Welcome to Oncopeptides Investor Conference Call 2026. 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.
Good morning, everyone, and thank you for joining us for this update on our Q4 sales and strategic outlook. My name is Sofia Heigis, CEO of Oncopeptides. I am today joined by our CFO, Henrik Bergentoft, and we will walk you through the numbers, the context behind them, and our updated path forward. This is what we announced yesterday, and I will address all these points this morning. Let's go to the numbers. For the fourth quarter of 2025, we achieved net sales of SEK 18.6 million . This represents a strong year-over-year growth of 88% compared to Q4 2024 and an increase of 125% versus 2024. This strong year-over-year growth is supported by all our key markets, not least Italy, that is exceeding expectations. The quarterly growth rate in our largest market, Germany, was decent, with double-digit growth.
It was, however, not sufficient to balance the negative impact from Spain during the fourth quarter due to a strike among medical doctors. While the year-over-year trend confirms our growth, the absolute number is below our initial projections. Based on the current run rate, we have recalibrated our financial expectations. We remain confident in the long-term value of the European business, and we now expect to reach cash flow positivity for the company to occur in 2027 rather than by the end of 2026. We are, of course, working to realize the value from Pepaxti beyond our key markets in Europe to compensate for the slower-than-expected sales growth.
This includes advancing the partnerships discussion with a potential partner in Japan, partnership discussions for Central and Eastern Europe, different options on how to launch beyond our key markets in Western Europe, and we still have our opportunistic partnership in the rest of the world where we believe the MENA region can contribute to revenue streams during 2026. Regarding our pipeline, we have primarily focused on our glioblastoma project and are progressing well. I will share more details about this exciting opportunity towards the end of the call. We are, in addition, taking immediate actions to optimize our cost base, particularly in Germany, which I will explain in a moment. Now, let's take a closer look at Europe. As you can see from the sales curve, the performance varies between different quarters, which is due to that we have learned that there are clear seasonal variations to the Pepaxti sales.
In addition, we have very convenient treatment options for physicians and patients that can be administered within a time range to allow the patient to be in the best shape possible when treatment is administered. This allows delays of administration and can impact a specific quarter negatively or positively. While the curve flattened in the fourth quarter of 2025, the overall trajectory for the full year demonstrates sales more than doubling compared to 2024, and we have clearly established Pepaxti as a growing brand. Our ambition remains to launch as fast as possible with a price that reflects our innovation. We are currently most active in our key markets with focus on Germany, Spain, and Italy. We do have a partner in Greece, and the momentum in Greece is very positive.
Greece is, however, also a market with fluctuations between the quarters due to the ordering pattern of the authority that is responsible to supply the full country by ordering from Germany, which in fact also has an impact on quarterly sales, not least in Q4 when the budget situation can be strained, which seemed to be the case in Q4 of 2025. For the rest of Europe, we have ongoing partnership discussions for all areas, with most advanced discussions for Central and Eastern Europe. The orange circles on these maps visualize the evolution of sales across Europe in Q4 2025 versus Q4 2024. During 2025, we hit the milestone of negotiating the price in Italy, and in Q4, we had reached 90% regional access. In Spain, we have managed to achieve 100% access, and in Germany, we have broadened our prescriber base, but the market is scattered.
Access to HCPs is becoming more and more limited, which is why the growth rate is slower than anticipated, and due to this, we have decided to sharpen our focus in Germany, which I will get back to in a short while. In Spain, the map demonstrates how we have achieved full regional access. In December, a doctor strike was initiated across Spain with a participation rate of 80%-90% among hematologists. This means a significant decrease in multiple myeloma patients that got their regular checkup visit to discover signs of progressive disease and new treatment initiation. Insights from HCPs and media tell us that the treatments administered in the hospital, like Pepaxti, were delayed due to the lack of HCPs, and basically only patients with acute symptoms or progression got a new treatment initiated.
