Laboratorios Farmaceuticos Rovi, S.A. (ROVI) Earnings Call Transcript & Summary

Good afternoon, and welcome everybody, to this 2021 Results Virtual Meeting, which will start in a moment. This is Javier Lopez-Belmonte, ROVI's Vice President of the Board and Chief Financial Officer. Please let me introduce ROVI's attendees today, Mr. Juan Lopez-Belmonte, Chairman and CEO; Ms. Marta Campos, Head of Investor Relations; Mr. Antonio Marquina, Investor Relations and myself. At the end of the presentation, our question-and-answer session will commence. If you want to ask any questions during the presentation, please do not hesitate to send them through the question button on the platform. Thank you for your presence here today.

Good afternoon, and welcome everybody, to this 2021 Results Virtual Meeting, which will start in a moment. This is Javier Lopez-Belmonte, ROVI's Vice President of the Board and Chief Financial Officer. Please let me introduce ROVI's attendees today, Mr. Juan Lopez-Belmonte, Chairman and CEO; Ms. Marta Campos, Head of Investor Relations; Mr. Antonio Marquina, Investor Relations and myself. At the end of the presentation, our question-and-answer session will commence. If you want to ask any questions during the presentation, 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, and I give Mr. Juan Lopez-Belmonte the floor.

Thank you, Javier, and welcome to everybody. I'm happy to present our 2021 results. In these exceptional times, ROVI's performance during the year has been above our expectations. Our 50% operating revenue growth was driven by the strength of the CMO business, which grew by 189% and by the Specialty Pharmaceutical business, which grew by 17%. According to IQVIA, a Spanish innovative product market increased by 4% in 2021 compared to the previous year. Nevertheless, ROVI prescription-based pharmaceutical product sales increased 17% in 2021, outperforming the market by more than 13 percentage points. The company forecast that it will continue to grow at a much higher rate than the Spanish pharmaceutical market expenditure in 2021, which according to the Ministry of Health, Consumption and Social Welfare, show a growth rate of 6.1%. Regarding the classification of laboratories, using data from IQVIA, ROVI was positioned 14th in terms of value and was the fastest-growing Spanish innovative company among the 14 top ranked companies in 2021. In 2021, ROVI gained 2 positions in this classification compared to the previous year. Last week, ROVI announced 2 very important milestones for the company. First, the European Commission has authorized the marketing of Okedi for the treatment of schizophrenia in adults for whom tolerability and effectiveness has been established with oral risperidone. Second, we expand our long-term collaboration with Moderna for the manufacture of mRNA medicines over the next 10 years. This new agreement, which has a term of 10 years, including a series of investments expected to allow the manufacturing capacity to increase across ROVI's facilities in Madrid. We are delighted to expand our collaboration with Moderna and become a long-term manufacturing partner. At ROVI, we are working to contribute all our experience as a high technological value contract manufacturer of injectables to the solution of this pandemic, and we are confident of our ability to take part in the manufacturing of new mRNA candidates in the future. To comment on the results, regarding the top line of the P&L, operating revenue increased by 54% to EUR 648.7 million in 2021. The main contributors to this growth were enoxaparin biosimilar, which grew 22% to an amount of EUR 124 million. Bemiparin, where sales rose 9% to EUR 110.7 million, Neparvis, sales of which grew by 30% and the CMO business, where sales increased 189%. The extraordinary increase in sales pushed profitability up by 8.8 percentage points to 31.3% in 2021. EBITDA increased by 115% to an amount of EUR 202.9 million. Likewise, net profit increased by 151% from EUR 61.1 million in 2020 to EUR 153.1 million in 2021. Moving to our first pillar of growth, which is our specialty pharma area, prescription-based pharmaceutical specialties grew by 17% in 2021. They are high strategic value products and contribute to keep ROVI at wider scope for the coming years. ROVI considers its heparin franchise as one of its driving forces. Sales of the heparin franchise increased by 16% to EUR 242 million in 2021. Heparin sales represented 37% of operating revenue last year, compared to 50% in 2020. We aim to become one of the leaders in the low molecular with heparin field worldwide with our 2 molecules, Bemiparin and enoxaparin biosimilar. Bemiparin show a positive performance in 2021 with sales up 9% to EUR 110.7 million and in enoxaparin sales increased 22% to EUR 124 million last year. ROVI continues with its internationalization plan. Sales outside of Spain increased by 105% to EUR 392 million in 2021, EUR 64.4 million or 60%, of which related to international subsidiaries, mainly due to either the increase in low molecular with heparin in international sales, the increase in the contract manufacturing organization business and sales outside of Spain represented 60% of operating revenues in 2021 compared to 46% in 2020. International sales of Bemiparin increased by 25% to EUR 41.3 million. This increase was mainly linked to the increase in sales prices to some partners and wholesalers due to the rise in low molecular weight heparin raw material prices and the increase in sales in the Russian, Turkish and Chinese markets. Sales of Bemiparin in Spain