Earnings call transcript: Hansa Biopharma Q4 2024 misses EPS, stock drops

Hansa Biopharma reported its Q4 2024 earnings, revealing a larger-than-expected loss and lower-than-forecast revenue. The company posted an EPS of -4.08, significantly missing the forecast of -1.98, and reported revenue of 32.3 million SEK, falling short of the anticipated 70.59 million SEK. Following these results, Hansa Biopharma’s stock dropped by 19.57% in pre-market trading, reflecting investor disappointment. According to InvestingPro data, the company’s market capitalization now stands at $167.62 million, with the stock trading near its 52-week low of $2.37.

Key Takeaways

• Hansa Biopharma’s Q4 2024 EPS was -4.08, missing forecasts by over 100%.
• Revenue for the quarter was 32.3 million SEK, below expectations.
• The company’s stock fell by 19.57% in pre-market trading.
• Positive developments in clinical trials, including Phase II results for Guillain-Barre Syndrome.
• Continued expansion in European markets, with reimbursement secured in 18 countries.

Company Performance

Hansa Biopharma reported a 28% increase in total revenue for 2024, reaching 171.3 million SEK. Full-year product sales surged by 83% to 189.7 million SEK. Despite these gains, the company faced a full-year operating loss of 641.4 million SEK, marking a 19% improvement compared to the previous year. The company ended Q4 with cash and cash equivalents of 405 million SEK, bolstered by a direct share issue of approximately 372 million SEK completed in Q2.

Financial Highlights

• Total (EPA:TTEF) 2024 revenue: 171.3 million SEK, up 28% year-over-year.
• Q4 2024 revenue: 32.3 million SEK.
• Full-year product sales: 189.7 million SEK, an 83% increase.
• Operating loss for 2024: 641.4 million SEK, improved by 19% from the previous year.

Earnings vs. Forecast

Hansa Biopharma’s Q4 2024 EPS of -4.08 was significantly below the forecasted -1.98, representing a miss of over 100%. Revenue also fell short, coming in at 32.3 million SEK compared to the expected 70.59 million SEK. This substantial miss in both earnings and revenue contributed to the sharp decline in the company’s stock price.

Market Reaction

Following the earnings announcement, Hansa Biopharma’s stock price dropped by 19.57% in pre-market trading. The stock’s last close was at 33.62 SEK, and it fell to 27.04 SEK. This decline positions the stock closer to its 52-week low of 25.2 SEK, indicating significant investor concern over the earnings miss.

Outlook & Guidance

Looking forward, Hansa Biopharma anticipates continued strong growth in Europe throughout 2025. The company expects data readouts from its US kidney transplant trial and other clinical studies, including the anti-GBM and Sarepta (NASDAQ:SRPT) Duchenne muscular dystrophy trials, in the second half of 2025. Additionally, Hansa is planning a Phase 1b study in myasthenia gravis and foresees potential milestone payments from partnerships amounting to up to $400 million.

Executive Commentary

CEO Soren Turf Schoch emphasized the opportunities for growth, stating, "We are seeing large opportunities becoming available for sales this year." He also expressed optimism about the European market, noting, "We expect continued strong growth in Europe." Schoch highlighted the potential in the US market, describing it as "very material."

Risks and Challenges

• Volatility in organ allocation impacting sales consistency.
• Potential delays in clinical trial progress.
• Regulatory hurdles in new market entries.
• Competitive pressures in the desensitization treatment market.
• Economic uncertainties affecting healthcare funding.

Q&A

During the earnings call, analysts inquired about the variability in quarterly sales due to organ availability, highlighting the importance of a growing patient pipeline. The potential expansion into the US transplant market was also a key topic, with discussions on R&D expense expectations for 2025.

The earnings miss and subsequent stock drop underscore the challenges Hansa Biopharma faces in aligning its financial performance with market expectations. However, the company’s strategic initiatives and ongoing clinical trials present opportunities for future growth.

Full transcript - Hansa Biopharma AB (HNSA) Q4 2024:

Conference Operator: Good day, and welcome to the Hands of Biopharma Year End and Fourth Quarter twenty twenty four Report. All participants will be in listen only mode. Please note this event is being recorded. I would now like to turn the conference over to Soren Tohlstrup, President and CEO. Please go ahead.

Soren Turf Schoch, President and CEO, Hansa Biopharma: Thank you, operator. Good afternoon, good morning, and welcome to the Hensa Biopharma conference call to review the full year and Q4 results for 2024. I’m Son Turf Schoch, President and CEO of Hensa Biopharma. Joining me today is Evan Ballantine, Chief Financial Officer and Hesu Kaufmann, Chief R and D Officer. 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 and an overview of today’s agenda. Today, we’ll discuss the progress we made during the fourth quarter and review the full year 2024 performance. The presentation should take roughly fifteen to twenty minutes, after which there will be an opportunity to ask questions during a Q and A session. Please turn to Slide four and an overview of our Q4 and full year performance.

