Welcome to Oncopeptides year-end earnings call for 2025. For the first part of the conference call, the participants will be in listen-only mode. During the questions and answers session, participants are able to ask questions by dialing pound key five on their telephone keypad. Now, I will hand the conference over to CEO Sofia Heigis and CFO Henrik Bergentoft. Please go ahead.
Hello, everyone, and welcome to the presentation of Oncopeptides year-end report for 2025. My name is Sofia Heigis, and I'm the CEO of the company. Before we begin, I would like to direct your attention to our standard disclaimer regarding forward-looking statements. I am joined by our CFO, Henrik Bergentoft, and today we will review a highly transformative year for the company and outline a 2026 that brings exciting potential. Let's look at where we stand today. As we have already communicated, we delivered strong commercial progress in 2025, with full year net sales more than doubling to SEK 71.1 million, representing a 125% increase compared to 2024. For the fourth quarter, net sales reached SEK 18.6 million, an 88% increase compared to the same period in 2024.
We have today also announced a rights issue of up to 200 million SEK, allowing us to invest in the first step to expand our PDC platform into the high unmet need of glioblastoma patients. An opportunity that comes with the potential to unlock significant value for both patients and Oncopeptides in the future. The rights issue will furthermore bridge our commercial operations towards our goal of positive cash flow in 2027. Henrik will discuss this in more detail shortly. The fourth quarter was shaped by a diverse performance in our key markets. The demand for Pepaxto in Italy exceeded our expectations. Our positive growth trajectory during the first half on European level was, however, muted during the second half of the year by a slower than expected growth in Germany and a medical doctor strike in Spain during Q4.
Looking at events post-period, we have completed a strategic review of our German as well as R&D operations, to sharpen our focus and optimize our business model. As many of the facts and figures for the fourth quarter has already been communicated, I will spend much of this presentation focused on our pipeline and the exciting opportunities that comes with the potential to completely transform Oncopeptides. Before that, I will hand over to Henrik to provide a closer look at our financials and the rationale behind today's capital raise.
Good morning, and thank you all for joining today's call. Let me begin with the rights issue announced today. Based on the mandate received from the AGM in 2025, the board has decided to launch a rights issue of SEK 200 million, of which SEK 190 million is guaranteed through underwriting and subscription commitments. Our main shareholder, HealthCap, together with members of management and the board, intend to participate in the rights issue. The purpose of the rights issue is to support the continued commercialization of Pepaxto in Europe. While the launch efforts have been focused and diligent, external market factors have negatively impacted the acceleration of our sales trajectory. Hence, the company has assessed the additional liquidity required for our commercial operations to reach cash flow positivity in 2027, based on the European commercialization of Pepaxto.
In addition, we have promising development projects within our pipeline, particularly related to the indication glioblastoma. Part of the proceeds will be used to enable a window of opportunity study in man for glioblastoma, an important step in clinical advancement of the assets. Turning to the quarter's financial performance. Net sales for the fourth quarter increased to SEK 18.6 million, nearly doubling compared to the same quarter last year. For the full year, net sales more than doubled to SEK 71.1 million. Gross profit for the year came in at SEK 68.7 million, corresponding to a strong gross margin of 97%, which continues to demonstrate the scalability and robustness of our business model. Operating expenses decreased by 16% in the quarter and 7% for the full year, reflecting disciplined cost control across the organization.
EBIT for the year improved to SEK -224.7 million from SEK -283 million last year. The full year financial items were impacted by a non-cash fair valuation of warrants, amounting to SEK -12.2 million. All in all, the year showed strong revenue growth, stable gross margin, and reduced operating expenses, all key pillars supporting our path towards a positive cash flow in 2027. Looking more closely at our operating expenses, sales and marketing expenses for the full year amounted to SEK 137.2 million, in line with last year. Already during 2024, we finalized our commercial organization in Spain and Germany, and in 2025, we established our Italian organization, all key markets for the launch of the Pepaxti in Europe.
