.
Thank you. If you would like to ask a question, please press star followed by one on your telephone keypad now. While preparing for your question, please ensure your phone is unmuted locally. To revoke your question, please press star followed by two. Our first question comes from Gonzalo Attali from ABG Sundal Collier. Please go ahead.
Hi, thank you for taking my questions. First one on the ConfIdeS study in the U.S. Now, you have enrolled 74 patients, 76 patients, sorry. From the way you describe it's difficult to know how fast these patients will be randomized. My question is, how sure are you that you will achieve the goal of full randomization by the end of the year? If it's a matter of number of patients being enrolled, how many patients would you like to have enrolled in the trial, let's say, by the end of Q3, to be sure that you will make it before the year end? Thank you.
Well, thank you for this, a very relevant question, Gonzalo. You're right. We've currently enrolled 76 patients. The reason why we've continued to enroll patients, even though we're, you know, above the target of 64 randomized patients, is because there is this delay between enrolling a patient and that patient actually getting an organ offer and being randomized. That delay is, it varies from patient to patient. Sometimes it's a month, sometimes it's a couple of months. Some patients may actually not receive an organ offer within the study period. That's why we've decided to continue to enroll patients.
A subsidiary reason is also that we really want to make sure that the centers have the opportunity to develop relevant expertise and experience in this field. How sure are we that we'll meet the target by the end of the year? Well, the randomization rate is increasing, and given what we see right now, we are continuing to guide that we will have all 64 patients randomized by the end of the year. Obviously, just like with the uptake in Europe, it is a little bit difficult to predict the exact rate of organ offers to the patients, but that is what we're guiding at this point in time.
Okay, great. Thank you very much. A second one, if I can, and it's regarding the Eurotransplant allocation tier. Could you give us some color on how this tier will speed up transplantations? I mean, the Eurotransplant Acceptable Mismatch Program has around 330 patients, had this amount of patients at the end of 2022, with 83 patients were transplanted in the same year. How much will this new tier, as part of the Acceptable Mismatch Program, speed up transplantation using imlifidase for the population that will not have an organ offer after 3 years, which should be around 35%, if I'm not wrong? Thank you.
Thanks again for this, the second question, Gonzalo, I'll hand over to Matt in just a minute or so. Overall, I mean, the Eurotransplant program has the great benefit that in a systematic way now, patients are identified, put on a list as part of a formal evaluation of, you know, the use of imlifidase. Certainly, it's very, very helpful, not just looking at the individual patients that will be identified and transplanted, hopefully, but also the fact that there is this focus on this from the Eurotransplant organization overall. We definitely think that this is something that will help speed up the penetration of the Eurotransplant markets, which, as you know, includes Germany, Benelux, certain Eastern European countries. But with this, I'll hand over.
Maybe, Matt, you have an additional comment or two on this.
Thank you, Søren. I think you covered the main principles here. I think the Acceptable Mismatch Program obviously will continue on. I think that there will be a high level of awareness around it. It's really the desensitization program where, you know, we, as we indicated in the call, we'll see 20 patients initially. Our understanding with Eurotransplant is that there's a substantially larger number of patients beyond that initial group of 20. Our understanding is that as organs become available, there will be a process.
... you know, by which a committee reaches out to centers that are known to have these patients. For this cohort that qualify for the desensitization program, you know, we see that there will be relatively quick identification of those patients, and treatment.
Thanks, Mike. Great, yeah, thank you very much.
We have our next question from Christopher Uhde from SEB. Please go ahead.
Hi there, thank you for taking my question. I guess I have a few that are sort of clinical and then a couple others. Starting with the clinical, we're getting close to the readout in GBS, as you highlighted. What can you say about what the bar for success is at this point? Do you have any more color you can offer there? You got a label in Australia for living donor transplantation, so congratulations. Are you planning a living donor transplantation trial for registration at this point? If so, can you offer any details, and if not, what more do you need to see happen in order to do it? I guess, yeah, then I'll come to my third one next. That's it.