Let’s first begin with full year performance. Total revenue for 2024 was SEK220.9 million and full year item break sales totaled SEK189.7 million representing an 83 increase over the prior year. This performance excludes the impact of a provision of SEK49.6 million taken in 2024 to reflect discounts and a one time retroactive rebate linked to successful special early access programs since the launch of IDEXX in 2020. Including the impact of the provision, full year 2024 total revenue was SEK171.3 million representing a 28% increase versus prior year. Additionally, full year IDEXBRAKE sales including the impact of the provision totaled SEK140.1 million representing a 35% increase over the prior year.

The solid year over year IDEXBRAKE sales growth reflects continued strong launch execution in Europe, which has resulted in an increase in clinical utilization in key markets and continued advancement of regional and local clinical guidelines on the appropriate use of IDI4X in highly sensitized kidney transplant patients. We’re especially encouraged not just by the growing number of key clinics with specific IDePRIX protocols in place, but also the growing number of clinics with repeat IDePRIX usage following successful outcomes of first transplants and we see this as a key driver of expected future growth. Please turn to Slide five. I’d also like to highlight the trailing twelve month product sales data that shows performance over the previous year. This underscores the continued launch progress and growing market uptake without quarterly volatility due to variations in the flow of organ offers to specific highly sensitized patients waiting for an organ offer, the volatility we expect will continue albeit with diminishing effect over time as we expand the ongoing usage of IDePRIX and penetrate new markets throughout Europe and beyond.

Please turn to Slide six. 20 20 four saw much progress in our pipeline projects and we’re very pleased with the delivery of several key pipeline catalysts and advancement of scientific exchange. Of note, we announced positive results from our Phase II trial in GBS and results of an indirect treatment comparison to the International Guillain Barre Syndrome Outcome Study or IGUS demonstrating the potential of aminipidase, our first generation IgG cleaning molecule to address a significant unmet need in GBS. Additionally, we completed enrollment in our Phase three study in anti GBM and initiated a Phase two trial with our partner Genifin in Crichland Najjar Syndrome. This marked our second gene therapy trial to commence last year.

The first trial was a Phase 1b study with our partner SURECTA in Duchenne muscular dystrophy. This trial continues to enroll patients. 2024 also marks significant progress with HANSO5487, our next generation IgG cleaning enzyme with redosing potential. In October, we shared positive data from our twelve month analysis of the NYSE-one first in human study. This analysis demonstrated that HANSA5487 can robustly and rapidly reduce ITG levels as redosing potential and a favorable safety and tolerability profile.

Early in the year, we completed randomization of all patients in The U. S. Confided Phase three trial in kidney transplantation. The trial is on track for data readout in the second half of twenty twenty five, followed by the expected submission of a BLA to the U. S.

FDA under the accelerated approval pathway. Mitu will share more details in a few minutes about these trials and our clinical development plans. Before moving to the next slide, I’d like to highlight our successful efforts to communicate the benefits of nifidase in scientific publications and presentations at leading medical congresses around the world. Please turn to Slide seven for an overview of the commercialization of IDH Breaks in Europe. We continue to make solid commercial progress with IDH Breaks in Europe as a desensitization treatment and kidney transplantation.

Due to the continued success of launch efforts in the number of centers gaining clinical experience with IDIFRx continues to grow with three additional centers added in Q4 and more than half of all clinics utilizing IDIFRx more than once after a positive first clinical experience. Additionally, I’m pleased to share that following the team’s successful engagement with key opinion leaders in Europe and medical societies there, there are now two published international consensus documents providing guidance on desensitization in kidney transplantation. The most recent guidance was published in Transplant International providing specific guidelines on the appropriate use of amelipidase in clinical practice to enable kidney transplants in highly sensitized patients. Finally, thanks to our continued successful market access efforts, we recently secured reimbursement in three additional European markets. HandsOnNow has secured reimbursement in 18 markets, including the five largest European markets.

We recognize the innate volatility in organ transplantation market due to variations in the flow of organ offers, but are encouraged by the growing number of clinics that are ready to treat with IDAPhRx and the increase in urine repeat users, providing a solid foundation for expected continued growth and market uptake. I will now turn it over to Hisu for an update on the pipeline and clinical development. Please turn to Slide eight.

Hesu Kaufmann, Chief R&D Officer, Hansa Biopharma: Thank you, Theron. Please turn to Slide nine for an update on the pipeline and clinical development highlights to date. As you can see, we continue to make good progress across the pipeline in all three therapeutic areas. And in the fourth quarter, we shared several updates in both the autoimmune and gene therapy areas. I’ll now walk through some of the specific trials and studies we have ongoing and the clinical development plans we have in place.

