Hello everyone and welcome to the Pharma Mar first half 2025 results call. My name is Emily and I'll be coordinating the call today. I will now hand over to José Luis Moreno, Vice President, Head of Capital Markets and Investor Relations. Please go ahead.
Thank you, Emily, and good morning to everyone. Thank you for joining today's Pharma Mar. earnings conference call for the financial results for the first half of 2025. On the call with me today are María Luisa de Francia , Chief Financial Officer; Luis Mora, Managing Director of Pharma Mar ; and Pascal Besman , Senior Vice President of Strategic Development. Following our prepared remarks today, we'll open the line for questions. I'd like to remind you that today's conference call might include forward-looking statements regarding future events or the future financial and operating performance of the company. Such forward-looking statements are only predictions based on our current expectations, and actual results might vary from those projected.
We disclaim any obligations to update any information provided during the hearing, and we'll refer you to a safe harbor statement on our corporate presentation, which is available on our website, together with a press release and a report of the results we released yesterday. Pharma Mar 's financial results for the first half of 2025 clearly reflect the positive momentum we are experiencing and our solid financial position. Total revenues grew by 18% compared to the same period last year, and this growth has been consistent across all revenue streams, including recurring income and non-recurring income. María Luisa will provide more detailed information on these revenues in a few minutes. The oncology segment significantly contributed to both sales and royalty income and, importantly, demonstrated the ability to generate cash from its own activities. This is particularly significant as nearly 50% of its revenues has been reinvested in R&D.
In fact, R&D investment totaled over EUR 47 million in this period, supporting our ongoing clinical development program in both late-stage and early-stage. Profitability also saw a clear improvement, with EBITDA reaching EUR 25 million and net profit rising to EUR 19.4 million, which is more than 5x the result of the first half in 2024. Finally, last May, we filed a marketing authorization application with EMA, for the third time, in combination with [Tetralliformats], for first-line maintenance treatment in small cell lung cancer. In summary, these results confirm that the group is in a strong and sustainable position to continue delivering innovation and value. Now, we'll go into more detail on all these figures, so I'll turn the floor over to María Luisa.
Thank you. Thank you, José Luis. Good morning, and thank you all for joining us in the Pharma Mar 20 25 half-year results call. The financial results we are presenting today, as José said, show the group's strong performance, solid operations, and stable financial position. Total revenue grew by 18%, sales increased 9%, license income, non-recurring revenues increased 87%, and royalty income remained flat. Regarding royalties, payments from our subsale partner, Janssen, were impacted this half-year for two main reasons: increased competition in the U.S., which affected Janssen sales, and less favorable dollar-euro exchange rate compared to the same period last year. Janssen royalties in the second quarter are an estimation. The overestimation in the first quarter has been adjusted. Sales growth was driven mainly by the strong performance of ZEPZELCA in Europe, both in sales and in compassionate use distribution.
Non-recurring revenues, basically license, increased by 80% thanks to the ZEPZELCA license agreement for Japan with Merck. This agreement included an upfront payment of EUR 22 million, of which EUR 21.7 million has been recorded as revenue by June 30. R&D expenses were 7% lower than in the same period last year. With regard to operating expenses, it should be noted that a part of the grant awarded to Sylentis by the European Commission under the IPCEI program, Important Projects of Common European Interest, as I was saying, a part of that grant was recorded as income under the heading "Other Operating Income Expenses." This grant covers the January 2023-August 2026 period, and EUR 14.7 million have been already recognized as income in our P&L as of June 30. The total grant amounts to EUR 21.1 million, which we have already received in July.
All of the above leads to an EBITDA of EUR 25.1 million compared to a negative EBITDA of EUR 0.8 million in the same period last year. Operating activities generated a positive cash flow of EUR 2.9 million, reflecting an improvement compared to EUR 0.1 million outflow recorded in the same period of the previous year. Capital expenditure was significantly reduced to EUR 1.9 million compared to EUR 9.4 million in the prior year period, mainly related to investments in the oligonucleotide manufacturing facilities. Furthermore, dividends amounting to EUR 14 million were distributed from the share premium account, and treasury shares were repurchased for a total consideration of EUR 12 million. As a result of the above, the group ended the half-year with cash and cash equivalents, with current and non-current financial investment amounting to EUR 182.9 million.
