Good afternoon. Welcome everybody to this first half results virtual meeting, which will start in a moment. This is Javier López-Belmonte, ROVI's Deputy Chairman and Chief Financial Officer. Please let me first introduce ROVI's attendees today: Juan López-Belmonte, Chairman and CEO; Marta Campos, Head of Investor Relations; Beatriz de Zavala, Investor Relations, and myself. At the end of the presentation, a question and answer session will commence. If you want to ask any questions during the presentations, please do not hesitate to send them through the question button on the platform. Thank you for your presence here today, and let's now start with the presentation. I give Mr. Juan López-Belmonte the floor. Thank you, Javier. Welcome to everybody. I'm happy to present our first half results of 2023. 2023 is the first year of a new post-pandemic scenario, where COVID-19 would forcibly be a seasonal disease. 2023 is a transitional year in which we are making a big investment effort to increase current capacities to be able to produce many more pharmaceutical units in the future. In this context, we have been able to achieve stable total revenue of EUR 381 million. It is worth highlighting the positive evolution of Okedi, Risperidone ISM, reaching EUR 5.2 million in the first six months of 2023. CMO sales increased by 4% to EUR 172.2 million, that offset the 3% drop in the specialty pharmaceutical business in the first six months of the year. Despite the slowdown in sales of our low molecular weight heparin division in the first half of 2023, due to the increased use of heparins in the first half of 2022 because of COVID-19, sales of our enoxaparin biosimilar increased 14% and 5% in the second quarter of 2023, compared to the first quarter of 2023 and the second quarter of 2022, respectively. We continue to consolidate our internalization strategy as one of our pillars of future growth, thanks to our enoxaparin biosimilar, which is already marketed in 40 countries, and we expect it will enable us to be present in more than 90 countries in the long term. For 2023, with the visibility that the company has at this moment, we are upgrading our operating revenue guidance for the full year from low double-digit negative growth to high single-digit negative growth. In the first half of this year, ROVI announced two milestones for the company. First, at the end of April, ROVI announced the decision to commence the clinical development of a new three-monthly formulation of letrozole, hereinafter Letrozole LEBE, rather than the initially planned annual formulation of Letrozole ISM. The objective of this new development is to reach bioequivalence in the plasma levels of letrozole in comparison with the daily administration of oral doses of Femara, 2.5 mg. With this new clinical program for Letrozole LEBE, ROVI estimates it could reduce the research times in comparison to those for an annual formulation of the product, thus making it likely that the three-monthly formulation could be marketed several years earlier, and furthermore, the investment necessary to attain the objectives of this project could also be reduced. The first clinical trial of Letrozole LEBE is planned to start by Q3 2023. Regarding the second milestone, ROVI informed on the evaluation process to obtain marketing authorization for Risvan, Risperidone ISM in the United States, and reported that the FDA has notified the company that the user fee goal date is July 27, 2023. The company is awaiting an FDA notification on the user fee goal date. The content of this notification will be reported as soon as it is received. No conference call regarding this notification is planned. To comment on the results, regarding the top line of the P&L, operating revenue remained stable at EUR 380.8 million in the first half of 2023, compared to the same period of 2022. The main contributors to sales in the first post-pandemic half year were CMO business, where sales increased 4%, Okedi, where sales reached an amount of EUR 5.2 million, Neparvis, where sales rose 17% to EUR 22.1 million. Likewise, Orvatez sales rose 12% to EUR 13.6 million in the first half of this year. ROVI ceased to distribute Absorcol as of thirty-first of December of twenty twenty-two, and Vytorin as of thirty-first of January of twenty twenty-three. I would like to comment that Volutsa sales decreased by 6% in the first half of twenty twenty-three, mainly due to a product price reduction of 47% in the second quarter of twenty twenty-three. In the first half of 2023, profitability was negatively impacted by the higher contribution to the CMO business of the income related to the activities to prepare the plant for drug production under the agreement with Moderna, which adds lower margins to group sales. EBITDA reached EUR 97.1 million in the first half of 2023, a decrease of 16% compared to the same period last year, reflecting a 5 percentage point decrease in the EBITDA margin, which was down to 25.5% in the first half of 2023, from 30.4% in the same period of 2022. Likewise, net profit decreased by 17% from EUR 80.6 million in the first half of 2022, to EUR 66.6 million in the same period of 2023. Moving to our first pillar of growth, which is our specialty pharma area, sales of prescription-based pharmaceutical products decreased 5% to EUR 184.5 million in the first half of 2023. Sales of the heparin franchise, low molecular weight heparins, and other heparins decreased by 13% to EUR 123.4 million in the first half of this year. Mainly because of the increase in orders from partners in 2022 related