Pharma Mar Aktie

Welcome, everyone, and thank you for joining the PharmaMar H1 2026 Results Presentation. My name is Yapel, and I will be coordinating your call today. I will now hand over to your host, Jose Luis Moreno, Head of Capital Markets and Investor Relations. Please go ahead.

Thank you, Gabi, and good morning, everyone. Thank you for joining us today for PharmaMar's First Half Earnings Conference Call. On the call with me today are Maria Luisa Alstantia, Chief Financial Officer; Luis Mora, Managing Director of PharmaMar; and Pascal Besman, our Chief Strategic Officer. And as we always do, after our comments, we'll open the floor to your questions. And before we begin, please note that certain statements made during this call might constitute forward-looking statements. And these statements are based on our current expectations, and actual results might differ materially from those projected. So our full safe harbor statement is available in the corporate presentation on our website together with the press release and the results reported that we issued yesterday. We undertake no obligation to update these statements, except as required by the applicable law. Well, I have to say that we're very e about the growth of our recurring business in the first 6 months of the year, particularly given that this growth was achieved even before the commercial sales of Zepzelca began in Europe.

So as you know, Zepzelca was only approved in Europe in June, and we began commercial launch in Germany and Austria in July as the first 2 countries that we're starting to commercialize in Europe other than Switzerland, of course, as you know. So we believe these results clearly demonstrate, a, the underlying strength of our business; and two, the quality of the revenue growth that we're delivering. I will particularly highlight the strong growth in royalties, especially those from Zepzelca in the U.S. which increased by more than 50%. So this is reflecting the strong commercial traction of the product following its launch in the first-line maintenance setting. But beyond the financial results, this has also been a particularly important period for the company, for PharmaMar. We are -- as we like to say, we are in the middle of our transformative period this time. I mean the approvals of Zepzelca in the U.S. in October in first line in October last year and in Europe in June this year, first-line maintenance are major milestones for us to not only mark a significant advance for patients by providing an important new treatment option, but also considerably expand the commercial opportunity of Zepzelca.

In particular, the launch in Europe opens a new source of growth that we expect will boost our recurring revenues. So this revenue growth, together with the stronger cash generation will help us to accelerate the development of our other pipeline assets and in-license new assets as we will see now with one of our goals being to have at least one registrational trial underway by the end of '28 or '29. So with that, I will hand over to Maria Luisa, who will walk you through the financials in more detail, and then Luis will provide an update on our development plans.

Thank you, José Luis, and thank you all for joining our earnings call for the first half of 2026. To understand the difference in results between the first half of 2026 and the first half of 2025, it is important to consider 2 significant items recognized in 2025. First, EUR 20.7 million of nonrecurring revenues corresponding to the recognition of the upfront payment received upon signing the license agreement with Merck. -- and second, EUR 14.7 million recognized under the heading other gains, losses net corresponding to the grant awarded to Cellentis. These 2 items largely explain the difference in EBITDA between June 2026, EUR 3.5 million and June 2025, EUR 25.1 million.

However, the first half of 2026 showed a strong performance in recurring revenues. So net sales from Zepzelca increased by 23%, offsetting the decline in sales. In addition, royalty income increased by 46% overall, driving by a 50% increase in Zepzelca royalties and a 30% increase in Yondelis royalties. This strong growth in recurring revenue has substantially mitigated the impact of the nonrecurring revenues in prior year. As a result, total revenues reached EUR 92.5 million in the first half of 2026 compared to EUR 95 million in the same period of 2025. just 3% lower. Looking ahead to the second half of the year, recurring revenues will be boosted by the start of commercial sales in the European Union, where marketing began on 1st July in some member states. Similarly, we expect to see sales continue to rise in other territories where Zepzelca has also been approved, meaning that royalties will also increase. On the cost side, R&D expenses remained broadly in line with previous year, while selling and marketing expenses increased in preparation for the European launch of a -- to conclude on the subject of expenses, I would like to point out that, as mentioned earlier, the EUR 15 million Cellentis grant was recorded in 2025 under the heading other gains, losses net.

As a result, 83% increase in operating expenses between the 2 periods has been reported. Excluding the impact of the grant in both periods, the increase in operating expenses would have been by approximately 11%. Let me conclude with 2 additional points that I believe are particularly relevant. First, the company generated positive operating cash flow of EUR 11.9 million during the period. And second, net cash amounted to EUR 126.4 million at the end of June 2026, representing a 4% increase compared with 31st December 2025. At the same time, debt was reduced to EUR 43 million, 8% lower than at year-end 2025. And I will now hand over to Luis Mora.

Thank you, Maria Luisa. As the approval of Zepzelca for first-line lung cancer will be transformational for the company. multiply our revenue in the coming years, allowing us to accelerate development in our pipeline and incorporate new assets. This first quarter revenues from Jazz are expected second quarter revenue. In Europe, where we launched in Germany and Austria in July, initial adoption has exceeded our expectations.

In fact, the rapid adoption in both the U.S.A. and Europe should not be surprising for us as both Atezo and Lurvy are well known to physicians with clinical data in small cell lung cancer for more than 6 years as well as the expanded access program we have managed in different and across different European countries. You can see the exceptional compassionate use results this quarter as an indicator of the physician enthusiasm. We have already submitted pricing and reimbursement dossiers in many European countries, where we expect that within a year, any European patients will have access to this innovative treatment. The SALUO trial is fully enrolled and the data will be available in the first half of 2027. This is an indication with fewer patients than small cell lung cancer. However, if we obtain the results we expected and which we saw in the [indiscernible], the number of cycles could be double compared to small cell lung cancer. Therefore, it is a good additional indication in area where we have a 20 years presence, knowing all the key opinion leaders and have established a good patient partnerships. We can expect a rapid and significant adoption, especially since the standard of care has not changed substantially in the last 4 years.

Furthermore, if approved in Europe, we will obtain an additional year of market exclusivity, then we move from 10 to 11 year market exclusivity. Regarding the pipeline with P54, we have already enrolled 120 patients in solid tumor trials to date. And the first clinical trial data will be presented at the poster at ESMO for the first Phase I dose range cohorts. We expect to begin a trial later this year in the last quarter with centers in the Europe and U.S.A., investigating different doses and dosing regimens, indications and combination to accelerate development, and we expect it to be in one or more registrational trials in 2028. The main indications for now are liposarcoma, mesothelioma, small cell lung cancer and melanoma. Regarding PM-534, we already dosed more than 60 patients with various doses and infusion regimens are observing encouraging things in head and neck, esophagus lung and sarcomas. We expect to have the first clinical data to share in 2027. And now Pascal will address you some items about business development progress.