General and administrative costs decreased to SEK 57.4 million from SEK 60.8 million, while R&D expenses decreased to SEK 103 million from SEK 121.2 million, reflecting a more focused R&D structure. We currently have no ongoing clinical studies, but we have made meaningful progress in our preclinical portfolio, particularly with Glioblastoma. The chart illustrates the quarterly development of our operating expenses over time, showing a steady and disciplined cost trend that supports our financial targets. Finally, a look at liquidity. Cash at year-end amounted to SEK 82 million. Our liquidity position will be significantly strengthened through the announced rights issue of approximately SEK 200 million. With the proceeds from the rights issue, we will be well positioned to continue executing our strategy and drive value creation.
The proceeds will enable us to maintain momentum in our European launch, while accelerating the development of our PDC platform towards indications beyond multiple myeloma, where we particularly look forward to initiating our clinical trial in glioblastoma in 2026, where we have the potential to address a significant unmet medical need. By that, I conclude the financial update and hand over back to you, Sofia.
Thank you, Henrik. Let's turn to the business update and our strategic priorities. Oncopeptides rests on three strong pillars. We are building the company from our commercial base in Europe. We are looking to add revenue streams by partnerships for the rest of the world, and we do have a potential in our pipeline that can transform Oncopeptides. So why invest in our business at this time point? We have a fully approved product with a SEK 1.5 billion European market potential. We have demonstrated a strong European growth momentum year-over-year, and we are working on strategic partnerships, and we do have an exciting pipeline targeting global multibillion-dollar markets like glioblastoma. Our preclinical efforts have really paid off as the data generated demonstrates a strong scientific rationale to advance the PDCs into clinic for glioblastoma.
To ensure you all get a good understanding of this exciting opportunity, I will today talk about our scientific findings and do a deep dive into our pipeline. But let's start with our Pepaxto business with focus on European sales first. This graph illustrates our sales trajectory. While we faced some external headwinds in Q4, the fundamental fact remains, our sales have more than doubled year-over-year, providing the scalable demand for Pepaxto in Europe that will support a strong growth during 2026. This map shows our European footprint in 2025. We have successfully transitioned from the market access phase into the full commercialization across our key territories. Looking back at how we built this throughout the year, in Q1, we negotiated price in Italy, which secured that we now have the solid foundation of three key markets.
In Q2, too, we saw momentum building rapidly, especially as we unlocked regional access in Spain and started to unlock regional access in Italy. Q3 was, as we anticipated, hit by the vacation period, but still demonstrated our ability to grow and expand our prescriber base and deepen our engagements. Our Q4 map shows the full, robust picture of our current European footprint with the three key markets with close to full market access. Behind those data points are more than 600 patients treated since our EMA approval. We have a clear inclusion in the EHA-EMN guideline, and Pepaxto is increasingly recognized as an important treatment option for triple-class refractory patients. Germany remains a critical market. We now have two full years of experience, and our analysis tells that the full innovative late-stage myeloma market is facing slow growth.
Germany is a scattered market with few patients per HCP. This, in combination with that, in particular, the office-based physicians have restricted access for pharma, some not allowing visits at all in their clinic, and majority only allowing 1-2, maximum two visits per year, results in that it takes longer time than anticipated to unlock new prescribers and identify new patients. In Q4, we did demonstrate double-digit growth in Germany, but at lower levels than we counted for in our projections. To ensure we stay realistic about our investment versus the growth pace, we aim to, and we do aim to reach country-level profitability in Germany during 2026. We are streamlining the organization and focusing our resources strictly on high-potential areas and areas with a positive momentum where we do have access to the physicians.
In Italy, 2026 is the first year with full or close to full access down to hospital level. Italy has been a standout performer, exceeding its targets for the first year. This is due to an excellent team built in a timely manner, a centralized prescriber base with recent experience of Pepaxto just ahead of launch. 2026 is the first year of full regional access in Spain. The full Spanish late-stage myeloma market was hit by the HCP strike in Q4. The strike was clearly affecting the number of patients reaching their hematologists on time to get a new treatment initiated. This is partly still a big concern, not least for patients, as the strike is continuing. Having said that, our team is very active. We are working with the KOLs in Spain and have initiated both national and regional projects together with them to catch up.
