Good afternoon, and welcome everybody to this 2023 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 introduce Rovi's attendees today. Juan López-Belmonte, Chairman and CEO, Marta Campos, Head of Finance, Beatriz de Zabala, Investor Relations, Victoria López-Belmonte, Investor Relations, and myself. At the end of the presentation, a question and answer session will start. 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. I give Mr. Juan López-Belmonte the floor.
Thank you, Javier, and welcome to everybody. I'm happy to present our 2023 results. 2023 was a complex year, the first year of a new endemic scenario, in which COVID-19 became a seasonal disease with annual vaccination. 2023 was a transitional year, in which we made a big investment effort to increase current capacities, to be able to produce many more pharmaceutical units in the future. In this difficult context, we have been able to demonstrate the resilience of our business and achieve total revenue of EUR 830.3 million, an increase of 1% compared to 2022. It is worth highlighting the positive evolution of Okedi, our risperidone ISM, reaching EUR 14.4 million last year.
CDMO sales increased by 1% to EUR 409.3 million, which offsets part of the 5% decline in the heparin business. The slowdown in sales of our low molecular weight heparin division in 2023 was due to the increased use of heparins in 2022 during the COVID-19 pandemic. We are very excited about the potential of our low molecular weight heparin franchise, and we aspire to become a benchmark player in this field worldwide. The importance we place on the heparin division can be seen with the inauguration of a new production plant for the active substance of heparins in Escúzar, Granada, in the fourth quarter last year. For 2024, with the visibility that the company has at this moment, Rovi expects its operating revenue to decrease by a mid-single digit percentage in comparison with 2023.
Last year, Rovi announced several milestones for the company. First, in January 2024, the FDA inspected the company's active substance manufacturing plant in Granada with a satisfactory result. The inspection focused on the processes of manufacture and control of the active substance to be used in the manufacture of Moderna's mRNA COVID-19 vaccine. This result authorizes Moderna to market the vaccines manufactured by Rovi in the United States. In addition, in September 2023, the FDA approved the company's CDMO's plans for injectables in Madrid, San Sebastián de los Reyes, and Alcalá de Henares, for the fill and finish syringe manufacturing of Moderna's COVID-19 mRNA vaccine. Rovi also expects to produce Moderna vaccines for supply in the United States from 2023 onwards.
Regarding the evaluation process to obtain marketing authorization for Risvan in the United States, on July 27th last year, ROVI reported that the FDA had issued a complete response letter. In this letter, the FDA informed ROVI that satisfactory resolution of the deficiencies from the last inspection was required before the approval of the application and that there were no outstanding questions related to the dossier. On September 21st, 2023, ROVI received the establishment inspection report from the FDA, with four outstanding observations from the FDA inspection of the facility. Rovi provided responses on September 29th last year, and the FDA established a new goal date of March 29th this year. To comment on the results, regarding the top line of the P&L, operating revenue increased 1% to EUR 829.5 million in 2023.
The main contributors to sales in the first post-pandemic year were the CDMO business, where sales increased 1%, Okedi, where sales reached an amount of EUR 14.4 million, Neparvis, where sales rose 16% to EUR 45.5 million. Likewise, Orvatez sales rose 8% to EUR 26.5 million last year, and Rovi ceased to distribute Absorcol as of the December 31st, 2022, and Vytorin as of the January 31st, 2023. I would like to comment as well that Volutsa sales decreased by 30% in 2023, and this was mainly due to a product price reduction of 47% in the second quarter of 2023.
In 2023, profitability was negatively impacted by the higher contribution to the CDMO business of the income related to the activities to prepare the plan for drug production under the agreement with Moderna, which adds lower margins to group sales and by the lower margin from the manufacture of the COVID-19 vaccine in 2023 compared to 2022. EBITDA reached EUR 244.5 million last year, a decrease of 12% compared to 2022, reflecting a 4.6 percentage point decrease in the EBITDA margin, which was down to 29.5% in 2023 from 34.1% in 2022. Likewise, net profit decreased by 15% from EUR 199.7 million in 2022 to EUR 170.3 million in 2023.
Moving to our first pillar of growth, which is our specialty pharma area, sales of prescription-based pharmaceutical products remained stable at EUR 373.5 million in 2023. Sales of the heparin franchise decreased by 5% to EUR 250.6 million in 2023, mainly as a result of the increase in orders from partners in 2022 related to the treatment for COVID-19, which has led to a lower volume of orders from partners last year, since they still hold a high level of stocks from 2022. Heparin sales represented 30% of operating revenue in 2023, compared to 32% in 2022. Bemiparin showed a negative performance in 2023, with sales down 9% to EUR 94.2 million last year. Enoxaparin sales decreased by 3% to EUR 147.9 million last year compared to 2022.
