Oncopeptides AB (publ) (ONCO) Earnings Call Transcript & Summary

Welcome to Oncopeptides Second Quarter Earnings Call for 2026. [Operator Instructions] Now I will hand the conference over to CEO, Sofia Heigis; and CFO Henrik Bergentoft. Please go ahead.

Welcome to the Oncopeptides webcast for the second quarter of 2026. Please note the disclaimer regarding forward-looking statements. Today's presentation is led by me, Sofia Heigis; and our CFO, Henrik Bergentoft. We delivered net sales of SEK 31.1 million in Q2 2026, representing a 62% increase compared to Q2 2025. For the first half of the year, net sales reached SEK 56.5 million, up with 74% year-over-year. Following the rights issue completed earlier this year, our cash position stood at SEK 158 million at the end of the second quarter. We remain on track towards reaching positive cash flow during 2027. During the second quarter, we achieved several critical commercial, clinical and regulatory milestones, which demonstrates that even though our organization is lean Oncopeptides consists of people with high level of competence, motivation level and drive. We submitted our type II variation application to the EMA to expand Pepaxti's label into third-line multiple myeloma patients. Preclinical data for our novel NK-Cell engager was presented at the AACR Annual Meeting. We presented 5 scientific abstracts and hosted a well-attended PDC symposium at the EHA Congress right here in Stockholm. In Germany, the first patient was enrolled in our noninterventional real-world-evidence study, MARINA. Outside of multiple myeloma, we received regulatory approval from Norwegian authorities and enrolled the first patient in our glioblastoma Window-of-Opportunity study. We signed a distribution agreement with Salus Group covering 11 countries across Central and Eastern Europe. And lastly, after the period, we achieved our first CEE expansion milestone by securing a list price for Pepaxti in Slovenia. Now over to Henrik for a walk-through of the second quarter financials.

Thank you, Sofia. So let me start with the operating momentum. Net sales reached SEK 31.1 million in the quarter, up 62% year-on-year, while first half sales increased 74% to SEK 56.5 million. The 98% gross margin for the first half shows that this growth converts efficiently into gross profit and reinforces the scalability of our business model. We are pairing that momentum with disciplined cost management. First half operating expenses decreased 2% to SEK 146.9 million, combined with the sales growth, helping improve the EBIT loss to SEK 86.2 million from SEK 116.1 million. Key message is that the business is moving in the right direction with sales uptake, strong margins and tight cost control. We are not buying growth at any price. We are scaling revenue while constantly monitoring the quality of every krona spent. Our approach to cost is very selective and execution-led. Quarterly operating expenses were SEK 81.1 million, with commercial investments focused on the European markets already generating growth, Germany, Spain and Italy. Sales and marketing spend of SEK 40.8 million, therefore, supports a clear revenue objective. At the same time, G&A costs decreased to SEK 16.7 million from SEK 18.6 million, demonstrating tangible cost control. R&D was SEK 23.5 million in the quarter, with efforts now focused on advancing our pipeline into clinic with the Glioblastoma Window-of-Opportunity. Across the first half, total operating expenses were down 2% year-on-year. As communicated, the second quarter cost base is higher than the first quarter, mainly due to additional congresses. All in all, our cost base is to be perceived as disciplined allocation to protect commercial momentum, control overhead costs and preserve the programs with the strongest potential, spending our funds to grow revenue today and build high-value options for tomorrow. We ended the quarter with SEK 158 million in cash. The rights issue completed in March contributed SEK 167 million after transaction costs, materially strengthening the liquidity position and providing a firmer financial base for execution towards a positive cash flow during 2027. And by that, over to you again, Sofia.