Our sales were significantly decreased, and this hit us hard as we anticipated growth, not sales decrease. This is a temporary external factor that is unfortunately out of our control. The underlying demand and our access status remain strong, and we expect this market to normalize once this situation is solved for. Let's continue with Germany, the first market to launch with the largest market potential. As you can see from the map, we have been broadening our prescriber base step by step since launch, and we have approximately 140 prescribers today. We have now been in the market for two years with a full team. We have advanced the launch and have an overall positive experience. We have gained peer-to-peer advocacy, but it has taken time. This is due to a scattered market with 2,000 prescribers treating approximately 2,500 patients in our target population.
Based on the momentum the first half of 2025, we anticipated more of an acceleration the second half of the year, but we did not manage to pull it through. This is due to that, unfortunately, the pharma access to HCPs is getting more and more limited, in particular in certain areas and with office-based physicians, several launches going on at the same time, and two new companies entering the market during the second half. It has impacted our ability to accelerate and level up as we planned for. To address this situation, we have made a careful analysis and launched a strategic initiative. We are streamlining the German organization to focus strictly on regions where we have established access and high potential. This quality-over-quantity approach will align our costs with our revenue reality and support us to become profitable on country level during 2026.
Italy is the highlight of the quarter. The launch is exceeding our expectation, and our team is doing an exceptional job. During 2025, we unlocked 90% regional access at hospital level. The compelling growth here validates that when we have clinical experience ahead of launch, meaning a good understanding of the patient profile for Pepaxti, there are more patients treated by every HCPs, and we are in a market with more easy access. The demand for Pepaxti is high, and we can quickly gain a strong position. The market potential for Pepaxti across Europe is still SEK 1.5 billion, and as I've already mentioned, we are working to ensure Pepaxti can reach patients also beyond our key markets to secure the full potential of Europe. We do have market exclusivity until 2037, and we still have many years to realize the value.
Beyond Europe, our expansion strategy is to partner smartly. We have secured different types of global partnerships, like the licensing deals in South Korea and opportunistic partnerships in, for example, MENA, and we are working to fill the gaps. The most significant potential near-term opportunity is Japan. Japan is a growing market with a swift access process. We have a confirmed regulatory pathway, and though Japan has a similar addressable market potential as Germany, Japan has more of a centralized prescriber base, and multiple myeloma HCPs will have pre-launch clinical experience as a Japanese partner would have to execute a study ahead of launch. This means Japan is more similar to Italy in its dynamic and a very promising market. Think German size and Italian dynamics. We are progressing well, and our potential partner is still finalizing due diligence, and we have just recently initiated contracting discussions.
I do wish to emphasize that a deal is, of course, not concluded until we have a signed contract. Let's look a bit into our pipeline and the very exciting opportunity of glioblastoma. I would like to remind you that glioblastoma is a brain tumor with a high unmet need and a growing market potential. It's one of the most common, but also one of the most aggressive brain cancers. It grows fast, it always relapses, and there is no cure. It is a rare but severe disease. It affects two to three people per 100,000 each year, and the average age is usually about 60. There is a poor survival prognosis for these patients, unfortunately.
It's only about 12- 15 months after diagnosis, and this is due to that it has been really difficult to develop effective treatment due to the limitation and the difficulties to cross the blood-brain barrier, so new therapies are urgently needed, and that is where our PDC platform comes to play because what we have realized and explored in the preclinical, both in vivo and in vitro, is that we can both address the barrier of the penetration across the blood-brain barrier where we have confirmed passage with OPD5 and promising preclinical data demonstrating this. In addition, we have in vivo mice models been showing a strong tumor reduction. Based on this data, we have decided to prioritize glioblastoma in our R&D department.
The market is promising and growing, and the companies that manage to develop drugs in this space will have a fast market opportunity due to the high unmet medical need. There is a high probability of an accelerated approval based on the single-phase I-II study. So in summary, we are working on our glioblastoma project where there is a very high unmet need, a very interesting market potential. We do this because we have a strong therapeutic rationale, we have a differentiated mode of action, and all of this is discussed and is being confirmed by key opinion leaders across Europe and in the U.S. that are very excited about this project just like we are. And finally, should we see activity in man and have successful clinical data, there is a potential for an accelerated approval.