to the treatment for COVID-19, which has led to a lower expected volume of orders from partners in 2023, since they still hold a high level of stocks from 2022. Heparin sales represented 32% of operating revenue in the first six months of 2023, compared to 37% in the same period last year. ROVI considers its heparin franchise as one of its driving forces, and we aim to become one of the leaders in the low molecular weight heparin field worldwide with our two molecules, bemiparin and enoxaparin biosimilar. Bemiparin showed a negative performance in the first half of 2023, with sales down 20% to EUR 44.5 million. Enoxaparin sales decreased 9% to EUR 74.5 million in the first half of 2023. The drop in sales of both products was mainly due to the increase in orders from partners in the first half of 2022 related to the treatment for COVID-19. ROVI expects low molecular weight heparin sales to decrease by a low single-digit figure in 2023. ROVIwill still continue with our internalization plan. Sales outside Spain decreased by 2% compared to the first half of 2022, to EUR 240.8 million in the first half of 2023. EUR 43.6 million, or 18% of which related to international subsidiaries, mainly due to a decrease in low molecular weight heparin international sales. Sales outside Spain represented 62% of the operating revenue in the first half of the year, compared to 65% in the same period of 2022. Regarding the enoxaparin biosimilar Becat, it is already present in 40 countries, and we have signed out license agreements to distribute the product in more than 90 countries. We started the commercialization in Q4 2017, with sales amounted to EUR 1.5 million, and sales increased quarter by quarter to reach EUR 152.9 million sales last year, a 23% rise compared with the previous year. In the first half of 2023, enoxaparin biosimilars sales decreased by 9% to EUR 74.5 million as a result of, as we explained before, the increase in orders from partners in the first half of 2022 related to the treatment of COVID-19. However, sales of the product increased 14% in the second quarter of 2023 to EUR 39.6 million, compared to the first quarter of the year, and rose 5% in the second quarter of 2023 compared to the second quarter of 2022. In the second quarter of 2023, the product sales were EUR 4.5 million, or 13% higher than the average quarterly sales of the product in the last 10 quarters. The product was launched in Jordan and Sri Lanka in the first half of 2023. Let me just summarize the opportunity here. This is a EUR 2 billion market, EUR 1.3 billion in Europe and EUR 0.7 billion in emerging countries, with high entry barriers, where biosimilars are likely to reach 50%-70% of market share and with only three other players in the market likewise Neparvis, Orvatez, and Okedi led the growth of the pharmaceutical specialty products. Sales of Neparvis, a specialty product from Novartis, launched in December 2016, indicated for the treatment of adult patients with symptomatic chronic heart failure and reduced ejection fraction, increased 70% to EUR 22.1 million in the first half of 2023, compared to EUR 18.9 million in the first half of 2022. Sales of Volutsa from Astellas Pharma, launched in Spain in February 2015, decreased by 6% to EUR 8.3 million in the first half of 2023, mainly due to a product price reduction of 47% in the second quarter of 2023. Sales of Vytorin and Orvatez, specialty products from Merck Sharp & Dohme, indicated as adjunctive therapy to diet in patients with hypercholesterolemia, decreased 14% to EUR 13.7 million in the first half of 2023. ROVI ceased to distribute Absorcol as of 31st of December of 2022, and Vytorin as of 31st of January of 2023. Orvatez sales rose 12% to EUR 13.6 million in the first half of 2023, compared to EUR 12.1 million in the first half of 2022. Sales of Absorcol and Vytorin accounted for 24% of total sales of the products involved to treat hypercholesterolemia in the first half of 2022. Sales of Okedi, the first ROVI product based on its leading-edge drug delivery technology, ISM, for the treatment of schizophrenia in adults for whom tolerability and effectiveness has been established with oral risperidone, reached an amount of EUR 5.2 million in the first half of 2023. Okedi sales increased by 36% in the second quarter of this year compared to the first quarter of the year. In 2022, it was launched in Germany in April, the U.K. in July, and Spain in September, and in January 2023 in Portugal. ROVI expects to launch the product in Italy and Austria during the second half of the year. Post-launch feedback has been positive. In Germany, the product was received very positively in the medical education activities carried out by ROVI and is already present in 58% of hospitals. Okedi's average monthly sales growth in the first six months of 2023 was 20%. In the United Kingdom, the product is in the introduction phase in the trusts, which are the entities that manage the health areas. In Spain, the product is available in the 100% of the autonomous communities and was being marketed in more than 80% of hospitals. In Portugal, access to doctors was positive. It was being marketed in 40% of hospitals, and it is expected to be in most of the hospitals by the end of the year. Finally, sales of contrast imaging agents and other hospital products increased by 18% to EUR 23.6 million in the first half of 2023. This increase shows the strong recovery of the Spanish and Portuguese hospital activity during this period after the effects of lockdowns during the pandemic. In February 2022, ROVI reinforced