increased [Technical Difficulty] last year, mainly due to a higher penetration of the product in the Treatment segment. Regarding the enoxaparin biosimilar BECAT, we launched the product in Germany in 2017. In U.K., Italy, Spain, France, Austria, Latvia and Estonia in 2018, in Portugal, Poland, Costa Rica, Finland and Sweden in 2019. In South Africa, Israel, Peru, Holland, Panama and the Dominican Republic in 2020 and in Canada, Malaysia, Albania, North Macedonia, Guatemala and Salvador, Honduras, Georgia, Jamaica, Gabon Democratic Republic of Congo and Trinidad and Tobago in 2021. We have signed 2 important licensing agreements to distribute and market our enoxaparin biosimilar. The first with Hikma Pharmaceuticals, who has exclusive rights for 17 Middle East and North Africa countries and the second with Sandoz for 14 countries or regions. We started the commercialization in Q4 2017 with sales accounted to EUR 1.5 million, and sales increased by quarter to reach EUR 124 million sales in 2021, a 22% rise compared with the previous year. So 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 markets with high entry barriers where biosimilars are likely to reach 50% to 70% of the market share and with only 3 other players in the market. The latest launches were again a strong driver of growth in 2021. Sales of Neparvis a specialty product from Novartis launched in December 2016, indicated for the treatment of other patients with symptomatic chronic heart failure and reduced ejection fraction, increased 30% to EUR 38.5 million in 2021 compared to EUR 29.6 million in 2020. Sales of Volutsa from Astellas Pharma increased by 14% to EUR 16.3 million in 2021. Sales of Vytorin, Orvatez, and Absorcol, specialty products from Merck Sharp & Dohme, indicated as an adjunctive therapy to diet in patients with hypercholesterolemia remain constant at EUR 20.83 million in 2021. In the second quarter of 2020, Orvatez price was reduced by 30% due to the entrance of hybrid products formulated with acetamide and atorvastatin. Sales of Hirobriz Breezhaler and Ulunar both inhaled bronchodilators from Novartis to patients with respiratory difficulties due to a pulmonary disease known as Chronic Obstructive Pulmonary Disease, launched in Spain in the fourth quarter of 2014, decreased 70% to EUR 9.4 million in 2021, compared to EUR 11.3 million in the previous year, mainly due to the Ulunar Breezhaler price reduction of 18% in the second quarter of 2020. As I commented before, ROVI has reinforced its long-term collaboration with Moderna. First, increased capacities for the compounding aesthetic feeling, inspection, leveling 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 will be made in the ROVI group's facility in Madrid. Regarding CMO, sales increased by 189% to EUR 264.7 million in 2021 as a result of first, the booking of the income related to the production of the COVID-19 vaccine, the booking of the income related to activities to prepare the plan for the COVID-19 vaccine production under agreement with Moderna and lastly, the direction of our CMO activities strategy towards high value-added products. That wise, in 2022, ROVI expects the CMO business to increase by between 30% and 40%, including production of the COVID-19 vaccine. Regarding our R&D strategy, Okedi, the Risperidone ISM is the first ROVI's product base in its leading-edge drug delivery technology, ISM. It is a novel investigational antipsychotic for the treatment of schizophrenia with once-monthly injections, which has been developed and patented by ROVI and which as of the first injection provides immediate and sustained plasmatic drug levels and does not require loading doses or supplementation with oral risperidone. On 16 December 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 the product for the treatment of schizophrenia. In others for home tolerability and effectiveness has been established with oral risperidone and it could be launched in Europe in the second quarter of 2022. Likewise, at this Capital Markets Day held on November 24, 2020, ROVI announced the filing of an NDA, new drug application, a registration this year to obtain marketing authorization in the U.S. with the FDA. ROVI was informed of the delay in the decision of the granting of marketing authorization for Risvan by the U.S. Food and Drug Administration. The FDA will be taking a number of actions, including an inside inspection of the European production plant where the product is manufactured, located in Madrid. The grant of the marketing authorization for Risvan by the FDA is subject to the result of this inspection. Furthermore, on September 24, 2021, ROVI received a complete response letter from the FDA with outstanding questions on the Risvan dossier. The company has already answered them since in its letter, the FDA recognized that it did not review some of the responses submitted during the valuation process. ROVI expects a response to clarify the outstanding questions. In the complete response letter, the FDA states that due to the exceptional situation caused by the pandemic, which has prevented the inspection from taking place within the term defined in the filing communication letter or the responses to outstanding questions will be evaluated in accordance with the time line described in the 2030 guidance for industry review time lines for applicant responses to complete response letter when a facility assessment is needed during the COVID-19 public health emergency with an estimated review time of 6 months as of the submission of the responses to the questions raised in the complete