Good day, and welcome to the Hansa Biopharma second quarter earnings conference call. All participants will be in listen-only mode. Should you need assistance, please signal a conference specialist by pressing the Star key followed by zero. After today's presentation, there will be an opportunity to ask questions. To ask a question, you may press Star then one on your telephone keypad, and to withdraw your question, please press Star then two. Please note today's event is being recorded. I would now like to turn the conference over to Renée Aguiar-Lucander, Chief Executive Officer. Please go ahead.
Thank you. Good afternoon and good morning, everyone, and welcome to the Hansa Biopharma conference call to review Q2 and half-year results for 2025. I'm Renée Aguiar-Lucander, CEO for Hansa Biopharma, and joining me today is Evan Ballantyne, Chief Financial Officer, Hitto Kaufmann, Chief Scientific and Technology Officer, and Maria Törnsén, Chief Operating Officer and President of the US. Please turn to slide two. Please allow me to draw your attention to the fact that we will be making forward-looking statements during this presentation, and you should therefore apply appropriate caution. Please turn to slide three. Today we'll discuss the progress we've made in the first half of 2025 and review the quarterly performance. I'll also share my reflections and insights based on my first few months in the role.
The presentation should take roughly 15- 20 minutes, after which there'll be an opportunity to ask questions during a Q&A session. If you can please turn to slide four for the significant achievements in the first half. In the first half of 2025, the company achieved several notable achievements. Of note, in Q2, we stabilized the business through a directed share issue and the restructuring of existing debts held by NovaQuest. Together, these actions ensure a cash runway into Q2 2026 and the opportunity to read out the two Phase III trials, the CONFIDUS US trial in kidney transplantation and the GUIDUS-09 trial in anti-GBM, both scheduled for readout later this year. Additionally, we further bolstered the executive leadership team with the addition of Maria Törnsén, COO and President of the US, and Dr. Richard Philipson, Chief Medical Officer, who just joined us this week.
In Q2, the company significantly increased sales revenues as compared to the previous year. We continue to see an increase in transplant clinics with initial and repeat usage of Idefirix, and we're encouraged about the number of regional and local clinical consensus on the appropriate use of Idefirix as desensitization treatment for highly sensitized patients. Additionally, in the first half of the year, we completed enrollment of the Phase III post-authorization efficacy and safety, or PAES, study in kidney transplantation. We expect the data readout for that trial to occur in the middle of 2026. The 15HNSA-09 Phase II study in Guillain-Barré syndrome delivered positive results for amyloid phase. This study was presented at a leading medical congress in Q2, and we look forward to following up with publishing the data during 2026. Please turn to page five.
As mentioned, the company posted solid financial performance in the first half of the year. Idefirix sales revenues for Q2 were SEK 47.9 million, representing a 76% increase when compared to Q2 2024. Idefirix sales revenue for the first half of 2025 amounted to SEK 113.5 million, representing a 52% increase in Idefirix sales revenues as compared to the same period last year, and around 80% of full-year product sales in 2024. As a consequence, the company's total revenue in the first half of 2025 represents a 27% increase as compared to the first half of 2024. It is important to note that full-year 2024 Idefirix product sales were SEK 140 million, and we believe, despite continued market volatility and quarterly variability, that we're well positioned to significantly exceed this in 2025. Please turn to slide six. As mentioned, there were two key financial catalysts for the company in Q2.
The first was a successful capital raise of SEK 232 million to support key data readouts in the second half of 2025, including CONFIDUS in kidney transplantation and GUIDUS-02 in anti-GBM. Additionally, the company restructured the existing debt agreement with NovaQuest. The original agreement, which was set in July of 2022, has been amended to offset $14.8 million of outstanding debt to new shares or equity for NovaQuest. The remaining debt will be paid in fixed cash payments in June 2027, 2028, and in 2029. A true-up payment of $14.9 million is also due, either in cash or in equity, at the discretion of Hansa Biopharma in January 2026. Please turn to slide seven for a brief overview of operational and strategic progress.