Thank you, Henrik. The foundation of Oncopeptides is built on our commercial execution in Europe, targeting an estimated SEK 1.5 billion market potential under our current label. In parallel, we are unlocking additional geographic markets through commercial partnerships. Long term, our PDC platform can unlock multiple indication potential in difficult-to-treat cancers, headlined by our CNS tumor program with initial focus on glioblastoma, addressing a global market expected to grow to USD 8 billion based on the high unmet need. Our execution during the second quarter has advanced every key pillar of this investment thesis. Commercial momentum delivered 62% revenue growth in Q2 compared to the same period last year. We formally submitted our type 2 variation to enter the third line of multiple myeloma. The glioblastoma Window-Of-Opportunity study was initiated and first patient dosed. We expanded our European reach via the Salus distribution partnership in Central and Eastern Europe, while continuing active business development discussions in Japan and other regions. Turning to our commercial performance across Europe. The contribution during the quarter comes from Germany, strong uptake in Italy and the level up in Spain. More than 1,000 patients have now been treated with Pepaxti across Europe since our EMA approval. This growing real-world clinical experience is generating peer-to-peer advocacy and validation. Furthermore, our 1B recommendation in EHA/EMN guideline continues to play an important role in defining Pepaxti's unique clinical position in a complex treatment landscape. In a rapid evolving market with many options being launched, it is critical to identify a unique position supported by both real-world data and experience. For Pepaxti, data consistently points to 3 distinct patient profiles where Pepaxti delivers clear value. First, for patients unable to receive immunotherapy due to, for example, frailty, advanced age, comorbidities or concerns about the risk for severe infection. As an ideal bridge between immune-based therapies, offering a non-cross-resistant disease control while allowing the immune system and the T-cells to recover as an effective post-immunotherapy salvage option for patients who have relapsed or become refractory to almost all other drugs, including BCMA-targeted agents and CAR-T cell therapy. During EHA in Stockholm in June, we hosted a symposium titled Beyond Immunotherapy, exploring the treatment class of PDC and clinical realities chaired by Professor Maria Kraut and featuring 6 leading hematologists from Germany, Spain and Italy. The symposium addressed sequencing strategies and highlighted how Pepaxti's unique PDC mechanism offer an outpatient-friendly solution that does not rely on host immune fitness. I was, of course, attending myself, and I enjoyed meeting and listening to all the experts, sharing their views and experience, 7 slightly different perspectives based on the country and their setting they came from, all confirming the unmet need and the use of Pepaxti and the positions in which we believe we can make the most difference for patients through external validation. In addition to the symposium, we had a Swedish themed booth. We launched digital engagement campaigns throughout EHA, and we had a high number of qualitative face-to-face interactions with health care professionals, mainly from our key markets, but also from other markets across the globe. These activities reinforced our core messaging around the necessity of the importance for patients to gain access to Pepaxti as they need therapy options complementing immunotherapy. Today, we have several collaborations with key experts underway based on the congress activities. In Germany, commercial momentum stepped up during the quarter with steady gains in monthly new patient starts and an expanding prescriber base across university hospitals and office-based practices. We also enrolled the first patient into the prospective MARINA RWE study strengthening our office-based data generation. With strict cost control and volume growth, Germany is progressing towards country-level profitability for the full year. We should be honest and say that it is only the experienced prescribers that do use Pepaxti in the exact right position and in fourth line in Germany. This means that once physicians gain experience, they gain confidence and move from very late lines to the right position. It also means we still have work to do to ensure we get more use in earlier lines, which commonly means even longer treatment duration. In short, a lot of potential to grab still in Germany. The German Pepaxti prescriber base continues to demonstrate steady growth. With a high number of multiple myeloma prescribers in Germany, we still have many more left to gain. Our focus is naturally unlocking sites with the highest potential. Italy continues to perform exceptionally well and remains a key growth driver. It represents our most mature market in terms of prescriber experience and fourth-line usage, showing the highest estimated average number of treatment cycles per patient. We are seeing a continuous broadening of the hospital accounts throughout the country. In Spain, we have worked hard to actively manage the local dynamics in a very stressed market. Spain has not only experienced many launches in a very short period, but also unusual limitation in access to HCPs due to the strike that has been ongoing during the full period. We do start to see results of our resilience and all the efforts with a clear step-up in commercial uptake in Q2, achieving an all-time high monthly sales level in June. We are continuing to work closely with key opinion leaders as peer-to-peer recommendations is key in a pressured market to sustain this positive momentum. Our phased rollout across Europe covers an estimated SEK 1.5 billion market potential under the current label, protected by market exclusivity until 2037. With direct commercial operations established in the Phase I and part of the Phase II markets, our recent agreement with Salus accelerates entry into Central and Eastern Europe, and I will get back to CEE in a short while. But first, let's focus on a brief update on where we stand with the type II variation submitted to EMA. Our submission to move from fourth line into third line represents a transformative opportunity. It can shift our indication from adult patients with -- that are refractory to PI, IMiD anti-CD38 monoclonal antibody up to patients with at least 2 prior lines of therapy and only being refractory to lenalidomide and their last line of therapy. Moving one line up and removing the triple-class refractory requirement allows clinicians to identify and treat patients earlier. Expanding into third-line therapy acts as a commercial and clinical multiplier coming with the opportunity to double the target patient population in Europe. In addition, the potential to double average treatment during duration based on the Phase III OCEAN data. Important to note is that the established German basket model supports innovative pricing. And maybe most important, we do fulfill an unmet need with a mode of action complementary to other therapies. Following our submission between May and July, we expect the CHMP opinion sometime between September to November. In case of a positive opinion, that can lead to an easy decision, which will come plus 30 to 60 days after a potential positive opinion. Timing on the CHMP opinion will depend on complexity and extent of feedback from EMA. Should we gain this approval, we will submit reimbursement dossier in our key markets as soon as administratively possible after the approval. In Germany, a company can according to local rules start to sell on the new indication right after reimbursement dossier has been submitted. In Italy and Spain, a price needs to be concluded for the new indication before on-label sales to third-line patients is possible. We will, of course, keep you updated on the progress. Our partnership strategy allow us to scale globally and capital efficiently. The Salus agreement announced during Q2 covers 11 CEE countries, representing an estimated addressable market with SEK 150 million potential under current label. Just like we did a launch sequence across Europe, Salus has assessed and made a launch sequence across CEE. Slovenia was first on that list. It's a small market, but most important from a recurring pricing perspective. To achieve a list price in Slovenia already now in August confirms that Salus is a partner with the right competence and drive. Sales in Slovenia can start once a price negotiation is concluded. Regarding launch sequence in CEE, Croatia and Czech Republic are next up. In parallel with our current partnerships, we remain very engaged in active partnership discussions in Japan and in other territories. Our pipeline leverages our proprietary PDC and SPikE platforms. Key assets include OPD5 currently focused on glioblastoma, OPDC3 designed for enhanced selectivity in solid tumors and OPSP1, our novel and natural killer cell engager. The first major obstacle in brain cancer is crossing the blood-brain barrier. Based on preclinical data, we believe we can overcome this barrier. This, however, needs to be confirmed in clinic. And through our 10-patient Window-Of-Opportunity study at Oslo University Hospital, we are using an approved PDC probe to rapidly be able to demonstrate human brain tumor penetration in a cost-efficient manner, aiming to generate the clinical validation needed for us to take the next step. We communicated the first patient into the study during Q2. The first step to allow further recruitment of patients was an assessment by the Safety Review Committee. This is completed and recruitment of additional patients has been initiated. We will keep you posted on the progress. To put our glioblastoma opportunity into perspective, the current standard of care drug, temozolomide, is an alkylating agent. This means alkylators are today considered to be the most effective drug class to use in glioblastoma patients. Glioblastoma is a sturdy and cold tumor. And so far, for example, immunotherapy has been very difficult to get to work. Despite the treatment with temozolomide, the prognosis is poor and the unmet need high mainly due to 3 additional barriers. Poor delivery, only around 30% of the drug crosses the blood-brain barrier and reaches the brain. Limited potency, it has relatively low cancer killing power. This is partly due to the last barrier, which is high and rapid resistant development. The tumor cells quickly adapt and learn to repair the damaged temozolomide [ causes ]. In fact, 60% of the patients do already at diagnosis, have the mutation that is supporting the tumor to repair the single stranded DNA damage caused in the nucleus. All glioblastoma patients need new treatment options, but these patients do have a high need already in the first line. Our PDCs do kill through alkylation, but it's engineered to overcome all 3 challenges. In preclinical testing, it demonstrates 100% blood-brain barrier penetration. In vitro and in vivo trials demonstrate high glioblastoma cytotoxicity that seems to be independent of the most common mutation for DNA repair. We do believe this is due to the high blood-brain barrier penetration in combination with the dual mechanism of action, damaging DNA double-stranded in the nucleus and in the mitochondria, allowing the PDCs to overcome resistance development. This makes our PDC a uniquely differentiated alkylating drug candidate designed to overcome the most barriers -- the most common barriers and treat hard-to-reach aggressive brain tumors where other therapies fall short. If we succeed, we have the opportunity to make a huge difference for patients, which makes me excited about this program. To summarize, Q2 2026 has been marked by strong execution across all fronts. 62% revenue growth in Q2 compared to the same period last year, a strengthened cash position supporting our pathway to 2027 cash flow positivity, regulatory submission to EMA with a purpose to potentially double the number of addressable patients and increase treatment duration, strategic partnership expansion across 11 CEE markets and clinical progress in glioblastoma, targeting a disease with a very high unmet need and the growing global market potential.