response letter. On the other hand, as previously reported, the risperidone ISM dossier is mainly supported by the pivotal clinical trial, PRISMA-3, whose results were published in November 2020 in the medical journal npj Schizophrenia. The PRISMA-3 study demonstrated that risperidone ISM provides rapid and progressive production of symptoms in patients with acute exacerbated schizophrenia without the need of oral risperidone supplement or loading doses. According to the authors of the article, Risperidone ISM represents an effective therapeutic strategy in patients with schizophrenia were admitted to the hospital with an acute episode with severe or moderate psychotic symptoms. The company also announced in July 2019, the completion of an open-label extension of the PRISMA-3 study, which provides clinical data on the long-term use of Risperidone ISM, 12 additional months. In addition, the company continues with the clinical development of Letrozole ISM, which represents the second candidate using ROVI's ISM technology platform. The first long-acting injectable aromatase inhibitor intended for the treatment of hormone-dependent breast cancer. ROVI has obtained positive results that confirm that this ISM formulation provides a prolonged release of Letrozole, which produces a sustained suppression of estrogenic hormones. The company has initiated discussions with the FDA to review these results as well as the next steps for continuing the clinical development of this novel acting -- long-acting injectable aromatase inhibitor. Lastly, ROVI's research and development team is progressing in the development of a new formulation of Risperidone ISM for a 3-monthly injection, which would complement the current formulation of Risperidone ISM for the maintenance treatment of patients with clinically stable schizophrenia. This development is currently undergoing regulatory toxicity studies needed to conduct a Phase I clinical trial in humans. And finally, we end this part operating our guidance for 2022. ROVI expects its operating revenue growth rate to increase between 15% and 20%, including the production of the Moderna COVID-19 vaccine. We have stayed on the path of sustained growth in 2021. We increased sales by 54% outperforming the market. We have expanded our heparin franchise through the launch of our enoxaparin biosimilar in 13 new countries in the last 12 months and the increase of our presence in countries where we have already launched the product. As well, we have consolidated our pharmaceutical specialties area, thanks to the strength of our leading products, such as Neparvis and Volutsa. And finally, we achieved growth of 189% in our CMO business, mainly thanks to the agreement with Moderna. Likewise, we are making a heavy investment effort in research and development, focused on our ISM technology, which we see 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 and Enoxaparin biosimilar, which will allow us to transform our European footprint and the agreement with Moderna, which is helping strengthen our manufacturing area and is providing 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 a high value-added CMO services. And 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. As you said, we are very happy with our performance for 2021. Our operating revenue increased by 54% last year. And this growth is driven by the good performance of our CMO business, our low molecular weight heparin franchise and our leading products, such as Neparvis and Volutsa, which we intend to achieve an advantageous position in the current competitive environment. Sales of prescription-based products increased by 17%, outperforming the market by 13 percentage points last year. Regarding our heparin franchise, we achieved a 16% growth. Sales of Bemiparin, our flagship product developing house, grew by 9% and enoxaparin biosimilar sales increased 22% to EUR 124 million last year. Gross profit increased by 59% to EUR 386.2 million in 2021. The gross margin showing an increase of 1.8 percentage points from 57.7% in 2020 to 59.5% in 2021, mainly because the increase in the CMO business contributed higher margins to group sales. This positive impact on the gross margin, offset the increase in the low molecular weight heparin cost of goods sold in 2021 compared to the previous year. ROVI expects heparin raw material prices to continue to decline in 2022 as a result of the increase in the pig population in China. Nevertheless, despite the potential decrease in the heparin raw material prices, the impact on the gross margin will continue to be negative because of the long heparin manufacturing process, in which the raw material currently being used, stocked for several months was purchased at slightly higher prices. ROVI continues to be committed to innovation. R&D expenses amounted to EUR 27.4 million in 2021. This figure is mainly the result of a focused investment in the ISM projects. Selling, general and administrative expenses, SG&A increased 25% to EUR 156 million last year, mainly due to an increase in expenses related to the manufacture of the Moderna vaccine and an increase in expenses due to the preparation of the Okedi launch in Europe. Expenses related to COVID-19 decreased to EUR 1.6 million in 2021 from EUR 4 million last year or in 2020 -- in 2020, I mean, excluding expenses related to COVID-19, SG&A would have increased by 28% to EUR 154.4 million in 2021 compared to EUR 120.4 million in 2020. EBITDA increased to EUR 202.9 million in 2021, a rise of 115% compared to the previous year, reflecting an 8.8 percentage point increase