Thank you, Luis. Good day to all on the call. Regarding business developments, the increasing cash flow and revenues, which Pepe, Maria Luisa and Luis referred to are going to allow us to prosecute a much deeper BDL strategy. We're going to continue to look for our late-stage assets to layer into our European commercial infrastructure. However, in addition, we will also be looking to complement our R&D efforts by looking at pipeline assets that fit into solid tumors. That doesn't mean we're going to do a deal at any price. We are going to retain our discipline to something that makes sense, delivering a positive return on investment for our shareholders. But currently, just to give you a little taste, we are engaged in a conversation with a company for a very synergistic late-stage asset in solid tumors for Europe. And we're also engaged in a number of pipeline assets to layer in usually for EU only, but we would look at rest of world. The modalities we are considering include small molecules, antibody drug conjugates, monoclonal antibodies. And of course, we are looking actively with multiple potential partners in China. Of course, I'm not going to offer you any comments on timing or probability or other things because my crystal ball doesn't work. However, I would assure you that we do have serious intent and the balance sheet to support the strategy so as to close a deal or deals in the near future. With that, let me pass the microphone back to Pepe.

Thank you, Pascal. And well, with this, we conclude our speech today, and we open the floor to questions. Kabi?

Our first question today is from [indiscernible]. We will now move on to -- the next question is from Ami Fadia from Needham.

Congrats on a nice quarter. My first question is if you could provide some color on how we should expect the ramp in Europe to be over the next year? I believe it was mentioned that you expect most of the pricing negotiations to come through over the course of the next year. And then so if you could give us some color on that, it would be helpful. And maybe as you're doing that, give us a sense on how you think that the market in Europe is going to look at Lurvy versus competition from Tara, how that may be different in Europe compared to the U.S.? And then I've got 1 or 2 other questions.

Right. This is going to be a question that's going to address Luis. But before we continue to let you know, I don't know if there's been some cut on the line. So I don't know if there's been any questions prior to that one. please. If there has been, please -- when we finish this one, we'll take that question. And apologies about that. We had some issues with the line. So Luis, will you take the question about the ramp-up and what we can expect about the sales in Europe?

Well, we never send guidance about that, but I can explain to you. The market access of enrollment is already addressed in practically the 80%, 90% of the European market. we expect that is a rapid adoption by the physicians like Germany and Austria, we observe and to grow very fast. But you can understand not all the countries are the same. We expect that in a year, have at least 95% of the European market already approved for reimbursement. Regarding the different -- the most important countries if we speak about the important countries by the size of the market is Spain, France, Italy and Spain. We expect to have full reimbursement for these countries in spring next year in order to grow faster in 80% of the market. The other smaller markets like Belgium, Portugal, Greece Croatia, et cetera, the timing for market access are completely different, okay? But we expected a rapid adoption. In fact, what our internal assumption is to have an important market share in Europe in the last quarter of '27.

Could you also address how you see the competitive landscape in Europe being different compared to the U.S., especially in the context of To?

In Europe today, the most important competitors we have, some are already reimbursed 2 Chinese products but they are approved in all the indications, induction and maintenance, atezolizumab and cprolimab. And this is the 2 competitors now. But we don't observe in these 2 products until today, the many big impact in the use by the physicians in this setting. I want to remind you the label we achieved is maintenance therapy, okay? And maintenance therapy is not especially in this setting, the unique drugs approved today is a combination rbinectedin plus atezolizumab. Regarding the other potential competitor, taflatamab, we don't expect that until even if the trial is positive and achieved the reimbursement in different countries u in Europe until '28 in the second half of '28.

That's helpful. Can you comment on the potential trajectory of the sales and marketing expenses? We've seen a slight step-up in the level of spending in the first half of the year. Could the second half reflect the same level? Or do you expect that to step up a little bit more?

We expected no. In fact, we expect a little less in the second half than the first half, taking account in the first half. We attend many meetings, ASCO, et cetera. All the team for the sales force and medical affairs across the Europe was already joined in the first half. You're seeing this is increased expenses to achieve these new enrollments. But we don't expect that -- we expect a lower in the second half. ESMO, European congresses in Madrid, okay? That is less expensive for us.

That makes sense. And any comment on R&D expenses? Is it likely to remain at the same level as the first half?

Yes. In the second half, we expected in the same level in the first half. Even if the pivotal trial, SAUDO trial and LA trial was already finished or finished enrollment, you see the expenses continues in the following months because many patients are still under treatment, and we can't close the trial. And this ambitious new platform trial with PF54 to increase the number of trials with PM534 will increase in the last quarter of this year. Then what we expect that is a similar figures in the second half than the first half regarding R&D.

Got it. Just the last question for me. I appreciate the comments on the business development pursuit. -- maybe you can comment on how large of a size of transactions you'd be willing to do as you consider a late-stage or in-market asset for Europe?

Yes. Ann, we're not looking for what most people would call a blockbuster because our niche is niche assets. And so we expect that our current balance sheet would allow us to use an upfront payment up to, let's say, $100 million without any stress. Of course, with an earlier-stage asset, you tend to have a much lower upfront and more milestone payments down the road. So we're probably looking at drugs that would have peak sales of $300 million or less.

Our next question is from Kambiz from BTIG.

Congratulations team. My apologies, I had a few technical difficulties. So if I missed any of Amy's questions, please just skip them. Maybe 3 questions for me. I was impressed by the EU compassionate use revenue growth kind of primarily driven by France. Kind of once you have formal reimbursement secured, how do you expect compassionate use revenues to transition to formal sales? -- maybe in terms of Saludo and the LMS opportunity, how should we think of that end market in comparison to first-line maintenance? I'll pause there.

Okay. Regarding -- thank you for your question. Regarding the compassionate use, this incredible increase in sales in France are because the French authorities is open in the compassionate use program in the first-line treatment after the EMA approved. Then obviously, the physicians is a huge medical need, that are very good, and they adopted this first-line maintenance therapy in France.