Today, it's been almost three months since I joined Hansa Biopharma, and during this time, I focused on reducing the annual burn rate to ensure a sustainable operating base for the company and also worked to simplify and clarify reporting lines to enhance transparency, accountability, and speed of decision-making. I can now report that the restructuring process has been completed, and we expect that annual savings will exceed the previous estimates to amount to approximately SEK 60 million on an annual basis. We're obviously sad to see many extremely experienced colleagues leave us at this juncture, but the challenging and extremely volatile macro environment has, as you know, resulted in biotech companies taking a hard look at their cost basis, and we've taken that responsibility very seriously, as reflected by the rapid action.
In conjunction with these actions, however, we will invest in systems and processes, market research and analytics to support productivity and efficacy across operational activities, as well as select key U.S. market-related competencies and expertise to support our pre-commercial activities in the U.S. At this stage, I'm very happy with where the organization stands with regards to complementary expertise we've been able to attract and add to the highly experienced staff, which Hansa Biopharma already has in place. I believe that we will, at the end of the year, have an extremely strong, experienced, and aligned team to execute on our strategic goals. On this basis, we look forward to the upcoming catalyst in the second half of 2025, which I believe will put the organization in a position to truly leverage these strategic initiatives.
I'd now like to turn it over to Maria Törnsén, who joined the company in Q2 as Chief Operating Officer and President of the U.S.
Thank you very much, Renée. I am very excited to join Hansa Biopharma at an important time for the company. I've spent the last several weeks assessing our priorities and current preparation for several key milestones in the second half of the year. In a few minutes, I'll talk about the opportunities we have in the market. First, I'd like to provide an update on the current European commercialization of Idefirix. Please turn to slide nine. In Q2 2025, we saw an increase in the overall number of centers using Idefirix. You may recall that last quarter, the PAES trial completed enrollment, and following this, 65% of these participating trial centers have now transitioned to commercial utilization. This affirms the fact that having both clinical experience and protocols in place to treat these highly sensitized kidney transplant patients is key to Idefirix utilization.
We also continue to see an increase in the total number of centers with repeat utilization. 60% of centers have had more than one positive clinical experience with Idefirix. This is good news, as it ensures that even more highly sensitized kidney transplant patients are gaining access to Idefirix and receiving a life-changing organ transplant. As mentioned in previous quarterly reports, the access to organs continues to fluctuate based on country and regional organ allocation system. Earlier in the year, Germany decided to pause the Eurotransplant prioritization program for highly sensitized kidney transplant patients. This is a program which is active in seven other European countries, and while German physicians can use Idefirix through the standard allocation system, this lack of this prioritized program impacted Q2 revenues from Germany. We expect this to continue to have a negative impact over the near term.
However, we are working with clinical, patient, and public health communities to understand the potential impact on commercialization in Germany over the longer- term. Earlier in the quarter, additional consensus guidelines were published in the journal Transplant. This consensus from Belgium marks the ninth country with guidelines supporting the use of Idefirix as a desensitization strategy and reinforcing its potential to be the standard of care in kidney transplantation for highly sensitized patients. Finally, in Q2, we secured access in two additional markets: Australia and Switzerland. Idefirix is now reimbursed in a total of 20 countries, including the five largest European markets. Please turn to slide 10. I thought it was worth sharing the learnings from the European market and how the progress we have made here is helping us prioritize activities as we plan for entry into the U.S. market.