Thank you for your time, and we will now open the line for questions. [Operator Instructions] The next question comes from Richard Ramanius from Redeye.

First question is about the sales situation in Spain. How do you see that working out over the next part of this year?

So as I said during the call, we did see a level up in Spain towards the end of the quarter. And it's uncertain, to be honest, about access to HCPs in the second half of the year because there is no clarity on if they will start to strike again. What we do know is that there is no resolution to the issue and that in terms of HCP availability during summer, that has been tough if you read in media, et cetera. Our tactic has been to engage the top experts to ensure that even though we don't have the same access and even though the competition is fierce, they always recommend capacity in the right position. And we have been working really, really hard and have several initiatives and projects running together with all the top KOLs in Spain. And I believe that is what we start to see impact of at the end of Q2. And we will obviously continue, as I said, with these collaborations and these projects to ensure that we maintain the momentum we have.

Okay. And then I was wondering about the collaboration with Salus Group. When do you think that can start to generate revenue?

Yes. So as I said, the first milestone is to get a list price in Slovenia because Slovenia is referencing Germany. And that means that the full region of CEE will look at the German or the Slovenian list price. But when it comes to launch sequence, even though Slovenia is a small market, that is also the first market where we negotiate price or where Salus will negotiate price. And they -- that process is ongoing now. And it's always tricky to know exactly how it runs because price negotiations can be unpredictable. But I think it's fair to say that first sales should come sometime in 2027.

Okay. Then a final question about finances and more specifically operating costs which came in above as I saw in the graph. But should we expect them to decline a bit towards trend in the next quarters this year?

Yes. Richard, thank you for that question. So what we have communicated earlier is that we expect the full year operating expenses to be in the vicinity of what we had for 2025, i.e., around about SEK 300 million. Now then the split between the quarters varies a little bit where typically Q2 and Q4 are more heavy weighted towards cost due to congresses. So mark that full year expense guidance from us and also mark how you can expect the quarters to vary, which also means that, yes, we expect Q3 to be slightly lower than Q2.

[Operator Instructions] 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.