This is the reason why we grew about 40% regarding last year. But by law when the drug is approved in Europe, in France, you close the compassionate use and move and the new figure is accès précoce. This access will start we expected in October -- September, October, the compassionate use will be finished, then will not a window for the patient. The patient will continue on the treatment, but close compassionate use, open the accès précoce. In summary, the accès précoce is the same compassionate use, but it's a different figures by law in France. And this accès précoce, the companies will be maintained until you have a pricing and reimbursement official one in France. Regarding the SALUO trial, the lomosarcoma first line, is seeing a huge opportunity for the patients and for the company. I will remember the SALUO trial combined in first-line Zepelca plus doxorubicin in 2 arms, high dose and low dose. If we compare this trial and this a combo with trabectedin, now it is in the NCCN guidelines. This was a trial conducted in France by Patricia Pautier. The jump in PFS from 6 months to very close to 12 months. 12 months represent about 15 cycles, 14, 15 cycles treatment.

I want to remark Zepzelca in second line was approved in U.S.A. in many countries and the cycle was 4. In first-line maintenance, the man of cycles is 7. Then if the SALUO trial showed a similar figure than travectedin, we expected about 12 to 14 cycles. then -- and this is very -- is about 3x -- more than 3x than the second line non-small cell lung cancer are double than first line. Then even if the potential number of patients in Europe every year is 4,500 patients with LEO U.S.A. about 2,000, 2,500. But if you see the number of cycles, this indication is very important for the future revenues.

Any more questions?

We will now move on to text questions. So I will hand over to Jose Luis Moreno. Please go ahead.

Thank you, Gaby. We have a few questions. We have some questions from Joe from Rx Securities. Joe, we're missing you on the call today. he couldn't make it on his questions. First question says, could you please restate your expectations for the length of exclusivity for Zepzelca? I guess in Europe because in the U.S., it's a question for.

Well, in Europe, the exclusivity is 10 years. We have an orphan drug status. If the unit track achieved the orphan drug status of today in maintenance therapy, then it's 10 years. The potential extension is 1 year more if we achieve the approval in lomoosarcoma in first line. Then in summary, if all goes well, we will arrive at 11-year exclusivity.

Thank you, -- so another question from Joe. So we recorded 4.8 licensing revenues in Q2. What is the expectation for the remainder '26 and how much deferred licensing income after all?

The licensing revenue that we recorded in the first half is EUR 7.1 million. And for the rest of the year in the second half, we have some -- we expect it will increase because there are some milestones that could happen. And that's all I can say about it.

The rest of the milestones are not disclosed, so we'll see. We have some other questions about lurbinectedin from someone else.

I will translate as a read. How do you think it could affect or it has any impact the joint clinical assessment of lurvinectedin for the reimbursement in Europe?

Well, the GCA is already public. And you can see until now, our contact with different regulatory authorities in different countries regarding the market access is not impact. We have -- it's not bad. It represent the same the same -- refer to the same figures you can see in the part in the EMA. Fortunately, in this JCA, we only have one arm is the same that the clinical trial. Then until now, we are not observed any impact regarding the joint clinical assessment. Thank you, L.

There's got a few questions, of course, about the launch in Europe and question related. They're also asking about the inclusion of Lurbine first line in Switzerland is approved in second line and they say how are things going to get approved in first-line maintenance?

Well, if the question is regarding the reimbursement for the first line, the negotiation is ongoing. The unique part was waiting was already launched in Europe in the 2 presentations, 4 milligrams and 2 milligrams in order to reduce the waste -- and in Switzerland, we expect the approval in the 2 milligrams vials in September in order to continue the negotiation. We expect it to close at the end of the year. But in any case, under the Article 71 in the Swiss law today, the drug is reimbursed.

Talking about Switzerland as well, there was a question in relation to the difference between the revenues in Switzerland, the first quarter last year and the first quarter this year.

Well in the commercial setting, the sales are growing if you compare this year with 2025. In '25 was one shot order by a big wholesaler. Usually, this one shot order was a big one, about 7 million 6 million was probably for some clinical trials, some companies around the world, and they bought this huge quantity in order to send for these clinical trials. But the commercial point of view, we are so happy that sales grew more than 35% in Switzerland.

Price. I know more about the European launch. There were questions about the price we're currently selling in Germany and Austria and well, particularly referring to Germany. And the question is like if we can expect the reimbursement price, final price to be a similar price to the price we're currently selling now.

Well, this is a public information. In the first 6 months in Germany, you sell the drug at the free price. The first 6 months, you don't need to return the difference is the final agreement are below lower than the launching price, the product. Always all the drugs, the drugs are lower price or confidential discounts in the negotiation. But I cannot advance anything because the negotiations will start in probably in November, December, and they probably 6 months, 7 months negotiation is a normal process.

Okay. So more about this, is not only about Germany, but the rest of other countries in Europe. They are asking about what do you think it could be the timing of the approvals, which countries do you think is going to be approved first after Germany, of course. And when do you think you could get approval in Spain?

Well, in Spain, we are already -- I can address you a huge collaboration with the Spanish authorities. We already had several meetings with them. The process is ongoing. And if all goes well, we expect that in Spain to launch the product under reimbursement in -- probably in December. This is our expectations. I think the collaboration with the authorities are so good, and we expect that in December, finally, the drug will be available in all the Spanish hospitals.

Okay. I think we've addressed this one, but if you want to add anything, say, how do you estimate the change in France from second line to first-line maintenance?

I already answered before.

Nothing else to add to this one. Yes. Going back to Germany, there's a question about the impact from the German reform and the impact on the price. I mean we have taken this into account when negotiate.

In Germany, the law is not already approved. Then we don't know what will be the final tax will be approved. In the draft in the law are included the increased the manufacturing discount from 7% to 15%. For the orphan drugs, before this draft, if you potential sales are below EUR 50 million, you don't need to present pharmacoeconomic dossier. Now they reduced under this law until 30 million. And under this law in the future, if you conduct clinical trials in Germany, you have some premium for the final. But the law is not already approved.