Okay. Well, thanks, Christopher, for those questions. First on the GBS study, as you know, this is going to be kind of a two-step readout process, where we'll have data relating to, you know, safety tolerability, coming out, you know, second half of this year. Then we're going to have the efficacy comparison to the IGOS, you know, match cohort next year. Obviously, what we expect and hope for, looking at the first data readout, is that this is a well-tolerated, again, you know, molecule in these patients, and hopefully there are some high-level conclusions on the efficacy.
We haven't set any specific kind of success bars for the first readout other than what I just said in broad parameters. Clearly, for the second batch or second readout next year, we would hope to see that there is a superior efficacy of imlifidase in the relevant treated patients versus the IGOS match cohort. I can't give you specifics there. It's the overall aim to demonstrate superior efficacy. On the second question, yes, we're very excited about the fact that we now have officially in the label kind of donor source agnostic, you know, transplantation using imlifidase as desensitization therapy.
This is the first time we've seen that. That obviously is an opportunity to expand the market and get out of the rate limiting factor caused by the availability of organs from deceased donors. In the first instance, it's good to have it in the label in Australia. Certainly we expect that that will lead to actual usage. There may be a usage, you know, outside of Australia as well. At some point in time, to get it officially into the label, we may have to run a trial. There are no specific plans at this point in time, certainly it is something that we aim at ensuring that there will be usage in the living donor population as well.
Okay, thanks. I mean, I guess, the thing I would wonder about that further is, I mean, there's obviously a trade-off between cash burn, which is I'm sure why you're waiting, but at a certain point, it starts to become, yeah, a drag on what you actually earn versus what the potential is. Yeah, I mean, I guess, if you could give a little bit more color around your thoughts on that. My last question for now would be, the obviously, you've done a lot of small trials, including IISs in the past, and you've experienced both the advantages and the disadvantages of them.
Now you've got an anti-GBM trial with almost as many sites as patients targeted, which brings challenges of different patient management strategies between centers into play. Of course, you also have now another IIS in ANCA-associated vasculitis. What learnings from past experiences can you apply here to facilitate a more rapid recruitment of patients and also more homogeneous patient management to maximize the odds of trial success? Thanks so much.
The anti-GBM pivotal study is one that we're running ourselves, right? Obviously, this is an ultra-rare disease, so it's important to have enough trial sites up and running quickly. There we are progressing quite nicely, and as we've just discussed, we have already four patients in here. We're quite pleased with the performance so far. As far as anti-GBM is concerned, the ANCA-associated vasculitis trial is a single center study. Again, it's off to a good start. We have not only, you know, the first patient in, we have several patients. We believe that, you know, working with this one clinic is quite helpful, and they're very, you know, engaged in this.
Let me then also follow up on your first comment there on living donor, you know, registrational trial plans. You're right. I mean, obviously, there is a need to prioritize those things that are critically important in the short run, which is what we're doing. We do think that there is a path forward in living donor transplant situations, and that may not be a path that requires a substantial, you know, trial, but it certainly is something that we're evaluating and having in our minds, getting that into the label and certainly getting that usage, is important for the uptake of remicade.
Søren, if I could just make a quick comment on living donor. I think it's, you know, really a encouraging and we're very pleased that TGA, you know, provided both living donor and deceased donor in the label. That's a view I think that reflects that from a scientific and a clinical perspective, the living donor setting is actually very similar to the deceased donor when it comes to our data and the, you know, overall safety and efficacy associated with the treatment. Also I think it's noteworthy that in general, for some parameters, including obvious things like cold ischemic time, that the living donor is actually a lower risk cohort.
you know, we'll continue to do things like in particular an observational study, you know, that includes but both deceased and living donors in Australia, and that'll be a source of data which will allow us to continue to evaluate the opportunity.
Yeah. Thanks, Matt.
Our next question comes from Douglas Tsao from H.C. Wainwright. Please go ahead when you're ready.
Hi, good morning, thanks for taking the questions. Just congrats on all the progress, both commercially as well as work on the pipeline. I'm just curious, in terms of the commercial performance, it sounds like you are starting to get a number of reorders. Just, can you provide a balance or some perspective on how meaningful that ultimately was this quarter? I mean, I know we're still talking about relatively low numbers. Thank you.
