Oncopeptides AB (publ)

Welcome to Oncopeptide's third quarter 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 5 on their telephone keypad. Now I will hand the conference over to CEO Sophia Hagas and CFO Henrik Bergentoft. Please go ahead.

Hi everyone and welcome to the presentation of Oncopeptides report for the third quarter of 2025. My name is Sofia Heggis and I am the CEO of Oncopeptides. As we have increased our shareholder base the last quarter I wish to welcome old as well as new shareholders to this earnings course. This is our standard disclaimer. As usually I'm joined by our CFO Henrik Bergentoft and together we present our financial and operational performance for the third quarter, which is concluding that we are still on track towards becoming a profitable company by the end of 2026. The third quarter was a strategically important period for local peptides, as we knew we would have to demonstrate resilience in execution given the vacation period. Net sales reached 20.2 million sets representing a 174% increase year over year and marking our fourth consecutive quarter over quarter growth. In July, we delivered an all-time high which was followed by another all-time high in September. In between, we saw a seasonal slowdown typical during the European vacation period. And all in all, we saw a quarter of growth, which is a stronger result than the same period in 2024. So even though we are still sensitive to seasonal effects, this is a sign of how we have strengthened our position and advanced our launch. Our cash position at the end of the period was 147.9 million SEK, reflecting the successful completion of a rights issue of 150 million SEK, which was oversubscribed by 157%. The strong investor interest underlies confidence in a long-term strategy and provides the financial flexibility to continue building momentum. while advancing our partnering discussions, including ongoing negotiations in Japan. On the scientific side, PEPAXD continued to gain credibility and recognition, and following its inclusion in the IHA-EMA clinical guidelines earlier this year, new independent publications and real-world presentations at the IMS annual meeting have further reinforced PEPAXD's efficacy and tolerability in real-life use. We also saw continued commercial traction in all our key European markets, with Italy leading the growth, Spain reaching full regional access, and Germany demonstrating more resilience than previous year in the same period. In short, a resilient and strategically important quarter that positioned us well for a strong finished 2025. I'll now hand over to Henrik for a closer look at the financials.

Thank you so much, Sofia. Let's start with the financial summary for the first quarter of 2025. As said, net sales increased to 20.2 million SEK, a 174% growth compared to last year, excluding the milestone payment from the South Korea licensing deal in 2024. This demonstrates significant top-line momentum. The gross profit reached 19.9 million SEK, reflecting a robust gross margin of 99%, which underscores the strength and scalability of our business model. Operating expenses decreased by about 3% for both the quarter and the nine-month period, showing our continued focus on cost control. As a direct function of sales growth and cost control, our EBIT improved from minus 61.3 billion SEK last year to minus 47.1 million SEK this quarter. The net profit amounted to minus 60.9 million SEK, highlighting that this includes net financial items that were impacted by the non-cash fair valuation of warrants amounted to minus 10.6 million SEK. Overall, these results demonstrate strong revenue growth and improved cost efficiency, despite ongoing investments in our operations, altogether taking us towards the next platform of being profitable. Looking at operating expenses, our quarterly sales and marketing cost increased from 29.8 million SEK in 2024 to 31.9 million SEK in 2025. This reflects our expansion efforts with the completion of our organization in Spain and Germany last year and the establishment of our Italian organization this year. General and administrative costs rose just slightly from 18.4 to 19 million SEK this year. Research and development costs decreased from 21.9 million SEK to 17.3 million SEK as we currently have no ongoing clinical studies. However, we are still advancing our preclinical portfolio. All combined, the cost trends shows our commitment to strategic cost conscious growth while maintaining discipline in our R&D spending. Turning to liquidity, our cash position at the end of Q3 amounted to 148 million SEK. following the successful rights issue in the third quarter, which was oversubscribed at 157% and injected approximately 150 million SEC before issue related costs. Our liquidity is now estimated to last until we reach cash flow positive at the end of 2026, assuming continued sales growth. We certainly are proud to have attracted such an interest from both existing and new shareholders in the rights issue. So ending up with some key takeaways from the financial perspective. The company is delivering rapid revenue growth and maintaining exceptional gross margins. Cost control measures are yielding results with operating might mean while revenue is growing. Liquidity is strong and recent capital raise provides a runway for continued execution and growth. The business is well positioned to achieve cash flow positive by the end of 2026, assuming our ongoing sales momentum. That concludes the financial presentation and I'll hand over back to you again, Sofia.