its long collaboration with Moderna by signing a new 10-year agreement, which will allow to increase capacities for the compounding, aseptic filling, inspection, labeling, and packaging of ROVI's facilities in Madrid. In addition to producing Moderna's COVID-19 vaccine, ROVI's platform could also be utilized to service future Moderna mRNA vaccine candidates. To this end, further industrial investments are being made in the ROVI Group's facilities in Julian Camarillo, San Sebastian de Los Reyes, and Alcalá de Henares. Regarding CMO sales, they increased by 4% to EUR 172.2 million in the first half of 2023 as a result of the booking of the income related to the production of the COVID-19 vaccine, the booking of the income related to the activities to prepare the plant for the COVID-19 vaccine production and the agreement with Moderna, and the reorientation of our contract manufacturing activities strategy towards high-value-added products. Regarding our research and development strategy, Okedi is the first ROVI's product based in its leading-edge drug delivery technology, ISM. It is a novel investigational antipsychotic for the treatment of schizophrenia with once monthly, every 28 days, injections, which has been developed and patented by ROVI, and which, as of the first injection, provides immediate and sustained plasma levels and does not require loading doses or supplementation with oral risperidone. In January 2020, ROVI announced the commencement of the centralized procedure for registration of Okedi with the European Medicines Agency. On December 16, 2021, the CHMP adopted a positive opinion recommending the granting of a marketing authorization for the medicinal product Okedi. Finally, on February 15, 2022, the European Commission authorized the marketing of Okedi for the treatment of schizophrenia in adults for whom tolerability and effectiveness has been established with oral risperidone. Likewise, at its Capital Markets Day, held on November 24, 2020, ROVI announced the filing of an NDA, a registration dossier to obtain marketing authorization in the U.S. with the FDA. ROVI was informed of the delay in a decision on granting marketing authorization for Risvan by the U.S. FDA. Furthermore, on September 24, 2021, ROVI received a complete response letter from the FDA with outstanding questions on the Risvan dossier, which were answered in January 2022. In Q3 2022, the FDA issued a second complete response letter with some outstanding questions for ROVI and also with questions for one of its manufacturers. Both ROVI and the manufacturer provided answers to the FDA, and the FDA notified ROVI that the user fee goal date is July 27, tomorrow, 2023. The grant of the marketing authorization for Risvan by the FDA is also subject to the closure of the observation issued by the FDA after the pre-approval inspection of the plant where the product is manufactured. That was conducted in the second half of June 2022. Responses to these observations were provided to the FDA. ROVI's plant has now been respected by the FDA, and the company is awaiting an FDA notification of the user fee goal date, which is tomorrow, and the content of this notification will be reported as soon as it is received. Likewise, ROVI's research and development team is progressing in the development of a new formulation of risperidone for a three-monthly injection, which would complement the current four-weekly formulation of Risperidone ISM for the maintenance treatment of patients with clinically stable schizophrenia. The regulatory toxicity studies needed to start the clinical development in humans have already been completed. The company is currently initiating all arrangements to conduct a phase I clinical trial to evaluate the safety, tolerability, and pharmacokinetics of various candidate formulations at different dose strengths and injection sites. Patients recruitment for this study is planned to begin by the third quarter of 2023. Lastly, the company has decided to commence the clinical development of a new 3-monthly formulation of letrozole, rather than the initially planned annual formulation of Letrozole ISM. The objective of this new development is to reach bioequivalence in the plasma levels of letrozole in comparison with the daily administration of oral doses of Femara, 2.5 mg. With this new clinical program for Letrozole LEBE, ROVI estimates it could reduce the research times in comparison to those for an annual formulation of the product, thus making it likely that the three-monthly formulation could be marketed several years earlier. Furthermore, the investment necessary to attain the objectives of this project could also be reduced. Accordingly, ROVI has recently applied in Europe for authorization of a phase I clinical trial to evaluate the pharmacokinetics, safety, and tolerability of single ascending doses of Letrozole LEBE at different strengths in voluntary, healthy, post-menopausal women in a study called LEILA-1. This first clinical trial of Letrozole LEBE is planned to start by the third quarter of 2023. Finally, we end this part with an upgrade of our guidance for 2023. November 2022 and February 2023, ROVI announced it expected the operating revenue for the full year 2023 to show a low double-digit negative growth on 2022, although positive growth of between 5% and 10% is expected in comparison with the 2021 figure. With the visibility that the company has at this moment, ROVI is upgrading its operating revenue guidance for the full year 2023 from low double-digit negative growth to high single-digit negative growth. For 