So to conclude, we are confident that Pepaxti is making a difference for patients across Europe, and we will be able to take a strong position in our market segment. We are adjusting our investment level in Germany, and we are sharpening our focus to ensure we reach profitability on country level in Germany during 2026. We were hit by a strike in Spain that had significant influence on our performance in the fourth quarter. Despite this, we demonstrated a strong year-over-year growth of 88% compared to Q4 2024, an increase of 125% versus 2024. We are working to ensure Pepaxti reaches more patients across the globe with a focus on advancing the partnership discussions in Japan, where we just recently entered into the contracting phase. We are furthermore looking at expansion across Europe to realize the full European market potential.
And finally, we do have a very exciting opportunity with our PDC platform in glioblastoma, which is the main focus of our R&D efforts and which I'm looking forward to come back to in our quarterly report in February. By that, I would like to thank you so much for listening, and we are now happy to take your questions.
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. I'll take them one by one. My first question is, could you specify when in 2027 you expect to have a, should we say, neutral cash flow and whether the company is funded until then?
Yeah, good morning, Richard, and thank you for the question. So what we are sharing now is the expectation of profitability to occur during 2027. Based on this strike in Spain that hit us with surprise, it's still continuing. They launched another strike initiative the other day. We refrained from giving more details on when, but rather refer to occur in 2027 at this time point. When it comes to funding, Henrik, would you like to comment on that?
Absolutely. Thank you. So I mean, if any additional financing of any kind should be needed, that is essentially a function of our future revenue growth and how we manage our cost base.
As announced today, we have taken measures to reduce our cost base and are optimistic about the future growth, albeit current sales growth was below our expectations. The company will for sure continue to review the strategic direction of the company and its financial position, which includes exploration of alternative options for funding beyond Pepaxti revenue in the company's European key markets, which includes, but it's not limited to the ongoing licensing deal in Japan that we just now discussed, or other Pepaxti partnering options or partnerships for Oncopeptides pipeline assets. Of course, we are always overseeing different financial solutions if needed. I mean, to answer your question straight on, whether or not we are financed, that is a function of different factors, but we are certainly planning to be funded until we are cash flow positive.
All right. Could you remind us how large staff you have in Germany, and could you say how much it will be reduced?
So we have never announced the size of our team. I think what's most important is to understand what we are doing. And as I mentioned, the German dynamics is true also for all our competitors. It's not only us. And even though there are always different factors behind slow growth rate in a specific market, what we have concluded is that it is due to the scatteredness of the market, but also due to that with many pharma companies launching at the same time, the physicians being more careful about their time, there is less time for us to see them.
So they are restricting and saying, "You can meet us once a year or you can meet us twice a year." And to change prescription behaviors to kind of launch a new treatment takes many more dialogues than just one dialogue. So what we are doing to start with from a more strategic viewpoint is that we have been analyzing the different regions, and we have been concluding where we have the highest potential, the strongest foundation to stand on, and where we will believe we will continue to accelerate because we, of course, in certain regions see great growth, but there are then other regions that are influencing the overall result that are extremely slow.
What we are doing is that we are removing field people of a certain competence in the regions where we see that we basically don't have enough access, even though we have the network, and it's due to the HCP's decision to limit access to pharma. For now, we are leaving those regions vacant and ensuring that we rather capture more potential in the regions where we have a stronger foundation. That is what we are doing and what I think is the most important message to convey. Obviously, our target is to ensure that we can run a profitable business, and that has to start on country level. If we see that this strategy is successful when we focus in here and spend our efforts here, we can, of course, start to reassess other regions and look into the dynamic later on.
Because if we look into how the treatment landscape is evolving, we know that there have been many bispecific antibodies being launched. We also know that they are not a direct competitor to Pepaxti because it's a very different type of treatment as it's immunotherapy. But the physicians are trying the bispecifics on probably more patients than they should because there is a hype around them and they don't know how they're going to behave. Real-world data tells that it's only around 30% that get the really, really good results that you see in the clinical trials. So over time now, and we have started to see that patients will relapse more and more from bispecifics, and the doctors will conclude more and more which patients shouldn't have bispecifics. So from that perspective, our segment of patients is actually growing, but that also takes time.