Yeah, I'm not sure I got all of your, the question there, but overall, you're right. I mean, it's obviously important for us to now see kind of repeat business, which is not at the patient level, as we've discussed, previously. It's really at the clinic level-
Yeah.
where seeing this in a growing number of clinics, and that's very encouraging. Matt, I don't know if you want to add to this, but, you know, clearly it's an encouraging development.
Yeah. Yeah, absolutely. You know, we're seeing a number of centers across Europe get to that point where they have repeat ordering. The other thing, of course, that we look at too, is when centers have a repeat utilization of patients across, you know, trial activity as well. When we look at repeated use in patients, you know, we get to the point where it's double-digit numbers of centers that have had multiple patients. We'll continue to evaluate this, you know, on a quarter-by-quarter basis as we look across Europe on our launch activities.
I guess to put it more simply, I mean, I guess what % of this quarter's sales were repeat business with centers?
I don't know that, you know, Douglas, we can give you a specific % at this point in time. I mean, clearly what you are seeing is that there are more centers having their first patient, than centers having, you know, number two or three, patients. So that's the overall picture. It's really impor- you know, encouraging to see, the growth in the number of centers having, you know, repeat business, and that's obviously based off of, you know, positive experiences in the first, patient or patients treated.
I guess just to follow up.
The other thing I.
Go ahead.
No, go ahead, please.
No, no. I was going to ask on a different subject. I wanted to just go finish up.
Yeah, I would just say that we're going to see volatility on a quarter-by-quarter basis, given that overall, you know, in the earlier stages of the launch, which, you know, we sort of remain in, overall, you know, patient numbers are going to be low. You know, if we come back at one quarter from now, there, you know, could be a change in this or it could be similar. It's more on the semester by semester basis that, you know, we probably would continue to see more meaningful patterns.
Okay, great. Obviously, you're adding a lot of new and quite significant markets from a, you know, number of transplants taking place basis. Do you expect to see a faster learning curve for them? I know it took some time for some of the early adopters to sort of work, imlifidase into their protocols. Just also as a follow-up on GBM, I think you said, Søren, that there were 12 sites now enrolling. We have, I guess, 30-40 targeted. How quickly do you think you will get to the targeted number of sites up and running in that study? Thank you.
So on your first question, obviously, I mean, there's always, you know, learnings that we're applying from market to market. I think overall, the launch so far has really played out almost exactly as expected, which is great. It does take a little while, you know, from having secure pricing and reimbursement to getting the specific protocols in place on a national level and, you know, within specific clinics. Clearly we're doing whatever we can to assist and speed up this process, also in new geographies....What is really important, I think we've learned, is to make sure that there are appropriate kind of groupings so that the centers can learn from each other, and they can align and so on. I was recently in France.
We hosted a very successful meeting with 30, 40 key opinion leaders and staff from the leading clinics across France, discussing, you know, patient experiences using imlifidase. That kind of activity is really very helpful because they also learn as they go, right? If we can facilitate a steeper learning curve that is really very beneficial. On your second question, anti-GBM, I cannot give you a specific kind of expected timing here. We're encouraged by the good start we're off to, right? We do expect that we'll have to set up a very significant number of sites to make sure that we can, you know, recruit the 50 patients within a reasonable time frame.
Okay, great. Thank you.
Thanks, Douglas.
We have our next question from Bo Zhang from Intron Health. Please go ahead when you're ready.
Hi, thank you for taking my question, and congratulations on a successful quarter. Just a few from me. First, on the Eurotransplant, we understand the long-term benefit of putting more focus in this patient setting, but just on the near term, what is the time frame you sort of expect the pilot program of enrolling 20 patients to wrap up? Then number 2, on PAS, on the post-approval study, is there any numbers you can give on the number of patients that have been enrolled, or even as a % will be helpful. The last one is on Australia. Again, on timeline, what is the expected timeline of, I guess, commercial readiness, or when we can start seeing revenues coming in from the region?
Is it more of looking for a commercial local partner for Australia? Thank you.