As you may recall, there are 170,000 people on the kidney transplant waitlist in Europe and in the U.S. Of that, approximately 25,000 have a CPRA above 98% and are considered highly sensitized, and more than 5,000 have a CPRA over 99.9%. Without national prioritization programs and access to a desensitizing treatment, these highly sensitized patients have a very low chance to receive a kidney transplant. Idefirix therefore represents a significant opportunity to transform kidney transplantation. Through commercialization of Idefirix in Europe, we have gained several important learnings, which will help us as we prepare to enter the U.S. market. Organ allocation systems can be complex and vary between countries, and having local guidelines and centers that are clinically ready to use Idefirix is critical for success. However, we need to remember that we will enter the U.S.
market with access to significantly more clinical data and experience compared to when we launched in Europe a few years ago. In addition to engaging with clinicians, we also need to establish an account approach to commercialization to ensure that the multidisciplinary team is educated on desensitization and treatment guidelines. We will also focus on establishing a strong market access team to build relationships with the payer community and secure access for patients. Additionally, we are engaging with patient advocacy groups and policymakers to elevate the discussion on the unmet needs and changing the standard of care for highly sensitized patients.
We are very excited and positive with regards to a potential launch into the U.S. market, assuming approval, as we will have substantial multicenter clinical data from the Phase III study in the U.S., several high-volume, high-quality transplant centers, as well as the readout of the PAES study from Europe in mid-2026 involving 50 patients. In addition to these substantial data sets, there is also significant real-world data from Europe, which we believe will be supportive for adoption of this groundbreaking and innovative approach. I will now turn it over to Hitto to cover off on the progress we have made with the pipeline.
Thank you, Maria. Please turn to slide 12 for an overview of the pipeline. As you can see, we have eight programs in various phases in both desensitization and autoimmune disease. In desensitization, I'll start with gene therapy. In collaboration with Genethon, we continue to enroll patients in the GNT-018 imlifidase Phase II program, evaluating imlifidase as a pretreatment to Genethon's gene therapy GNT-003 in clinical laboratories. GNT-003 is currently being evaluated in a pivotal clinical study in France, Italy, and the Netherlands, and has received PRIME status from the European Medicines Agency. We look forward to reporting out on top-line data later this year. Additionally, we continue to progress with the Sarepta Therapeutics Phase IB trial in Duchenne muscular dystrophy, evaluating the effectiveness of imlifidase as a pretreatment to Sarepta Therapeutics gene therapy. Again, we look forward to sharing initial data later this year.
In May, data from the 15H-MEK imlifidase S-09 Phase II study of imlifidase in Guillain-Barré syndrome, also known as GBS, were presented at the Peripheral Nerve Society annual meeting in Glasgow. This was followed by a deep dive discussion we hosted with key opinion leaders Dr. David Cornblath from Johns Hopkins University and Simon Rinaldi, MRCP PhD, University of Oxford, and we look forward to publishing the data later this year. Please turn to slide 13 for a summary of the CONFIDUS Phase III pivotal trial in kidney transplantation. As Maria mentioned, there is significant unmet medical need when it comes to highly sensitized kidney transplant patients. The CONFIDUS U.S. pivotal Phase III trial was fully randomized in May 2024.
There are 23 participating centers in the trial, which is an open-label, controlled, randomized trial evaluating kidney function in 64 highly sensitized, CPRA 99.9% and above kidney transplant patients with positive cross-match against a deceased donor, comparing desensitization using imlifidase with standard of care. The primary endpoint of the trial is kidney graft function at 12 months, measured by estimated glomerular filtration rate, called eGFR. The total trial duration is five years, including a long-term follow-up as agreed with the U.S. FDA as part of the accelerated approval pathway. We look forward to sharing top-line data from the CONFIDUS trial later this year, followed by a BLA submission to the U.S. FDA. Please turn to slide 14 for a look at the GUIDUS-02 study in anti-GBM. We anticipate that we will have data from the GUIDUS-02 Phase III trial in anti-GBM later this year.