Insights tells us that despite decreased sales in Q4, our position remains clear, and the experience generated is positive, which is the foundation we are building from in 2026. And then we, of course, truly hope that the strike situation will be solved for soon to allow patients to visit their HCPs in a timely manner, and in addition, allowing time for the HCPs to properly interact with the pharma industry. Even though our investment is currently focused on our key markets, we are looking into how to capture the full European potential. We do have market exclusivity until 2037, meaning there is still time to both gain access and reach peak year sales in more countries across Europe. We are committed to find the most value-generating business model for the company and to make this happen, as soon as possible.
We will, of course, keep you posted on progress. Let's now move from Europe and look into the rest of the world. Outside of Europe, our strategy is straightforward: grow geographically and partner smartly. Our greatest focus is on Japan, but we do in addition, have a partner in South Korea and opportunistic partnerships with the World Orphan Drug Alliance for more complex geographies. We have all the time known these geographies will be slow, but based on recent insights from our partners, we do hope to see progress in the MENA region this year. For Japan, we have a good foundation to stand on with formal positive advice from the regulatory authorities. We are currently focused on one well-established pharmaceutical company that has become our preferred partner option. The contemplated transaction features an upfront payment, milestone payments, and a double-digit royalty.
The timeline for the deal is currently at large out of our control, which means it is difficult to estimate when a potential deal can be closed. We will, of course, keep you posted. Now, let's move into our pipeline, which I am very excited about. We have, over the last quarter, made some significant progress, generating data that has given us a better understanding of why our PDCs are so unique. The data is validated by external experts and supports us to take the first step on the journey to expand our PDC platform into indications with very high unmet needs. If we manage to generate clinical data in line with what we see in the preclinical, we will be able to transform Oncopeptides into a company with global potential, reaching far beyond our current opportunity with Pepaxti in multiple myeloma.
As a recap, Oncopeptides holds two proprietary technology platforms, the PDC and the SPiKE. The pipeline includes OPD5, offering a global opportunity for additional indications in difficult to treat tumors with high unmet needs, and OPDC3, designed for enhanced selectivity in solid tumors. OPSP1 is the first candidate drug selected from our innovative immunotherapy platform focused on NK cell engagement. To facilitate the shift from preclinical research into clinical development that we will make during 2026, we are reallocating our resources. To stay cost-conscious and focused, we are reducing our internal R&D efforts in preclinical and will rely more on external strategic collaborations to advance these platforms. I am very excited about us being able to move into a new and more advanced phase for our PDCs, targeting large patient populations with high unmet needs.
Our European commercialization of Pepaxti serves as an important foundation for Oncopeptides, and it is the real-world proof of concept for the PDC platform. The majority of the future value, however, lies in our pipeline as we expand into addressing global markets with high unmet needs, serving us with the opportunity to create shareholder and patient value far beyond where we are today. As I have indicated in the past, we believe that through the commercialization of Pepaxti, we have achieved a strong clinical validation of our science. Lately, we have also gained an even better understanding of why PDCs can support patients with aggressive and resistant disease. So we are now aiming to deploy the same mechanisms to new indications. Let me tell you more about our latest findings.
What we have realized is that our PDCs enhance alkylation through dual targeting of both nuclear and mitochondrial DNA, which results in that we can support patients with very aggressive tumor types that has developed resistance to other treatments. So what does this really mean, and how does this really work?... Let's start with the basics and what we have known for a long time. The idea behind the PDC platform is that by conjugating peptides to an alkylating or cytotoxic payload, the PDCs becomes very lipophilic, fat loving, which means they are entering cells freely without the need of transporter proteins. This is due to that the cell membrane is built of lipids, or to put it simple, fat. Once inside, the PDCs are quickly hydrolyzed or cut into pieces by peptidases and esterases that act as small scissors.