2023, ROVI is assuming a new post-pandemic scenario in which COVID-19 would forcibly be a seasonal disease, and in principle, the vaccine would be administered once a year. The uncertainty related to the evolution of the disease is still very high. It is not, therefore, possible to make a precise assessment of the impact that this new scenario could have on the CMO business. Likewise, under the terms of the agreement signed with Moderna in February 2022, ROVI is still investing in increasing the compounding, aseptic filling, inspection, labeling, and packaging capacities at its facilities, and expects them to be fully installed by the end of 2024. Taking account of the aforementioned guidance on a decrease in operating revenue in 2023, as well as the fact that ROVI will continue with its investment policy as stated, it is reasonable to expect that the company's profits may also see a downward adjustment in 2023. We are satisfied with the evolution of the company in the first half of 2023, because we have been able to achieve stable total revenue of EUR 381 million. We have continued our internalization strategy in our heparin division through the launch of our enoxaparin biosimilar in 2 new countries in the first six months of 2023. We have increased sales of Neparvis and Orvatez, which have increased by 17% and 12%, respectively, in the first half of 2023 compared to the first half of 2022. The launch of Okedi in Portugal, reaching sales of EUR 5.2 million in the first half of this year, and increasing sales by 30% in the second quarter of 2023 compared to the first quarter of the year. We have achieved growth of 4% in the manufacturing business for third parties, thanks mainly to the collaboration agreement with Moderna. Likewise, we are making an investment effort in research and development focused on our ISM technology, which we see as a new avenue for ROVI's future growth. To conclude, we believe we are at a growth inflection point, with a strong growth opportunity driven by the launch of Okedi, our first candidate, validating our leading-edge drug delivery technology, ISM. Secondly, our enoxaparin biosimilar, which is allowing us to transform our European footprint. Thirdly, the agreement with Moderna, which is helping strengthen our manufacturing area. Lastly, the increase in our production capacities that could provide us with a significant growth opportunity in the area. These growth levers are firmly underpinned by a very solid ongoing business that has delivered year after year, based on our leading specialty pharma franchise and our high-value-added CMO services. Now, I hand you over to Javier, who will run you through the financials in more detail. Thank you very much for your attention and for taking the time to participate in this virtual meeting. Thanks, Juan. We are extremely happy with the evolution of the company in the first half of the year. As Juan already said, we have been able to deliver a stable total operating revenue of EUR 380.8 million in the first post-pandemic half year. The 3% drop in the specialty pharmaceutical business was offset by the 4% growth in the CMO business in the first six months of the year. The main drivers of growth in this first half of the year were Okedi, our reference products, Neparvis and Orvatez, and of course, our CMO businesses. Sales of low molecular weight heparins decreased by 14% to EUR 119.1 million in the first half of 2023, mainly due to the lower volume of orders from partners as a result of the increase in the product use in the first half last year because of COVID-19. Bemiparin showed a negative performance in the first half of 2023, with sales down 20% to EUR 44.5 million. Despite the enoxaparin sales decrease of 9% to EUR 74.5 million in the first half of this year, the product increased 14% and 5% in Q2 2023, compared to the first quarter of 2023 and the second quarter of 2022, respectively. Gross profit decreased 5% to EUR 215.7 million in the first half of this year, compared to the same period of 2022. Gross margin showed a decrease of 3.1 percentage points, from 59.7% in the first months of last year to 56.6% in the same period of 2023, mainly due to the higher contribution to the CMO business of the income related to the activities to prepare the plan for drug production and the agreement with Moderna, which adds lower margins to group sales. ROVI continues to be committed to innovation. R&D expenses amounted to EUR 10.8 million in the first half of the year. This figure is mainly the result of a focused investment in the ISM projects, preparing the development of the next phase of Letrozole LEBE and the development of a new formulation of Risperidone ISM for a three-month injection. Selling, general, and administrative expenses, SG&A, increased 7% to EUR 107.8 million in the first half of 2023, mainly as a result of an increase in expenses due to the Okedi launch in Europe. EBITDA reached EUR 97.1 million in the first half of 2023, a decrease of 16% compared to the same period of 2022, reflecting a 5% percentage point decrease in the EBITDA margin, which was down to 25.5% in the first half of 2023, from 30.4% in the same period last year. EBIT decreased by 18% to EUR 85.2 million in the first half of this year, reflecting a 5.1 percentage point decline in the EBIT margin, which was down to 22.4% in the first six months of 2023, from 27.5% in the same period of 2022. The effective tax rate was 22.4% in the first six months of the year, compared to 23.5% in the same period of last year, mainly due to the decrease of the profit before