And in this period of time, we simply have to focus where we can capture most patients.
And a perfect answer. You answered my follow-up as well. So yeah, that's all the questions I had. Thank you.
Excellent. Thank you so much, Richard.
As a reminder, if you wish to ask a question, please dial pound key five on your telephone keypad. There are no more questions at this time, so I hand the conference back to the speakers for any written questions and closing comments.
Yeah, and as for written questions, there's a few, starting with John who is asking, "I thought the sales figures were okay, but now disaster. Why did you choose to communicate ahead of the regular Q4 report?"
Yeah, so thank you for that question. I agree with you.
The sales figures are definitely decent, and the dynamic, as I outlined, is very different in the different markets where we have an excellent result in Italy, where we have a decent but not sufficient result in Germany, and where we have really been hit in Spain. And then there is kind of these volume fluctuations coming from Greece that is contributing. So just to review the sales results. So the question is, why did we release it now? Because the assessment of the company is that we need to move our financial expectations of profitability from the end of 2026 into the year of to occur in the year of 2027. And by that, we have been moving our financial guidance, and then the market abuse rules in Sweden are triggering us to announce this immediately when we have concluded that.
Great. Oscar is wondering, could you please comment on Japanese partnership discussions a bit more? The due diligence process, you said, is ongoing since August already. Is discussions ongoing with the same company, or is it a new company? What's the factor that are standing between finalization now and finalization of the deal?
Thank you, Oscar, for your question. To start with the first part, yes, it's the same company that we are progressing with. When it comes to the process, so just to explain the kind of general processes for these kind of partnership discussions, due diligence is kind of done in different phases.
So first, you start to assess business opportunity, then you start to look into the quality of the company, and you kind of finalize with looking into production and the ability of the company to supply, etc. And dependent on the time, you may, once you have kind of concluded all your due diligence, come back to look at, okay, so is the business case still there? Is the potential still true as we assessed in the beginning? Because these processes commonly take between 9- 12 months. So that is the due diligence process, and it takes time. I mean, usually, it takes at least six months, only this part of the discussion. And our partner is now in the very final stage of that. Once you have completed due diligence or towards the end of due diligence in parallel, you start with contracting.
Contracting is based on that you have before you start to put a lot of resources on due diligence, agreed on a non-binding term sheet. We have announced that we have a non-binding term sheet with this company. As I said, it's still the same. We have now started to integrate the terms in that non-binding term sheet into a real contract where you are regulating a lot of different aspects. What is then between now and conclusion of this deal? First, in Japan, most of the companies, and that's true also for this company, they have a very strict structure and governance. You need to take your decisions through a number of committees and eventually to the board of directors. That process will have to be concluded. Then in regards to the contracting, it's like any contracting.
You negotiate, and you discuss the different terms, and you conclude, and that is basically what we have left to do now.
Okay. Joan is asking, using a simplified assumption that a four-day doctor strike corresponds to a 33% loss in treatment opportunities and assuming sales track proportionally, can you help us understand whether the decline we saw in Spain in Q4, I'm assuming, is broadly in line with what the expected impact was, or if the drop in sales was meaningfully larger than what the strike alone would explain?
So, I can start to say, in short, the loss was significantly larger than you would have anticipated if you just say that, yeah, there was a strike of three days, and let me explain why, and I'm going to get a bit detailed for you to understand.
So December is a month when, I mean, we all know it's a holiday season towards the end of December. So the dynamic, and in the hematology space, you have a big congress in the U.S. where the kind of top KOLs go to. So they are out of office in the middle of December. But there are, of course, still a lot of prescribers. So what you count on in December is basically they have a bank holiday on the 8th of December, and then Christmas is initiated just before the 24th. So most of the sales, you count to get the very first days before the 8th of December, and then during the week of the 8th and the week thereafter. So what happened was that they had a bank holiday on the 8th of December.