Certain tumor cells, like for example, multiple myeloma cells, have an overexpression of these scissors. The pieces are active and cytotoxic metabolites that are more water loving and now trapped inside of the sick cell, which are filled with fluid. This process happens rapidly, which triggers a concentration gradient that is drawing more of the PDCs into the sick cells. So the result is a high concentration of alkylating or cytotoxic agent inside of the cell that leads to cell death. What we have realized is that the cell is most likely not only killed due to double-strand DNA damage inside of the cell nucleus, like with conventional alkylators. But we have lately generated evidence suggesting that the PDCs have a dual killing mechanism, also damaging the mitochondrial DNA. This is a critical finding and super exciting, as the mitochondria is acting as the powerhouse of a cell.
The ability to damage the mitochondria means the ability to overcome resistant and kill aggressive tumor cells. These findings suggests an explanation to why we have seen in clinic that our PDCs are so powerful and can support patients that are refractory to other alkylators, and why the PDCs can support patients that has developed resistance. Let me take some time to explain this in more detail, as this is important for you to understand and to get how valuable the full PDC platform can be. One example is that patients with multiple myeloma and P53 deficiency hardly respond to any treatment, but do respond to Pepaxti. Now, let me explain this more in detail. The P53 is a tumor suppressor gene and normally acts as a safety guard.
It checks for DNA damage, it stops damaged cells from dividing, and it can kill damaged cells to prevent them from growing a tumor. When p53 is deficient, that is not working, damaged cells don't stop growing. Cells with DNA errors can survive and multiply, and this increases the risk of cancer growth. Because many cancer treatments works by damaging only the nucleus DNA and not the mitochondrial DNA, p53 deficiency can make cancer cells resistant to treatment, such as conventional chemotherapy or radiation, and this is happening by upregulation, regulating the repair mechanisms of the DNA in the nucleus. With our dual mechanism of action, we can address the barrier of resistance developed by the upgrade of DNA repair in the cell nucleus and support patients with no treatment options.
This has already been proven with Pepaxti in multiple myeloma, and we are now looking to further prove this in glioblastoma. But there are also other high unmet need indications, like for example, acute myeloid leukemia, where we have interesting preclinical data generated. To summarize all of this in brief, the PDC platform is now a validated scientific breakthrough, and we now understand why we can overcome treatment resistance, which opens the door for us to developing PDCs into supporting patients with very aggressive tumors and very high unmet need indications, such as glioblastoma, meaning we can target multibillion-dollar global market potentials. We now do have multiple opportunities, but our financial reality tells us we need to focus, which we will do on the opportunity of glioblastoma, and let me tell you a bit more why. Glioblastoma is a very aggressive brain cancer with no cure and poor survival rates.
It is a rare disease with high unmet need, and if there are new treatment options approved, there is an estimated global market opportunity going from today's around $3 billion to around $8 billion in 2035. There are a number of challenges in treating glioblastoma. The tumors are sturdy. Most agents exhibit no activity at pharmacological concentrations inside the brain. The first challenge in treating this disease is, however, the blood-brain barrier, which blocks most of the drugs from even reaching the tumor. Glioblastoma is a typical tumor where upregulation of DNA repair mechanism commonly happens, and resistance is being developed. And finally, the tumor is cold, meaning the opportunity for immunotherapy is limited without making the tumor hot, which means that you have to ensure the immune cells that can support cell death actually reaches the tumor.
The current standard of care is an alkylator, temozolomide, which can partly support patients, but it's well known that it has no efficacy in patients with upregulated DNA repair mechanism. If we look at how temozolomide can support patients, we can conclude that alkylating agents do have activity in glioblastoma cells. In the case of temozolomide, there is limitation due to both only 30% bioavailability, as well as that temozolomide is a single arm alkylator, meaning it breaks only one of the DNA strands, which is why upregulating or repairing the DNA is commonly developed and the tumor becomes resistant. It is also important to note that temozolomide is not damaging the mitochondrial DNA.