income tax. Next, profit. Net profit already decreased by 17% from EUR 80.6 million in the first half of 2022 to EUR 66.6 million in the same period of this year. EBITDA pre-R&D, calculated excluding R&D expenses in the first half of 2023 and the first half of 2022, decreased by 15%. In the same way, EBIT pre-R&D decreased by 16%, and net profit pre-R&D decreased by 15%. ROVI invested EUR 18.2 million in the first half of 2023, compared to EUR 9.9 million in the same period of last year. Of this amount, EUR 15.7 million relates to investment CapEx regarding our facilities, including important projects such as the ISM industrialization, the building of a second low molecular weight heparin API facility in Escúzar, Granada, the glycopeptide joint venture from the construction of a plant dedicated to the production of compounds of high biological value from the intestinal mucosa of the pigs, and lastly, the new lines for the Moderna products and the operations expansion. On top of that, EUR 2.5 million relates to maintenance and other CapEx. Cash flow from operating activities decreased to EUR 52.5 million in the first half of 2023, from EUR 169.4 million in the same period of 2022. This decrease was mainly due to the decrease of EUR 19.5 million in profit before income tax, the booking of EUR 23.3 million under negatives under the cash flow, under the provision, under the cash flow from provision of manufacturing services, sorry, captured in the first half of 2023, mainly due to the allocation of more revenue to the income statement than payments received, compared to EUR 74.1 million recognized in the first half of last year. The decrease of EUR 40.1 million in the inventory item in the first half of this year, compared to a decrease of EUR 21.2 million last year, mostly due to an increase in heparin stock and in a stock related to the production of the COVID-19 vaccine. Finally, the decrease of EUR 21.6 million in the trade and other payables item in the first half of 2023, compared to an increase of EUR 2.9 million, same period, in the same period of 2022. Regarding our debt, as of 30th June, 2023, ROVI total debt decreased to EUR 66.5 million from EUR 72.2 million as at the end of last year. Of this debt, EUR 40.9 million is debt with banks, representing 62% of the total debt, while EUR 9.6 million correspond to debt with public administration related to the development of R&D projects, which is zero interest rate debt, representing 14% of total debt. EUR 16 million correspond to financial liabilities for leases, representing 24% of our total debt. As the first half of the year, ROVI had a gross cash position of EUR 156.9 million, compared to EUR 126.4 million as of December 31st, 2022, and a net cash position of EUR 90.4 million, compared to EUR 54.2 million as end of last year. As you know, regarding the dividend, ROVI's general shareholders' meeting approved the payment of a gross dividend of EUR 1.2938 per share, which represents a 35% increase on the dividend charged to the 2021 profit. This dividend was fully paid on the 5th of July this year. Considering the group's cash generation and the market situation, ROVI has decided to launch a buyback program for the company's share, effective as of today's date, 26th of July, 2023, in order to cancel ROVI shares, and at the same time, boost the remuneration of the ROVI shareholder by increasing the profit per share. The program is for a maximum amount of EUR 130 million and a duration of 12 months. Finally, regarding news flow for 2023, we will continue to monitor the evolution of the manufacturing of the Moderna products. We expect to announce Okedi's launch in some European countries. Let me remind you that the product has already been launched in Germany, U.K., Spain, and Portugal, and it's expected to be launched in Italy and Austria during the second half of this year. In addition, we expect to inform on new national marketing approvals for the enoxaparin biosimilar outside Europe. With regards to R&D, hopefully, we expect to obtain the marketing authorization for Risperidone ISM in the U.S. Regarding Letrozole ISM, ROVI has decided to commence the clinical development of a new three-monthly formulation of letrozole, what we call Letrozole LEBE, it is planned to start by the third quarter of 2023. Lastly, ROVI is progressing in the development of a new formulation of Risperidone for a three-monthly injection. The company is currently initiating all arrangements to conduct a phase I clinical trial, which patients' recruitment for this study is planned to begin by the third quarter of the year. That's all. That's all regarding our financial results for the first half of 2023. We can now start the Q&A session. You know, if you want to ask any questions, please do not hesitate to send them through the question button on the platform. Thank you very much, Javier. We have received a lot of questions. We are going to try to answer all of them. The first question is from Guilherme Macedo, from CaixaBank: "Juan, could you provide some granularity on the evolution and current state of the FDA review process of your Risvan supplier, following the new observations raised earlier in the year"? Hi, good afternoon. Thank you, and thank you for your question. Unfortunately, I cannot provide much more information than the one I've shared a few minutes ago. I mean, we have been working closely with our manufacturers to try to assess adequately all the concerns of the FDA. We feel very much confident that we have done the work that the FDA was requiring, and we are just