We have 2 more questions or 3 in regard to what they were asking or requesting if we could do. A guidance on future revenues or future income. As you know, we do not -- currently, we're not giving guidance. And I mean the reasons for that. I mean the fact that first part of our -- an important part of our revenues are coming from our partner in U.S., which is not giving those guidance by product. So we're not going to do it.

And also, we're in the middle of a reimbursement process in Europe. So we don't know what the prices are going to be and everything. And we think at this stage, it's prudent to not give this guidance. In any case, Luis has given some hints about what we expect the OpEx could be in the following years. Also, we provide some information to help people to work out or try to model what the revenues could be. There's a presentation about the incidence, number of cycles, total population that we could address to. So it's not that difficult to work it out. But as you'll understand, we're not giving guidance at this stage yet. We also had another question, which I'm going to take as well about the share buyback program. As you know, we started a share buyback program in 1st of July.

We're currently doing it. So we don't give an update. We give -- we're not giving -- other than the periods we do. We do update once a month, and we're doing in writting. So whenever we have those updates, you'll see that every month. And I believe that with this, we finish all the questions for today. Thank you. Thank you very much, and thank you to all of you for joining, and thank you to the team for taking all your questions and for your time. And with this, we conclude our speech today, and thank you very much, Gaby, for your help and your assistance.

Thank you. This concludes today's PharmaMar H1 2026 results presentation. Thank you for joining. You may now disconnect your lines.

Hello, everyone, and welcome to the PharmaMar LAGOON Trial Conference Call. My name is Carla, and I will be coordinating your call today. [Operator Instructions]

I would now like to hand the call over to José Luis Moreno, Vice President, Head of Capital Markets and Investor Relations, to begin. Please go ahead when you're ready.

Thank you, Carla, and good afternoon to everyone, and thank you for joining us today for the LAGOON trial conference call. On the call with me today are Luis Mora, Managing Director of PharmaMar; José Antonio López-Vilariño, Global Product Lead of Oncology; and Pascal Besman, Senior Vice President of Strategic Development.

And after comments, we will open the floor for your questions, and we will take the written questions. Let me just make -- mention that all these written questions, questions only related to the topic today, which is the LAGOON trial. And before we begin, please note that our full safe harbor statement is available in the corporate presentation in our website, together with the press release about the results of LAGOON issued on Friday. And we undertake no obligation to update these statements, except as required by the applicable law.

Pascal?

Thank you, José Luis, and good morning or good afternoon, depending where you are. I'd like to make 4 quick points to make sure they are well understood by everyone, even though they were included in the press release we put out on Friday.

The first one is that we stated clearly, I believe, that we did not meet the primary endpoint, which was overall survival of lurbinectedin monotherapy versus the control arm. And as of today, with not complete data, what we can say is you can control a lot of things in a clinical trial, but you can't control everything. And in this case, point number two, the results were very surprising to us given the strength seen in the control arm, fully 30% better compared to all historical trials, as quoted in the press release.

Number three, the safety was better than the control, consistent with prior studies and real-world data with no new signals. As of today, we believe that given our recent approvals in the first-line maintenance setting that the revenue impact for PharmaMar will be modest. And lastly, we do not expect any impact to our first-line approval and that regulatory reviews that are currently underway in the first-line maintenance setting will not be affected as well.

To summarize, we are fully focused now on the first-line launches.

With that, let me turn it over to Dr. López-Vilariño to go over some of the clinical information that he can share. Thank you.

Thank you, Pascal. Good morning, good afternoon. I will just make a quick review on the protocol design, just as a little reminder of what we are talking about. The LAGOON trial was a Phase III randomized trial in relapsed small cell lung cancer. Patients to be included must have received a prior platinum-containing line with or without an anti-PD-1 or anti-PD-L1 agent as per standard of care in first-line small cell lung cancer when the LAGOON trial was designed. Patients with a chemotherapy-free interval less than 30 days were excluded, and patients with ECOG 0 to 2 were included.

At the moment of randomization, patients were randomized into 2 different experimental arms. Arm A was lurbinectedin as a single agent at 3.2 milligrams per square meter, given each 3 weeks. Arm B was the combination of lurbinectedin plus irinotecan. And Arm C was the control arm, which was an institutional choice between topotecan given either orally or IV or irinotecan given at 350 milligrams per square meter each 3 weeks as per the last clinical trial in which irinotecan was used as a control arm, which was the distinct trial, irinotecan was used.

Patients were stratified according to CTFI, meaning chemotherapy-free interval between sensitive and resistant, according to the fact that they had received prior treatment with IO, according to LDH values, upper or lower normal limits, according to CNS involvement and of course, according to the investigator preference for the control arm. The primary objective of the trial was overall survival, and the secondary endpoints were the usual ones, PFS, response, duration of response, safety and of course, patient reported outcomes.

I must say that the trial was conducted impeccably in all aspects. And as I've said, the primary analysis was the comparison of overall survival between the monotherapy arm and the control arm. As Pascal has said, this did not meet the primary overall survival endpoint, making any further analysis exploratory.

And that's the end of my part.

Okay. So with this, we'll conclude our speech today, and we'll open the floor to questions. Carla?

[Operator Instructions] And our first question comes from Ami Fadia with Needham.

My first question is if you could elaborate a little bit on the impact on revenues? So it's obviously -- the market is moving towards utilizing Zepzelca in first-line maintenance, and that's where the growth opportunity lies. Would you anticipate any impact on a temporary or a short-term basis to the utilization in second line as -- while the first-line maintenance utilization ramps up? So that's my first question.

And I have 2 other quick ones.

Fadia, I'm Luis. Well, regarding U.S.A., Jazz has included in the press release. Jazz has not modified the guidance they show in the very beginning of this year. Then for our part, this is a U.S.A., Jazz territory. Jazz said, don't modify the guidance regarding the revenues. Regarding Europe, the impact in the short term is not impact. We are -- the indication approved is in first line. Our effort is in first line. All the market access are ongoing in the first line, then we don't expect any impact in our potential revenues in the next years for this setting.

Relating other territories, probably the more relevant territory is China. And China, according to our partner, it's Luye, it said, lurbinectedin, the approved indication, clinical use, patient access and ongoing medical communication in China, are not affected on this LAGOON top line results. The product, the federal conditional approval from NMPA in December '24, and this approval status remains valid. I want to remark our partner has conducted a local pivotal trial in China as a confirmatory trial for this approval. Then we don't expect it in our potential revenues, these results come from the LAGOON.