As a reminder, the GUIDUS-02 trial is a Phase III open-label, controlled, randomized multicenter trial across Europe and the U.S. and is evaluating renal function and the need for dialysis at six months in patients with severe anti-GBM disease. Encouraged by our Phase II data, which showed that 10 out of 15 patients were dialysis-independent after six months versus the historic cohort where only 18% were dialysis-independent at this point in time. These results were published in JAMA in 2022, and we believe imlifidase has significant potential in improving the outcome of these patients and address the unmet medical need. Imlifidase has been granted orphan drug designation for the treatment of anti-GBM disease by both the US Food and Drug Administration and the European Medicines Agency. I'd like to now turn over to Evan to cover financial performance.
Thank you very much, Hitto. Total revenues for Q2 2025 were SEK 49.1 million, representing a 43% increase compared to Q2 2024 of SEK 34.3 million. Idefirix product sales for Q2 2025 were SEK 48 million, representing a 76% increase compared to Q2 2024. Product sales for the first half of 2025 totaled SEK 113.5 million, representing a 52% increase compared to the same period a year ago. As Renée mentioned, we continue to see fluctuation in our performance quarter over quarter. However, it should be noted that year-over-year performance continues to increase. Quarterly volatility represents the unpredictability of the organ allocation market. We expect this fluctuation to diminish over time, having recently completed a post-authorization efficacy study and as Hansa Biopharma continues to enter new markets. Next slide. For Q2 2025, SG&A expense totaled approximately SEK 90.5 million, which was 2.6% unfavorable compared to Q2 2024.
SG&A expenses in Q2 2025 included a SEK 21 million reserve to reflect restructuring actions taken by the company in late Q2 to reduce costs and improve operating efficiency. Excluding the impact of the restructuring charge, Hansa Biopharma's SG&A expenses would have been 20% favorable compared to the same period a year ago. R&D expenses in Q2 2025 totaled approximately SEK 95.8 million and were 4.4% unfavorable compared to Q2 2024 expense of SEK 91.7 million. R&D expenses in Q2 2025 also included a restructuring charge. Excluding the impact of the restructuring charge, R&D expenses in Q2 2025 were essentially flat compared to the same period a year ago. In Q2 2025, financial income and expense net represents a charge of approximately SEK 23.3 million compared to a SEK 20.5 million charge in Q2 2024.
Changes in financial income and expense compared to the same period a year ago were primarily driven by favorable changes in the U.S. dollar exchange rate against the Swedish krona, non-cash interest expense related to the NovaQuest note, and a SEK 59.4 million charge taken by the company to reflect the NovaQuest loan restructuring modification. In Q2 2025, the company's operating loss was SEK 154.8 million, or 17% favorable compared to Q2 2024, of SEK 187.4 million. For the first half of 2025, Hansa Biopharma's operating loss was 28% favorable compared to the same period a year ago. On a year-to-date basis, Hansa Biopharma's cost of sales was approximately SEK 20 million favorable compared to the first half of 2024. The company's gross margin in the first half of 2025 was 66% compared to 35% in 2024.
The improvement in Hansa's Q2 and year-to-date operating loss was driven by increased sales, a substantial improvement in the company's gross margin associated with a lower cost of goods sold, and a reduction in expenses across all departments, a very positive trend. Next slide 18. Cash used in operations in Q2 2025 totaled SEK 111.7 million, an improvement of SEK 77.5 million compared to the same period a year ago. For the period ended June 30, 2025, cash and cash equivalents totaled SEK 354.4 million. With the recent capital raise and debt restructuring, the company has extended its cash runway into early Q2 2026. I would like to turn the presentation back to Renée for closing marks and for the Q&A portion of the call. Renée.
Thank you, Evan. With this overview, our presentation is now concluded, and we'd be happy to open it up for any questions. Operator?
Yes, ma'am. If you'd like to ask a question, please press star then one on your telephone keypad. If your question has already been addressed and you'd like to remove yourself from queue, please press star then two. Today's first question comes from Sushila Hernandez with Van Lanschot Kempen. Please go ahead.
