Pharma Mar, S.A. (PHM) Earnings Call Transcript & Summary

Thank you, Charlie, and good morning to everyone. Thank you for joining today's PharmaMar earnings conference call for the financial results for the year '24. On the call with me today are María Luisa de Francia, Chief Financial Officer of PharmaMar; Luis Mora, Managing Director of PharmaMar; and Pascal Besman, Senior Vice President of Strategic Development. Following our prepared remarks today, we'll open the line for questions. And I would 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 current expectations, and actual results might vary from those projected. We disclaim any obligation to update any information provided herein, and we refer you to our safe harbor statement on our corporate presentation, which is available on our website together with the press release, the report of the results we released this morning and the presentation we are seeing in this call. Well, we're delighted to share with you what has been a year of solid growth, strategic progress and continued commitment to innovation. Firstly, we're pleased to report that PharmaMar closed '24 with a double-digit revenue growth, primarily driven by ZEPZELCA, along with growth from YONDELIS total revenues, which included milestones. I'd like to highlight the strong performance of ZEPZELCA sales in the U.S., which significantly contributed to an 18% growth in our total royalty revenues in '24. Our financial success is reflected in our robust bottom line, achieving an EBITDA of EUR 13 million and a net profit surge of EUR 26 million in '24, as Maria Luisa will explain in a minute. This underscores our strong operating performance and ongoing investment in R&D, which is, of course, a cornerstone of our long-term growth strategy. Our financial position remains robust with net cash over EUR 100 million, reinforcing our financial stability and providing a strong foundation for future growth. Lastly, I want to emphasize recent significant developments like the highly encouraging results from the Phase III IMforte trial. And based on those -- on these positive results, we plan to submit a marketing authorization application to the EMA, as Luis will elaborate on later. Our partner, Jazz, has indicated that they will file in the U.S. also in the first half of '25. And now I will turn the floor to Maria Luisa, who will provide more detail into our financial results. Maria Luisa?

Thank you, José Luis. Good morning, and thank you all for joining us in the PharmaMar's 2024 Full Year Results Call. 2024 has been a very positive year, not only from a financial point of view, but I will focus on this part. We have seen an increase in our total revenues with good performance in each of the lines. On the recurring revenue side, sales of the active ingredient to our partners, leading indicator of future sales in partners' territories almost offset the decline in sales of YONDELIS in its second full year of coexistence with generics. ZEPZELCA continued to be available under the access compassionate program in France and had a good year of commercial sales in Switzerland, where sales amounted to EUR 6.4 million. Royalties from ZEPZELCA sales in United States increased by 15%. Royalties, including those from YONDELIS, increased 18% over the previous year. Nonrecurring revenues also increased by 38% due to milestones received from Janssen for YONDELIS and a milestone received from Luye Pharma for the conditional approval of ZEPZELCA in China. Looking at revenues by product, ZEPZELCA accounts for approximately 70% of total income in both years. And in 2024, revenues from ZEPZELCA amounted to EUR 120 million and YONDELIS to EUR 54.5 million. R&D expenses have increased by 4% year-on-year to EUR 3.5 million, sorry, mainly in oncology due to the development of our pipeline, which Luis Mora will now explain. The rest of expenses have remained fairly stable with the exception of general expenses, which include the cost of the new oligonucleotide production facility completed this year. All this leads to an EBITDA of EUR 13 million compared to EUR 2.1 million last year. Net profit reached EUR 26.2 million, EUR 1.1 million in 2023, driven by both positive financial results and positive tax gains, the latter mainly as a result of the monetization of tax deductions for R&D investments. Financial results are the result of good market conditions, particularly in the first half of the year and of dollar deposits, which were mark-to-market at the end of the year with positive results. I would like to end my presentation by referring to the net cash position of EUR 109 million, which is the sum of cash and cash equivalents plus current and noncurrent financial assets amounting to EUR 157 million, minus total financial debt of EUR 47.8 million. I would like also to mention that the cash flow generated from operations of EUR 6 million versus EUR 13.5 million of cash used in operations in 2023. Finally, a brief reference to ESG activities during the year, mentioned that the annual sustainability report was produced in accordance with CSRD standards. The Board has been very active in this area, approving policies on human rights and biodiversity as well as a sustainability action plan setting out the group strategy for 2024 to 2026. This year also saw the completion of the net zero carbon emission plan and an analysis of climate change risk and opportunities. To conclude, I would say that we expect revenues to grow in 2025, although the major inflection point should be in 2026. On the cost -- on the expenses and cost side, we expect most of them to remain stable. And now I pass the word to Luis Mora.