Got it. That's helpful. With regards to the agreement with Jazz, was there any anticipated milestone following this data readout that we should just be aware of for modeling purposes?

Well, we never disclosed the milestones could come from our partners. But I want to remark the drug was approved in 2020, conditional approval for second line and was approved last year for first line in the same indication.

Okay. And maybe just a broader question. As we think about the activities that are ongoing currently for the pricing negotiations, et cetera, in Europe. Can you just talk about the latest progress in terms of that and how we should anticipate some of the commercial activities ramping up in Europe and where we should anticipate revenues coming in from?

Well, all the activities are ongoing as planned. Our dossiers for pricing and reimbursement are ongoing in different countries in Europe. The data for submission after we received the approval from the European Commission are on time. The first country where we will launch the product will be in Germany. In Germany, as a special condition, you can launch the drug free price. Then this is the first country, Germany and Austria. In the rest of the countries, depending on the timing of negotiation pricing, we will sequentially launch -- we will launch the product, but all is ongoing as planned before and with not affected the LAGOON trial, IMforte trial based in first-line approval. In fact, the population is different. But to remark, the IMforte trial is a combination trial of atezolizumab and is first-line maintenance therapy. This is totally different than second line.

And the next question comes from Joseph Hedden with Rx Securities.

I'm just wondering if I could dig a little further into control arm, if possible. So I'm just wondering if you have the information on what proportion of patients got topo and who received irinotecan and whether you saw any meaningful difference in the overall survival between the 2 agents? And then is there anything else in the control arm that might explain its much better-than-expected performance, such as availability of supportive therapies or imbalance of subsequent lines of treatment, et cetera?

Yes. Thank you for this question. Yes. At this moment, we are reviewing all this data, as you could perfectly imagine. In terms of balancing between the control arm, there is no real big disbalance between both options being nearly half and half of patients receiving topotecan and irinotecan. And as I said, at this point, we do not have a clear explanation on this. It's true that, by way of comparison, in the most recent Phase III clinical trials in relapsed small cell lung cancer, in which not only topotecan, but some other options have been used as a control arm. It's pretty well known that the median overall survival, generally speaking, is around 8.3, 8.4. So the control arm of the LAGOON trial was over around 25% to 30% higher than the average of the last clinical trials that have been performed in this setting.

Okay. And then perhaps does this -- do you suspect this result will impact the compassionate use program in France and perhaps the sales that you see there before you see a first-line launch in that territory?

Thank you for your question. In principle, no. The compassionate use in France is ongoing in second line. But now the situation in France changed from the recent approval in first line. Then when the drug is approved in any line, in France, is -- accordingly, the procedures start the accès précoce is different model than compassionate use, but in first line. Then if we take into account the final study report of the LAGOON is -- we don't have already, probably takes several months. In this period of time, the accès précoce in first line will be open in a few weeks. Then these new accès précoce will substitute the compassionate use in second line. But this is independent of the LAGOON result. This is the procedure.

[Operator Instructions] The next question comes from Kambiz Yazdi with BTIG.

Have you or Jazz had any preliminary communication with the FDA about the status of 2L accelerated approval following LAGOON? What are kind of reasonable time frames around 2L U.S. labeling discussions?

Well, in that release that was included that the top line was already shared with the FDA. But now it's just [ rhetoric ], but in this -- the final study report I explained before, is not already finished yet, probably takes several months, is normal in this type of clinical trials, but never there's any kind of time line about these potential discussions.

What is interesting of this trial, and I want to remark, the p-value is not positive in favor of lurbi, but even is not in favor in the control arm. Arm is very important. The safety profile in the lurbinectedin arm is much, much better than the control arm. Then in any case, the patients can receive lurbinectedin in the point of view of the safety profile is much better and non-detrimental in the efficacy. But in any case, this will be a discussion with our partner and the authorities.

And the next question comes from Juan Ros with ODDO BHF.

I'm sorry, I just had a trouble connecting. So maybe they were made already. In any case, I just want to know if the payers are already reacting to the LAGOON data? Or maybe do you expect any kind of reimbursement issues in the short run? Or do you expect it to remain unchanged until the FDA provides a formal review? And also, maybe, I want to have your opinion on physician confidence on Zepzelca in first line after the second-line monotherapy reading. Do you think it could be impacted at all?

No, thank you for your question. In the first-line setting, the market access process and procedures, even the joint clinical assessment, is never affected. It's not for this second-line trial because it's a different population, et cetera, et cetera. Then the impact is zero. Regarding other countries where the drug is already ongoing in this type of market access in first line is the same setting. What is interesting in this is what will happen with the potential new drugs are today in the same process in second line for market access. And if the HTA will be take in account this new data for topotecan, this, I don't know. For these, other drugs are actually in this process.

And regarding the second part of your question on the physicians' confidence on the efficacy of lurbinectedin in the first-line maintenance, it is important to point out that the first-line maintenance data and the study, the IMforte study, has been performed in a different setting, with a different population, which is first-line maintenance instead of the LAGOON trial, which is second-line relapsed small cell lung cancer.

And the next question comes from Jaime Escribano with Santander.

One question from my side. So in terms of next steps with the FDA, so my first question would be, we assume that Zepzelca will continue to be sold in the U.S. in second line until at least the FDA makes a decision. And how many months or how is the process? Maybe if you can elaborate a little bit on what are the next steps in terms of the discussions and when the FDA could decide anything?

And then maybe a second question. Did you have the opportunity to speak with Jazz to understand how much of Zepzelca sales in the U.S. are coming from first line and how much in second line? Because I presume there is a cannibalization and probably most of the patients are being treated in first line. So I wonder what is the impact in the end, the real impact in second line in Zepzelca U.S. sales?

Thanks, Jaime. In terms of the playbook for the FDA, this is not something that's got a playbook. There is no set time lines written or statute that you must make a decision by the 6 months or anything like this. So thinking aloud, just generally speaking, not in this case, as Luis has already said, we don't have the complete study report yet, and we won't for probably 3-plus months. At that point, we need to understand what's in the report, but more importantly, Jazz does. And at that point, it's submitted to the FDA, and then they need to understand what's in the report.