I will conclude my presentation by emphasizing, as I did at the beginning, the strong performance, the operational robustness of the business, and its solid financial position. I now pass the microphone to Luis Mora.
Hello. Good morning. Thank you, María Luisa. It has truly been a very good half-year both in terms of financial results and the progress of our ongoing projects. The Sylentis sales in Europe are performing better than expected despite having five generic products in the market. Thus, despite the impact on price and the 15% difference in values compared to 2024, there has been a 12% increase in unit sales. This is remarkable, and the positioning of the product in Europe is a standard of care, and they still maintain about 30% of the market share in soft tissue sarcoma. The Sylentis sales in the U.S. through our partner, Janssen, have also increased significantly, resulting in royalties 2.5x higher than those for the same period in 2024, reaching EUR 5.4 million in royalties. In summary, Sylentis total net revenue remains stable compared to 2024, around EUR 23 million in this period.
We're having an update on July 23, 2025, with a site to withdraw the plitidepsin dossier for the treatment of multiple myeloma as part of the re-examination process for the marketing authorization of that compound. As indicated in the reason for withdrawal, the reason is commercial. Eight years have passed since the EMA refusal, and after the court ruling in favor of Pharma Mar , a re-examination process was initiated. However, during this time, there have been substantial modifications to both the treatment algorithms and the available therapies in validating the clinical trial that serves as the basis for the marketing authorization application in the potential clinical practice. There is currently a clinical trial underway with plitidepsin. Pharma Mar. is not a sponsor for the treatment on Long COVID. This investment has been very important for ZEPZELCA .
The marketing authorization application for the first line of maintenance treatment based on the IMPORTA trial was submitted to the EMA. The review process has begun, and we await the EMA opinion by the end of the first quarter of 2026. We have already initiated all the pre-launch activity, market access, sales network sizing, and medical affairs activity, leading up to the product launch in the first half of 2026 in Europe. On the other hand, our partner, Janssen, also announced the submission of the dossier to the FDA and announced that the PDUFA date will be on October 7th this year. At this point, it should be noted that through the ORBIS project, other countries are also evaluating the registration of dossiers like Israel, Switzerland, Australia, and Singapore. We expect the news from these agencies a few months after the FDA opinion.
Following the representation at ASCO and the publication of the important trial results, the combination of lurbinectedin plus atezolizumab for treatment of small cell lung cancer in first-line maintenance treatment is expected to be included in the NCCN guidelines. The royalties come from ZEPZELCA and U.S. territory included in our accounts include already adjusted figures for the first quarter and our estimate for the second quarter, which we maintain the same figure in the first quarter, as we don't have the actual data at the end of this period. Regarding compassionate use, this quarter has been excellent, with the use of lurbinectedin increasing in all the countries where it is used in this system of compassionate use, including France, Austria, Portugal, and Spain, reaching a 26% increase compared with the same period of 2023. Sales of ZEPZELCA through our subsidiary in Switzerland have also reached EUR 8.4 million.
This represents a 75% increase compared to 2024. In summary, we can say that ZEPZELCA in Europe is already positioning itself as a true treatment alternative for small cell lung cancer, and we hope that after its approval for first line, it can offer more patients a very valuable and effective alternative for this disease. We can also announce that our partner, WuXi Pharma, launches ZEPZELCA in China for the treatment of second-line small cell lung cancer in mid-May. We consider the launch to be going very well, and we have already received approximately EUR 1.2 million in royalties. This semester has been very important for the progress of our SaLuDo trial, which combines lurbinectedin plus doxorubicin for the first line of treatment of leiomyosarcoma. This trial is now in phase III.
The patient cohort has been expanded to 450 patients, and we hope to complete recruitment as initially planned in the first half of next year. It is important to note that recruitment is going much better than expected, with more than 250 patients already included in the trial. This is the most important remark. Thank you for your attention. Now is the Pepe turn.
Thank you, Luis. With this, we conclude our speech today and open the floor for questions. Emily, I believe there's someone raising a hand already.