Please move to Slide 10. Let me start with the left hand side of this slide and reiterate the continuous focus of Hampta on advancing science in areas where there remains high unmet medical need. I’m pleased to share that over the course of twenty twenty four, we have presented at several leading congresses in autoimmune, gene therapy and transplantation and published 10 articles in peer reviewed journals. These efforts underscore our commitment to advancing the understanding of potential applications for our molecules as well as the science behind complex conditions with very few treatment options. On the right hand of the slide, you can see a summary of the progress we have made in 2024, and specifically the clinical development of emlithidase and AMP5487.

In autoimmune, we communicated two key pieces of data in Q4. The first is the positive results of the 15H meditis nine Phase two study of omephedase, an indirect treatment analysis of that data to the International Green Barre Syndrome Outcome Study or IGOR in Green Bar Syndrome, also known as DBS. The second is the completed enrollment of GoodIDAS-two Phase III trial in anti GBM. The GoodIDAS-two 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. Anti GBM is a rare severe autoimmune condition affecting around one point six people per million annually. Encouraged by our Phase II data, we believe emlithidase has significant potential in improving the outcome of these patients and address the unmet medical needs. Emlicitas has been granted orphan drug designation for the treatment of anti GBM disease by both the U. S.

Food and Drug Administration and the European Medicines Agency. Q4 also marks the commencement of our second trial in gene therapy. In December, we announced the initiation of a trial with Genton, one of our gene therapy partners in Crigler Najjar Syndrome. The trial, ZMT018 IVY is a Phase II trial in patients with Crigler Major Syndrome with pre existing antibodies against adeno associated virus vectors or AAV. The trial will evaluate the efficacy and safety of single intravenous administration of Genitorm’s gene therapy, GNT003, following pretreatment with emliphidase.

Antibodies against ACE vectors remain a major challenge as their presence in patients excludes them from entering clinical studies with potential curative gene therapy treatment and from access to currently marketed and future gene therapies. Crichyland Lejeune syndrome is a rare genetic liver disease characterized by abnormally high levels of bilirubin in the blood, which leads to irreversible neurological damage manifested as muscle weakness, lethargy, deafness, intellectual disability and eye movement paralysis. At present, patients must undergo phototherapy for up to twelve hours a day to keep the bilirubin levels below the toxicity threshold. Crigler Najjar Syndrome is an ultra rare disease affecting less than one case per one million per year. GNT3003 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.

Of note, enrollment in SRP 9,000 and one-one hundred and four Phase 1b trial continues. As a reminder, the trial is evaluating the use of emlicipidase as a pretreatment to SURECTA therapeutics and Levitus gene therapy in Duchenne muscle dystrophy. In transplantation, we continue to progress enrollment of patients in the Postauthorization Efficacy and Safety Study, PAES,

: as part

Hesu Kaufmann, Chief R&D Officer, Hansa Biopharma: of our obligation to the European Medicines Agency. As mentioned, we are now at 96 enrollment rate with forty eight out of fifty patients enrolled. This study will support adoption of Ideherics more broadly and allow even more clinics to gain clinical experience. Once completed, centers are expected to commence or increase usage of commercial product. And the confided U.

S. Pivotal trial three in Phase III was fully randomized in May, and we plan to deliver data in the February ’25 followed by a BLA submission to the U. S. FDA. Moving to one hundred and fifty four eighty seven, our next generation IgG cleaving enzyme.

In October of twenty twenty four, we announced positive results of the NKTR-one first in human trial and findings from a twelve month analysis of that data. The analysis demonstrated that one hundred and fifty four eighty seven can robustly and very rapidly reduce IgG levels, has redosing potential and a favorable safety and tolerability profile. We believe HANZA-five thousand four hundred and eighty seven has a highly differentiated profile compared to published data from studies with other IgG targeted therapies. HANZA-five thousand four hundred and eighty seven has the potential to address significant unmet need across a spectrum of chronic autoimmune diseases, where IgG plays a role in disease pathology, including autoimmune conditions, and where the need for management of repeat acute immune system attacks is crucial. We will focus initial clinical development in neuro autoimmune diseases with a well characterized role of specific autoantibodies in disease pathology and recurring acute phases, specifically myasthenia gravis or MG.

A significant number of patients with chronic neurological autoimmune diseases face exacerbations and even severe crisis leading to hospitalization demonstrating the high unmet medical need today. In the first half of the 02/25, we plan to align with regulatory agencies on the clinical development path of HANDSS-five thousand four hundred and eighty seven in myasthenia and others. Please turn to Slide 11 for a summary of the data from 15H METIDIS study in GBS. I want to spend just a few minutes providing a bit more context on the Phase II study, the 15 H METIDIS nine and the indirect treatment comparison to IGOST. As a reminder, 15 HMET IDS09 is an open label, single arm, multicenter study across The UK, France and The Netherlands.