in the EBITDA margin, which was up to 31.3% in 2021 from 22.4% in 2020. EBIT increased by 143% to EUR 181.6 million in 2021, reflecting a 10.2 percentage point rise in the EBIT margin, which was up to 28% in 2021 from 17.8% in the previous year. Net finance result amounted to EUR 1.1 million in 2021 compared to minus EUR 2.1 million in 2020, mainly due to the higher income related to exchange rate derivative financial instruments. The effective tax rate was 16.2% last year compared to 15.9% in the previous year, mainly due to the increase of the profit before income tax. As of the end of 2021 on the group's negative tax basis had been used. Net profit increased by 151% from EUR 61.1 million in 2020 to EUR 153.1 million in 2021. EBITDA pre-R&D calculated excluding R&D expenses in 2021 and 2020 increased by 95% from EUR 118 million in 2020 to EUR 230.4 million in 2021, reflecting a 7.4 percentage point rise in the EBITDA margin to 35.5% in 2021. EBIT pre-R&D calculated excluding again, R&D expenses in '21 and 2020 increased by 112% from EUR98.5 in 2020 to EUR 209 million in 2021, reflecting an 8.8 percentage point rise in the EBIT margin to 32.2% in 2021. Net profit pre-R&D, again, calculated excluding R&D expenses in 2021 and 2020 increased by 117% from EUR 81.1 million in 2020 to EUR 176.1 million last year. ROVI invested EUR 40.9 million last year compared to EUR 39.7 million the previous year. Of this amount, EUR 27.2 million related to the investment CapEx regarding our facilities, including important projects, such as the -- what we call ISM industrialization, the building of a second low molecular weight heparin API facility in Escuzar, Granada and the new lines for the Moderna vaccine. EUR 13.8 million relates to maintenance and CapEx and other CapEx. Cash flow from operating activities increased to EUR 149.4 million in 2021 from EUR 46.9 million in 2020. This increase was mainly due to the increase of EUR 110 million in profit before income tax, a decrease of EUR 23.4 million in the inventory line item in 2021 compared to a decrease of EUR 70.4 million in 2020, an increase of EUR 35.4 million in the trade and other payables item in 2021 and the booking of EUR 34.4 million in the proceeds from CMO services line, mainly due to the payments received that are pending to be allocated to the income statement. Regarding our debt, as of 31st December 2021, ROVI's total debt decreased to EUR73.2 million from EUR74.4 million as of 31st December 2020. Let me say that EUR44.8 million is debt with banks, representing 61% of total debt, while EUR10.7 million correspond to debt with public administration, which related -- is related to the development of R&D projects, which is 0 interest rate debt, representing therefore, 15% of our total debt and EUR17.7 million correspond to financial liabilities for leases representing 24% of total debt. At the end of last year, ROVI had a gross cash position of EUR 100.5 million compared to EUR 54.6 million as of 31st December 2020, and net cash position of EUR 27.4 million compared to net debt of EUR 19.8 million at the end of the previous year. Regarding the dividend, ROVI will propose to the shareholders general meeting a dividend of EUR0.9556 per share with dividend rights on 2021 earnings. This proposed dividend would mean an increase of 151% compared to a dividend of 2020 earnings and represents a 35% payout. Yesterday, ROVI announced the end of the share buyback program, effective as of the 3rd of November 2021 and the launching of a new share buyback program, effective as of today, 23rd, February '22. In accordance with the following terms. The purpose and the scope is the redemption of ROVI's own shares and at the same time, contribute to ROVI's shareholder remuneration by increasing earnings per share. The duration of the period is from today and for a period up to 6 months. The maximum monetary amount is up to EUR 46 million, and the maximum number of shares to be acquired is 560,700 company shares, representing approximately 1% of ROVI's share capital as of today. We are in a transformation phase and as you know, 2021 has been an extraordinary year for ROVI. We believe in the company's positive evolution and that the company's operating profit will remain at current levels and growth. We want to reward our shareholders, and there are no other options, we believe right now that can generate more value in the short-term. At present, we have an excellent cash-generating capacity, and we do not like keeping money in the bank, which as you all know, it's also bear our cost right now. And ROVI will have always taken our shareholders into account and the previous share buyback program as well as this new one are an example of these policies. Regarding news flow for 2022, we will monitor the evolution of the manufacturing of the Moderna vaccine. We expect to announce Okedi's launch in the second quarter of the year. In addition, we expect to inform new national marketing approvals for Enoxaparin biosimilar outside Europe. With regards to R&D, we expect to obtain the marketing authorization for Risperidone ISM in the United States in the third quarter of this year. Regarding Letrozole ISM, we have initiated discussions with the FDA to review Phase I results as well as the next steps for continuing the clinical development of this novel long-acting injectable aromatase inhibitor. And that's all regarding our financial results for 2021. We can now then start the Q&A session. If you want to ask any questions, please do not hesitate to send them through the platform through the question bottom.

