Welcome, everyone, thank you for joining the PharmaMar H1 2026 results presentation. My name is Gabrielle, I will be coordinating your call today. I will now hand over to your host, José Luis Moreno, Chief of Capital Markets and Investor Relations. Please go ahead.
Thank you, Gabby, good morning, everyone. Thank you for joining us today for PharmaMar's first half earnings conference call. On the call with me today are María Luisa de Francia, Chief Financial Officer, Luis Mora, Managing Director of PharmaMar, Pascal Besman, our Chief Strategic Officer. As we always do, after our comments, we'll open the floor to your questions. Before we begin, please note that certain statements made during this call might constitute forward-looking statements. These statements are based on our current expectations, actual results might differ materially from those projected. A 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 excited about the growth of our recurring business in the first six months of the year, particularly given that this growth was achieved even before the commercial sales of Zepzelca began in Europe. As you know, Zepzelca was only approved in Europe in June, we began commercial launch in Germany and Austria in July as the first two countries that we start in commercializing Europe other than Switzerland, of course, as you know. We believe these results clearly demonstrate, A, the underlying strength of our business and two, B, 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%. This reflecting the strong commercial traction of the product following its launch in the first-line maintenance setting.
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 a 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, in first-line maintenance, are major milestones for us. They 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. This revenue growth, together with the stronger cash generation, will help us to accelerate the development of our other pipeline assets and in licensed new assets, as we'll see now.
With one of our goals being to have at least one registrational trial underway by the end of 2028 or 2029. With that, I will hand over to María 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 two significant items recognized in 2025. First, EUR 20.7 million of non-recurring revenues corresponding to the recognition of the upfront payment received upon signing the license agreement with Merck. Second, EUR 14.7 million recognized under the heading, other gains, losses net, corresponding to the grant awarded to Sylentis. These two 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. Net sales from Zepzelca increased by 23%, offsetting the decline in Yondelis 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 non-recurring 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 Zepzelca. To conclude on the subject of expenses, I would like to point out that, as mentioned earlier, the EUR 15 million Sylentis grant was recorded in 2025 under the heading, other gains losses net. As a result, 83% increase in operating expenses between the two 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 two additional points that I believe are particularly relevant. First, the company generated positive operating cash flow of EUR 11.9 million during the period. 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. I'll now hand over to Luis Mora.
Thank you, María Luisa. As Pepe well said, the approval of Zepzelca in Europe for first-line treatment of small cell lung cancer will be transformational for the company. I think we'll multiply our revenue in the coming years, allowing us to accelerate development in our pipeline and incorporate new assets. This is all send third quarter revenues from just an expected a second-quarter revenue increase. 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 atezolizumab and Lurbi are well known to physicians. With clinical data in the small cell lung cancer for more than six years, as well as the expanded access program we have managed 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 expected that within a year, any European patients will have access to this innovative treatment. The SALUDO 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 Patricia Pautier study with trabectedin, the number of cycles could be double compared to a small cell lung cancer. Therefore, it is a good additional indication in area where we have a 20-year presence, knowing all the key opinion leaders and have established a good patient partnership.
We can expect a rapid and significant adoption, especially since the standard of care are not changed substantially in the last four years. If approved in Europe, we will obtain an additional year of market exclusivity. We move from 10- to 11-year market exclusivity. Regarding the pipeline with PM534, we already enrolled 120 patients in solid tumors trials to date. The first clinical trial data will be presented as a poster at ESMO for the first phase I dose range cohorts. We expect to begin a platform trial later this year, in last quarter, with centers in the Europe and U.S.A., investigating different dosage and dosing regimens, indications, and combination to accelerate development. 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 PM534, 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. Now, Pascal, we address you some items about business development progress.
Thank you, Luis. Good day to all on the call. Regarding business developments, the increase in cash flow and revenues, which Pepe and Mapi and Luis referred to, are going to allow us to prosecute a much deeper BD&L 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 for something that makes sense, delivering a positive return on investment for our shareholders.
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. 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 this 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. Well, with this, we conclude our speech today, and we open the floor to questions. Gabby?
Thank you. To ask a question, please press star followed by one on your telephone keypad now. If you change your mind, please press star followed by two. When preparing to ask your question, please ensure your device is unmuted locally. If you have joined us online, you can submit a text question via the question tab. Our first question today is from Kambiz Yazdi from BTIG. Your line is now open. Please go ahead. Kambiz, your line is now open. Please ask your question. We will now move on to the next question. The next question is from Ami Fadia from Needham. Your line is now open. Please go ahead.
Hi. Good morning. Congrats on a nice quarter, and thanks for taking my questions. 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. If you could give us some color on that, it would be helpful. I believe it was mentioned that you expect most of the pricing negotiations to come through over the course of the next year. I've got one or two other questions. Maybe as you're doing that, give us a sense on how you think that the market in Europe is going to look at Lurbi versus competition from tarlatamab and how that may be different in Europe compared to the U.S. Then I've got, one or two other question.