Patients with severe GBS included all patients with a disability score at and above three. The study evaluated safety, tolerability and efficacy of single dose amelicitase in combination with intravenous hemoglobin or IVIG in twenty seven adult GBS patients. Data from the study demonstrated that severe GBS patients treated with amifidase plus IVIG had rapid overall improvement in functional status, including expedited recovery of muscle strength, rapid return to independently walking and a median time to improve by at least one grade in the GBS study at six days. The key results from the study are one week after treatment, thirty seven percent of patients were able to independently walk and the median treatment in muscle strength was 10.7 points as assessed by Medical (TASE:PMCN) Research Council or MRC sum score. Additionally, the median time to independently walk for patients treated in the study was sixteen days.

Finally, at week eight, sixty seven percent of patients were able to walk independently, forty one percent of patients had regained the ability to run and thirty seven percent of patients had improved by at least three points in the GBS disability score. Finally, at six months, sixty three percent of patients were able to run or had no functional disability. Please turn to Slide 12. When compared to the IGOR’s real world comparative group, seven fifty four severe GBS patients treated with IVIg, patients in the 15 METITUS study, which included twenty seven severe GBS patients treated with emlithidate in combination with IVIg, experienced statistically significant improvements across several clinical meaningful measures. The indirect treatment comparison concluded that patients in the 15H METADIS nine study treated with amlutidate plus IVIG returned to independently walking six weeks sooner when compared to severe GBS patients in the IGOS reward comparator group treated with IVIg alone.

Additionally, patients in the 15 HVAD iosinone study experienced statistically significant improvement across several clinically meaningful measures at multiple time points. At week one, patients were 6.4 times more likely to walk independently compared to the IGOS real world comparator group. In GBS, IgG is a key driver of inflammatory attacks on peripheral nerve and has been clinically linked to the severity and progression of the disease. Rapid reduction of IgG levels has the potential to benefit GBS patients by depleting pathological IgG antibodies, thereby halting disease progression, resulting in faster recovery and less severe disease. Improvement in GBS disability score is important because it directly affects the clinical outcomes recovery and quality of the life for patients.

Better management of disease severity can help reduce the risk of life threatening complications, shorten recovery time, prevent long term disability, lower health care costs and improve overall patient well-being. We believe these results demonstrate the significant role in that emlithidase may play in the treatment of GBS in combination with the standard of care IVIg. Unlike other molecules, emlithidase can effectively and very rapidly cleave IgG, potentially halting the progression of MRF (NSE:MRF) damage associated with GBS and stopping the progression of the GBS. I will now turn it over to Evan to cover financial performance. Please turn

: to Hito. Could

Evan Ballantine, Chief Financial Officer, Hansa Biopharma: we advance one more slide? Thank you, Hito. Let’s walk through the company’s financial performance for Q4 and the full year. Revenue for the full year totaled SEK171.3 million, representing a 28% increase from the previous year of SEK134.1 million. Q4 revenue totaled SEK32.3 million, including IDIFRX product sales of SEK25.6 million.

Excluding the impact of the aforementioned provision, product sales for the full year were SEK189.7 million, representing an increase of 83% or SEK86 million compared to the prior year compared to the prior year product sales of SEK103.7 million. It is important to recognize that despite strong full year 2024 sales of IDIFRX, quarterly sales continue to fluctuate as a direct result of variations in the European kidney allocation systems. As mentioned in previous quarters, the company recorded a provision totaling SEK 49,600,000.0 to reflect discounts and a one time retroactive rebate on cumulative sales since the launch of Adiferrex in 2020. At this time, the company does not expect any further provisions will be necessary. Next (LON:NXT) slide please, 15.

SG and A expenses totaled approximately SEK88.5 million for Q4 and SEK343.8 million for the full year 2024. Full year SG and A expense was SEK106.7 million or 24% favorable compared to the prior year. Restructuring activities help reduce total year over year SG and A expense. And as previously mentioned, SG and A expenses included a restructuring reserve of approximately SEK3.5 million. For the full year 2024, SG and A expense included a SEK24 million non cash charge related to the company’s Long Term Incentive Programs or LTIP.

R and D expenses totaled approximately SEK101.4 million for Q4 and approximately SEK375.7 million for the full year. Full year R and D primarily driven by restructuring actions. Full year R and D expense included approximately SEK7.9 million of non cash charges related to the company’s LTIP program and a restructuring reserve of SEK6.6 million. For the full year, net financial income and expense resulted in total expense of approximately SEK166.3 million compared to SEK42.3 million in Q3 or in 2024 or 2023. In Q4, net financial income and expense represented an expense of approximately SE100 million in contrast to income of SEK51.3 million in Q4 of twenty twenty three.