Thank you, Henrik. Let's now turn to the commercial side where we continue to build strong momentum across Europe and make real progress towards our long-term goal of profitability. We have seen a strong growth trajectory in the last three quarters and our European business continues to grow supported by positive clinical experience and peer-to-peer recommendations. Looking back, the third quarter is always affected by the vacation period, which is why it is encouraging to see growth and increased demand now in Q3 2025. It's a clear sign of more markets contributing to our revenue stream. Following the inclusion of the EHA-EMN guidelines in July, Papasti has gained further recognition from leading myeloma experts. This type of validation has a tangible effect in the field. It strengthens awareness, drives clarity on positioning of capacity, generate confidence among HCPs, which leads to new prescribers through peer-to-peer recommendations. All these factors are critical to our large success, which support us to make a real difference for more and more patients, which in turn, of course, drives uptake to generate shareholder value. We continue to build on peptides around the European opportunity for pepaxity, which we estimate at roughly 1.5 billion sec annually. There are, however, patients in need for pepaxity also in the rest of the world. And we are working with current partners and to find new partners to address that unmet need and add revenue streams. The long-term value will be generated from our pipeline, which we are advancing in the preclinical setting with several exciting assets getting closer to clinic. Outside of Europe, our focus remains on concluding a partnership for Japan. Discussions are advancing well, but takes time, a lot due to internal processes and governance. And we are still in late stage due diligence phase. The structure of the potential agreement follows market practice, including upfront and milestone payments and double-digit royalties, with the partner assuming all costs related to regulatory and commercial activities in Japan. Japan represents a market roughly the size of Germany, with a well-defined path to approval agreed with the Japanese regulatory authorities and key opinion leaders supporting them in need of the PAC state. To close a Japanese partnership will be a landmark event for Oncopeptides, unlocking significant long-term value for both patients and shareholders. And we are focused on concluding a deal that is a win-win for both us and our partner, which naturally will be a win for patients in Japan. Let's move to an update on our European key markets. Regarding market access, we have seen some very positive progress for Irish patients lately. We had an early access programme open to ensure HCPs could gain experience to assess if they would support the unread need for Papaxi on Ireland. This support is critical to be able to get into a price negotiation. Ireland is a small and centralised market and in a fairly short time we have seen 12 patients being included in the AP programme. The data that has been submitted to the payer authority is very encouraging and KOLs are supporting the need, which is once more confirming that the packs deliver at or even beyond expectations in real life. We are discussing with HCPs on Ireland to publish the very encouraging data that they have generated, which can support launches also in other markets. We are hopeful that the strong evidence leads to access, but having said that, it commonly takes time and is usually very difficult to gain on Ireland. We expect to know more within the coming quarters. As already mentioned, we hit all-time high demand in July, followed by all-time high demand in September. The vacation period in Europe, with a primarily very slow August, is temporarily affecting net sales growth. I will get more into details per country in a short while. Important to note is that by the end of Q3, more than 550 patients have been treated since launch, and we are now really making a difference to many patients in Europe. In rare disease launches, it is not only the effort of the company, but all launches are dependent on peer-to-peer recommendations. These can originate from own experience, published real-world data, or guidelines as some of the most important sources for such recommendations. And as already mentioned, in the last quarter, we saw great progress in these areas. We have two real-world datasets published and presented at the International Myeloma Society, We got the inclusion of PEPAX-D in the updated EHA EMA guidelines in July, and we got a strong 1B recommendation in our monthly position, which is great as these guidelines are now being referenced across Europe. One more important aspect for the mid- and long-term delivery of the launch is to close evidence gaps. that appears due to how the treatment landscape evolves and that can support differentiation and inform treatment decisions over time. As a small company, we don't see the return of investment in setting up our own studies to close these gaps, but we do invest in ideas that fit our strategy, coming from external investigators. This type of study is very cost-effective for us and generates scientific engagements, which is also important to the launch. Here we do see increased interest from KOLs to generate data on capacity and the PDC platform. And we now have investigator-initiated trials contracted in all markets. Here is a heat map illustrating the sales growth across Europe in Q3 compared to previous quarters. And I will now get into more details per market. Germany remains our largest market. It's the market most affected by the vacation period. And when we look at our segments, we can conclude by our sales data that the vacation period is affecting the overall multiple myeloma market. And we even do see a decline in demand in August. This is also the case for capacity. We anticipated this and are looking to catch up in Q4. Given the slowness in the market, it's important and encouraging to see how we are continuously broadening the prescriber base. Increased experience in Germany has led to several RVD applications being generated currently. And on the topic of scientific progress, we just recently signed our very first investigator-initiated study, which will investigate the impact of PEPAX-D on systemic inflammation that is ongoing in multiple myeloma patients, the effect on T cells and exploring further how the PaxT is differentiated from other alkylators by not only affecting the nucleus DNA, but also the mitochondrial DNA. These are important scientific questions that will advance our scientific understanding and fuel our launch. We in addition have several proposals under review from German KOLs, which is demonstrating the increased interest in PEPAX-D and the PDC platform, which we actually lacked at launch. So very encouraging signs, as these studies have the potential to close important evidence gaps that can support our launch mid and long term and also support our pipeline development. Finally, we do see good progress in awareness, which was confirmed by and boosted by the annual German speaking Hematology Congress taking place now in October. Majority of companies are focused on immunotherapy and early lines of treatments. And our symposium, which was focused on the real life patients that are more old and frail than the clinical trials, attracted so many participants that we had to use the overflow room to accommodate everyone. This is a sign that there is a great interest and need