At that point is when if there are going to be discussions that they would begin. But how long they last, I can't tell you. I can say that in every case in the last 15 years where a drug has ended up getting withdrawn, it's been a relatively drawn-out process accumulating from 1 to 4 years unless it was voluntarily withdrawn very promptly.

Regarding the second question, the percentage of Jazz's sales in the second-line setting, I'll let Luis answer that one.

Well, it's not disclosed what the number of patients in first line or second line. What we say is that you see the first quarter sales increased by two figures. Then this is represent the big efforts for Jazz in U.S.A., obviously, is in the first-line treatment where it demonstrated very good clinically meaningful results. But we don't have this disclosure between first line or second line.

[Operator Instructions]

Thank you, Carla. We've received quite a few questions in written. Some of them have already been answered. Most of them are in relation to topotecan or if these results may affect the approval in first-line maintenance, which have already been answered. But since we've received quite a few of them in this regard, I'll ask Pascal, if you want to repeat what we've mentioned about the first-line maintenance?

Thank you, Luis, and thank you to people who've posted those questions. The second-line approval has no impact on existing approvals in first-line maintenance and it's not going to have an impact in those, even those that are ongoing deliberations on a regulatory level currently, each trial has to stand on its own 2 feet. And especially in this case, where the safety profile was actually better, there was no harm done to patients. We expect there to be absolutely no regulatory impact from this other than in the second-line setting, which is primarily in the United States. Thank you.

José Luis?

Thank you. And yes, again, a lot of questions or comments about topotecan. It's been a surprise, the outcome of the control arm. So José Antonio, if you want to have any further comment on this?

Yes. Yes, it's true that, as I've said before, the control arm of the LAGOON trial has outperformed in a way that has never seen in the most recent clinical trials in which topo or irino has been used as comparators. Nevertheless, although the LAGOON trial did not meet the primary objective, the comparison between lurbinectedin single agent and the control arm was not detrimental against lurbinectedin. And importantly, safety profile of lurbinectedin was much better than the one of the control arm with around half of, for example, treatment-related adverse events, Grade 3, 4, when compared to those of topotecan.

Thank you, José Antonio. We've received other questions about the commercial prices in Europe and how the reimbursement is going, which Luis has addressed already. And we received some others not related to the call today. So we'll be happy to answer all these questions offline in our phone or e-mail. And all the questions in regard to the trial today are done.

So with this, we conclude our call today. Thank you very much for joining. And Carla?

Thank you. This concludes today's call. Thank you, everyone, for joining. You may now disconnect. Have a great rest of your day, everyone.

Hello, everyone, and thank you for joining the PharmaMar Full Year Results 2025. My name is Gabriel, and I will be coordinating your call today. [Operator Instructions]

I will now hand over to your host, José Luis Moreno, Head of Capital Markets and Investor Relations. Please go ahead.

Thank you, Gabriel, and good morning to everyone, and thank you for joining us for today's PharmaMar Earnings Conference Call to discuss our 2025 Financial Results. On the call with me today are María Luisa de Francia, Chief Financial Officer; Luis Mora, Managing Director of PharmaMar; and Pascal Besman, the Senior Vice President of Strategic Development. After our comments, we'll open the floor for your questions.

And before we begin, please note that certain statements made during this call may constitute forward-looking statements, and these statements are based on current expectations, and actual results might differ materially from those projected. A full safe harbor statement is available in the corporate presentation on our website and together with the press release and the results report issued this morning. We undertake no obligation to update these statements, except as required by the applicable law.

All right. Well, I'm pleased to say that 2025 was a very strong year for the company with clear progress, both strategically and financially. Strategically, a key milestone in 2025 was the U.S. approval of Zepzelca as first-line maintenance therapy in October. And this, of course, represents an important step for patients and a meaningful catalyst for the business.

Financially, we delivered very strong -- very solid performance. Revenues grew 27% year-on-year, reflecting strong execution and the increased scale of our business. Our top line growth translated into a significant step in profitability with EBITDA up by roughly 5x versus '24 and net income up 187% year-on-year. Importantly, we achieved these results ahead of the expected European approval for Zepzelca, which is granted, it should provide an additional tailwind to revenues and further reinforce our growth trajectory.

And with that, I will hand over to María Luisa to walk you through the financials in more detail. And then Luis Mora will update you on our development plans for the years ahead. María Luisa?

Thank you, José Luis. Good morning, and thank you all for joining us in the 2025 results conference call. Regarding the financial statements for the year just ended, we would like to highlight the following points.

First, a substantial increase in revenue from all of the company's sources of income, sales plus 20%, royalties plus 4% and licensing revenues 66%. We expect this trend to continue in 2026 with growth in sales due to the potential approval of Zepzelca for Europe and also growth in royalties due to the approval of Zepzelca as a first-line maintenance treatment last October, which will increase sales for our partners in the U.S. in 2026.

Another point is the maintenance of R&D expenditure at the same level as last year and in line with our expectations for next year with the projects we are involved in, which Luis Mora will detail below. We had also a slight increase in operating expenses, for example, in commercial expenses, where activities have been carried out to prepare for the eventual launch of Zepzelca in Europe in 2026. This increase has been -- this increase in expenses -- in operating expenses has been partially netted out by the European grants obtained its first the Sylentis project.

All the above has led to EBITDA of EUR 68 million, approximately 5x that of the previous year, as José said before, and to a net profit of EUR 75 million. Finally, and also noteworthy is the generation of operating cash flow amounting to EUR 53 million. This has enabled us to close the year with cash and financial investment of EUR 168 million, while debt remains at similar levels to 2024. This financial situation enabled us to continue with our ongoing projects without any pressure as Luis Mora is going to explain right now, and I pass the floor to Luis Mora.

Okay. Thank you, María Luisa. 2025 has been a great year for PharmaMar with significant milestones achieved for both patients and the company. We obtained the approval in the United States and Switzerland for Zepzelca in first-line maintenance non-small cell lung cancer. The compound was licensed to Merck for Japan and both the pivotal trials, LAGOON and SaLuDo trials continued successful according to schedule. We also submitted the registration dossier for Zepzelca in Europe for first-line maintenance non-small cell lung cancer and the compounds P54 and PM534 are continuing day-to-day development.