Changes in financial income and expense are primarily driven by non cash expense related to the NovaQuest note and changes in the U. S. Dollar exchange rate against the Swedish krona. The full year operating loss of SEK641.4 million was SEK147.3 million or 19% favorable compared to the operating loss

: of

Evan Ballantine, Chief Financial Officer, Hansa Biopharma: SEK88.5 million in 2023. The Q4 operating loss of approximately SEK 173,600,000.0 was essentially flat compared to the prior year. The improvement in Hans’ operating loss compared to the prior year was driven by increased sales as well as an overall reduction in expense. Please turn to the next slide. Cash used in operations for Q4 totaled SEK148 million and SEK675 million for the full year ended 12/31/2020 or December 31.

As previously mentioned, the company completed the direct share issue of approximately SEK372 million or approximately US35 million dollars in the second quarter. In Q4, cash and cash equivalents totaled SEK405 million. I’d like to turn the presentation back to Soren. Please turn to Slide 17.

Soren Turf Schoch, President and CEO, Hansa Biopharma: Thank you, Evan. With this overview, our presentation has now concluded and we’d like to open the call for questions. Operator, please begin.

Conference Operator: We will begin the question and answer session. You. Our first question comes from Suzanne Van Hoeghien with Kempen. Please go ahead.

Suzanne Van Hoeghien, Analyst, Kempen: Hi, team. This is Suzanne from Kempen. Thanks for taking my questions. Could you elaborate a bit more on your planned regulatory interactions on the repeat dose candidates in MG? Like what type of meeting is it that you plan with the FDA?

And what should we expect in terms of an update on next steps for this program in the first half of this year? And in a similar fashion, you’ve had the Phase II comparison data for GBS. What are next steps for this program or when should we hear more on advancing the program into a Phase III? And then I have a follow-up as well.

Soren Turf Schoch, President and CEO, Hansa Biopharma: Well, thank you, Susan, for those two questions. So first on the planned interaction with regulatory agencies on the next step for 05/1987. As we have communicated, it is our intent to move into mycena gravis here. And so the plan for this interaction is to consult and get feedback on the proposed clinical trial design. And we said earlier during this call, we expect this interaction to happen in the coming months essentially.

I don’t know, Hissed, do you want to add anything to this?

Hesu Kaufmann, Chief R&D Officer, Hansa Biopharma: Sure. Thank you, sir. And just to add a little bit of flavor here, very specifically, we are planning for a Phase 1b study in patients and we have, as you can imagine, detailed protocol and we’ll discuss that we’ll have authorities, especially since in myasthenia gravis, it’s important to carefully consider the subpopulation of patients that we want to target in an early study. You could also safely assume that there will be some dose finding elements in there. However, we will only post conversation with health authorities detail out the study plan and that’s what you can expect at some point in time.

Suzanne Van Hoeghien, Analyst, Kempen: Got it. Thanks, Hesiod. And for GBS?

Soren Turf Schoch, President and CEO, Hansa Biopharma: Yes. And for GBS, again, Hesiod, do you want to take this? Sure. So

Hesu Kaufmann, Chief R&D Officer, Hansa Biopharma: our refined thinking on GBS is clear to commence with a Phase three study that would have a control arm that reflects the current either standard of care or practice of medicine, depending on which country you look at, which is essentially IVIg. So that’s what we’ve disclosed so far. And again, we are in continuous dialogue there as well.

Suzanne Van Hoeghien, Analyst, Kempen: Got it. Thank you. And maybe with regards to the Phase three readouts for The U. S. Kidney trial and the study in NTGBM in particular, what amount of data disclosure can we expect in the top line release?

Will this be primarily qualitative in nature of meeting the endpoint or not? Or will you also report the kidney function result itself and perhaps some more? Thank you.

Soren Turf Schoch, President and CEO, Hansa Biopharma: Well, thanks for that additional question, Susan. So we expect that the first readout essentially would be the overall conclusion right on primary endpoint. And I think these two trials have been very carefully designed to be able to make a conclusion on that. And then of course subsequently there will be more full disclosure of additional results.

Suzanne Van Hoeghien, Analyst, Kempen: All right. Thank you.

Soren Turf Schoch, President and CEO, Hansa Biopharma: Thanks, Hassan.

Conference Operator: And the next question comes from Alexander Kramer with ABG. Please go ahead.

: Yes. Good afternoon. I have two questions. Maybe to start with looking at the outlook into 2025, what are the key triggers that could drive an improved EU sales? Is it a finalization of the PEAS PEES study?

Is it the ureter transplant or cells or some other component, which I’m missing here? And then I have a second question.

Soren Turf Schoch, President and CEO, Hansa Biopharma: Well, thanks, Alexander, for that question. So we’re quite optimistic for 2025. We’ve seen solid growth in 2024. If we look at all of the indicators of a successful launch, I. E.

Number of clinics with protocols in place, number of clinics that have tried the product, number of clinics that have tried the product successfully and have used it in a second and third patient and so on. All of the lights there are on green. We are also expanding the footprint, the reimbursement footprint in Europe. Towards the end of the year, we got reimbursement at the national level in Spain and Italy, Two very important kidney transplant markets in Europe. It’s been translated from the national level to regional level in Italy.