Hello. Good morning. Thank you, Maria Luisa. 2024 has been a great year for PharmaMar. Apart from the good financial results that Maria Luisa just mentioned, important milestones have been achieved in the different compounds that make up our pipeline. As you can see, we have currently 6 compounds in our pipeline, 3 already approved in different indications and another 3 compounds in clinical development, all of which come from our technology platform. YONDELIS, the first compound approved in 2007 and which in 2022 in Europe become a generic continues to be a cash generator, exceeding in revenues those obtained in 2023, especially in territories outside Europe. And today, it is still considered a standard of treatment in second line of soft tissue sarcoma. Aplidin, approval for multiple myeloma in Australia, we hope that during this year 2025, the revaluation in Europe will take place. After we won the lawsuit that we filed against the European Commission before the Luxembourg Court for the negative opinion obtained in 2018, and that is the court revoked in the 2018 decision, considering that there have been a conflict of interest. Regarding the compassionate use for small cell lung cancer, the value of this compassionate use beyond the revenues, the increased awareness of the product across Europe is demonstrated is mainly concentrated in France, Austria, Portugal and Greece, where more than 1,200 patients have been treated in nearly 230 different hospitals in 2024, growing by more than 15% compared to 2023. Our launch ZEPZELCA in Switzerland is also being a success in reaching a market share of 30% in second-line extensive disease treatment in 2024. In October, we announced the positive data from Phase III of ZEPZELCA plus atezolizumab in first-line maintenance small cell lung cancer. The data were statistical significant in the 2 primary endpoints, PFS and overall survival and clinically relevant. This will lead the presentation of the registration dossier in Europe by PharmaMar and the U.S.A. by our partner, Jazz Pharmaceutical in the first half of this year. We believe -- strongly believe that the data from this trial will change the treatment paradigm in this label. And we expect that this data will be present this year in the major medical meetings and to publish in medical journal. Thus lurbinectedin, we expect it to increase our current income several times over. Small cell lung cancer in first-line maintenance means being able to access European market of approximately 65,000 patients, of which 70% have extensive disease and of this 90% have access to the first line of treatment. It means being able to treat about 30% more patients than in second line, lurbinectedin for small cell lung cancer, extensive disease in second line of treatment is based in the LAGOON trial, which we announced at the end of recruitment in December 2024. It is a 3-arm trial, ZEPZELCA monotherapy, ZEPZELCA combined with irinotecan on the control arm, topotecan or irinotecan. This trial, if positive and clinically relevant, may also offer second-line patients in Europe and other therapeutic alternatives and has 2 possibility for factors, either monotherapy or combination with irinotecan. The first indication is leiomyosarcoma in first line combined with doxorubicin. Approximately 4,500 patients are diagnosed in Europe each year and about 2,500 patients in the U.S.A. The Phase II/III clinical trial is recruiting better than expected, and we hope to finish the enrollment in the first quarter next year. Then we will have 3 registrational dossier, one in 2026, first-line small cell lung cancer maintenance therapy in 2027 in second line in small cell lung cancer and in 2028 in first-line leiomyosarcoma. Regarding market access, we are already working to accelerate the entry of the product into the different European markets as much as possible. We have an excellent sales network in Europe, which we will gradually and appropriate reinforce once the price and reimbursement are obtained in the different European countries. In the rest of the world, ZEPZELCA is already approved in 17 countries for small cell lung cancer second-line treatment. It is marketed through our partners and the new registration of dossier will also be presented through 2025 and 2026. There are also the main territory left to license ZEPZELCA in Japan. We are in conversations with different companies, and we hope to give news in 2025. As said before, we have the other 3 compounds in clinical development. Ecubectedin is currently in Phase II in different tumor types. And the first indication we are going to focus is in the small cell neuroendocrine high-grade prostate cancer. In this semester, we plan a meeting with the FDA to agree on the development in this indication. In addition, it is in development in combination with immunotherapy, and we are seeing tumor responses. PM54, potentially a second generation of lurbinectedin with a very good safety profile, we have already seen partial responses, long stabilization in different tumor types in the Phase I, and we are already planning the Phase II trials, single agent and new Phase I combination. Lastly, PM534, a new tubulin inhibitor unique in this class, we have not observed neurotoxicity and it is already producing very interesting activity signals in solid tumor. The plan with these 3 compounds is that in '28, '29, they will be in different Phases III. And now I pass the word to Jose Luis Moreno.

Thank you, Luis. And with this, we conclude our prepared remarks today, and we open the line for questions. Charlie?

[Operator Instructions] Our first question comes from Ami Fadia of Needham.

Hi, this is Poorna on for Ami. I just wanted to know how are you approaching business development in 2025? Is there any activity that we can see over there? And my second question is...

I'm sorry. We can barely hear you. Could you speak a little louder, please, or closer to the microphone?

Can you hear me better now?

Much better.