The total revenue as María Luisa described it has grown by 27%. I would like to highlight the growth of Zepzelca in Switzerland and especially in France under the early use model with a 31% increase. This clearly demonstrates that Zepzelca is changing the treatment paradigm for the patients. I also want to highlight to increase Yondelis raw material sales to our partners with a 20% growth compared with '24 as well as the growth in Yondelis royalties in the U.S.A., which have more than doubled compared with 2024. This means that Yondelis continues to grow, being considered a standard treatment for soft tissue sarcoma.

In Europe, where there are already 6 approved generic version of Yondelis, the unit sales have grown by approximately 4% compared with '24. This help us to introduce in the future lurbinectedin in leiomyosarcoma in first-line treatment.

Regarding Zepzelca in the United States, the royalties have decreased by 12% compared with '24 for 2 reasons. One is the exchange rate Euro-U.S. dollar, which has had a negative impact 7.5% and another to enter a new competitor into the market. However, in this last quarter, we have seen a significant change that we expect that will continue to grow in 2026 with the approval of [indiscernible] in first-line small cell lung cancer maintenance therapy.

Finally, looking ahead to the next 12 months, important milestones are on the horizon that will be transformative for the company. The European registration dossier for Zepzelca for first-line maintenance non-small cell lung cancer is currently under evaluation by EMA, and we expect the opinion likely in the first quarter of this year. If this is the case and given the European Commission time lines, we could begin marketing the product in some European countries in the second half of this year. In fact, our entire marketing, sales, market access, medical affairs, logistics team is working intensively on this. We expect it to grow in commercial expenditure in 30% over the next [ 2 ] years.

The LAGOON trial for second-line treatment non-small cell lung cancer is expected the top line results in the second half of this year. If the results are positive in either arm where Zepzelca is administrated either as a single agent or in combination with irinotecan. It will lead to another registration dossier likely in the second half of this year for the second line, and this is the objective of the company to any patient with small cell lung cancer will have the opportunity to take lurbinectedin in first on the second line.

The SaLuDo trial, which compares Zepzelca plus high-dose doxorubicin, Zepzelca plus low-dose doxorubicin against doxorubicin alone is expected to complete enrollment in the first half of this year ahead of the schedule. We expect the results in the first half of '27, and if positive, they will lead another registration dossier in 2027 with potential approval in '28.

The other 2 products we have in the clinical development pipeline, PM54 has already reached the recommended dose in both infusion regimens included in the separated Phase I trials, and we expect it to show the data in the next ESMO Congress in Madrid in October as we have observed very manageable safety and promising efficacy.

This encourages us to begin a very ambitious plan in 2026 with expansion as a single agent for different tumor types as well as initiating combination trial with another chemotherapy agent and immunotherapy. In fact, the FDA already approved the new IND for this combination trial with immunotherapy at the end of 2025. Similarly, PM534 is in dose escalation in 2 different Phase I trials with 2 different institution regimens, and we expect to begin expanding 1 of 2 regimens in different tumor types in the second half of this year.

In summary, '25, we executed as planned and '26 will be a transformative year for the company with significant milestones, both commercially and in the development for our compounds.

Now I pass across to [indiscernible] Thank you.

Thank you, Luis. And well, with this, we conclude our speech today, and we open the floor to questions. Gabriel?

[Operator Instructions] Our first question is from Joseph Hedden from Rx Securities.

It's been the first quarter since Zepzelca's label was expanded for first-line use. So 90 million sales in the U.S. Can you just tell us how that compares to your internal expectations? And perhaps any feedback that you've received from U.S. docs or any kind of usage metrics other than the sales that you may have?

All right Joe, Pascal here. We're not going to tell you what our projections are and Jazz doesn't give you what their projections are. So unfortunately, not much that I can help you with. And in terms of inventory levels that you're asking, that's not something that we make public other than if there was a situation where there was a problem with inventory, then we would feel that would be material.

But obviously, we were expecting to see an uptake after the October FDA approval in the first-line maintenance setting. That happened with a 13% quarter-over-quarter bump, which we're pleased to see. And we expect, personally, we as PharmaMar expect that to continue, as Jazz indicated on their call earlier in the week.

Okay. Fair enough. And then perhaps if I could have one on Yondelis. It was interesting to see that U.S. sales climbing again there after the NCCN inclusion. Do you expect that trend to continue through this year of having a much better year with royalties coming from J&J sales there?

Yes. We expect that continues to grow if you compare '26 with '25. In fact, from the inclusion in NCCN guidelines, the combination of Yondelis plus doxorubicin in first-line leiomyosarcoma, the use of Yondelis is increasing dramatically, and we expect that to continue to grow in 2026.

Okay. And then perhaps if you could just reconfirm your expectations for generic entry for Yondelis in the U.S.?

I don't know. This is not -- remember, it's J&J territory, it's not PharmaMar territory, then we don't know where they will potentially enter the generics. So we don't know. I can advise you not -- in principle, not in 2026.

Our next question is from [ Rowan Ropali ] from Santander.

Can you hear me?

Yes.

Okay. Perfect. So I have a few questions. The first one is on the potential approval of Zepzelca in the first-line maintenance setting in Europe. Are there any updates on the pricing negotiation process that we should be aware of? And have you already initiated discussions with the relevant national authorities in key European markets?

The second one was concerning the M&A and in-licensing. How is the process progressing at this stage? So should we expect any concrete developments or announcements this year? And that would be everything.

Okay. Thank you very much. As I said in my speech minutes ago, we expected accordingly the calendar from the EMA opinion at the end of this quarter for first-line small cell lung cancer maintenance therapy. That is we expected.

And then accordingly, the European Commission time lines, they have 2 months after the EMA opinion to send us the authorization for commercialization in this territory. This is the time line.

Regarding the pricing, the procedure in all the European countries, you can start the submission dossier for pricing and not before the EMA opinion because at the end of the day, you negotiate the pricing and reimbursement from one particular label. And the label is included in the EMA opinion, then you can negotiate before you have this label, okay? But in fact, this is all the PharmaMar team regarding this matter as working more than 1 year ago. Then in order to be ready, the dossier for submission immediately after the EMA opinion.