I think we’re at north of 90% of regions and in Spain, we now have reimbursement in the second very important region. We got the first Catalonia very recently. That’s the most important region in Spain. And so we are seeing large opportunities becoming available for sales this year. So that’s certainly one part of it impacting our thinking around the growth opportunities in 2025.

Another is, as you mentioned, the completion of enrollment in the post approval efficacy study, we’re very, very close to having this fully involved, forty

: eight

Soren Turf Schoch, President and CEO, Hansa Biopharma: out of fifty patients have been enrolled. Obviously, these patients have kind of been cannibalizing sales in the past. And when the study is fully involved, we expect that these key centers that now have significant experience actually transplanting patients using IDIS rates to desensitize ahead of the transplant will be converted to commercial sales. And they have even lined up patients as part of participating in this trial. So that’s clearly also going to be a growth driver in 2025.

And then you mentioned the urethransplant program, which covers Germany, Benelux, Croatia, Hungary, Slovenia, a few other countries. And that is moving forward as well. So as that progresses and data becomes available throughout the participating clinics and they gain experience, we expect a positive impact also on transplants taking place outside of this specific program. So there’s really a number of reasons why we think 2025 is going to be another year with significant growth.

: Okay. Thank you. And second question on the Sarepta, maybe it’s a mistake, but in the report, I think you do not write anymore the initial data readout in 2025, but I think you had it on the slides. Could you elaborate a little bit like what are the bottlenecks with that trial? I mean, I know Assessarepta is running it, but maybe you could look shed a little bit more light on what this means in terms of like also the milestone payments and the collaboration revenue you expect from SACEURREPT into 2025.

Is this something that is going to increase compared to 2024 levels?

Soren Turf Schoch, President and CEO, Hansa Biopharma: So as you said, this study is being run by partner Sarepta. We have a very good collaboration with them and we are excited to see the trial progress. It’s still enrolling patients and so patients are being lined up and enrolled and we do expect data to be available this year. This is what Sarepta has also communicated in the public domain. So as I said, moving forward as planned, and we’re really excited about that.

We’re also very excited about the second clinical stage trial we have ongoing in the gene therapy space with our French partner, Jonathan, in Crickland Azhar, where we have started the trial and we have enrolled the first patient. This is a group of patients where there’s a very high proportion of them that have too high targets of neutralizing antibodies against the vector used in the gene therapy and therefore there’s a significant unmet medical need in a very serious disease to enable administration of hopefully successful gene therapy in these patients. So moving forward as well and we’re certainly hoping to get data this year as well in that disease and that will be then in different tissue than the SUREXA trial in Duchenne. In Duchenne, it’s muscle tissue. In Krigonajar, it’s liver tissue.

So ’25, we hope, is going to be very, very exciting and important year for our efforts in the gene therapy space.

: Great. And maybe just on the financial aspect of DASILARABDA, please.

Soren Turf Schoch, President and CEO, Hansa Biopharma: Yes. Well, there is a number of milestones, as you know, significant amount of milestones potentially ahead, right, up to just shy of $400,000,000 We have not communicated the specifics around timing and so on of these milestones, but obviously as the program progresses, this is becoming more near term.

: Okay, all right, great. Thank you very much.

Soren Turf Schoch, President and CEO, Hansa Biopharma: Thanks, Alexander.

Conference Operator: And the next question comes from Douglas Zhao with H. C. Wainwright. Please go ahead.

Douglas Zhao, Analyst, H.C. Wainwright: Hi. Can you hear me?

Soren Turf Schoch, President and CEO, Hansa Biopharma: Yes. Good morning, Doug.

Douglas Zhao, Analyst, H.C. Wainwright: Hey, good morning, Sohr. Just maybe just to start with the performance in the fourth quarter. Was there any particular markets that maybe were sort of came in below sort of your current expectations? I know there’s always some variability, but just were there any sort of specific markets in particular I’m thinking about France that may have been a little slower than had been the prior trend?

Soren Turf Schoch, President and CEO, Hansa Biopharma: I cannot offer that level of granularity. What I do want to say overall is as we’ve discussed and as you know very well, Doug, sales is volatile, right, whether a number of patients are transplanted this side of the quarter or the other side really depends on availability of organs and acceptance of organs and the value of one single transplant versus the total sales is significant and material, right? So I’m not surprised that we see a quarter that is not on a par with the previous quarter, which was our best quarter ever, right? So that’s what I can say. I would say on France, France really continues to be a growth driver.