Right. This is going to be a question that's going to address Luis. But before we continue, just to let you know, I don't know if because there's been some cut on the line, so I don't know if there's been any questions prior to that one. 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 Ami's 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 reimbursement is already addressed in practically the 80%-90% of the European market. We expect that there's a rapid adoption by the physicians like Germany and Austria, what we observed, and to grow very fast. But you can understand not all the countries have the same. We expect that in a year, have at least 95% of the European market already approved for reimbursements. Regarding the most important countries, if we speak about the important countries by the size of the market is Spain, France, Italy and Spain. We expected to have a 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?
We expected a rapid adoption. In fact, what our internal assumption is to have important market share in Europe in the last quarter of 2027.
Thank you. Could you also address how you see the competitive landscape in Europe being different compared to the U.S., especially in the context of tarlatamab?
In Europe today, the most important competitors we have, some are already reimbursed, are two Chinese products. They are approved in all the indication, induction and maintenance, are tarlatamab and serplulimab. This is the two competitors now. We don't observe in these two products until today, the many big impact in the use by the physicians in this setting. I want to remind you, the label we achieve is maintenance therapy. Okay. In maintenance therapy, it's not, especially in this setting, the unique drug approved today is a combination lurbinectedin plus atezolizumab. Regarding the other potential competitor, tarlatamab, we don't expect it until, even if the trial is positive and achieve the reimbursement in different countries in Europe until 2028. In the second half of 2028.
That's helpful. Thank you so much. 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-
Well.
level or do you expect that to step up a little bit more?
We expect that no. In fact, we expect a little less in the second half than the first half. Taking account in the first half, we attend in many meetings, ASCO, et cetera. All the team for the sales force and medical affairs across Europe was already joined in the first half. You're saying this is increased expenses to achieve these new enrollments. We expect that the lower figure in the second half. ESMO, the European Congress, is in Madrid. Okay? That is less expensive for us.
That makes sense. Any comment on R&D expenses? Is it likely to remain at the same level as the first half?
Yeah. In the second half, we expect it in the same level as first half. Even if the pivotal trial, SALUDO trial and the LAGOON 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. This ambitious new platform trial with PM534 had to increase the number of trials with PM534 will increase in the last quarter of this year. When we expect that is a similar figures in the second half than the first half regarding the R&D.
Got it. Just a last question from me. Appreciate the comments on the business development pursuit. Maybe if you can comment on how large of a size of transaction you'd be willing to do, as you consider a late-stage or end-market asset for Europe.
Yeah. Hi, Ami. We're not looking for what most people would call a blockbuster because our niche is niche assets. We expect that our current balance sheet would allow us to use an upfront payment up to, let's say, EUR 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. We're probably looking at drugs that would have peak sales of EUR 300 million or less.
Thank you so much. I'll jump back in the queue if I have more questions.
You got it.
Thank you, Ami.
Thank you, Ami. Our next question is from Kambiz Yazdi from BTIG. Your line is now open. Please go ahead.
Congratulations, team, and thank you for the questions. My apologies, I had a few technical difficulties. If I missed any of Ami's questions, please just skip them. Maybe three questions from me. I was impressed by the EU Compassionate Use revenue growth, kind of primarily driven by France. 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. Thank you for your question. Regarding the Compassionate Use, this incredible increase in sales in France are because the French authorities opened in the Compassionate Use program, the first-line treatment after the EMA approved. Obviously, the physicians, it's a huge medical need. The data are very good, very safe. They adopted this first-line maintenance therapy in France. This is the reason why it grow about 40% regarding last year. 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 accès précoce will start, we expect it in October. September, October, the Compassionate Use will be finished. There will not a window for the patient. The patient will continue on the treatment, but close Compassionate Use, it open the accès précoce.
In summary, the accès précoce is the same than compassionate use, but is a different figures by law in French. This accès précoce, the companies will be maintained until you have a repricing and reimbursement, official one in France. Regarding the SALUDO trial, the leiomyosarcoma in first line is seen as a huge opportunity for the patients and for the company. I will remember the SALUDO trial combined in first line, Zepzelca plus doxorubicin in two arms, high dose and low dose. If we compare this trial and this combo with trabectedin, now it is in the NCCN guidelines. This was a trial conducted in France by Patricia Pautier. They jumped in PFS from six months to very close to 12 months. 12 months represent about 14, 15 cycles treatment.
I want to remark, Zepzelca in second line was approved in U.S.A., in many countries, and the median of cycles was four. In first-line maintenance, the median of cycles is seven. If the SALUDO trial show the similar figures than trabectedin, we expect at about 12-14 cycles. This is about more than three times than the second line, as most solid cancer are double than first line. Even if the potential number of patients in Europe every year is 4,500 patients with leiomyo, or in U.S.A., about 2,000-2,500. If you see the number of cycles, this indication is very important for the future revenues. Okay. Any more questions, Kambiz? All right. Thank you.