And regarding the licensing here, okay, we can't disclose the [indiscernible] and the process. We have some options in the table. And when we will arrive some type of agreement, we will disclose.

We will now move on to text questions. So I will hand over to the management team. Please go ahead.

Thank you. Now we have some written questions that we received. And we can start with these ones about Zepzelca. The first one says, now that the FDA has approved lurbinectedin as a first-line maintenance therapy for small cell lung cancer, could we expect significant increase in U.S. royalties by 2026?

Yes, that is what we expected in the second line, you compare with the first-line maintenance therapy. First of all, the number of cycles in the IMforte trial, if we compare with the basket trial, is quite a double and it's about 30% of the patients potentially in this disease. Then we expect the royalties will be growing across 2026.

We have another question about some regulatory issues also regarding with Zepzelca. Could you please confirm whether IMforte has been officially approved in Uruguay and Ecuador as mentioned by [ Adrian ].

Yes, Uruguay was approved in the last quarter 2025 and Ecuador in this year, January.

We have another question also in regulatory issues. As the dossier for IMforte being submitted in the Japanese authorities for approval?

Well, I want to remember it's not about territory. We license the drug to Merck, and this is the Merck task. And when Merck decide to disclosed or not, this process is a Merck decision. It's not PharmaMar decision.

Okay. More about pricing. When do you anticipate receiving reimbursement for IMforte in Switzerland?

Well, we are in the negotiation process actively. This is a normal process. We expected in the middle of the year, finalize this process in order to have the price and reimbursement for first-line maintenance therapy. But I want to remind you that from the commercial point of view, we are already selling in first line, but we're waiting for final pricing and reimbursement.

So in that regard, there's another question of the same person that he asked about if you could say anything about the pricing that we have in Switzerland for [indiscernible].

No, it's in the negotiation process. You can't disclose that.

Okay. All right. We have other questions about other molecules in the pipeline, PM54. So the FDA has approved IND for the new Phase I/II of PM54 with immunotherapy since the trial targets multiple tumor indications, could we expect to include several immunotherapies as well?

Well, we are in the decision process when we will start the trial, we will announce. We have several options like in the synergistic effect is already demonstrated with this type of compounds. We have several options, and we will start the trial, we will disclose, okay? Could be atezolizumab, pembrolizumab, durvalumab, et cetera, et cetera.

In this regard, there are also questions about what's the time frame when we could start. You've mentioned that we'll start this year. What can we expect about starting point and endpoint?

Yes, we are already prepared every seeing the protocol. We already contacted with the centers to start the trial, and we expected to start the trial in the first half of this year.

All right. We have a question about Sylentis. And if you could provide any update on SYL1801 and specifically, is the Phase Ib trial expected to start surely.

Well, when the SYL1801 was disclosed the data, the team are still analyzing the data. They have worked so hard in the preclinical setting in order to be focused in the next trials in some subtype of DCC. And when we will start the trial, we will announce. We are working on that.

Thank you. We're receiving more questions. Here's another one. R&D investment decreased from EUR 103 million to EUR 95 million this year. Does this reflect a natural tailing of late-stage trial costs? Or is a strategic decision to be more selective in early-stage compounds like PM534, PM54?

No, this is a normal one. When you have several Phase III ongoing or you finalize the Phase III, the investment in R&D are down, in fact, given the Phase III ongoing. But according to María Luisa's speech, we expect the similar numbers in 2023 than 2025, but this is the major reason.

Okay. We have another one about Zepzelca. With the FDA approval of Zepzelca in combination with atezolizumab, how does management expect this change in treatment paradigm to impact the long-term peak sales estimates compared to the previous second-line monotherapy use?

Well, to echo what Luis said recently, maybe I'll add a little bit more. Out of 100 patients who are diagnosed with extensive stage small cell lung cancer, about 95% are treated in first-line induction. About 75% have been seen to be treated in first-line maintenance, about 50% to 60% in second line. So right away, you can see by having the first-line maintenance label, there are more patients in the pool.

In addition, as Luis also mentioned, the number of cycles that are seen on a mean or median basis is about double from 4 to 8, moving from second line to first line. And a third key point is to consider market share between atezolizumab and durvalumab, which are both approved insofar that these 2 drugs are widely seen as Coke and Pepsi, especially in small cell interchangeable duopoly. And therefore, if atezo plus lurbinectedin is better than atezo, it's seen that atezo lurbinectedin is better than durva.

In addition to that, in terms of market share potential, atezolizumab has a version that's been approved in the U.S., U.K. and Europe and Switzerland of a subcutaneous, whereas durvalumab does not and will not have one. So with all that said and with the caveat that we're not making predictions that Jazz hasn't themselves made, we expect sales to be improved starting this year as they were in the last quarter after the first -- the approval in October.

Thank you, Pascal. We have received -- talking about Jazz, we have received some other questions about the patent situation in the U.S. and we cannot answer these questions. I guess these are more questions for our partner, Jazz, who's doing a great job in the U.S.

The final question here says the company spent EUR 34 million on share buybacks in '25. Given the cash position, how is management balancing further buybacks against potential M&A or licensing opportunities to diversify the oncology portfolio? I'll take this one.

We do not -- I mean, from the company, we do not see either doing one or another. I mean the fact that we're doing share buybacks program does not mean that we cannot consider, as Luis has mentioned now, in-license deals or any other deals. So we could do both, and we're happy to look at everything. Talking about share buybacks, if we're going to do further buybacks, as you know, we decide that on a yearly basis, same as the dividend policy. I mean, from our perspective, from the company perspective, our first priority is investment in R&D. And once we've covered all that and we have room for more stuff like dividend increase or the share buyback, then we decide on the year. But again, the fact that we do additional share buybacks, if we do it or whatever, does not mean that we're not going to consider in-license agreements or M&A or any other deal.

And I think these are all questions that we received in written. So in summary, just to wrap up, our 2025 results demonstrate robust growth driven by rising Zepzelca revenues and a meaningful advance across our clinical development portfolio. And in addition, we expect a strong flow of important news in the near term.

And with this, we conclude our call today, and we would like to thank you all for joining us and Gabriel.

Thank you. This concludes today's PharmaMar Full Year Results 2025. Thank you for joining. You may now disconnect your lines.