Oncopeptides AB (publ)

Hi everyone and welcome to this presentation of our year end report of 2024. This is our standard disclaimer. I am Sofia Heggis, CEO of Oncopeptides and with me I have Henrik Bergentoft who will give the financial update later. First, I will go through some of the key highlights of the fourth quarter and the beginning of 2025. Revenue in Q4 was 9.9 million SEK. And while we are still not at the level of sales where we would want to be, we are encouraged by a 35% increase of European sales in Q4 versus Q3. The cash position was 179 million SEK by the end of the year, and we remain on track for cash flow positivity towards the end of 2026. The promising start we saw in Spain continued into Q4, and we have now secured regional access to ensure we can deliver on our financial projections for Spain in 2025. Germany was the major contributing market to our reported growth. We have seen a strong increase in momentum during the last few weeks of Q4 and in the beginning of 2025, which support our confidence in that we have reached a new level of sales that support further acceleration this year. During Q4, we reached an agreement with the Italian medicines agency AIFA regarding pricing and reimbursement in Italy, paving the way for the formal approval that we received in January. We are now fully focused on unlocking regional access and expect sales during the first half of the year. Outside of the European market, I'm excited to share that we are advancing in Japan. we have taken some important steps, including both an alignment with the Japanese regulator on a path forward, as well as moving into advanced stage of negotiations with a partner regarding a licensing deal. A deal for the Japanese market carries significant potential for oncopeptides in terms of financial impact. Looking to the events after After the period, we have announced the publication of strong real world experience on Benflufen from the US market. Additionally, we had an exploratory discussion with the FDA on our pipeline molecule OPD5. I will come back to all of these topics in a short while. Now, let me hand over to Henrik for a financial update.

Thank you so much, Sofia. Starting off with an overview of the profit and loss statement for the fourth quarter and full year compared to same period last year. Sales for the full year 2024 amounted to 31.6 million SEK compared to underlying 10.9 million SEK in 2023, excluding effects of a reversal of a return reserve in the US. Total operating expenses for the full year amounted to 390 million SEK, to be compared with the underlying 338 million SEK last year, adjusting for a refund related to closed clinical studies in 2023 of 43 million SEK. So in summary, OncoPeptides has invested heavily in building a commercial organization in Europe, primarily in Germany, Spain and Italy, that has and will generate sales growth, but in total with a lower cost base, signaling that the company is completely focused on sales growth in combination with cost efficiency. Now moving to the next slides, we take a closer look at our operating expenses. Marketing and sales cost amounted to 43 million SEK in a quarter compared to 33 million SEK last year. Behind the increased cost is the ongoing commercialization activities in Europe, which Sofia will describe in more detail further in the presentation. Administrative costs for the quarter amounted to 8 million SEK compared to 16 million SEK last year, a decrease that is a direct function of the cost focus initiated in the later part of 2024. Research and development cost amounted to 43 million SEK in the quarter, an increase compared to last year's 33 million SEK. No clinical studies are currently ongoing, but in the quarter, some investments have been made in the preclinical portfolio, including securing important patents. In addition, We had a mandatory EMA regulatory inspection during Q4, driving some one-off costs. Hence, the Q4 cost level of research and development is not to be perceived as the run rate going into 2025. So let's move to the next slide for our liquidity position. So our cash position at the end of the year amounted to 179 million SEK. And this cash position is in accordance with our internal plans to take us to cash flow positive in 2026. Of course, that is continuing on that we meet our plans on sales growth and conclude additional business development partnerships as a minimum. So with that, I conclude the financial section and hand over back to you again, Sofia.