This is Poorna on for Ami. Just 2 questions on my end. How are you approaching business development in 2025? Is there any activity that we can see there? And second question, could you provide us an overview of the study assessing ZEPZELCA with doxorubicin for LMS, the design of the Phase IIb/III trial and time line? And what gives you confidence regarding the study?

Well, I'll take the first one, and Luis will take the second. On the business development front, we continue to be active in seeking late-stage or commercial stage assets, primarily for Europe. The process is arduous and continues. Prices continue to be elevated, and we continue to be disciplined. We're not going to give any guidance on time lines that we don't control, however, so we can just say that once we've got the ink dry on a piece of paper, we'll make it publicly known shortly thereafter. And I think the second question was regarding the trial design of the sarcoma trial. Is that right with doxorubicin?

Yes.

Thank you, Ami. The trial design is in 2 parts, the Phase II and Phase III is 3 arms trial in the first part. The one arm is lurbinectedin plus low-dose doxorubicin. The second arm, lurbinectedin plus high-dose doxorubicin and the control arm is full dose doxorubicin. The idea is when we achieve this number of events, the IDMC pick the winner of the 2 lurbinectedin arms or with high dose or low dose of doxorubicin in order to continue the enrollment to finalize the Phase III. We don't stop the trial in this period of time to select the winner, the transition the Phase II to Phase III is automatic, okay? The enrollment was fantastic, much better than expected. We are open about 100 hospital centers in U.S.A., mainly in U.S.A. and Europe. And we expect to finalize enrollment in the first quarter of next year. The primary endpoint is PFS, but is powered for overall survival. Then we expected the readout data in the first half of '27.

We have some more written questions, Luis, and so we can address them. I had a few questions about the license of lurbinectedin in Japan. I know you've mentioned that, but if you could remind about what you just said about the license in Japan.

Yes, absolutely. We are happy with the contract with several companies. We are in advanced conversation with different companies, and we expect to finalize this negotiation in 2025, okay? We -- obviously, we can't disclose the company, we can't say exactly when we achieve this agreement. But what is interesting is several companies have huge interest in this drug for Japan.

We have 2 more questions before we take another question who just got over the phone. This again is another reminder. I know you've mentioned it, but if you could remind what is the estimated date for approval of lurbinectedin in first line in Europe?

Well, we announced we will submit the dossier in the first half. The timing for the EMA depends, if it is considered an accelerated review or not. This is in the EMA hands. Then you can take from the submission, you can consider between 7, 8 months to 12, this is normal official time in the EMA if it's considered an accelerated review or not.

And the final one we received in written, they asked about when we can see the first revenues from sales from China.

From China. Well, our partner, Luye Pharma announced the drug was approved in 2024 in the last quarter in December. After this approval in China, they needed to perform several activities before launch, and we expect it to launch in the first half of this year.

Charlie, I believe there's another question on the phone.

Yes, that's correct. Our next question comes from Samir Devani of Rx Securities.

Congrats on the results. I think I've got 3, a couple on the numbers and maybe just one on the pipeline. I guess on the numbers, you just mentioned about China and Luis, and I just wanted to confirm that, that revenue all from really in the 2024 numbers was the approval milestone. Is that correct?

Yes. It's correct.

Yes, that's correct.

Okay. That's fine. And then there was no mention in the press release about a dividend.

No, we haven't mentioned because the Board hasn't decided yet about dividends for this year.

And then the final question is just on ecubectedin. There's obviously a basket trial ongoing. Can you just remind us of the size of that study, the different tumor types you're looking at and when we can expect to see the data?

Yes. The basket trial is ongoing. In the basket trial, I think 5, 6 different tumor types. One of them is the neuroendocrine tumors. And I said before, now we will plan to meet with FDA this semester in order to agree the development plan in this indication. But the basket trial is not stopped, then still continuous enrollment. Then we expect it to finalize enrollment across this year because several tumor types, then from -- we finalize enrollment, follow up the patients probably next year, we can have some data.

And sorry, just one follow-up. Just on the lurbinectedin sNDA in the U.S. is it fair to assume that you're going to get priority review based on the data?

That's going to be FDA's decision when they get it. And so out of our hands, we've not been privy to the conversations at this point nor will we. So we hope Jazz is very successful with that, but I can't help you, Samir, sorry.

We have no further questions registered on today's call. So I'll hand back over to the management team for any further or final closing remarks.

Thank you. Thank you, Charlie, for your help today. In summary, our '24 results, I have to say that they reflect a robust growth with increasing revenues from ZEPZELCA and significant advances in our clinical development. And additionally, we have an exciting and relevant news flow ahead and that we can expect in the following months. So with this, we conclude our call today, and I would like to thank you all for joining, and thank you, and have a nice weekend. Thank you very much.