hours away from having the FDA feedback. I'm sa- I'm... I can just restate that I believe that the company and the team has done a tremendous good job. I think we have got engaged in a program to meet the FDA standards as they required. I have to say that today, with the information that we have, we are confident that we successfully get the approval of the product in the States. I'm just looking forward to be able to announce it tomorrow, once or the day after tomorrow, once we get the feedback from the FDA. Thank you, Juan. Javier, Guilherme asks: Could you comment on the main drivers for the guidance upgrade? To what extent were the second quarter 2023 low margin tech transfer revenues incorporated in your previous guidance? Are you considering in your revised guidance, a better second half of the year than first half of the year in total manufacturing, as mentioned with the first quarter 2023 results? Hello, good afternoon again. We believe and we are extremely happy with the results of the company in the first half of the year. I think it was surprisingly positive even for us. Yes, we had in our previous guidance the tech transfer activities. Probably this figure has been bigger than previously forecasted, and we are also forecasting some activities for the second part of the year, you know, in these tech transfer regards. Basically, in the second part of the year, we expect to increase potentially our contract manufacturing business with regards to the manufacturing of the vaccine itself. We remain very positive, more positive for the second part of the year than in the previous, than in the first part of the year. We remain confident that the second part of the year is gonna be better, and especially I think, the contract manufacturing business revenues, we expect that the percentage of business coming from recurrent manufacturing activities is gonna be bigger than in the first half. The tech transfer activities are gonna be slightly lower in the second part of the year, which, as we've been commenting today, it will help us to potentially have better margins in the second part of the year. Thanks, Javier. Guilherme also asks: could you provide more details on how does the postponement of Okedi's launch in France impact your SG&A budget for 2023? Uh, I mean- Yeah, I mean, [cross talk]. Sorry. Go ahead. Go ahead, Javier. Go ahead. I mean, the... I mean, getting the reimbursement process throughout Europe is getting more and more complicated. This is a tendency that started several years ago. France, regarding long-acting injectables, they had a scenario with considerably lower prices than the rest of the European countries. Again, it's not going to impact our figures for 2023, but definitely we keep on working, and we are trying our best, and we are still holding conversations with the French authorities to see how we can get the reimbursement process in time and in the right prices that it can make the sales and operations profitable for the company. We believe Okedi provides tremendous added value to the patients. It's clearly addressing an unmet medical need today, especially in the acute patients scenario. We have as well a very constructive channel open with the French authorities, we are still working on trying to find a way to get the product reimbursed. Straightforward answering to your questions, we don't see a major impact on our budget and our figures for 2023. Thanks, Juan. The next question comes from Francisco Ruiz from Exane. Javier, assuming that sales should accelerate in the second half in absolute terms, thanks to vaccine seasonal contribution, it is fair to think that EBITDA in the second half would be better in absolute terms than in the first half? Thank you. As everybody knows, we don't provide guidance on profitability or on EBITDA levels. Yeah, it's clear that if we increase our manufacturing activities, especially manufacturing other value products as the COVID-19 vaccine, potentially we could increase margins, and potentially we could increase our profitability, you know? Still, this year is a post-pandemic year. The first post-pandemic year is very difficult to forecast. Yeah, hopefully, if we increase our revenue coming from the CMO in the second part of the year, potentially it's opportunity to increase the profitability of the company. Thanks, Javier. Juan, Francisco also asks: imagine there is a green light from the FDA to proceed, what will be the following steps? What would be the milestone we could expect from the partner? Hi, Francisco. Good afternoon. Again, I can assure you that we have done our homework properly. We're just waiting to get the green light, hopefully, this week. As we have shared with investors in many different sessions, we really want to close conversations once we got the approval in place. We are holding conversations with different players, with some of them more advanced than we know with others, and we should be able, in September, to be able to give more visibility and clarity on the different agreements that we'll be signing. We are still gathering information from a strategic intelligence on the market in place in the US, and how it should be the best way to proceed to make this product a successful launch. we expect that by September, beginning of October, we should be able to provide a positive feedback to the market. Thanks, Juan. Álvaro Lence from Alantra has several questions. The first one is, Javier, what are the expected costs for the first trial of Letrozole LEBE? Should it all be included in the second half results? Well, the good thing