Pharma Mar, S.A.

Thank you, Laura, and good morning to everyone. I'd like to welcome to all of you to our full 22 results conference call. On the call with me today are Mr. Luis Mora, Managing Director of Farmama, Maria Luisa de Francia, Chief Financial Officer, and Pascal Besman, which is Vice President, Strategic Development. Following our prepared remarks today, we'll open the line for questions. And before we start, I'd like to remind you that today's conference call may include forward-looking statements regarding future events or the future financial and operating performance of a company. Such forward-looking statements are only predictions based on our current expectations, and actual results may vary from those projected. We disclaim any obligation to update any information provided herein. And we refer you to our safe harbor statement and our corporate presentation, which is available on our website together with the press release and the report of the results we released yesterday. Last year, it was an important year for the company because we achieved important goals and we had an important advance in our development. I guess you had a chance to see our press release yesterday, so I'll not go through every little detail, but let me highlight the most important news from last year. In 22, we saw the approval of lorbinactidine for commercialization for the treatment of small cell lung cancer in countries like South Korea, Qatar, or Emirates. That adds, of course, to U.S., Australia, or Singapore, where the drug has been approved already. As you know, one of our main targets with Abcelka in the next future is to achieve approval in Europe and full approval in the U.S., And in the meantime, we'll have more news about approvals and filings in other countries. Talking about other developments, the two Phase III trials that are ongoing with lorabinectadine for small cell lung cancer are currently recruiting. And in the case of the trial in first line in combination with Tocentric in small cell, that our partner, Josh, is doing together with Roche. They announced in January that recruitment will be completed this year. The Lagoon trial, which is phase three for second line in small cell lung cancer, using lorbinactidine as a monotherapy, is also progressing with this recruitment. It is worth mentioning that both trials will be fileable not only in U.S., and Europe, but also in other territories. Also, last year, we reached an agreement with a company provider of the immunotherapy that will combine with Zephselka for the phase three trial in mesothelioma that we expect to start later on this year. In 2022, we also advanced in the progress of other oncology molecules in our pipeline and we had a new molecule, PM534, entering into clinical development in phase one. And we also did all the work and have ready to include another new molecule in the pipeline, which will happen later on this year. In other therapeutic areas, like RNA of interference, last year we started another phase three trial with Ativan Isidan. So currently we have two phase threes, two phase 3s ongoing with T-vanicidin, one to demonstrate activity, and another one to assess safety, which started in April last year. Also, in RNA of interference, last year we started a phase 2 trial in macular degeneration with another molecule called SIL-18001. which is worth highlighting the fact that it's administered as eye drop solution for this indication. I will turn over now to Maria Luisa, who will give you more details about the financial results.