Sure. Let me hand over to you, Matt, to talk about the Eurotransplant program, right? Obviously, we have the 20 patients and different cohorts, then we can take the post-approval efficacy study afterwards. Maybe let me just address that because I can't give you the specific number, but we do have a very material number of patients enrolled at this point. As you know, the aim is 50, and we need to have the study concluded by the end of 2025, which is then what we're aiming at. The third question was around the timeline for Australia, which again, I think I'll let you answer, Matt. Over to you, Matt.
Sure, yeah. happily talk about both the Eurotransplant desensitization program and Australia timing. Yeah, we, we, just to close the loop on the post-approval study, we don't have, you know, specific data available to answer that question. Now, I do know that post-approval study, again, is a situation where we have multiple centers treating multiple patients. That much I can say. As for the Eurotransplant desensitization program and timing there, you... Our understanding is that patients are already identified that would be appropriate and fit within that cohort. It's difficult for us to provide more guidance on exact timing.
Again, as organs become available and are in the protocol associated with that program, there's a central committee that then reviews the match between the organ that's been allocated for the program and the patients from across the centers in Eurotransplant that have been identified. There's an alignment that happens between the local center that's gonna do the complex immunologic procedure and the central committee. Between the process of the organ, the allocation going into the program, and then that match happening, it's difficult for us to say exactly how long it's gonna take for that first group of 20. We have been told that there's a substantially larger number than the 20, but the actual speed is difficult for us to provide guidance on.
Again, on a timing question, you know, related to Australia, again, there we're really encouraged by TGA and their decision on labeling. We have conversations ongoing with MSAC related to reimbursement coverage and the pricing point. We think it's gonna be a little bit later in the year when those conversations are resolved. You know, we're very encouraged with the initial steps in that process, again, we think it's gonna be until sometime in the second half of the year that we have reimbursement and the price secured. Needless to say, though, there was very good support within Australia for our labeling. We anticipate that patient identification is gonna happen pretty quickly in Australia.
When we get that price and reimbursement secured, then we do anticipate seeing some patient treatment fairly quickly in that country.
Thank you. Just a quick follow-up for Australia. Is it more of thinking of building commercial teams, sales forces in-house, or is it more of a partnership opportunity?
Matt, I think.
We're gonna finalize. Yeah, happy to go, Søren. We're gonna finalize those decisions when we work through the pricing and the reimbursement coverage. You know, right now, we've got a couple avenues that we've looked at very, very thoroughly, and when we have sort of a final disposition on pricing and reimbursement, and we can combine that with what we already know about the label, then we'll make a final call on it. I would also say that regardless of what direction we go, we've outlined a number of what we consider to be very strong options for the commercialization.
As I'm sure you know from dialogue with management here at the company and your understanding of the space, it's really a commercial and medical process, that's really critical, you know, managing the complex protocols associated with these patients. We, we believe that the avenues that we have, to pursue are gonna rise to that level of complexity.
Okay. Thank you.
We have our next question from Ingrid Gafanhao, from Bryan Garnier. Please go ahead.
Hi, good afternoon. Thank you for taking my questions. I'll be fairly quick. I have some questions on the Australian approval. I wanted to confirm with you that you are not required to do any country-specific additional studies in a post-approval setting? The second question would be, I know you're still having some discussions in the second half of this year, what are you thinking in terms of pricing? Is it going to be at least in line with what you have now for Europe? Thanks.
Well, thanks. Essentially, I mean, we obviously need to submit additional data, and as we said, you know, we can get that from other sources. That's the overall situation. As far as pricing is concerned, clearly, you know, we will use the same value proposition approach that we've taken in Europe successfully and apply that also in Australia. Matt, I don't know if you have any additional comments on Australia.
Yeah, I guess I would just say that, you know, we've seen some fairly positive opinions in Europe, and the same data and analysis from a health economics and an outcomes standpoint that we've used in Europe will be the same information that we're using with MSAC in Australia. You know, we can't provide very specific guidance on the Australian price recommendation, but I think what we can say is that, you know, we don't anticipate that it's gonna be substantially out of line with what we've seen in some other markets.
Clear. Thank you. If I may have just a follow-up on this. I think Australia is sort of the first territory that was a little bit different than the ones that you had gotten approval before. Are you pursuing a similar approach in any other territory at the moment, or is still more for the long term? Thanks. That was my last question.