to discuss the target patient profile of pepaxtin and that there is a need to complement immunotherapy. As mentioned, it's encouraging to see that we quarter over quarter grow our prescriber base. And what we can conclude is that there is still enough room to continue this trend, both through our own activities and through peer to peer recommendations. The heat map for Germany is visualizing how we are broadening sales of the Paxil. Even though Germany is a scattered market and we have many customers, focusing on the highly populated areas is of actual importance. And these areas are the most crowded with many pharma companies working to build awareness and at the same time, many physicians starting to restrict access to pharma. The challenge for us is that we are a small company and the only company launching PDC, while there are many companies launching bispecifics. The opportunity, however, lies in that we are unique. We have a unique product that really delivers in real life. And when physicians gain experience, they appreciate the capacity and they continue to use. We have a resilient team and we are continuing to capture potential step by step. Italy is the second largest market and was the strongest contributor to demand growth in the third quarter. Italy is an excellent example of how better understanding and awareness of papaxity due to positive clinical experience already ahead of launch and with a more centralized prescriber base can directly translate into change of prescribing behavior when physicians now get access to papaxity. In the third quarter, we reached 90% access at hospital level, and we now only have one high potential region left to fully unlock. Looking at the uptake, the strong collaboration between our local field team and prescribers continues to drive performance, confirming that Papaxi is making a meaningful difference for patients with encouraging real-world data from Italy presented at the IMX annual meeting. This data is highlighting the effectiveness and tolerability in heavily pre-treated patients, further supporting uptake in peer-to-peer advocacy. In Italy, we have several investigators from our clinical development program, and already now we have one investigator-initiated trial ongoing to close an important evidence gap. To conclude on Italy, we have a strong start of the launch and a very promising foundation to build on. The heat map is visualizing the accumulated sales and sold vials per quarter, and it's demonstrating the evolution of the Italian launch. We sold the first vials already in Q1 ahead of plan. We started to gain regional access in Q2, and we now have a fairly broad base of prescribers already in Q3. Spain stands out as a model of scalability for our commercial approach. We now have full regional access across the country. This means we have seen orders from all the regions with multiple myeloma patients, and this is another milestone achieved. Also in Spain, we see scientific progress and large supporting activities progressing. The real-world data from Spanish investigators presented at the IMS annual meeting is the first of its kind. as all patients are previously treated with a bispecific antibody. Given that this drug class is recently launched, we don't have data from our clinical program on how these patients respond to PEPAXTI. This is why it's so important and very encouraging to see that also in this patient group, PEPAXTI effectiveness and safety is confirmed. Just like in Italy, we have an investigator-initiated trial running. And in Spain, the focus is not only on PEPAXTI, but also generating evidence in the preclinic for a PDC platform, which can support our partnership discussions for other PDCs. The Spanish heat map is visualizing full coverage of the country, and now it's about increasing the number of prescribers and ensuring even more patients are getting PEPAXTI already in fourth line to continue to accelerate the sales appetite for Spain. Moving to partnerships. In addition to the ongoing negotiations with Japanese partners, we continue to explore other deals. In fact, earlier this week, I attended BioEurope, where we had many interesting and promising first discussions with different type of partners for both the Pax General Pipeline. To share a very brief summary and reflection, there is an increased interest to look into NK cell engagement as a result of that the T cell space is becoming crowded. In addition, indications with extremely high unmet needs like glioblastoma is of interest to many companies. Concluding that this is not only us finding our pipelines strategically interesting, but also many partners are showing interest and want to understand the many opportunities we have at Bongo Peptides even better. Discussions will continue and we will keep the market posted. To our current partnerships in South Korea, our partners SEBIO has launched an access program for pipaxity. providing full financial support to patients with triple-class refractory multiple myeloma patients. The program marks PEPAXB's first formal introduction in Asia beyond the clinical development program, with the first patient being treated at Seoul St. Mary's Hospital. This initiative not only broadens PEPAXB's global footprint, but also underscores its recognition as a meaningful treatment option for patients with few remaining alternatives. The next step in South Korea is a regulatory submission, which our partner is working towards. We continue to build our PDC platform with Papaxity leading the way, serving as a proof of concept for the technology. In parallel, we are advancing our Spike platform, focusing on NK cell engagement for oncology, hematology and autoimmune disease. Both programs illustrate our broader strategy to grow geographically, to partner smartly and innovate purposefully. I will not elaborate more on the pipeline right now, as I will get more into details in our upcoming capital markets update next week. And before I conclude, I would like to remind everyone about this event, which is on November the 13th from 9th to 12th century European time. It will be an online event broadcast here from Stockholm featuring leading myeloma experts, key stakeholders to oncopeptides, and myself who will give an update on the future of oncopeptides, focusing on opportunities beyond what is our core today. If you haven't already, I encourage you to register via our website. It will be an insightful session on both our commercial progress and scientific roadmap. To summarize, we have a growth momentum. We are now delivering the fourth consecutive quarter of growth tracking towards profitability by end of 2026. We have a strong European foundation. PIPAX is fully approved and reimbursed in key markets representing about half of the total European opportunity estimated at 1.5%. billion SEK per year. We are expanding globally, advancing negotiations ongoing for Japan and with established partnerships already in South Korea, Africa and MENA. We are demonstrating scientific progress with real-world data publications, guideline inclusion and investigator-initiated trials in all markets, which are strengthening the PACT's disposition. We have an innovative pipeline with next-generation PDCs and a spike platform that offers long-term growth potential in oncology, hematology and immunology. And with solid execution, disciplined cost management and growing market endorsement, OncoPeptides is well on track to deliver sustainable value creation. That concludes the presentation and I would like to open up for questions.

