Thank you, Gabrielle, and good morning to everyone. 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, who is the Senior Vice President of Strategic Development. After our comments, we will 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, 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. 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 US approval of Zepzelca as first-line maintenance therapy in October. This of course represents an important step for patients and a meaningful catalyst for the business.

Financially, we delivered 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 profitability with EBITDA up by roughly 5 times versus '24, and net income up 187% year on year. Importantly, we achieved these results ahead of the expected European approval for Zepzelca, which if granted, should provide an additional tailwind to revenues and further reinforce our growth trajectory.

With that, I'll 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 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 US 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 operating expenses has been partially netted out by the European grants obtained for the Sylentis project.

All the above has led to EBITDA of €68 million, approximately 5 times that of the previous year, as José Luis said before, and to a net profit of €75 million. Finally, and also noteworthy, is the generation of operating cash flow amounting to €53 million.

This has enabled us to close the year with cash and financial investments of €168 million, while debt remains at similar levels to 2024. This financial situation enables 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 in small cell lung cancer.

The compound was licensed to Merck for Japan, and both the pivotal trials, the LAGOON and SaLuDo trials, continued successful according to the schedule. We also submitted the registration dossier for Zepzelca in Europe for first-line maintenance in small cell lung cancer, and the compounds PM54 and PM534 are continuing their development.

The total revenue, as María Luisa described, has grown by 27%. I would like to highlight the grow 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 highlight the Yondelis raw material sales to our partners, with a 20% grow compared with '24, as well as the grow 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 '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 two reasons.

One is the exchange rate euro-US dollar, which had 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 obtained 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. European registration dossier for Zepzelca for first-line maintenance small cell lung cancer is currently under evaluation by the EMA, and we expect that 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 teams is working intensively on this.

We expect that to grow in commercial expenditure in 30% over next 3 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 irinotecan, it will lead to another registration dossier, 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 in 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 the enrollment in the first half of this year, ahead of the schedule. We expect that 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 two products we have in the clinical development pipeline, PM54 has already reached the recommended dose in both infusion regimens included in the separated Phase 1 trials, and we expect that to show the data in the next ESMO Congress in Madrid in October. As we have observed very manageable safety and promising efficacy, this encourage us to begin a very ambitious plan in 2026 with expansion as a single agent for different tumor types, as well 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 1 trials with two different infusion regimens, and we expect that to begin expanding one of two 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 milestone both commercially and in the development for our compounds. Now I pass the cross to Pepe.

Thank you.

Thank you, Luis. With this, we conclude our speech today, and we open the floor to questions.

Gabrielle?

Good afternoon. Thanks for taking my questions.

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

Thanks.

Hi, Joe. Pascal here.

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 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. Personally, we as PharmaMar expect that to continue, as Jazz indicated on their call earlier in the week.

Okay. Thanks, Pascal.

Fair enough. Then perhaps if I could have one on Yondelis.

It was interesting to see that US 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?

Yeah. We expect that that continues to grow.

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

Okay. Thank you.

Then perhaps if you could just reconfirm your expectations for generic entry for Yondelis in the US?

I don't know. Remember this is a J&J territory.

It's not PharmaMar territory. Then we don't know where they will potentially enter the generics.

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.

Hello. Can you hear me?

Yes.

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.

What I say in my speech few minutes ago, we expect that, 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 expect that.

Then accordingly the European Commission timelines, they have 2 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 cannot start the submission dossier for pricing not before that 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. Then you cannot negotiate before you have this label.

Okay? In fact, this is all the PharmaMar team regarding this matter has working more than 1 year ago.

Then in order to be ready the dossiers for submission immediately after the EMA opinion. Regarding the licensing in, okay, we can disclose the interest 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. Now we'll have some written questions that we've received, and I 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 US royalties by 2026?"

That is what we expect that in the second line, if 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 the double and is about 30% more 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, if mentioned by Adium?"

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

We have another question also in regulatory issues. "Has the dossier for IMforte been submitted in the Japanese health authorities for approval?"

I want to remember it's not our territory. We licensed the drug to Merck, and this is the Merck task.

When Merck decided to disclose 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?"

We are in the negotiation process actively. This is normal process.

We expect that in the middle of this year finalize this process in order to have the price and reimbursement for first-line maintenance therapy. I want to advise you that from the commercial point of view, we are already selling in first line, but we're waiting for final pricing and reimbursement.

In that regard, there's another question of this same person that he asked about if we could say anything about the pricing that we have in Switzerland so far.

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

okay?

Okay. All right.

We have other questions about all the molecules in the pipeline, PM54. "So the FDA has approved IND for the new Phase 1/2 of PM54 with immunotherapy.

Since the trial targets multiple tumor indications, could we expect to include several immunotherapies as well, or"

We are in the decision process. When we will start the trial, we will announce.

The synergistic effect is already demonstrated with this type of compounds. We have a several options, and we will start the trial, we will disclose.

Okay? Could be atezolizumab, pembrolizumab, durvalumab, etc.,

etc. In this regard, they also question about what's the timeframe, when we could start.

You've mentioned that we'll start this year, but what can we expect about starting point and endpoint?

We are already prepare everything, the protocol. We already contacted with the centers to start the trial, and we expect that 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 if the Phase 1b trial is expected to start shortly.

When the SYL1801 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 this disease.

When we will start that trial, we will announce. We're working on that.

Right. Here we're receiving more questions.

Here's another one. "R&D investment decreased from 103 million to 95 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 3 ongoing or you finalize the Phase 3, the investment in R&D up, down, in fact, given the Phase 3 ongoing.

Accordingly María Luisa's speech, we expect that the similar numbers in 2026 than 2025. This is the major reason.

Okay. Here 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?"

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.

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 to 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-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 US, UK, and Europe, and Switzerland of the 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 approval in October.

Thank you.

Thank you,

Pascal. Talking about Jazz, we have received some other questions about the patent situation in the US, but we cannot answer these questions.

I guess these are more questions for our partner Jazz, who is doing a great job in the US. There's a final question here.

It says, "The company spent 34 million on share buybacks in '25. Given the cash position, how is management balancing further buybacks against potential M&A or licensing-in opportunities to diversify the oncology portfolio?"

I'll take this one. From the company, we do not see either doing one or another.

The fact that we're doing share buybacks program does not mean that we cannot consider, as Luis mentioned, in-licensing deals or any other deals. We could do both.

We happy to look at everything. Talking about share buybacks, if we're going to do further buybacks, as we decide that on a yearly basis, same as the dividend policy.

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 dividend increase or the share buybacks, 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 going to consider in-licensing agreements or M&A or any other deals. I think these are all questions that we've 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. Gabrielle?