With our unique PDC platform and the unique mode of action I just described with a dual killing mechanism, we believe we have the potential to provide a better response to this incurable disease that has proven really difficult to find new treatment options for. Our focus on glioblastoma actually originates from external findings in 2020, which was published in 2022, and eventually led to research grant from Sweden's Innovation Agency to explore our PDC platform in what we call the GLIOPEP project. The data published in 2022 demonstrates that a PDC was the most efficacious compound in killing glioblastoma cells, clearly outperforming the standard of care. This graph is showing the viability of glioblastoma cells. The lower you find the dots, the more cell killing.
In this panel, melphalan was used, and as you can see, the dots in the yellow box are much lower than most other drugs. Today's standard of care is circled in the red box. The GLIOPEP project consists of four collaboration partners, and the grant was received to explore the potential of the PDC platform in preclinical. The data from this project confirms that the PDCs, and in this case, OPD5, can address some of the most evident barriers for drug development in glioblastoma cells and in animal models. OPD5 has shown promising preclinical data with good activity at pharmacological concentrations, and OPD5 has shown an efficient blood-brain barrier penetration and strong tumor reduction in preclinical models. Stay tuned for more data to be published from this project.
These findings are logical based on the PDC mode of action, as it's also well known that mitochondrial function is critical for glioblastoma growth. This aligns perfectly with the mode of action to target mitochondrial DNA in addition to a double-strand break of the nucleus DNA. The last two quarters, we have generated evidence that altogether provides a very strong and logical scientific rationale, suggesting that we can address all the most common glioblastoma barriers. In summary, our preclinical data demonstrates that our alkylating PDCs have low sensitivity to DNA repair upregulation due to both being a double-armed alkylator and damaging the mitochondrial DNA, concluding a dual mode of action, and crucially, demonstrated near 100% bioavailability in the brain, which translates into strong tumor reduction in animals.
As we have an alkylating mode of action, we are not dependent on the immune system, like all the immunotherapy that is making great breakthroughs for other cancer types, but has not managed to address the unmet need of glioblastoma patients. So we believe we have an answer to a very high unmet need. What is then our next step? Historically, glioblastoma trials have 1%-2% success rate, partly due to the difficulty to get drugs over the blood-brain barrier. So we ask the experts within the field, what is the most clever approach to enter the clinic? The conclusion is to initiate a capital efficient window of opportunity study using our approved, approved drug, melphalan, as a clinical probe in approximately 10 patients. We will generate human proof of concept data with the aim to confirm that PDCs passes the blood-brain barrier also in humans.
This cost is a fraction of a full phase 1 trial and can inform if we are to move and invest into the development of our next generation asset, OPD5, which is an excellent PDC candidate for glioblastoma patients. Bringing this all together, we enter 2026 with an optimized business model and a clear focus on the most value-driving activities. With the rights issue we have announced today, we expect our commercial operations to be funded to profitability, which, of course, is contingent upon revenue growth. Furthermore, we are excited to initiate the clinical trial for glioblastoma to generate proof of concept data of blood-brain barrier passage in humans. Our mission remains unchanged. We are bringing hope through science to patients with difficult to treat cancers. Thank you for your attention today, and, we will now open the floor for any questions you might have.
If you wish to ask a question, please dial pound key five on your telephone keypad to enter the queue. If you wish to withdraw your question, please dial pound key six on your telephone keypad. The next question comes from Richard Ramanius from RedEye. Please go ahead.
Good morning. I have a few questions. Let's start with Pepaxti. Could you give us some more details about how the situation is in Spain in Q1 versus Q4, and similar comments for Italy?
Thank you, Richard, and good morning. When it comes to... So we refrain from commenting on sales already now for the first quarter. When it comes to the situation in Spain, the strike, and you can read this in media, is unfortunately continuing. It's less intense than it was in December, because in December it was a full week, that was where doctors were basically out of office, also due to bank holidays. And that, together with the Christmas holiday period, concluded very few days for patients to visit doctors throughout all of December. Of course, the situation has improved somewhat from that in January, which is not so crowded with bank holidays.