Thank you, Juan, and Javier. So the first question comes from Alejandro Conde from Banco Santander. It's for you Javier. Can you provide some color on the main reasons explaining the quarter-on-quarter deterioration on working capital, especially inventories and trade receivables. How should we think about the company's working capital needs going into 2022?

Well, thank you, Alejandro, for your question. Just talking first about the trade receivables. We do believe it's just something that happened in the quarter and probably -- and we expect that next quarter, the figure will turn back to normal. With regards to inventory, we have a smaller growth of the stock levels this year or 2021 compared to 2020. And we do believe that this year, we can have also a small increase of the inventory levels. Again, the company is growing very, very quick. We need to make sure that we don't face any out-of-stock situation right now. And you all know the current supply chain issues around the world, and they need to be in the safe position not to have any out-of-stock situations, I was saying, due to these all world transportation issues and the increase also the -- some of the raw materials. So we prefer to be safer and have safety stocks.

Okay. Juan, Guilherme Sampaio from CaixaBank asks, could you provide further details on the recent agreement with Moderna, namely in terms of scope and capacity additions plans. Could you provide additional color on how are your conversations with the FDA involving -- regarding Letrozole ISM?

Guilherme, regarding the -- I think the Moderna agreement is just a follow-up of our recent agreements that we have agreed with them in the past. I think Moderna agreement where it states the trustworthy [ reasons ] that Moderna and we have got in the manufacturing front. Unfortunately, I cannot give you more details regarding the content of the agreement. I think what is important to highlight is that a 10-year long-term agreement notes that there is an alliance in the manufacturing front between Moderna and ROVI. I think that's the important thing that we have to take into account. We are really one of the worldwide CMO experts today in the fill and finish of mRNA products. And I think the fact that we are agreed to have a long-term agreement, 10 years is something very unlikely to find in the manufacturing CMO activities. I mean that demonstrates that we are one of the top leaders in this segment of business, in the fill and finish of aseptic filling and we do believe that there is going to be a lot of good coming up from this agreement. Moderna has got as well a very rich pipeline. And I think this is going to be a tremendous fruitful collaboration between the 2 companies. We hope that we will be able to provide more details in the future regarding the investments and regarding the focus of what does mean this on -- this 10-year agreement with Moderna. But I think this is one of the most important agreements that probably has signed in the CMO front, probably in the last 10 years. Regarding your second question, the FDA with Letrozole. Again, we are right now, we're then discussing the next steps in the clinical development. I think we have a very strong, very interesting data on our long-acting injectable Letrozole. When we were talking about risperidone development, we were a follower. There were different products already been tested and been approved. So the regulatory pathway was very straightforward defined by the regulatory bodies, not only by the FDA, but also by the EMEA. When it comes to Letrozole, ROVI, we are really the first to try an aromatase inhibitor for this sort of pathology. So again, we're discussing with the FDA is really how to move forward the product, whether we need a Phase II, whether we need a Phase IIb, whether we can jump directly to a Phase III, what sort of -- in terms of indications, the size of the clinical trial. I think we're having a very fruitful and rich conversation with the FDA, and I believe that in the next coming quarters, we could provide more information and keep more color on what's going to be the development and the time lines, and we will require to get this product to the market.

Thanks, Juan. Francisco Ruiz from Exane asks, what is the difference for Juan to -- what is the difference between the new agreement and the former one, as you have always said that was a long-term agreement?