about this new development of Letrozole LEBE is that the cost of the clinical trial development is much lower, no? As I think we commented today, we are about to start the clinical trial. Probably, it will last until first quarter next year, so some of the costs will be splitted by this year and the following one. Mainly, all the costs will come this year, no? Roughly speaking, probably the cost of the trial is around EUR 10 million. Probably, as I was saying, most of the cost will impact it this year. Thanks, Javier. Juan, Álvaro also asks, Do you have a sense of what is the setting in which physicians are using Okedi? Are you seeing physicians switching treatment for their patients use only in acute patients? I mean, what we are getting from the physicians' community is extremely positive feedback. Obviously, as we have mentioned several times, we are only focusing on naive patients. I mean, those patients that unfortunately they are starting with a long-acting injectable, or they have to switch to an alternative long-acting injectables because for whatever or different reasons, their current treatment doesn't cover their psychotic symptoms. The positive is extremely positive. Obviously, initially, most of the physicians started using the product on the acute phase, but now we're seeing more and more physicians who are starting to use the product as the starting long-acting injectable for their patients. Really, the trend is going positive. Important to mention is that this trend is very much homogeneous to the different countries, we are extremely happy with the response that we are getting so far. We see that we're going to have a steady growth in terms of sales of Okedi in the next coming quarters. Thanks, Juan. Alvaro also asks, "Are you still open to licensing letrozole now that you have changed the development path? I mean, as, I think the going back to Okedi, I think the importance of Okedi, that's something I have highlighted in all our calls, is that Okedi meant for ROVI two major milestones. The first one is the approval of the product itself, but the second milestone is the validation of our ISM platform. In that sense, that's a major, a major push for the company's strategy and growth for the future. Regarding letrozole, I think we have done a terrific job with the annual annual dose or the annual treatment of Letrozole ISM. We have moved to the quarterly injection because the goal of the company as to the extent our financials may allow us, we would like to market the product ourselves. Having said that, we are open and I don't want to deny that we are holding conversations and that we have entered into different level of discussions with companies regarding letrozole. Our major goal is to try to bring products that can improve the adherence and can cover unmet medical needs. We definitely see that letrozole, in terms of adherence and in terms of management of the disease, is a real major blockbuster drug. We are following both avenues. We are developing the product by ourselves, but at the same time, we are not neglecting that we are having conversations with third parties. Thanks, Juan. Álvaro also asks, "With Letrozole LEBE presumably taking less resources, are you planning on expanding the pipeline further? Are any other therapeutic areas to which ISM could be applied? I mean, with Letrozole LEBE, you're right, Álvaro. I mean, that is going to allow us to be able to look into different areas. We have different candidates in the preclinical stage, and hopefully, we expect soon to be able to announce that we are probably moving another candidate into last or preclinical phases or even early clinical phases. Again, the approval of Risvan in the U.S. and letrozole is taking not only most of our financials, but also most of our time, of our people, of our team in the research and development. So far, our strategy has always to try to focus on what we have in place, which it was important, not only urgent. Now that Risvan, we should have a final decision by the FDA in the next coming days, and that we are moving into already plan quarterly injection treatment of letrozole. We are positive that we will be able to try to move one of those candidates that we have already in the preclinical phase into clinical stages. We expect that in the next quarter, we should be able to share this information with investors. Definitely, I think the ISM platform is going to be a tremendous avenue of growth for the company for the next decade, and definitely there are more products that should come from this technology. Thanks, Juan. James Vane -Tempest from Jefferies has several questions. The first one, Javier, is for you. "Guidance of lower profitability in 2023, can you quantify this or provide a floor, given the impact of potential investments for growth could make it as much as 50% lower? Thank you, Marta. Again, this year is very difficult for us to forecast, no? As it's our first post-pandemic year. We are extremely happy with the outcome of the first half. Probably, I'm sure it was better than expected for us. Second half of the year, it looks enticing. We have already commented that, probably, we'll have a stronger business in the CMO business, which will drive our profitability, our profits, and our margins. It will make them better. Probably, again, it's still early for us to quantify. We don't think that the degrees of the profitability will be to 50%, no? If I listen right to the question, I don't think it will be that negative. Again, we want to be cautious. We want to go quarter by quarter. If all our