Obviously, we're, you know, we plan to use the data we have and the approval in Europe to get additional approvals. If your question is around whether we want to secure a different type of label, I mean, that really depends on the specific dialogues that we're having, obviously, with the relevant regulatory authorities.
Yeah, Søren, I guess the only thing.
Please go ahead.
Go ahead, Matt.
Yeah, I was just gonna say, not necessarily that we have a, you know, a specific plan, you know, related to expanded, you know, labeling in existing markets, but I think one thing that we do plan to do is gather some data in Australia, related to both the deceased and living donors that are treated, you know, with the product. As we gather that data, that can be useful in the future, and we'll evaluate our options as we gather that data to use it with regulatory authorities in other markets. Again, I think that's a situation where, you know, we wanna gather the data first, see how things look, and then evaluate our options in other markets.
It, no question, I think this is some of the nature of the question. You know, it's an opportunity to have living donor patients in Australia and in some ways to gather the data on it. We're still pulling together our plans on, you know, how exactly we'll do that in a way that, you know, suits our future strategic interests.
That was clear. Thanks.
Thanks, Ingrid.
We have our next question from Matt Phipps, from William Blair. Please go ahead.
Hi, team. Thanks for taking my questions. Congrats on a nice quarter of sales. I was wondering if you could give us any more info on HNSA-5487, and just what you might be able to disclose after you analyze the data. Then any sense of timing for, you know, when you will disclose indications? Is that something we can get later this year?
Yeah, thanks, Matt, for that question. Yeah, we're certainly very excited about the potential that, you know, HNSA-5487 offers. The ability to use a more, and hopefully a more flexible dosing regimen. AMR has, you know, more longer, extended, IgG-free windows and repeat dosing and so on and so forth. Through the study in healthy volunteers, obviously, we'll be able to get data that we can compare to the very extensive data set we have from our preclinical and clinical trials with imlifidase.
You know, based on what we know so far, we're very optimistic that we can develop and that we have a molecule here that we can develop further, that is superior to imlifidase in terms of the immunogenicity. We expect to complete this phase 1 trial in the second half of this year. Based off of this, we would then make a decision as to the specific next indication that we would pursue with this molecule, and we expect then to initiate a trial next year. There is a range of options available.
We really see tremendous potential, certainly in the autoimmune disease space, where there's a number of IgG-driven, more chronic diseases, where the patients would benefit from induction therapy and add-on to their maintenance therapy when they have flares. There's quite a range of diseases there that would be relevant. We clearly see a tremendous opportunity in the gene therapy space, where right now, with imlifidase obviously really focused on pre-existing, neutralizing antibodies against the vector used. There is, I think, an even larger opportunity for, let's say, ameliorating the performance of the gene therapy, and certainly also allowing repeat dosing of the gene therapy, which, given the issues with durability of response, is likely to be, you know, required for a number of the gene therapies currently in development.
That's another broad opportunity. Clearly, you know, we talked about hematopoietic stem cell transplantation and the broader oncology space previously. That's another broad area. Finally, even in transplantation, where we have a fantastic molecule in imlifidase, given the opportunity to treat not just patients that are prohibited from actually accessing kidney transplant and making a kidney transplant, these patients, and some other patients certainly will have, you know, issues with AMR following the transplantation, and that's another opportunity in the transplant space for 5487 potentially. There's a very broad range of indications that could be relevant.
We'll get back, of course, as quickly as we can when we make that decision to talk about, the path forward.
Okay, great. Excellent.
Thanks, Matt.
Our next question comes from Johan Unnerus from Redeye. Please go ahead when you're ready.
Thank you for taking our questions. Johan Unnerus from Redeye. A few questions. The first, just to follow up on the US study. You are now targeting at least or possibly more than 20 centers, just a clarification. Will these centers also participate in sort of long-term follow-up studies and the post-approval study, possibly with aim to secure unconditional approval in the future?