I mean the -- I would say there are several main differences. The first one, the first agreement that we signed with Moderna, and we have to be clear it was a long-term agreement, but it was mainly focused on the pandemic situation of the COVID-19. ROVI, as we have mentioned before, we are one of the worldwide players in the aseptic filling of both vials and prefilled syringes. And definitely, we were in touch with most of the COVID-19 manufacturers at the time. The deal with Moderna was long-term, but it was precisely to try to cover the need of producing fast and the COVID-19 vaccine on a pandemic situation. I think the importance of this new agreement and what makes a big difference is, first, is not focused on COVID-19 vaccine. It covers COVID-19 vaccine, but also there are potential additional mRNA candidates for other pathologies. So it provides ROVI a much broader scope of collaboration with Moderna. And secondly, hopefully, we'll be moving very soon from pandemic to endemic scenario. And again, I think what Moderna has stated is that ROVI is a contract manufacturer of choice for all markets outside the U.S.A. So I think -- I mean this agreement is really a major milestone. I cannot be able to provide financials of what is going to be for the company, but definitely, this is going to be, as I said before, probably is the most important agreement we have resigned in the CMO front.

The next question comes from Alvaro Lenze from Alantra. While the final details of the extended agreement are still pending, can you comment whether Moderna will have exclusivity on the use of the new facilities or not? Also similar to the previous agreement, is Moderna expected to cover the potential CapEx needs for the new capacity?

Again, unfortunately, I cannot give too much detail on the content of the agreement. What I think is important to state is that ROVI's CMO. So again, exclusivity is extremely well balanced in the agreement that we have signed with Moderna. Obviously, and it's pure common sense -- at the end of the day, you cannot be filling too many COVID-19 vaccines for different manufacturers. I mean, in terms of not only of technological exclusivity, but also in terms of potential capacity availability. Again, I think what we have tried to balance is on one side of this agreement, the exclusivity in terms that, obviously, we were looking forward to partner with Moderna, not for a short term, but for a long term and as well for the growth of the R&D candidates, which that's something that we have achieved. But on the other hand, ROVI has complete and total freedom to keep on looking for potential customers for the fill and finish capabilities. I think in that sense, although I would -- I wish I could give you further details to clarify all those concerns and questions. Really, this is a big win-win agreement between Moderna and ROVI. It won't cap any potential ROVI development on the CMO activities. On the other hand, I believe that we have jumped into what is going to be one of the technology of the future for many products that we are going to bring really a tremendous need for some on medical disease that today they are not covered.

Thanks, Juan. Javier, [ Ignacio Menderil from EVM ] says congratulations for those amazing results. And asks, you have booked a EUR 35 million payment in your cash flow related to manufacturing activities. What annual amount should we expect in the cash flow for the next year?

Well, thank you for your kind words, Ignacio. I think you are reflecting to an inflow in the company related to the flow of cash related to the contract manufacturing services, which basically is referred to some works that we have to do on the facilities and that has been covered by a customer that once we fulfill our activities, those -- this inflow will be passed through the P&L statement. Again, this is something not very recurrent, thanks to our new agreements, we'll have some of these inflows coming from -- coming into the cash flow statement that we'll be passing through the P&L while we satisfy the different request. So this is nonrecurrent, which is recurrent is the invoicing of our services, and those are paid and -- or invoiced and paid in a normal way. So a good look more into the normal service fee that we invoiced to our customers, which is the recurrent services. The other assumption is referring to some influence to some basically increasing of capacities that has been covered by a customer.

Thanks, Javier. The next question comes from Alvaro Lenze from Alantra. You have already started pre-marketing activities for Okedi in Europe. When should we expect the first steps towards preparing the launch in the U.S?

Thank you for your question. Regarding Okedi, we just received on February 16, the final go ahead from the European Commission. So now we are starting all the pre-marketing activities in Germany, U.K., Spain and certain European countries. We need -- German and U.K. will be the first runners to get both market as the reimbursement process there is extremely fast, and you don't need a preauthorization from the regulatory authorities. So we expect that in second quarter this year, we should be able to start booking sales in both Germany and the U.K. Regarding Spain, our goal is to be able to launch the product in Spain before the year-end. And we will see like we did with a rollout of the product in the different countries across Europe. Regarding the FDA, as I mentioned before, we are just waiting for the final approval from the FDA body. And again, unfortunately, the COVID-19 has been very beneficial for us on the CMO activities, but a negative aspect of the COVID-19 has been that the FDA has not been able to perform inspections outside the U.S. territory. There is plenty of information in the web regarding the backlog of audit -- international audits that they have to perform this year and next year. And we're there just waiting, just waiting to get from them dates -- potential dates where they will come to inspect our facilities. The FDA approval follows a different procedure compared to the European Commission. So when they perform the inspection, as I have mentioned in my presentation, that will also cover certain subjects that they don't cover on their regular revision of the dossier. But hopefully, and that's our goal is that we should be able, by third quarter or hopefully this year to get the inspection and to get the go ahead and I think until we have a complete knowledge of how it's going to be the [ SMPC ], it would be very risky for us to share what is going to be our strategy in the U.S. As I mentioned in many other calls before, we are very open to different options. We are looking -- one option is say, to do it by ourselves or either to sign a certified JV with certain companies, whether virtual or really understand that JV. What -- definitely what we want to make sure is that we don't lose the rate of our product in the sense that we really want to start gaining market knowledge of how the U.S. market operates compared to Europe. As I have mentioned many times, Okedi is a major milestone for the company, but we need approval in Europe and hopefully, the problem in the U.S. also validates the ISM platform. And we believe that Okedi is going to be the first candidate of hopefully many others that will come following Okedi in the next coming years.