But it is a fact that the strike continues, which is influencing patients to get new treatments initiated, and which is influencing all of the pharma industry to interact with the HCPs. As I said, we are working with the top experts in the field to understand how we can catch up during the year, of course, and effective ways be able to communicate with the HCPs and ensure that more new patients get Pepaxti prescribed. When it comes to Italy, I mean, we have a very successful launch in Italy, and that is based on that we have excellent team members that have managed to really capture the pre-launch experience and build on that. And I would argue that there are no changes to that kind of dynamic in Italy.
All right. Could you say something more about the clinical development in glioblastoma? So what's the medium-term plan for clinical development?
Yes. So what we're doing, as I said, is that we are initiating a window of opportunity study. You can also name it phase zero if you want to, because you do such a study ahead of phase one. And we are currently working to, of course, prepare for this study. We are interacting with investigators, we are interacting with regulatory authorities, and our aim is to initiate this study during the year. As said, it's 10 patients, and we will be able to monitor these patients one by one. Because what you are doing, to get a bit detailed, is that you are giving one dose of a PDC, in this case, melphalan, ahead of surgery. And then you examine the tumor post-surgery to see that you have been able to pass the blood-brain barrier.
You can also, as secondary objectives, look into the cells, the tumor cells as well. Stay tuned for more information, and we will, of course, keep the market updated on any progress we are making here.
Okay, I have a last question about the rights issue. How much of the proceeds are intended for Pepaxti, and how much for other uses?
So thank you, Richard, for that question, and we have not expressed any exact numbers, but we are stating that the purpose of the rights issue is to support the continued commercialization of Pepaxti in Europe, and also advancing our very exciting opportunity with glioblastoma. But the majority of the funds is still directed towards the commercialization of Pepaxti in Europe.
Okay. That answers my questions. Thank you.
Thank you so much.
As a reminder, if you wish to ask a question, please dial pound key five on your telephone keypad. There are no more phone questions at this time, so I hand the conference back to the speakers for any written questions and closing comments.
Thank you. We have a few written questions. First one is, you communicated cash flow positivity by the end of 2026, as recently as the Q3 report in November. What specifically changed during Q4 that caused the target to shift?
Thank you for the question. So, first half of last year, we had a really positive momentum, and we did deliver on our kind of projected growth of 30%-40%, and even more in Q2. In Q3, we were hit by the vacation period, in particular in August, so Q3 came with lower growth. But we anticipated that, that we would be able to catch up in Q4 based on the first half of the year, and that you commonly see this effect in the third quarter. What happened in the fourth quarter, I mean, as I said, different dynamic in the different markets. But, if you take kind of the countries, one by one. So Italy did exceed expectations in the fourth quarter, which was very positive and it kind of proves the, the unmet need of Pepaxti continuously.
But the other markets, we had some issues. So Spain, there was this doctor strike in December. It took some time, we should admit, for Spain to recover from the vacation period, but just when we started to recover and we saw a positive momentum, this strike completely disrupted our sales. We basically had very, very few new patients in December in Spain. And as our sales and our business model is built on that you get new patients that are treated for 4-5 months, it really kind of disrupted and decreased sales in Spain. What should be mentioned, and what's important to understand, is that Pepaxto is injected or infused once a month, but which is good for patients and physicians.
It is possible to delay the administration if needed, and the physicians really took advantage of this, given that they had so few slots to treat patients during December because of the strike and bank holidays and other things that are happening in December. So we saw a lot of postponed treatments, and we saw very few new patients coming in in Spain. And we have, of course, been analyzing the market, and this is true also for all our competitors. All the myeloma late-stage drugs decreased during December. So that was a big hit because we, of course, should have and have had ambitious targets. And such a decrease in one of our key markets really affected us, also kind of built on the lower than anticipated growth in Q3.
Germany is important to understand because we did see very good speed in Germany the first half of the year, but with increased volume, the kind of growth rate started to slow down. And this has to do with that the German market has changed in the way that our prescriber base is large. It consists to the majority of office-based physicians, and during the second half of last year, two more companies launched into multiple myeloma. This means that there are many companies currently want to speak to the office-based physicians about myeloma. They are treating around 20 different tumor types, so... and they are overall restricting visits to pharma. Some of them are saying that we can't allow pharma anymore in our clinics because we need to meet patients, because that is, of course, generating their business.