Yes, that's correct. We are targeting at least 20 centers to be involved here. A, because obviously we want to speed up the randomization, and B, because it is critically important to get experience with imlifidase prior to the launch. We've seen that in Europe. We're very encouraged by the strong interest from a broad range of leading transplant centers in the U.S. to participate in the ConfIdeS trial. We do expect these centers to also to continue to assist us with the clinical trial activity, you know, also looking at post-approval commitments. Yes, that's the case.
Thanks for that clarification. Also, the ANCA at this stage in the parent independent study, it seems to be an interesting acute setting then. If I got it correctly, it's already started to recruit patients. Could you clarify when it's reasonable to expect result? Also, if possible, to get a feel for what is to be expected normally with the present standard of care for this troublesome patient group, I guess, they're on immune-suppressing therapies now.
Yes, that's correct. If I start, you know, taking back part of your questions. Clearly, this is a very, very severe disease with a high degree of unmet medical need, the mortality rate overall is close to 20%, if I'm correct. You know, you see organ damage, kidney organ damage, lung damage, and so on. This is the outcome of the existing, you know, standard of care. Clearly, as I said, there is a high degree of unmet medical need. It is not just kind of a hyperacute, you know, monophasic disease.
I mean, some patients will be treated well and will respond well and will not necessarily have kind of a chronic situation, but some patients will be affected for long periods and will have, again, you know, various levels of disease and symptoms. That's the disease per se. I can't give you a specific kind of expected timing for completion of enrollment of this trial. It is aiming to enroll 10 patients, and as I said, we have, you know, more than one patient enrolled at this point. But it is dangerous, you know, at this point, so early on to make any specific predictions.
It's not a huge trial, so hopefully we'll get this completed, and analyzed, you know, sooner rather than later.
In a reasonably successful scenario, you have sort of onboarded independent studies earlier. Another clarification, if possible, could this move on to phase 3 straight away?
I didn't get the first part of your question. Can you repeat that?
Just, yeah, just a reflection that we've seen in Hansa, sort of a, that you have experienced independent trials earlier and then made them your own at the next following stage. I guess this is a potential scenario.
Yeah, okay.
For this initiative as well.
Yeah, yeah, sure. That's what we've seen in anti-GBM, right? Where it was an investigator-initiated trial with 15 patients and now followed by pivotal trial run by us in 50 patients. That certainly is a possible path forward for the ANCA-associated vasculitis indication as well.
Yeah. Then to the financial side, it's clearly a few moving parts. FX is one, cost inflation is another, and of course, activity is the third, and that goes for both SG&A and R&D. Is it possible to give any more insight into these moving parts?
I will hand over to Donato to talk a little bit about this.
Sure. Yeah, happy to give you a little bit of more insight, Johan Unnerus. Obviously, the biggest drivers are certainly our expansion in our operational activities, right? I mean, on the commercial side in Europe, but also then starting to build up our footprint in the U.S. and obviously also the expanded activities related to our clinical pipeline. That's certainly the biggest impact. On the inflation side and on the FX side, you know, you've seen inflation average inflation rates in Europe getting up to 10%. The devaluation of the SEK versus USD and EUR is also about 10% against each of these currencies.
If you look back, first half of 2023 versus first half of 2022. Hope this gives you a little bit of a flavor of what drives the increase in the cost versus periods of last year.
Thanks. That's useful. Just to round it off then, you said something along the line that the first half or possibly Q2 is a sort of an indication for the second half of the year. Should we read that as R&D and SG&A activity, that Q2 levels is a good indication for the second half?
I would say the first half is also a reasonably good indication of what to expect for the second half.
Could that mean that we actually could see quarters with less OpEx than Q2?
That could mean that you see quarters with less, yeah. We don't expect to continue to grow on a quarter-on-quarter basis, right? Overall, I think, you know, first half is indicative of what we would expect for the second half.
Okay. Thank you.
Thanks, Johan.
We have no further questions registered at this time, so I will now hand back to the management team for final remarks.
Well, thank you, operator, and thank you, everyone, for your interest in Hansa Biopharma. As you've heard, we've had a good and exciting quarter, and we look very much forward to keeping you updated on further progress for the remainder of the year. Thank you so much.
This concludes today's call. Thank you all for joining. You may now disconnect your lines. Have a great day!