Okay. Alvaro Lenze from Alantra also asks, does the approval of Okedi accelerate in any way the R&D regulatory process of letrozole ISM?

I mean definitely, I don't know if from a regulatory point of view will help to accelerate the letrozole clinical pathway. But definitely, as I mentioned before, it validates our platform. It validates in terms of safety. Again, we haven't had any issue or any comments from the EMEA and that is a major milestone when it comes to a new platform. Secondly, we have now data of efficacy as well, the stability of the product, although with a different compound. So although we have to wait to get the feedback from the EMEA and the FDA regarding which or what sort of clinical trials and how many they will require us to get the product approved. Definitely, the Okedi approval is a major push for letrozole and for other potential candidates like the quarterly injection of risperidone as I mentioned before. And we have mentioned for the last 3, 4 years, Okedi, we're a follower. We are not the first to come with a long acting injector in the schizophrenia market. We might be the first with a monthly injection risperidone, but there are other schizophrenia treatments on a long-acting injectable prefilled syringe device. But what it does really help us is that it validates the platform, and it provides a tremendous potential for the future for the company to bring new products to the market.

Okay, the next question comes from [ Emmanuel Godron from Westar ]. Is ROVI -- for you, Juan, sorry. Is ROVI already hiring sales representatives for the launch of locating in Germany?

Yes, yes. Yes. As I mentioned before, we have already a sales force in place in Germany. We have already gone through the training process. and we will start pretty soon the pre-marketing activities. And hopefully, in the next coming weeks, we will proceed to launch the product in Germany. Definitely, yes. I mean the whole commercial rollout of the product has already been prepared. It has been -- we have been working on this for the last almost 16 months. And we are extremely excited by the fact that we'll start booking Okedi in Germany, hopefully, beginning of the second quarter.

Okay, Javier. Alvaro Lenze from Alantra asks, the cash position remains strong even after the recent extension of the buyback program. Are there any M&A deals in the pipeline that could materialize? Would you consider repaying debt in absence of other alternatives? Or would you continue to buy shares back?

Thank you, Alvaro. Again, as we have been telling our investors and shareholders, our main goal is to keep the company growing. So we are always looking at opportunities that could enhance the value of the company. And when I'm saying looking at opportunities, we are looking at M&A transactions and deals. However, the company always wanted to try to make sure or be sure that anything that we buy will bring value to the company. So we are still looking at opportunities and hopefully, we'll have the opportunity to use the money we are generating through an M&A deal, which, again, this is not strategic for the company, but we believe it's a good way to accelerate the growth of ROVI. Meanwhile, I think the debt of the company is very small right now, it's EUR 44.8 million, the debt that corresponds with banks with very limited interest rate. So we are very comfortable with this debt. But probably, if in any case, at the end of the year or in some months, we don't have any opportunity or we don't use the cash, it could be a good idea to reduce that debt or maybe the Board of Directors try to keep buying sales if we don't find alternatives. But again, the main goal of the company is to keep growing and probably the most useful use of the resources will be an M&A transaction.

Thanks, Javier. The next question comes from James Vane-Tempest from Jefferies. About BECAT, you state about long-term entering new markets? Are you taking share from Sanofi and given the market dynamics you've laid out, what level of peak sales do you think is possible? And as you've given an indication for the CMO performance this year, is the 22% BECAT growth in 2021 sustainable? And about Doria, can you update us on your U.S. commercialization strategy?