If you wish to ask a question, please dial pound key 5 on your telephone keypad. To enter the queue, if you wish to withdraw your question, please dial pound key 6 on your telephone keypad. The next question comes from Richard Romanious from Red Eye. Please go ahead.

Good morning. I have a few questions. I'll take them one by one. The first one is, how do vacations impact sales exactly? Is that due to since representatives being on holiday, since I assume patients who are sick are going to continue being treated and doctors continuing treating them.

Good morning, Rika. Thank you for the question. So it's actually a mix of several different aspects. One is just, as you said, that we are, of course, committed to give our teams vacation. So our activity is reduced during certain periods over summertime, like in all businesses. But it's also important to note that when the HCPs go on vacation, and in particular in Germany, where you have office-based clinics, they are quite many times quite few HCPs seeing these patients so they are having fewer patient visits basically and of course if multiple myeloma patients are progressing and getting acutely ill they will still get treatment and that is of course why we still see growth because the physicians have learned to identify the patients for propensity better also without us being there as as frequent. But I would argue that those are the two main factors. So it is really relating to less ACPs in the offices and, of course, lower activity from oncopeptides.

All right. Then I had a question about costs, which decreased quarter over quarter. Is this going to carry over into next quarters or are Q1 and Q2 more representative of future costs?

Thank you, Richard, for the question. What we've said is that we have established an organization that is in place words to give just a repeat of what we had said before. But answering more directly to your question, Q1 and Q2 is more representative for the final quarter because Q3 by natural reasons contain less activities as compared to the fourth quarter.

Yeah, I understand. I also looked at the heat maps that you Sophia presented from the various countries and I noticed especially Italy seems to have a higher growth trend than Spain or uptake and Spain higher than Germany. Would you agree to this and this trend you could extrapolate into 2026?