Kambiz, please make sure that your line is unmuted if you would like to ask any more questions. We will now move on to text questions. I will hand over to José Luis Moreno. Please go ahead.
Thank you, Gabby. We have a few questions. We have some questions from Joe from Regions Financial. Joe, we're missing you in the call today. Apparently, he couldn't make it, but he sent his questions. First question, he says, "Could you please restate your expectations for the length of exclusivity for Zepzelca?" I guess he means in Europe, because in the U.S. is a question for.
Well, in Europe, the exclusivity is 10 years. We have Orphan Drug Status. It is a unique drug, achieve the Orphan Drug Status of today in maintenance therapy, then is 10 years. The potential extension is one- year more if we achieve the approval in leiomyosarcoma in first line. In summary, if all goes well, we will arrive at 11 years exclusivity.
Thank you, Luis. Another question from Joe. Say, you or we recorded EUR 4.8 million licensing revenues in Q2. What is the expectation for the remainder 2026? How much deferred licensing income after all?
The licensing revenue that we recorded in this first half is EUR 7.1 million. For the rest of the year, in the second half, we expect it will increase because there are some milestones that could happen. That's all I can say about it.
Yeah, Joe, the rest of the milestones are not disclosed. We'll see.
We have some other questions, about lurbinectedin. That is from someone else. I will translate as I read, so forgive me. How do you think it could affect, or it has any impact, the joint clinical assessment of lurbinectedin for the reimbursement in Europe?
The JCA is already public, and you can see is, until now, our contact with different regulatory authorities in different countries regarding the market access is not impact. It is not bad. It represent literally the same figures you can see in the EMA. Fortunately, in this JCA, we only have one PICO. Okay. The atezolizumab is the same that the clinical trial. Until now, we are not observed any impact regarding this, the joint clinical assessment.
Thank you, Luis. There is quite a few questions, of course, about the launch in Europe and questions related. They are also asking about the inclusion of Lurbi in first line in Switzerland. It is approved in second line, and they say, how are things going to get approved in first-line maintenance?
If the question is regarding the reimbursement for the first line, the negotiation is ongoing. The unique part was waiting because it was already launched in Europe in the two presentations, 4 mg and 2 mg , in order to reduce the wastage. In Switzerland, we expected the approval in this 2 mg vials in September in order to continue the negotiation. We expect it to close at the end of the year. 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 saying in relation to the difference between the revenues in Switzerland the first quarter last year and the first quarter this year.
Yeah. Well, in the commercial setting, the sales are growing if you compare this year with 2025. In 2025 was one short order by a big wholesaler. Usually, this one short order was a big one, about EUR 7 million, EUR 6 million, was probably for some clinical trial, some company around the world, and they bought this huge quantity in order to sell for these clinical trials. The commercial point of view, we are so happy the sales grow more than 35% in Switzerland.
Right. More about the European launch. There were questions about the price we currently selling in Germany and Austria, well, they're particularly referring to Germany. The question is if we can expect the reimbursement price, final price, to be a similar price or the price we're currently selling now.
Well, this is public information. In the first six months in Germany, you sell the drug at the free price. The first six months, you don't need to return the difference if the final agreement are below, lower than the launching price, the product. Always, all the drugs are a lower price or at confidential discounts in the negotiation. I can't advance anything because the negotiations will start probably in November, December, and they probably six months, seven months negotiation is a normal process.
Okay. More about this. 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 timings of the approvals, which countries 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, I can address you with a huge collaboration with the Spanish authorities. We already have 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 probably in December. This is our expectations. I think the collaboration with the authorities are so good, and we expect it 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 to Ami.
Nothing else to add to this one. Yeah, going back to Germany, there's a question about the impact from the German reform and the impact on the health care price.
Well-
If we have taken this into account when negotiating.
In Germany, the law is not already approved. We don't know what will be the final text will be approved. In the draft, the law are included, they increase the manufacturing discount from 7%- 15%. For the orphan drugs, before this draft, if your potential sales are below EUR 50 million, you don't need to present pharmacoeconomic dossier. Now they reduce under this law at EUR 30 million. Under this law in the future, if you conduct clinical trials in Germany, you have some premium for the final agreement. I repeat, the law is not already approved.
Thank you. We have two more questions or three in regard to all they were asking or requesting if we could do a guidance on future revenues or future income. As you know, currently, we're not giving guidance, and there's a reason for that. I mean the fact, the 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. 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. We think at this stage it's prudent not give these guidance. In any case, Luis has given some hints about what we expect the OPEX could be in the following years.
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 incident, number of cycles, total population that we could address to. It's not that difficult to work it out. 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 the 1st of July. We're currently doing it. We're not giving updates. We're not giving other than the periods we do. We do update once a month, and we do it in written, whenever we have those updates, you'll see that every month. I believe with this, we finish all the questions for today. Thank you. Thank you very much.
Thank you to all of you for joining, thank you, the team, for taking all your questions and for your time. With this, we conclude our speech today. Thank you very much, Gabby, 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.