Yes, thank you for taking our questions from our side. On the Eurotransplant desensitization program that was closed in Germany, are you expecting an update from the other European countries where it's still active? Do you anticipate it closing in these countries? A second question on your Sarepta Therapeutics partnership. Yesterday, Sarepta Therapeutics announced restructuring and strategic changes. With this current sequence of events, how does Sarepta Therapeutics look at your partnership, and what kind of data can we expect this half of the year? Thank you.
Thank you. No, we're not expecting this to be the case in other countries or regions. We have had no information, data, or any signs of that being the case. I do think that historically as well, I think Germany has had quite a conservative approach generally to transplantation, but we have no reason to believe that this is going to be the case. With regards to Sarepta Therapeutics, yes, you are correct indeed. There was a very interesting release, obviously, from them yesterday. I guess in terms of any potential impact on our program with them, my point of view is that obviously, if anything, this would probably mean that Sarepta Therapeutics is going to be even more interested, I think, and really want to try to reach all patients on label with their commercial drug.
I don't see that the restructuring or any other actions that Sarepta Therapeutics is taking would have any negative impact on our program at all. Quite the opposite. Obviously, there is the outstanding question of limb girdle, which also is covered by our contract with Sarepta Therapeutics, and with that, I don't have any particular updates on that from Sarepta Therapeutics as of yet. With regards to the vast majority, here is with regards to the DMD program, and as I said, from our perspective, I think that this really should make it even more interesting and exciting for both of us to continue with that program. I'll hear if you have any additional comments on that.
Thanks, Renée. I would just add, because you also asked about the sort of what type of data are we generating in the study that's currently ongoing. What Sarepta and Hansa would like to demonstrate is that through a conditioning treatment with imlifidase, we can bring down the anti-AAV antibody levels and enable virus transduction, and that's how the study is designed. Ultimately, we demonstrate that the transcript is expressed in the relevant tissue, and that's the type of data we expect to have this year.
Okay, thank you so much.
Thank you. Our next question today comes from Matthew Phipps at William Blair & Company L.L.C. Please go ahead.
Hi, thanks for taking my call. A question on the call. Do you guys have a sense of what you will be able to disclose in the top-line release from the CONFIDUS trial? Just wondering if it'll be purely qualitative or maybe get some of the numerical eGFR data. It seems like there have not been any comments on HNSA-5487. Just wondering if any of the plans for that program have changed. Thank you.
Sure. I'll briefly cover the HNSA-5487, and then Hitto, I will hand over to you for the CONFIDUS top line. In terms of the HNSA-5487, that is something where you can squarely blame me for that not being an update. Actually, what we are doing since I've been here for a fairly short period of time, I do want to kind of go through in some detail in terms of what the best kind of positioning and indication, et cetera, is for HNSA-5487. We are in the midst of an internal review of that, really involves all aspects, the market aspect as well as the profile of the drug. We are making a fairly significant internal assessment and review to make sure that whatever clinical plans we then present with regards to HNSA-5487 are well anchored and aligned within the entire organization.
We will be sharing that probably, my guess is that we'll probably share that publicly in Q4 would be my best guess at this point in time. Hitto, please.
Thanks, Renée. We have not yet shared in detail what we will disclose as part of the top-line results, but the clear focus is, A, on the primary endpoint, which is eGFR measured 12 months post-transplant. That will, of course, be something that we will have done some statistical analysis to see whether we have reached that primary endpoint with a statistical significance. The other thing we obviously will be looking at very early on is any safety signals, and that's roughly what you could expect for a top-line result.
All right, thank you. As a reminder, ladies and gentlemen, if you'd like to ask a question, please press star then one at this time. Our next question today comes from Douglas Tsao with H.C. Wainwright . Please go ahead.
Hi, good morning. Thanks for taking the questions. Renée, to confirm on HNSA-5487, it sounds like the prior guidance in terms of positioning or pursuit of indications is kind of on pause and that you're going to just reconsider whether things like MG are necessarily the right indication for the sort of initial clinical work. As a follow-up, I'm just curious, in terms of Germany and Eurotransplant, do you have a sense of what the catalyst was for them to stop the program? Thank you.