Thank you, Henrik. I will now talk a bit about our European commercialization in general, followed by more details on Germany and Italy. As a reminder, our key markets are Germany, including Austria, Spain and Italy. These countries will be able to take us to profitability by the end of 2026. This graph shows our sales trajectory in revenue quarter of a quarter since Q1 2023 up until Q4 2024. Should the trend continue in the pace we saw in Q4, we are on track to become profitable by the end of 2026. Further growth will be based on that we now have managed to secure 85% of regional access in Spain, which in fact is all we need to capture the major potential of Spain. A clear step up in Germany based on the positive clinical experience in key accounts, supporting prescriber breadth and depth, and the addition of Italy to our revenue stream. Our European commercialization case is based on that we have a fully approved drug for treatment of an incurable disease that provides an expanding market opportunity valued at 1.5 billion SEK. As a reminder, while our focus is on reaching profitability through our key markets, we are continuing to work with payers to gain access in more markets to be able to address the full market potential. I wish to remind you that the market access processes are different in time and effort between the different European markets, and in our next phase of markets, it is longer and more complicated than the first phases. Looking at the roadmap, one such example is France, where we recently received a decision by the HASS regarding papaxity, advising against reimbursement in France. We do respect the outcome, which was expected based on assessments and time to market for other drugs in France. We however do have KOL supporting the unmet need for PEPAXTI and we do see that we can make a difference for patients also in France, which is why we will continue to engage with HUS and healthcare stakeholders to find a pathway ensuring patients do gain access to PEPAXTI and we can start to sell. As a reminder, France is not part of our goal to become profitable in 2026. Italy, on the other hand, is. And we are thrilled that we have now secured national access in all of our key markets and full regional access as we need in Spain. Regarding Italy, the reimbursement decision was the key milestone of Q4, followed by the price publication in January, which allow us to move on to regional access. As a reminder, Italy is a strong market, has strong clinical experience, which we do expect to support the launch. In terms of the size of the market, Italy is larger than Spain and smaller than Germany. But again, once we have unlocked the region, we expect more rapid uptake than in Germany. This given the high unmet need demonstrated by the number of patients in the early access program and the positive clinical experience gained not only during the EFP, but also during the clinical development programme, where we had 79 Italian patients included. As a next step we are now then in the process to ensuring regional access and to the right you can see the map of Italy with the 20 regions we are currently working on. The timelines to unlock regional access varies from two months up to more than 12 months for some of the smaller regions. As previously communicated we do expect to see first sales during the first half of 2025. Moving to Germany, it is a scattered market with our target population of 2,500 patients being treated by 2,000 prescribers. Generating a positive clinical experience in key accounts to drive volumes not only through our own team members, but in addition through peer-to-peer recommendations is key to succeed in Germany. This map illustrates the population density of 65-year-old people in Germany and the orange bubbles represent the sales across the country. We are encouraged that the feedback on our product is so far overall positive. And in 2024, we did get the sales dynamic confirmed by seeing acceleration in territories, both smaller and larger sites, once we had unlocked the key accounts. This trend has continued and the step up in Q4 was based on simultaneous increase in prescriber depth and breadth, will ensure future demand. I'm happy to share that we have activated one of the most difficult yet important accounts in Germany during the fourth quarter and this means that we today have 10 out of 12 key accounts in Germany with positive clinical experience recommending capacity. We are of course working hard to unlock the two last. We saw a 30% increase in number of prescribers in Q4 versus Q3, and we are also seeing that the duration of therapy is gradually increasing in Germany. This indicates even better patient selection and therapy management, which is based on a better understanding of papaxity due to gained clinical experience. Longer duration of therapy will naturally further support our growth. Moving to our next step value drivers, we continue to see exciting opportunities outside of Europe. Particularly this quarter, we have progressed in both our pipeline and the rest of the world opportunities. Let me start with the progress in Japan. In 2024, we took several steps. We consulted with the Japanese Medicines Agency, PMDA, to get clarity on the regulatory path for Japan, During this consultation, we have ensured that we and the regulator agreed on a high unmet need for our drug and the regulatory pathway forward. This means we now have regulatory alignment and clarity on what it will take to get an approval for PEPAXTI in Japan. In addition, we had several advisory boards with KOLs that confirms the high unmet need for PEPAXTI. This confirmation from both regulators and KOLs has in turn triggered interest from several potential partners. We are currently in advanced negotiations with one specific partner. And as already mentioned, a deal for the Japanese market carries significant potential for oncopeptides, both in terms of financial impact, but it also demonstrates the high unmet need for pepaxiv. Regarding our current partnerships, our South Korean partner, SEBIO, has filed documents for PEPACSTI to the regulatory authority for a preliminary review earlier than expected. And we anticipate clarity regarding next steps during the first half of 2025. We expect first sales in other markets where we have partnerships through the World Orphan Drug Alliance during the first half of the year. As for our pipeline, we have over the winter been engaging engaging in exploratory discussions with US FDA regarding our molecule OPD5. OPD5 is a follow-on molecule to PEPAXID with a potentially improved risk-benefit profile and longer patent protection. The feedback received was positive and in line with our expectations. And we are currently working on outlining a clinical development path based on the advice from the FDA. While there is a long way from here to commercialization, we are confident that OPD5 is an asset with true potential to get us back to the important US market in the future. As the unmet need for PDCs remains. This was confirmed by USQ opinion leaders in an advisory board that we held during the fourth quarter. To note this, that just this week an article suggesting strong real-world efficacy and safety data for PEPAX-D, written by researchers at the Anna Farber Cancer Institute in Boston, Harvard, was published in the European Journal of Hematology. This article demonstrates strong real-world experience with melflufen in the US, and the authors conclude high unmet need for new mode of actions complementing immunotherapy. The data is encouraging and confirm our view from Europe. that Melflufen can really make a difference to patients also in the real world setting, which consists of more elderly and frail patients than in clinical trials. Regarding the rest of our pipeline, and particularly the Spikes platform, we're proceeding with preclinical work. And in addition, we are currently focused on assessing the scientific, rational and business opportunity for Spikes in autoimmune diseases. This is a market with high need for new treatment approaches in innovative medicines in multiple diseases and indications. And with that, I would like to say thank you to everyone for listening and hand over to the moderator for any questions.