The drop in sales of both products was mainly due to the increase in orders from partners in 2022 related to the treatment for COVID-19. Rovi continues with its internationalization plan. Sales outside Spain remained stable at EUR 556.2 million last year, mainly due to the CDMO business, and sales outside Spain represented 7% of operating revenue in 2023, compared to 68% in the previous year. Regarding the Enoxaparin biosimilar Becat, it is already present in 40 countries, and we have signed out-licensing agreements to distribute the product in more countries. In 2023, Enoxaparin biosimilar sales decreased by 2% to EUR 147.9 million as a result of, as we explained before, the increase in orders from partners in 2022.
However, sales of the product increased 18% in the fourth quarter last year to EUR 39.8 million compared to the third quarter of the year, and rose 18% in the fourth quarter of last year compared to the fourth quarter of 2022. The product was launched in Jordan and Sri Lanka as well last year. Likewise, Neparvis, Orvatez, and Okedi led the growth of 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 16% to EUR 45.5 million last year, compared to EUR 39.1 million in 2022.
Sales of Volutsa from Astellas Pharma, launched in Spain in February 2015, decreased by 30% to EUR 12.4 million in 2023, mainly due to a product price reduction of 47% in the second quarter of last year. Sales of Vytorin and Orvatez, specialty products from Merck Sharp & Dohme, indicated as adjunctive therapy to diet in patients with hypercholesterolemia, decreased 17% to EUR 26.6 million in 2023. Rovi ceased to distribute Zetia as of December 31st, 2022, and Vytorin as of January 31, 2023. Orvatez sales rose 8% to EUR 26.5 million in 2023, compared to EUR 24.5 million the previous year. Sales of Zetia and Vytorin accounted for 24% of total sales of the products indicated to treat hypercholesterolemia in 2022.
These two products, sorry, they are from Organon, not Merck Sharp & Dohme. Sorry for the mistake. 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 EUR 14.4 million in 2023. Okedi sales increased by 42% in the fourth quarter of 2023 compared to the third quarter of the year. In 2022, it was launched in Germany, U.K., and Spain, and in 2023, it was launched in Portugal, Italy, Austria, Greece, and Serbia. As you know, Rovi and Moderna have signed a long-term, 10-year collaboration agreement in February 2022. Under this agreement, Rovi participates in Moderna's development phase program to the new generation of COVID-19 vaccine, as well as mRNA vaccines against RSV and influenza.
Rovi collaborates with Moderna in the end-to-end supply chain, including the active substance at the Granada plant and fill and finish at the Madrid facilities. There is no doubt that one of our main achievements in 2023 was the FDA approval of Rovi's CDMO's injectable plants for the manufacture of Moderna's COVID-19 mRNA vaccine. That has allowed us to support the 2023 vaccination campaign in the U.S. To this end, further industrial investments have been made in the Rovi Group's facilities in Julian Camarillo, San Sebastián de los Reyes, and Alcalá de Henares. Likewise, in January 2024, Rovi's Granada facility was inspected and approved by the FDA, allowing Moderna to market the vaccine manufactured by Rovi in the U.S.
Regarding CDMO sales, increased by 1% to EUR 409.3 million last year, 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 under the agreement with Moderna, and the reorientation of our contract manufacturing activities strategy towards high value-added products. Regarding our research and development strategy, we are waiting for the approval of Risvan in the USA. The FDA established a new goal date of March 29th, 2024. Likewise, Rovi's R&D 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 adult patients with clinically stable schizophrenia.
The company is currently conducting a phase I clinical trial to evaluate the safety, tolerability, and pharmacokinetics of various candidate formulations at different dose strengths and injection sites. Patient recruitment for this study began in September 2023. Lastly, the company has commenced the clinical development of a new three-monthly formulation of letrozole, Letrozole LEBE. 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.
Accordingly, Rovi is currently carrying out a phase I clinical trial in Europe to evaluate the pharmacokinetics, safety, and tolerability of single ascending doses of Letrozole LEBE at different strengths in voluntary, healthy, post-menopausal women, the LEILA-1 study, and this first clinical trial of Letrozole LEBE began in July last year. Proof of Rovi's commitment to a sustainable business model is the recognition obtained by the company through the evaluation by Sustainalytics. In 2023, and for the second year running, Rovi obtained the best ESG rating among the 431 companies evaluated in the pharmaceutical industry category. The company was likewise ranked 22nd out of a total of 895 companies in the entire sector, which includes biotechnology companies, pharmaceutical laboratories, and laboratory equipment companies. Furthermore, Rovi improved its ESG rating to 16.4 points versus the 17.3 points obtained in 2022.