news we are confirmed, as we are saying, probably the second half of the year will be even better than the first half in terms of revenues, and that will probably make a better P&L. Thanks, Javier. James also asks: "Inventories are up materially due to increase in heparin stock and COVID-19 production vaccine, but when do you expect this to normalize? Well, hopefully, we expect those stocks to be normalized at the end of the year. Again, with heparin, as you know, we want always to make sure that we are comfortable with the stocks, that we can also handle our manufacturing production as it's most efficient for the company, and we don't hesitate to increase inventories if that's the way to make the company more efficient, no? Again, probably at the end of the year, we could see those stocks normalized. The last one from James, Javier: "How material and when was the mRNA income to prepare the plant? Group gross margins in the second quarter were around 50%, please help us understand the second half gross margin dynamics from here. Yeah, the second half dynamic of the year, if everything is confirmed, we will probably have more revenues coming from the manufacturing of the mRNA vaccine. That will make margins look better, as we've been trying to explain. The tech transfer activities that we try to also to explain to investors, probably they will be lower in the second part of the year, and that means that we have lower margin on those activities. Probably, although, all in all, again, margins should go up in the next quarters. Again, always, take into account that these forecasts are confirmed and that we end up manufacturing the vaccines that we expect in this two next quarters. Thanks, Javier. Álvaro Lence from Alantra asks, "Should we expect a significant acceleration of SG&A in the second half, considering that vaccine production should pick up? Yeah, probably we'll have some increase on SG&A. We try to remain all the expenditure very controlled and in a very strict way. Again, if we are manufacturing more in the second part of the year, probably we'll have an increase, no, on the SG&A. As everybody knows also, we are adding new lines to the company, and adding new lines means adding new people to the company, too. It's fair to say that probably we'll have a higher SG&A at the end of the year, no? However, having said that, we try to be very efficient, and probably it could be not that material, no? Thanks, Javier. Álvaro also wants to know, should we understand that there are no M&A opportunities in the short term? I think as we announced today, this share buyback program is that, in the short term, we don't find any attractive and synergetic opportunities for ROVI in the short term. I think it's it makes sense to say that there are no big opportunities or anything material to come in the next quarters. Thanks, Javier. Ignacio Ortiz de Mendivil from EDM asks, "Should we expect the dividend to be paid in 2022 to be a floor, or could we expect it to decrease in line with the net profit decrease in 2023? So far, the dividend policy of the company has been a payout of 35% of the net profit. Again, this the dividend for 2023, I think it's still early to talk about that, but probably if nothing change, the dividend for the year will be around 35% the net profit of the year. Thanks, Javier. Nicholas Schmidlin asks, "What was the growth of the CMO base business in the first half of 2023? It's been a moderate growth. I don't have the numbers. I don't know the numbers by heart. I think when you're referring to base business, it's excluding Moderna, I guess, and the growth has been modest also because still, until we add new lines to the company, we still to give the current capacity to Moderna. Hopefully, from second part of the year and especially next year onwards, we'll have a great opportunity to have new customers on board and to expand in a significant way these new customers base in business. I would say that is the main opportunity for the company in the next years, but still we need to implement and to have the capacity on board. Thanks, Javier. The last question comes from Richard Brighart from Avantgarde. Juan, given the strong development of the heparin franchise, especially enoxaparin, during the second quarter, is it right to assume that the de-stocking at your partners is now done? Hi, Richard. Thank you for your question. For us, it's difficult to assess that because we don't have that much visibility. Yes, we do believe that the stock it should end at least by the end of next quarter. I think the COVID-19 pandemic raised stocks last year. It was, as you may know, enoxaparin and most of the low molecular weight heparins, they were declared essential and strategic drugs for the COVID-19 treatment. Governments across Europe forced companies to increase the stocks to make sure that they had the right supply of both prophylactic and treatment dosage. Now what we are seeing after the pandemic scenario into this new endemic setting, that those stocks have been gradually decreased, and we expect that just by last quarter, we should be in a normal setting scenario. Thanks, Juan. Thank you very much for your high participation. Let me now turn the floor over to our Deputy Chairman and CFO, Mr. Javier López-Belmonte, for the closure of the presentation. Thanks, Marta. I think there is no more time for more Q&A. The team will help anyone to answer all the pending questions. Therefore, we end this conference call right now. Thank you very much for joining us today, and we wish you a great summer break too. Thank you.