Thanks. I will hand over to Maria for the background on the kind of German decision. Yes, you are correct. I do think that it is, particularly in these times that we live in, I do want to make absolutely sure that when we make a decision to spend significant dollars in any kind of clinical research program, we have an extremely clear view on how we can possibly accelerate that as much as possible, how we can target that market and truly be a dominant player in that market. I think we really need to make sure that we've done the homework in order to ensure that the indications that we will choose are the right ones. Obviously, in this case, it's a good problem to have, but I think this enzyme can actually be used in quite a variety of ways and indications.
I think it's a little bit of just making sure that we have assessed all of those different options and that when we do come out, we are very clear on the rationale for the positioning of HNSA-5487. That is correct. Maria, I will hand over to you with regards to Germany.
Sure, and thank you for the question. Within the Eurotransplant zone, there are several countries that collaborate on organ allocation and guidelines and things like that. There are two programs. There's a general allocation program, and there's a program for the highly sensitized patients, which has been in place for a couple of years. In Germany, that is the highly sensitized program that has been paused for the moment. I would like to say that this has nothing, first of all, this has nothing to do with the belief in Idefirix as a product.
What it has to do with is, I think, a couple of things. If you look historically, Germany has had an organ transplant scandal many years ago, and there's a general hesitancy in terms of how to transplant organs in Germany. That's the situation that has been the case in Germany for many years. When it comes to these highly sensitized patients, they end up in this priority program for specific reasons. Let's say they've had a previous transplant, they have been pregnant, they've had a blood transfusion, so you know the reason why they're highly sensitized. In Germany, what they have really been discussing is this health equity, that certain patients end up in this program.
That is the reason for the pause, is that they are really evaluating how do you ensure that, you know, you treat everybody the same and it's, you know, health equity and equal care for all patients that may be in need of a transplant. It has nothing to do with the belief in Idefirix. You know, we have physicians in Germany that have used Idefirix in transplants and have had great success, you know. There is a strong belief among the German physicians in the product itself. It only has to do with the health equity part of it.
Okay, great, that's helpful. I guess, Maria, just as a follow-up, in terms of those physicians who do believe strongly in it, but then sort of counterbalance with the sort of health equity issues, it sounds like this is, to some extent, a little bit more of a political issue than a clinical issue. How does that necessarily, over the long- term, impact the commercial opportunity in Germany? Let's use a quick follow-up also, in terms of the restructuring that you took and the cost savings, is there any impact in terms of the size of the European Commercial Organization? Thank you.
I'll follow up on that Eurotransplant question. You are correct that, like the physicians in Germany, they believe in the product. We have had successful transplantations in Germany for several years, and they can continue to transplant through that general allocation system in Germany. We saw an impact in Q2, as we disclosed. We are expecting that it's going to have a near-term impact as we work through this by obviously speaking to German physicians and other policymakers and other stakeholders in Germany to see what is the best path forward. At this point in time, we've said that in the near term, we expect that this will continue to have an impact in Germany, but obviously, we are looking at the long-term effect. We are evaluating that, and at this point in time, that's nothing that I can comment on because we are in discussions at the moment.
Renée, do you want to take the restructuring question or?
Sure. With regards to the restructuring, in terms of the impact on the European Commercial kind of group organization, there was virtually very, very limited or hardly any, I would say, impact on the European organization. It was very limited. There was some, but it was very limited in terms of the impact on the commercial organization.
Okay, great, thanks for all the answers.
Thank you. This concludes our question- and answer session. I'd like to turn the conference back over to the company for any closing remarks.
Thank you very much to everybody who's listened in to this Q2 report, and we look forward to a very exciting rest of the year here at Hansa Biopharma. Thank you.
Thank you. This concludes today's conference call. We thank you all for attending today's presentation. You may now disconnect your lines and have a wonderful day.