Pharma Mar, S.A.

Good morning to everyone. I would like to welcome to our third quarter results conference call. On the call with me today are Maria Luisa de Francia, Chief Financial Officer, Luis Mora, Managing Director of Pharmamar, and Pascal Vesman, which is the Vice President of Strategic Development. Following our prepared remarks today, we'll open the line for questions, as we always do. 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 our current expectations, and actual results might vary from those projected. We disclaim any obligations to update any information provided herein. And we refer you to a safe harbor statement on our corporate presentation, which is available on our website together with the press release and the report of the results we released yesterday. Well, as shown in the preceding quarters of this year, in the third quarter, our commitment to increase our investment in R&D remains evident. Most of these R&D investment is in oncology, and we're making substantial progress in advancing our development efforts. It is worth highlighting that LAWN trial, which represents the confirmatory phase three study of lorinectadine as monotherapy in second line for small cell lung cancer, is recruiting, or recruiting is proceeding as planned. We're also making significant headway in the preparatory work for launching the phase two, three trial of lorbinactidine in first-line leiomyosarcoma, which we expect to start shortly. Also, in oncology, we're actively engaged in early-stage clinical trials with other molecules like ectobactidine, PM534, and PM54. These underscore a strong belief in the potential of these molecules, and we're fully committed to ongoing R&D investment That will foster sustained growth in the years ahead. Turning to our revenues, we're pleased to report a notable increase in royalties from the sales of the Celca in the U.S. for this quarter. It is important to note that this is an estimate, as we're currently awaiting sales information from our partner, JAS, which is scheduled for release results on November the 8th. We maintain a robust balance sheet and strong cash position, even after distributing dividends and factoring in the funds allocated for the acquisition of company treasury shares. With that, I'll now pass the floor to Maria Luisa, who will provide you with more comprehensive overview of our financial results.

Thank you, José Luis. Good morning, and thank you all for joining this conference call on third quarter 2023 financial results. I will start by reviewing the evolution of revenues. The first quarter of the year is a continuation of the previous quarter and does not contain any exceptional elements. YonDeli sales continue to reflect the impact of the arrival of generics directed in products from the market, resulting in a 61 percent decline in YonDeli sales. mainly due to lower prices as the volume impact is 18% compared to the same period last year. In relation to lorbinectin proceeds associated with the early access or compassionate use program in France principally, demand is this nine-month period has been slightly higher than in previous year, approximately 3%. I would like to remind you that the main cause of the increase in this item between periods is due to the positive recalculation made in relation to the 2022 rebates once we received from the French authorities the settlement in relation to such rebates. This adjustment was recorded on the second quarter of 2023. Following with recurring revenues, royalties received from our partners performed well in this quarter, particularly royalties from SEPCELCA sales in the U.S. In the first nine months, royalties increased 8% year on year. As I always mention, just third quarter royalties is an estimate made by PharmaMart. On the expenditure side, The most noteworthy is the increase in Airbnb expenditure, which is up 19% to €70.3 million. This increase is mainly due to the Phase 3 trials currently underway, plus preparatory work for those trials about to begin, as Luis Mora will explain later. All other operating expenses remained fairly stable between the two periods, taking into account that in 2022, they included certain amounts corresponding to the genomic liquidation process, which do not take place in 2023. All of the above lead PharmaMar to a net result of €8 million, including a positive €5.1 million of income tax due to the monetization of R&D deductions. I will finish highlighting the net cash position as of September 2023 that amounts to 145.9 million euros after deducting 39.8 million euros of total financial debt. At this point, we should mention the capex investment in the period which exceeds 10 million euros mainly due to the new first of a new oligonucleotide manufacturing plant that is in progress that Luis Mora will comment later. We should also mention the shared buyback program to which we have allocated about €7 million since its launch until 13 September. To conclude, as Jose Luis Moreno mentioned before, we have a solid balance sheet to continue with our business plan. And now I pass the microphone to Luis Mora.

Thank you, Maria Luisa. Good morning. As Maria Luisa has already commented, generality sales in Europe continue to be affected by the generatics. There are currently two generic companies market-interactive in Europe, which parts with a greater pressure on price and sales volumes. Though in volume, the difference compared to 2022 is only 18%. The same does not happen in the rest of the markets where we see an increase in the use of jondelis. The increase of jondelis in the NCCN guidelines in first line in combination with doxorubicin for layer amino sarcoma is very positive in sales in the USA. Regarding Tepscalca, the estimated royalty figure for the quarter reflects a notable increase in sales in the USA, and we expect it to be maintained in the coming quarters. In September, we launched Tepscalca in Switzerland with reimbursement, and it's being very well received by the doctors and meeting our expectations. The compassionate use program is demonstrating that Tepscalca is already establishing itself in France as standard treatment in small cell lung cancer in second and third line. The Lagoon Trial, a confirmatory trial for the USA and registration trial for Europe, continues recruitment as expected in about 140 hospitals, and we hope to increase the number of centers to 200. And we hope to complete the inclusion of patients in the summer of the next year. So far, the information received by the IDNC regarding safety is positive. Another important trial that has already completed its recruitment is a Phase II in small cell lung cancer with a combination of lurbinectadine plus irinotecan, and we expected the results around end of this year. The first line maintenance trial in small cell lung cancer that our partner, Just Pharmaceutical, is carrying out with Roche remains on the data they have communicated, and they expected to have an interim result in the last quarter of the next year. The pivotal trial and frontline registration of leiomyosarcoma with lurbinactivine plus doxorubicin versus doxorubicin, we hope to include the first patient very soon. This has raised great interest among specialists in the recent ESMO Congress. Regarding the trial of lurbinactivine in esoterioma, we have evaluated the project and we have decided to not start it. The rest of the compounds that we have in clinical development are cuvectidine, P534, P54, continuing the clinical development in the Phase II and Phase I, according to the plan. In the regulatory field, perhaps the more relevant things refer to the Cephselkalocea in China. It is already being presented and is in the evaluation phase without major problems. And we hope to know the opinion of the Chinese authorities in the middle of the next year. In parallel to this dossier, the Chinese authorities have authorized our partner for a region of China to launch a compassionate use program. Now regarding the virology area, the most relevant is the NERATA trial, the Phase II trial with politideftin in immunosuppressed patients, which is in the recruitment phase in 11 countries. Xylantis, which is in Phase III, with the product Ibaniciran for dry eye syndrome in patients with Sondgren syndrome, has already completed recruitment, and we expect the data in the first quarter of 24. During this year, 2023, the construction of an industrial oligonucleotide manufacturing plant is being carried out, which will serve both to cover the needs of Cilentis and for third-party manufacturing. The first phase of the construction will be finished this year, and after validation and inspections work, we hope it will be operational in 2024. And now I pass the word to Pascal. Thank you, Luis.