Hello, everyone. Thank you for joining the PharmaMar full year results 2025. My name is Gabrielle. I will be coordinating your call today. During the presentation, you can register a question by pressing star followed by one on your telephone keypad. If you change your mind, please press star followed by two on your telephone keypad. I will now hand over to your host, José Luis Moreno, Head of Capital Markets and Investor Relations. Please go ahead.
Thank you, Gabrielle, 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, Senior Vice President of Strategic Development. After a comment, we'll open the floor for your questions. Before we begin, please note that certain statements made during this call might constitute forward-looking statements, these statements are based on current expectations, and actual results might differ materially from those projected. A full safe harbor statement is available on the corporate presentation on our website 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, 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. That top-line growth translated into a significant step in our profitability, with EBITDA up by roughly 5 times versus 2024, and net income up 187% year-on-year.
Importantly, we achieved these results ahead of the expected European approval for Zepzelca, which if granted, it should provide an additional tailwind to revenues and further reinforce our growth trajectory. 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, + 20%, royalties, + 4%, and license and licensing revenue, 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 in expenses, in operating expenses, has been partially netted out by the European grants obtained for the Sylentis project. All the above has led to an EBITDA of EUR 68 million, approximately 5 times that of the previous year, as José Luis 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 enable us to continue with our ongoing projects without any pressure, as Luis Mora is going to explain right now. 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 and first-line maintenance 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 small cell lung cancer, and the compounds PM54 and PM534 are continuing their development. The total revenue, as María Luisa described it, have grown by 27%. I would like to highlight the growth of Zepzelca in Switzerland and especially in France, under the Early Access Program with a 31% increase. This clearly demonstrates that Zepzelca is changing the treatment paradigm for the patients.
I also want to highlight the increased Yondelis raw material sales to our partners, with a 20% growth compared with 2024, as well as the growth in Yondelis royalties in the USA, 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 six approved generic version of Yondelis, the unit sales have grown by approximately 4% compared with 2024. 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 2024 for two reasons. One is the change rate EUR-USD , 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 will continue to grow in 2026, with the approval obtained in first line with 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 of small cell lung cancer is currently under evaluation by the EMA, and we expect their opinion likely in the first quarter of this year. If this is the case, and given the European Commission timelines, 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 two years. The LAGOON trial for second-line treatment in 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 administered, either as a single agent or in combination with vinorelbine, it will lead to another registration this year, likely in the second half of this year, for the second line. This is the objective of the company, to any patient with a small cell lung cancer will have the opportunity to take lurbinectedin in first or 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 2027. If positive, they will lead another registration dossier in 2027, with potential approval in 2028. The other two products we have in the clinical development pipeline, PM54, have already reached the recommended dose in both infusion regimens included in the separated phase I trials. We expected 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 agents 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 two different phase I trials with two different infusion regimens. We expected to begin expanding one of two regimens in different tumor types in the second half of this year. In summary, 2025, we executed as planned, and 2026 will be a transformative year for the company, with significant milestones, both commercially and in the development for our compounds. Now I pass the across to Pepe. Thank you.
Thank you, Luis. Well, with this, we conclude our speech today and we open the floor to questions. Gabrielle?
Thank you very much. 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. Our first question is from Joseph Hedden, from Rx Securities. Your line is now open. Please go ahead.
Good afternoon. Thanks for taking my questions. It's been the first quarter since Zepzelca's label was expanded for first-line use. 90 million sales in the U.S. Can you just tell us how that compares to your internal expectations? 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? Thanks.
Hi, Joe. Pascal here. You know, we're not going to tell you what our projections are, and Jazz doesn't give you what their projections are. Unfortunately, there's not much that I can help you with. 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 inventories, then we would feel that would be material. 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, thanks, Pascal. Fair enough. Perhaps if I could have one on Yondelis. It was interesting to see the U.S. sales climbing again there after the NCCN inclusion. Do you expect that trend to continue through this year of having a, you know, a much better year with royalties coming from J&J sales there?
Yeah, we expect that to continues to grow if you compare 2026 with 2025. In fact, from the inclusion in the NCCN guidelines, the combination, Yondelis post-observancy and first-line leiomyosarcoma, the use of Yondelis is increasing dramatically, and we expect it to continues to grow in 2026.
Okay, thank you. 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 a J&J territory, it's not PharmaMar territory, we don't know where they will potentially enter the genetics. We don't know.
Okay, thanks very much.
I can advise you, not, in principle, not in 2026.
Okay, fair enough. Thank you.
Thank you, Joe.
Thank you, Joseph. Our next question is from [crosstalk] , from Santander. Your line is now open. Please go ahead.
hello, can you hear me?
Yes.
Okay, perfect. I have a few questions. The first one is on the potential approval of Zepzelca in first-line maintenance setting in Europe. Are there any updates on the pricing negotiation process that we should be aware of? 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? Should we expect any concrete developments or announcements this year? That would be everything. Thanks.