Thank you. Before we begin the question and answer session, if you would like to ask a question today, please do so now by pressing the star followed by the number one on your telephone keypad. Our first question today comes from Joseph Hedden with RX Securities. Please go ahead, Joseph.
Hi there. Thanks for taking my questions. On the royalty line that you've reported, you've reported Janssen and Luis Mora together. Could you give us any indication of what you attribute to each of the geography, please? Thank you.
The ZEPZELCA report, I say we maintain the same level of royalties than the real in the first quarter. This included EUR 1.2 million from China, I explained before, regarding ZEPZELCA . Regarding [delis], I included the EUR 5.4 million from Janssen, plus a little amount from Japan.
Thank you. On the ZEPZELCA in China, is it possible to get an idea of your overall market expectations and perhaps peak royalty expectations for their drug over there? Thank you.
We never send the first of all, because WuXi is our partner. The launch was fantastic. More than 80 Chinese key opinion leaders in one month and 1/2 , you see the royalties we received were fantastic, and we expected the growing in the following months to use ZEPZELCA in second line.
Okay, thanks very much.
You too.
Thank you. As a reminder, if you would like to ask a question today, please do so now by pressing the star followed by the number one on your telephone keypad.
Emily, if there are no more questions, I have some written questions that we've received.
We have received an audio question from Christopher Liu with Lucid Capital Markets. Christopher, your line is now open.
Hey, guys. Thanks for the question. Just wondering what your thoughts are on the largest near-term opportunities for you guys and what the competition may look like.
Should we start by the competition, Pascal?
Sure. Thank you, Christopher. The largest near-term opportunity, I guess, is pretty obvious. It's lurbinectedin or ZEPZELCA in Europe. The other territories matter as well. In terms of your second question, which will transcend all geographies, the nearest competitor at the moment is [Depsha], which is approved in the U.S. in the relapsed setting. In Europe, not approved and not filed as far as we know. Behind that is Daiichi Sankyo with their B7-H3 ifinatamab deruxtecan, often called I-DXd, which is in a phase III due to report out their first endpoint for potential accelerated approval next year in the relapsed setting as well. There is a plethora of people who are kind of three, four years behind that it's hard to handicap. I'd say that Amgen and Daiichi are the first and second-place candidates for mention as competitors.
Thank you.
Thank you. We have no further audio questions registered, and I'll hand back to the management team to make the written questions.
Thank you. We received some questions. Some of the questions were in regard to the China royalties, so we just answered to you, Joe. We have some other questions in regard to the regulatory submission. I guess it's called first-line maintenance in Japan and China. Luis, if you want to take that one.
In Japan, as we announced, we license the drug to Merck, and this is Merck territory and Merck TASP, but they are planning a meeting, several meetings with the PMDA in order to show them the imported trial and what will be the best path for registration. This is the task for Merck and lurbinectedin in this territory. Regarding China, for the first line, they are planning to have the meeting with the Chinese authority in order to explore the best path for the registration.
Today, I remember in China, it's approved in the second line, then the session for the disapproval.
We have another question in regard to the commercialization cost that we've mentioned in regard to this increase of 19% that we said is related to the preparation of the lines. I don't know if you can give more granularity or we don't really disclose much, but is there anything you want to comment on that?
It's true the percentage is 19%, but the values are not so high. You can imagine in parallel to the submission with the registration dossier we already submitted for the new process in Europe, the joint clinical assessment, the HCA, and this is a very different cost.
We started to prepare all the local dossiers for market access, reinforced the Germany team because it will be the first country where we will launch the product, and all the activities for medical affairs and marketing are already started. This is included in the figure.
Thank you, Luis. We have no more written questions. With this, we conclude our speech today. Just finally, for those of you who would like to meet with our management team in person, we'll be participating in the upcoming healthcare conference hosted by Morgan Stanley, New York, commencing on the week of the 8th of September. With this, we conclude our call today. We'd like to thank you for joining and wish you all a pleasant rest of the summer. Thank you, Emily, for your help today.
Thank you.
Thank you, everyone, for joining us today. This concludes our call, and you may now disconnect.