We’re very, very encouraged by what we’ve seen in France. And again, France is the one major market in Europe where we’ve had access for a number of years through the early access program and it is a country where there was a little bit of experience early on that we’ve been able to leverage and spread throughout the country, right. So we’re looking really to emulate what has happened in France and some of the other key markets and certainly a promising one is Spain, which is really one of the most sophisticated kidney transplant markets in Europe. So we’re encouraged by what we’ve seen so far. I should mention that we’re also looking at some markets outside of Europe like Australia where we got approval with a label even including living donor situations.

That’s obviously a way to expand the market and be less exposed to the challenge of competing for available deceased donor organs. And so hopefully, we’re negotiating with the Australian authorities, but that’s a market where also right now there is actually material significant experience. I think it’s around eight patients that have been transplanted, quite a number of those living donor transplants. So we have good hopes there and clearly ahead of us are other very important markets, not just in Europe, Middle East, Asia, Latin America, but also importantly The U. S, of course.

Douglas Zhao, Analyst, H.C. Wainwright: And maybe as a follow-up question in terms of GBS, There has been some other clinical development activity by competitors. I’m just curious, does that influence in any way how you’re thinking about sort of moving into a pivotal study design? Thank you.

Soren Turf Schoch, President and CEO, Hansa Biopharma: Yes, you’re right. There has been recent clinical activities in that space. And actually, we’ve been encouraged by the attention that this has attracted. Clearly, there is a high unmet medical need for these patients. It’s a very serious disease.

It just hits you very, very suddenly. These patients are hospitalized in ICUs and it’s extremely important to have very fast, very rapid and significant impact on the disease. And so we are very encouraged by the data that we’ve been able to generate looking at also patients in the ICUS database and that kind of confirms our intent to move forward in this market. We have not changed our plans for, let’s say, the sign of Phase III trial or anything based on newly available data from other trials. We think this is a great way to demonstrate a benefit versus standard of care, which really in The U.

S. And in Europe is IVIG. So we think we have a really, really good starting point to generate the data that the market will value and will guide their prescription pattern.

Douglas Zhao, Analyst, H.C. Wainwright: Okay, great. Thank you so much.

Soren Turf Schoch, President and CEO, Hansa Biopharma: Thanks, Doug.

Conference Operator: And the next question comes from Eric Young with William Blair. Please go ahead.

Eric Young, Analyst, William Blair: Hi. This is Eric on for Matt Phipps. Thanks for taking the question. Just two questions. So first, after the seasonality impact in the fourth quarter, can you comment on all about how the transplant rates have started in the 2025 year?

And secondly, can you characterize or provide any additional granularity on how much benefit completing the post authorization efficacy study will provide to revenue in Europe in 2025?

Soren Turf Schoch, President and CEO, Hansa Biopharma: Thanks Eric for those two questions. So as far as seasonality is concerned, I think it’s too early to say that there is specific seasonality here. Like I explained, we have expected from the start that there will be significant volatility quarter on quarter just depending on the organ offer flow and whether specific organs are accepted by specific clinics for specific patients. And I’m not going to comment on how this year started and so on other than saying that clearly we expect for the reasons that I discussed just before, we expect continued strong growth in Europe. Then you asked about the benefits, specific benefits of the post approval efficacy study.

And really of course there are two benefits, well three, I should say. First, as I discussed earlier, the fact that all patients soon will be enrolled means that there will be no cannibalization going forward, right? We have shown about fifty patients that have been transplanted in this trial, in parallel with us actually marketing commercial products in the same region. And so that effect is going to stop. Then you will have centers that will be ready to use commercial products and who will have actual experience and even protocols in place in these clinics.

So that’s going to be helpful as well. And then of course, we are looking forward of course to getting the data. We believe that the data will reinforce the, let’s say, the positive position of IDAPhRx in the market. We have generated now quite some data also commercially transplanted patients or data has been generated in various markets and that has been reflected also in guidelines and so on, we believe that additional data obviously will be helpful. And of course, in the end, we’re looking to get full approval in Europe based on the totality of data generated also from this post approval study.

: Got it. Thank you.

Hesu Kaufmann, Chief R&D Officer, Hansa Biopharma: Thanks, Eric.

Conference Operator: And the next question comes from Johan Amaram with Redeye. Please go ahead.

: Thank you for taking a question. You want to hear us? Yes. First, moving into then 2025, what about the ability to see patients that are about both, call it, pipeline of patients, patients being ready at centers, what’s your level of visibility as you move into 2025?

Soren Turf Schoch, President and CEO, Hansa Biopharma: Yes, great question. So what we’ve seen over the past twelve to eighteen months is actually an increase in the pipeline of patients, right? They’re being identified by the centers and and by specific programs like the uro transplant program, which screens a large number of patients and then identify quite a number and so on. So there is a growing pipeline of patients and that again confirms the unmet medical need and also the desire by the clinics and the medical community to actually do something. Clearly, what you also want to see at some point is that patients start to become active, right, because there is a competition for available deceased donor organs, But typically, again, through my experience with previous launches, that is going to come at some point.