So some are seeing us maybe once or twice a year because they only have so much time to speak about myeloma, when they also need to speak about lung cancer and breast cancer, et cetera. So this dynamic with a crowded market when it comes to share a voice together, with kind of the scattered market, has made us realize that based on where we are now and the volumes that we are at now, it takes longer than anticipated to grow Pepaxto. So we did have a double-digit growth, and a fair growth, but not to the level of 30%-40%. And this, together with that, we actually had very limited orders from Greece in the fourth quarter. It's a small market, but it's a volume market, so we count on getting some volumes every quarter.
The volumes in Greece, they were pushed at large into 2026 because of budget constraints from the authority that is actually ordering and paying Pepaxto from Germany to Greece. So all of this together concluded decreased sales and made us realize that we will not be able to reach the cash flow positive target in 2026, but we have pushed it to 2027. So I hope that that was a detailed answer enough for you to get a better understanding. And then if we look at 2026, we are obviously working very hard, and we are very active in all of our markets to ensure that we grow as fast and as strong as possible.
Thank you. Can you give an accurate description of what your go-to-market and sales strategy is beyond working with partnerships? Considering the bleak results from partnerships, one would expect Onco to be more hands-on in the sales process, considering you know the product best.
Thank you for that question. So I would say that we have different types of partnerships, and I would like to describe them. We have a partnership in Greece that is working very well. That is a commercial partnership. The Greek team is very close to the Oncopeptides team, and the market was very well prepared because the investigators or the physicians in Greece had experience from Pepaxto. We have a similar situation in South Korea, where the investigators or the clinicians have had experience from Pepaxto, and they are actually currently using Pepaxto in early access. But in South Korea, we have the regulatory process to pull through, both to kind of apply for orphan drug designation, as well as pulling through the regular regulatory process and market access process.
And that is what our partner is working on currently, and that's a lengthy process and why you don't see any sales from South Korea at this time point. When it comes to the rest of the world, I would agree that I would have hoped to see more demand, even if we have complex geographies like Africa or Middle East, but it has taken time for our partners to kind of convince and get the good understanding for their experts that had no understanding of the PDCs whatsoever. We are starting to work up an interest, in particular in the Middle East. There is an interest in Africa, but in Africa, the payer situation is very difficult. So, several patients have kind of been rejected in Africa from a payer perspective.
The reason why we are not doing this alone, but we have chosen to go for a partner in the rest of the world, and of course, to your point, we will assess your partner to see if it's the right partner over time. But for us, it would take a lot of resource and effort to build that kind of pre-launch understanding and demand. And then we rather focus those resources based on the size of the company to the markets in Europe, where we actually do have price negotiated and can drive sales.
Thank you. Sven, two questions on the same topic, and you addressed it in your presentation, but can you say something else about the partnership with Japan potential?
Well, I think I said what I can say. The timeline is a bit longer than we had anticipated. Usually, you kind of aim to close a deal like this in a year, but it's at large out of our control on our partner side. So we can't control their internal processes, their internal decision-making, and their internal strategic kind of priority. So, we do believe we have a very good partner that we are discussing with. But, I wish I could give you a timeline, but I unfortunately can't because it's really, it's really out of our control. But we are, of course, doing everything we can to push this and supporting them with all the information they need to have from us.
Thank you. With that, back to you, Sofia, for any concluding remarks.
Thank you so much. So, thank you to everyone who has been attending this investor conference. I know there has been a lot of information shared today as we are entering 2026, with focus on Europe, of course, on our geographic expansion, but we also see very exciting pipeline advancement that I really wanted you to get a better understanding of. Because these opportunities can really take Oncopeptides from being, in a sense, a quite niched player with the European commercialization, to becoming a big player with several indications for the PDC platform beyond multiple myeloma. So thank you for your patience, for listening in all this time, and of course, should you have any more questions, just reach out to us. And by that, I wish you a very nice day!