Okay, thank you very much. I say in my speech, a few minutes ago, we expected accordingly, the calendar from the EMA, the EMA opinion, and the end of this quarter. For first-line small cell lung cancer maintenance therapy. That is we expected. Accordingly, the European Commission timelines, they have two months after the EMA opinion to send us the authorization for commercialization in this territory. This is the timeline.
Regarding the pricing, the procedure in all the European countries, you kind of start the submission this year for pricing, and not before than the EMA opinion, because at the end of the day, you negotiate the pricing and reimbursement for one particular label, and the label is included in the EMA opinion. You can negotiate before you have this label. Okay?
In fact, this is, all the PharmaMar team, regarding this matter, are working more than one year old. In order to be ready, they negotiate for submission immediately after the EMA opinion. Regarding the licensing in, okay, we can't disclose the actors and the process. We have some options in the table, and when we will arrive some type of agreement, we will disclose. Okay. Thank you.
Many thanks.
Thank you.
Thank you. We will now move on to text questions, I will hand over to the management team. Please go ahead.
Thank you. Now we'll have some written questions that we've received, and you know, 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?
That is what we expected in the second line, as you compare with the first line maintenance therapy. First of all, the number of cycles in the pivotal trial, if we compare with the basket trial, is quite a double and is about 30% more the patients potentially in this disease. We expect the royalties will be growing across 2026.
We have another question about some regulatory issues also regarding with Zepzelca. "Can you please confirm whether Forte has been officially approved in Uruguay and Ecuador?" As mentioned by Adrian.
Yeah. Uruguay was approved in the last quarter, 2025, and Ecuador in this year, January.
Well, we have another question also in regulatory issues. "Has the dossier for import been submitted in the Japanese authorities for approval?"
I want to remember, it's not our territory. We'll license the drug to Merck, this is the Merck task. When Merck, the fact it is closed or not, this process is a Merck decision. It's not PharmaMar decision.
Okay. More about pricing. "When do you anticipate receiving reimbursement for import in Switzerland?"
Well, we are in a negotiation process actively. This is a normal process. We expect it in the middle of the year, finalize this process in order to have the price and reimbursement for first line maintenance therapy. I want to remind you that from the commercial point of view, we are already selling in first line, but we waiting for final pricing and reimbursement.
In that regard, there's another question of the same person that he asked about if we could say anything about the pricing, that we have in Switzerland for buyer.
No, it's in the negotiation process. We can't disclose.
Okay.
Okay.
We have other questions about all the molecules in the pipeline, PM54. "The FDA has approved IND for the new phase I/II of PM54 with immunotherapies. Since the trial targets multiple tumor indications, do we expect to include several immunotherapies as well, or?"
Well, we are in the decision process. When we will start the trial, we will announce. These are several options like, you know, in the synergistic effect is already demonstrated with this type of compound. We have several options. We will start the trial, we will disclose.
Right.
Okay? Could be atezolizumab, pembrolizumab, durvalumab, et c.
Right. "In this regard, there are also questions about what's the timeframe when we could start. You've mentioned that we'll start this year, what can we expect about starting point and endpoint?"
Yeah, we are already preparing everything, the protocol. We already contacted with the centers to start the trial. We expected to start the trial in the first half of this year.
All right. We have a question about Sylentis, "I f you could provide any update on SIL1801, and specifically, if the Phase I-B trial is expected to start shortly."
When the SIL1801 was disclosed the data, the team are still analyzing the data. They are worked so hard in the preclinical setting in order to be focused in the next trial in some subtype of diseases, and when we will start the trial, we will announce. We are working in that.
Well, thank you. We're receiving more questions. Here's another one. "R&D investment decreased from EUR 103 million - EUR 95 million this year. Does this reflect a natural tailing off 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, even the phase III ongoing. According to María Luisa's speech, we expected the similar numbers in 2026 and 2025. This is the major question.
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%-60% in second line. 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 is seen on mean or median basis is about double, from 4-8, moving from second line to first line.
A third key point is to consider market share between atezolizumab and durvalumab, which are both approved, insofar that these two drugs are widely seen as Coke and Pepsi, especially in small cell, interchangeable duopoly. Therefore, if atezo plus lurbinectedin is better than atezo, it's seen that atezo liriovernictinib 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. 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 approval in October.
Thank you.
Thank you.
Thank you, Pascal. We have received, talking about Jazz, we have received some of the questions about the patent situation in the U.S. You know, we cannot answer these questions. I guess these are more questions for our partner, Jazz, who's doing a, you know, great job in the U.S. There's a final question here, "The company spent EUR 34 million on share buybacks in 2025. 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. We could do both.
We, you know, happy to look at everything. Talking about share buybacks, if we're gonna 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. Once we've covered all that and we have room for more, stuff like, you know, dividend increase or the share buyback, then we decide on the year. Again, the fact that we do additional share buybacks, if we do it or whatever, does not mean that we're not, you know, gonna consider in-license agreements or M&A or, you know, any other deal. I think these are all questions that we received in written.
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. In addition, we expect a strong flow of important news in the near term. With this, we conclude our call today, and we would like to thank you all for joining us. You know, Gabrielle?
Thank you. This concludes today's PharmaMar full year results 2025. Thank you for joining. You may now disconnect your lines.