I would definitely agree to that. That's a very good analysis made of you. And it comes, of course, with the experience ahead of launch in the different countries where we have previously said that both Italy and Spain, they have more experience for our clinical development program. In Spain, we had the chance to have quite few patients in therapy access because luckily we got the price negotiated really fast. In Italy, in addition to the clinical development program, we also had a quite comprehensive early access program with close to 100 patients being included in that program. And that kind of recent superior experience in this current treatment landscape is really giving the prescribers confidence from the very start. Then another aspect that I mentioned many times before, but I think it can be repeated, is that both Spain and Italy are commonly faster in uptake in multiple myeloma due to that they have a more centralized prescriber base. So they have pure hematologists, specialists on multiple myeloma prescribing, meaning that every physician see more patients. When it comes to Germany, that is a more scattered market where we have office-based physicians and they see all the different oncology and hematology indications and fewer patients per prescriber. And that is together with basically no chance to prepare the launch based on where the oncopeptides financial situation when we got the price is. It is then making Germany stand out to be a slower market if you look at the launch uptake from the very start. Italy is for sure the strongest and then Spain.

Okay, thanks for checking my questions.

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. And there are a couple of written questions. The first one is, can you comment on October sales?

I almost anticipated that question as we actually did comment on July sales in our last report. And we did that due to that we had the rights issue and we wanted to be as transparent as possible. So what I can say to Oktober as we are not really assessing sales per month, but more per quarter. But as I've shared throughout my presentation, we have a very strong momentum in our markets. During the month of October, we have had all the annual Hematology Society meetings. They take place both in Spain, in Italy, and in Germany during this month. And late September, we also had IMS. And the reason why I'm mentioning this is because IMS, you have all the global top KOLs in multiple myeloma. And in the annual meetings, you have the top KOLs in the countries, but also many prescribers. And that gives us a great opportunity to really pressure test where we stand. gain insights and also engage, of course, a lot with these physicians. And all in all, the outcome of those meetings, like the symposium I mentioned in Germany, where we had to use the overflow room, which is actually quite rare, is very positive. So we are seeing in October that it's really, as I mentioned, we're seeing how the guidelines are starting to kind of kick in. We are seeing a very good sentiment in the markets.

Question on timeline for the spike platform. Is that something you can elaborate on?

Yes. So when it comes to the spike platform, we are, it's a very, as many of you know, NK cell engagement, that's novel, it's innovative and it's new. And that is why it requires more work in preclinic because the preclinic data will then inform how you go about in the clinic, which is a much, much higher investment. So you want to do the right studies in preclinic to inform your clinical programme to really ensure that you make the right investment at that phase. So we are currently still in pre-trimming. We also need to do formulation work because these are completely new assets. And when it comes to the timeline, I would refrain from comment on that because it actually has to do with finances, either if Open Peptides would be able to finance or if a partnership would be able to finance. And when it comes to partnerships, we have interesting discussions. But as we know, both from Oncopeptides and other companies, these type of discussions takes time. So I would like to refrain from commenting on when we can enter, because it really comes down to both the preclinical efforts we are making to build kind of a good direction for the clinic, but also the financial situation.

Thank you. And speaking of timelines, last question. Do you expect that Japan will be concluded in 2025?

So like I mentioned, the discussions are advancing well. We still are advancing with the partner we have been talking about before, but we also have interest from several other partners that we are discussing with. to ensure that we at the end of the day can conclude the best possible deal. When it comes to the timeline, it's a lot due to the internal processes and governance on the Japanese partner side. Because Ongo Peptides, we are a very small company and we operate with, I would argue, fair speed, but in Japan there is a culture and rightfully so where they have a lot of committees and where they seek consensus and they need to go through these committees maybe one, two, three times. So we are not controlling the timeline. What we are controlling is that we are progressing, ensuring that we are working towards the best deal possible.

The session is concluded and you want to give some final remarks, Sofia?

Yes, sure. So first of all, thank you everyone for joining us and listening to us today. With four consecutive quarters of strong growth, increasing scientific recognition and a strengthened financial foundation, we are now entering the final quarter of 2025. We both focus in confidence. We continue to execute with discipline. We will continue to work to expand access to capacity across Europe and in the rest of the world. And we are still progressing towards our profitability target for 2026. And I am looking forward to seeing many of you again at our capital market update next week on November the 13th. So thank you so much and have a great day.