Thank you, José Luis. Good morning, and thank you all for joining this conference call about 2022 full-year financial results. The main events that had an impact on the 2022 financial statement were as follows. Firstly, we will point out the new legislation applicable in France with respect to drugs marketed under the Authorization d'Accès Compassionnel Early Access Programme, which has resulted in significant discounts leading to the need for a provision of 15.2 million euros. units sold in France in 2022 were slightly higher than those sold in 2021. Secondly, in the last quarter of the year, and after 15 years of Chandeliers on the market, the generic products selected in began to be marketed in Europe. with the consequent pressure on prices and volumes. In 2022, the impact, although failed, has not yet been significant. In 2022, Iondelis reached one of the commercial milestones set in the license agreement signed with J&J in 2001 for 10 million euros. Finally, the decision to discontinue the diagnostic segment results in the recognition of a number of expenses and provisions amounting to some 3.5 to 4 million euros. Thus, in the analysis of recurring revenues, we see a decrease of 5% compared to the previous year. As you know, these recurring revenues are made up of sales and royalties received from our partners. YONDELI's sales in Europe were 63.8 million euros. In 2021, they were 69.4 million. Sales in Europe of CEXELCA under the Authorization to Access Compassionate Program amounted to 15.5 million euros, 30.2 million in 2021. This decline in sales was partially offset by an increase in royalties of 23% to 50.3 million euros, of which 46.9 million euros correspond to just pharmaceutical sales of Celca in the United States. and by an increase in raw material sales to our partners for both John Daly's and Cepselka, up 11.6% from 19.2 million euros to 21.4 million euros. In relation to non-recurring revenues, the main difference was due to the achievement in 2021 of a commercial milestone under the Just Pharmaceuticals Agreement, which resulted in revenues of 22 million euros, as well as to the amount recognized as revenues from those deferred incomes from the same agreement, which also was higher in 2021 by about 10 million euros. These differences were also partially offset by the achievement in 2022 of the milestone under the J&J License Agreement for Yondeli in the mentioned amount of €10 million. In terms of expenses, there was an increase in R&D expenses as a result of the up to four phase III trials ongoing in 2022. 11.3 million euros more than the previous year, or 16% higher. In marketing and general expenses, the return to international face-to-face meetings, congresses, and commercial actions have also led to a certain increase in expenses. And finally, as we mentioned at the beginning, the income statement is also affected by the discontinuation of diagnostic activity. All of the above leads to an EBITDA of 51.4 million euros compared to 97.8 million euros in 2021. And a net result for the period amounting to 49.4 million euros. Income taxes in 2022, 5.6 million positive, includes the activation of tax credit to be applied in the future, as well as the monetization of R&D deductions received in 2022. Finally, it's important to note that in 2022 operating activities generated gas of 38.3 million euros. Thus, the net gas position at the end of the year amounts to 192.8 million euros after deducting the 39 million euros of total financial debt. This is 15% above the net cash at the end of 2021. To summarize the financial part, I would like to highlight the generation of operating cash flows, even with growing R&D expenditure, with the consequence maintenance of cash levels and reduction of debt. I would like to end my intervention with a reference to ESG issues. As far as environmental concerns In 2022, the group has measured its carbon footprint, including scopes 1, 2, and 3. In 2023, the group is planning to work on an emission reduction plan in accordance with the science-based target initiative standards. On the social side, I will briefly give some data on quality of employment. For instance, 98.8% of the contracts are permanent, and all of our employees have a health insurance policy. On diversity, we have employees of 15 different nationalities, and on equality, 60% of our employees are women with a weighted wage gap of 3.4%. Finally, regarding governance, I would add that 41% of our board members are independent, 33% are women, and also 47% of our senior management and management are women, too. And now I pass the microphone to Luis Mora.

Thank you, Maria Luisa. Our pipeline, you can see the confirmation of our investment strategy in R&D. There's a strong increase in the H3 client for this year, 2023, and new molecules under development. Regarding John Daly's, after already 15 years in the market and maintaining an excellent market share of more than 30% in its label, Closer to 2022, we've done increases in salt, demonstrating that this is a standard of care in soft tissues or coma. And we have an excellent commercial network. But in the last quarter of 2022, and Maria Luisa explained before, the generic of directive already appear, impacting in price in different European territories. According to the different regulations, the initial impact oscillates between 30 to 50% time reduction, depending on the countries, and the different distribution channels. Also, in some countries, the access system changed, starting the offers to tenders, and we will see what is the evolution to 2023. It is important to highlight the important development plan, which we've been active in, with two phases in the small cell and cancer, in first-line and second-line treatment, with trials underway. Three new factors three, mesothelioma, leiomyosarcoma, And in the last quarter of this year, we plan to start considering the ovarian cancer trial. This aside, Pascal will do more details. In 2022, we have reached an important agreement with the company that is going to collaborate in the mesothelioma trial, and we hope to start around the summer of this year. Regarding Cylentis, two phase three and one phase two in advancing according to the plan under development. And the recruitment is ongoing, and we will see the results of that when it's coming, but we expect it in early next year, so probably we will have the 3,000 data. In Phases 1 and 2, we have a cuvectinine, P534, and also in this third quarter, a new compound, P54, we will start the Phase 1. Finally, with haplidine, putideptin, we are initiating a Phase 2 trial in immunosuppressed patients, with SARS-CoV-2. As you can see, this is an ambitious development program that will certainly bring new treatment options for the patient and new opportunities for PharmaMart. Now, Pascal will review more details in some clinical trials. Pascal?