Okay, James. Regarding BECAT, I think the business is really going very smoothly. We are gaining market share. You are right, mainly from Sanofi in all the markets that we have already established sales. And we're also gaining market share from them in all those countries where we are launching Enoxaparin. As we mentioned before, I mean, really the goal of the company is to become one of the worldwide market leaders of low molecular weight heparin with 2 compounds. So definitely, we'll keep on pushing in gaining market share. I'm not sure -- I cannot figure out which is going to be really the big sales that we can achieve with BECAT. I think this is going to be a continuous growth year after year. We have mentioned many times that we believe that biosimilars globally will take -- will grab between 50% to 70% of market share of Sanofi. So we believe that we still have a long road to grow. So we believe that we'll manage to have a continuous growth, not this year, not next year. So -- but we're going to have a growth -- continuous growth for at least 4, 5 years. And that's the rationale why we have built a new APA factory in the south of Spain. That's why we are expanding our fill and finish capabilities because we do believe that BECAT is going to be a driver of growth for the company, not in the short-term, but for the long-term. The good thing is that low molecular weight heparin is the standard treatment for [indiscernible] tomembolies and for the treatment indication. And ROVI with the combination of Bemiparin and Enoxaparin, we do have all the ingredients to become one of the major market leaders worldwide. The second question was regarding Doria on the U.S. strategy. Again, as I mentioned before, the COVID-19 has done to compare out of good, if I may say so, regarding our CMO activities. On the other hand, it has provoked a tremendous backlog in international audits by the FDA, which is public and well known. The FDA covers around 4,000 sites outside the U.S. They have barely done less than 20, 30 inspections last year. So there is a tremendous backlog. They are now taking actions. So hopefully, we expect to get their visit this year. I wish I could say well, but unfortunately, we don't have any visit in that sense. And again, it's very difficult to come to a -- to decide on a strategy of commercialization in the U.S. if we don't have potential quarters of potential approval, and we don't have yet visibility on how the finance embassy is going to be. As I mentioned before, we are open-minded and still working on different scenarios from a potential standard license deal or via JV or even why not in it by ourselves. And hopefully, once we get visibility of a potential date of commercialization of Okedi, definitely we will make an announcement to what is going to be our final decision on how to proceed with the commercialization of Okedi. And there was a third question, Matt, I know wasn't it? It was Okedi and the...

There wasn't. No there wasn't. There was -- there were only 2 questions. So the next question comes from Pedro Echeguren from Bankinter. Javier, contract manufacturing sales were down 1.5% quarter-over-quarter in Q4. Can you comment on what caused this decline.

Well, thank you, Pedro, for your question. Basically, normally, the third quarter in our manufacturing services is the most important things that we do also, we manufacture the flu vaccine, and that is performed in the month of June, July, August. And then September is we usually close for holidays, and we have to give holidays to our people. In addition to that, if we take into account that Christmas is in December, and we also have to close down the facility for holidays for our people. It means that the third quarter is always -- there are more manufacturing days than in the last quarter. We have to take into account that the injectables production, we need at least 15 days after manufacturing to release the sterile test. So after manufacturing, we need at least 2, 3 weeks to release the product and therefore, to invoice to our customers. So that's why, again, third quarter is always stronger than the fourth normally.

Okay. And the last question, Javier comes from Guilherme Sampaio from CaixaBank. Could you provide some color on the performance of your manufacturing business, excluding the activities with Moderna in 2021 as well as the outlook for 2022?

Yes. Thank you, Guilherme for your question, which I'm absolutely delighted is that we've been able to increase and scale up our manufacturing services to Moderna last year. I think it was -- well, actually a real miracle taking into account the pandemia and all the COVID-19 doses that we manufacture. I'm really delighted that we could even increase our former customer base and our ex-Moderna revenue base -- customer base of clients for our contract manufacturing business. So again, the outlook for next year or for this year, as we have already commented is also important and important growth. And the main growth will be coming from Moderna as we have already explained. In manufacturing, we have to be very cautious to increase production in a sensible way in order not to have any incidents or any accidents during the production. So next -- this year is going to be also very relevant with an important increase between 30% to 40% as we have guided the market. And therefore, we have to be very focused and concentrated on this new volume growth.

Okay. Thank you very much, Javier and Juan. There are no more questions. So thank you very much for your high participation. Let me now turn the call over to Javier for the closure of the presentation.

Thanks, Marta. As you were saying, it seems that there are no more questions right now. Anyhow, if you need any further assistance, please don't hesitate to contact us later on. We'll be willing to help you with any more questions outside. And now, therefore, we can end this full year financial results call. Thanks to all for attending the call, and have a nice day. Bye-bye.