On 9th of December, the strike was, and it lasted then 9th, 10th, 11th, and 12th, I believe, so a full week disappeared. And as there were, of course, all hematologists can't enter into strike, but they had a very high participation rate because this strike was not only in hematology, it was in all the different specialties. It's a general doctor strike, and the hematologists had a very high participation rate, so they simply had to deal with the acute patients. And it's not only multiple myeloma, I mean, it's all the leukemia patients. All their acute patients had to be prioritized, and this means that basically from that bank holiday, the 8th and forward, sales simply stopped, except for some vials for more acute patients, so it was a significant hit. That is what we can conclude, and it was very unfortunate it was in December.
If you google and you read articles about this, one more aspect that journalists are bringing up is that the COVID rate was very high in December as well. And that put extra pressure on the hospitals with these sensitive patients. And it, of course, also then impacted more sick leaves of physicians. So a very unfortunate month all in all.
Stefan is asking how come the short-selling professionals get information about the press releases before the market. And maybe I, as a head of IR, can answer that, that they don't. Next question is, will we see the launch of Pepaxti in the Nordic regions?
So that's a very, very good question. What we have said is that we would like to make Pepaxti available, and we would like to expand Pepaxti sales across Europe. And of course, Nordics is part of that.
Nordic is, however, a very small market when it comes to potential, and it requires quite a lot of resources given that you have eight or in the Nordics, four different healthcare systems, reimbursement bodies, etc. So what we have done is that we have been assessing Nordics. We have submitted a reimbursement dossier to Norway. We have a very, very lengthy negotiation in Norway that is still not concluded. In Sweden, we are in between different systems, which is, I think, a shame for Swedish patients because we have made Pepaxti available in Sweden. It's possible for the pharmacies to order it from us. We have taken all the steps and put it on the shelf. But it's not reimbursed by the national process because it's a rare disease. There is something called the National Council in Sweden.
They did an assessment based on the U.S. indication we had many, many years ago, and they said that the patient population is too small for us to give a recommendation, but the different regions will have to look into this, so where we are now is that the different regions in Sweden will have to pull through a very heavy administrative burden to buy Pepaxti, and of course, if you look at Sweden with 20 regions, the patients are super rare in each region, and I think both you and we know that the Swedish healthcare system is pressured, so I think it's very unfortunate, to be honest, that a drug like Pepaxti that can really support patients is sitting on the shelf, but the processes in Sweden are preventing us from getting into patients.
And of course, physicians can really push for this, but if they have a progressing patient, they can't wait a month to pull through this process. So that's the case of Sweden, being a bit detailed as we are in Sweden and really would like to be able to support Swedish patients. When it comes to Finland, it's a quite small group of physicians treating, and they have requested for early access because you can, it's allowed to provide early access in Finland, which we can't do in Sweden due to the rules and regulations. And they are assessing what patients they can put on early access to get an experience because in Finland, they need to submit a reimbursement dossier. It's not our task, but the physician's task to send in. And then they need to have experience.
So that is also initiated, but given the small size of the population and that these patients are very rare, it takes time. And then finally, Denmark requires very heavy investment. And given our financial constraints, we have said that we are, as of today and as of now and as of Oncopeptides, not willing to invest in Denmark because it takes time to get sales, but we'd rather invest those money into the markets where we actually do have prices negotiated. Having said that, and referring to what I said previously, we are definitely looking into and discussing with different options and partners how we can reach patients in all the European countries because we think they deserve to get access to Pepaxti.
One more question here from Fleming, and I'm trying to summarize it. Are you considering a larger partnership with a distributor to manage several countries in Europe rather than going commercializing on your own?
So thank you for the question. We are considering different options. We are not ruling out anything. What I should say is that when we look at Europe and the different countries, etc., and we talk about big pharma, and then we are referring to the really big players like Pfizer, GSK, AstraZeneca, the potential for Pepaxti for such a company is quite small, while it's significant for smaller or mid-sized companies. So that is kind of our target group of partnership discussions.
That's all the questions we have. And back to you, Sofia, for some closing remarks.
Thank you so much. So thank you for all the questions on the call today. We have, as I said, confidence in Europe. We are really excited about our pipeline, and we are looking forward to share more details with you in our quarterly report in February, so by that, I would like to wish you all a nice Friday and a nice weekend eventually.