There is increasing awareness of the fact that some patients really don’t have access to lifesaving kidney transplants. And I don’t think that that’s going to be accepted for many years into the future. So we’re also looking for patient growth at some point.

: Thanks. That’s very useful. And related to that, of course, that you’re not in the position or nobody is to promote off label use, but perhaps there is sense or if you notice that there are centers keeping very strict to the label or is it are some considering using your products also for less extremely sensitized patients?

Soren Turf Schoch, President and CEO, Hansa Biopharma: Well, I mean, let’s say the rules, the guidelines, instructions for what patients qualify and what patients don’t qualify vary from country to country and sometimes from center to center, right? But in general, of course, it’s on label in the sense that they’re transplanting highly sensitized patients that are unlikely to be transplanted given local organ allocation system. So that’s the overall judgment that’s been used by the centers and other decision makers here.

: Interesting. And finally then on the COMPASS studio study, is it possible to give a sense of how many new centers that has not been that are naive to ID3 earlier that it will sort of be added towards the network with the prior study?

Soren Turf Schoch, President and CEO, Hansa Biopharma: And

: also the same question for the uro transplant program?

Soren Turf Schoch, President and CEO, Hansa Biopharma: Well, I mean, of course, from the start, all of the centers have been more or less naive, right? We had a limited number of centers involved in Phase II trials and therefore the COMFIDUS trial is important not just in generating data, but also in generating experience in what are the really the key centers for kidney transplantation in The U. S. And as you know, we have involved a large number north of 20 centers here. And so the situation in The U.

S. Is going to be very, very unlike the situation in Europe in that we’re going to have at least 10 times as many key clinics with experience at the time of launch. And we’ve seen in France what that means, right? So we’ve essentially done the most perfect premarketing job you can do, namely run this Phase III trial against The U. S.

Kidney allocation system. So the centers have also learned how to operate within that system. So we’re really encouraged by the progress there, the engagement by the trial sites and also broadly in The U. S. We’ve been in contact of course with HERSA and other key stakeholders and decision makers in this space.

The current administration is also very, I wouldn’t say optimistic, but they’re really pushing for an improvement in the transplant rate when they were lost in power. They set a target of doubling the transplant rate in The U. S. And I’ve heard numbers as high as north of sixty thousand transplants. Now there are twenty thousand something.

So that’s really good tailwind as well. So we think that there are a lot of indicators showing that The U. S. Opportunity (SO:FTCE11B) is very, very material and that we’re able to we will be able to explore and exploit that much faster than what has happened in Europe.

: Excellent. That’s very useful. I think about Europe and the uro transplant program, that program is also adding centers presumably and also the confirmatory study in Europe?

Soren Turf Schoch, President and CEO, Hansa Biopharma: Yes, absolutely. So again, the uro transplant study is obviously a, let’s say, regulated plant way of generating experience in these particular patients in Europe in participating countries. And so that’s also great. And then the post approval efficacy study clearly involves centers also that from the start didn’t have experience and now they have experience and even protocols in place, as I said. So that’s important.

I mean, take a country like Netherlands, for instance, which has a number of centers participating. It’s going to be very important for that country that now this study is fully involved soon and of course with hopefully supporting data.

: Excellent. Is it possible to ask questions regarding OpEx and especially R and D?

Soren Turf Schoch, President and CEO, Hansa Biopharma: Yes, you can have one last question Johan. You too.

: Thank you. Yes, R and D side, it was a step up in Q4. What sort of level of trending should we expect moving into 2025 is Q4 level we should be familiar with or is this a bit on the high side?

Soren Turf Schoch, President and CEO, Hansa Biopharma: I’ll turn it over to

Evan Ballantine, Chief Financial Officer, Hansa Biopharma: Yes, Evan here. I think it’s a bit on the high side right now, but look, the CONFIDUS trial in The U. S. Is winding down. As Heatho discussed, he’s meeting with the FDA and regulatory bodies in Europe and The U.

S. To launch trials, additional trials for 05/1987. So my expectation is that in the latter half of the year, we’ll see R and D expense go up as we enter those clinical trials, but come down as we complete the PAES trial, which as Soren mentioned is almost fully enrolled and as we complete the CONFIDUS U. S. Phase III trial.

: So it sounds like we should expect a bit lower in the first half and then perhaps trending upwards afterwards.

Evan Ballantine, Chief Financial Officer, Hansa Biopharma: Yes.

: Excellent. Thank you.

Conference Operator: This concludes our question and answer session. I would like to turn the conference back over to Soren Solstrapp for any closing remarks.

Soren Turf Schoch, President and CEO, Hansa Biopharma: Well, thank you, operator, and thank you everyone who called in. We appreciate your interest in Hansa. We’ve got an exciting year ahead of us and look forward to keeping you updated. Thank you.

Conference Operator: The conference is now concluded. Thank you for attending today’s presentation. You may now disconnect.

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