Among the actions that allowed the rating to improve last year, Rovi stood out for its environmental commitment due to the implementation of greenhouse gas reduction programs and the use of energy from renewable energy. These initiatives have enabled Rovi to be considered a carbon neutral company in Scope 1 and 2 emissions since 2021. In addition, Rovi has been considered by Sustainalytics as a world leader among companies in the industry due to its involvement in a series of activities, such as the supervision of ESG issues by senior management, its anti-corruption, anti-bribery policy in the corporate governance chapter, as well as in the social area for the implementation of a solid equality and non-discrimination policy. Rovi's resilience towards ESG risks have been evaluated by MSCI, having obtained an A rating.
MSCI ESG research provides ESG ratings on companies on a scale that runs from AA A, leader, to CC C, laggard. MSCI has valued Rovi's initiatives in the area of corporate governance, highlighting the area of ethics and compliance. Rovi has continued to work on the implementation of its ESG Master Plan 2023-2025, approved by the board of directors in December 2022. Throughout 2023, 60% of the 45 KPIs included in the master plan were completed. Such progress is supervised by the Sustainability Committee, created in mid-2023, which reports annually to the board committees on the progress of the plan. Finally, we end this part with our guidance for 2024. As I mentioned earlier, for 2024, Rovi expects its operating revenue to decrease by a mid-single-digit percentage in comparison with 2023.
Notwithstanding, there are certain factors that have been considered when calculating this guidance that, although they could be relevant to the estimates, are difficult to specify at present, including, among others: First, the saturation of the national health systems due to the low vaccination rates during the 2023 COVID-19 campaign that could favor a more successful vaccination campaign in 2024. However, as of today's date, the company is not in a position to forecast how demand and production might evolve for the vaccination campaign this year. Second, it is hoped that the expansion of the compounding, aseptic filling, inspection, labeling, and packaging capabilities at Rovi's facilities in Madrid and the current high demand for CDMO services in the market might favor obtaining new customers with a resulting sales impact. This would have to be taken into consideration, but cannot be estimated at present.
And last, Rovi expects to obtain marketing authorization for Risvan from the United States Food and Drug Administration in March 2024, and to market the product on the U.S. market, probably through a partner. The potential sales of this product in 2024 will depend on the terms of the agreement reached with the potential partner, which could likewise affect the estimates for 2024. But globally, we are satisfied with the evolution of the company in 2023. We have been able to surpass the previous year's revenue by 1%, reaching a total of EUR 830.3 million. We have continued our internationalization strategy in our heparin division, increased sales of Neparvis and Orvatez, which have risen by 16% and 8% respectively in 2023 compared to 2022.
We have launched Okedi in Portugal, Italy, Austria, Greece, and Serbia, reaching sales of EUR 14.4 million in 2023 and increasing sales by 42% in the fourth quarter of 2023 compared to the third quarter of the year. We have achieved growth of 1% in the manufacturing business for third parties, thanks mainly to the FDA approval of ROVI's CDMO's injectable plants for the manufacture of Moderna's COVID-19 mRNA vaccine in the U.S. from 2023 onwards. 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 that 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.
Our Enoxaparin biosimilar, which is allowing us to transform our European footprint. The agreement with Moderna, which is helping strengthen our manufacturing area. And finally, the increase in our production capabilities 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 CDMO 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. We are very happy with the evolution of the company in 2023. As Juan said, we have been able to achieve a 1% increase in total revenue, which rose to EUR 830.3 million in 2023, driven by the CDMO business, which grew 1% to EUR 409.3 million, and the specialty pharma business, where sales rose 1% compared to 2022. The main drivers of growth in 2023 were Okedi and our reference product, Neparvis and Orvatez, and our CDMO business. Sales of low-molecular-weight heparins decreased by 6% to EUR 242.1 million in 2023, mainly due to the lower volume of orders from partners as a result of the increase in the product use in 2022 because of COVID-19.
Despite the Enoxaparin sales decreased, the product increased 18% in the fourth quarter of 2023, compared to the third quarter of 2023 and the fourth quarter of 2022. Gross profit decreased 6% to EUR 489.2 million in 2023, compared to 2022. Gross margin showed a decrease of 4.5 percentage points from 63.5% in 2022 to 59% in 2023. This drop is mainly due to the higher contribution to the CDMO 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, and the lower margin from the manufacture of the COVID-19 vaccines in 2023 compared to 2022.
In the fourth quarter of 2023, low molecular weight heparin raw material prices decreased by around 35% in comparison with the fourth quarter of 2022. ROVI expects this decline to accelerate in 2024. Nevertheless, despite this price decrease, the impact on gross margin remained negative in 2023 due to the length of the heparin manufacturing process, where the raw material currently being used has been stocked for several months and was purchased at higher prices. However, a positive impact on gross margin is expected to be seen from 2025. Rovi continues to be committed to innovation. R&D expenses amounted to EUR 24.9 million in 2023. They were mainly related to the development of the phase I of Letrozole LEBE and the development of the phase I of a new formulation of Risperidone ISM for a three-monthly injection.
Selling, general, and administrative expenses, G&A, increased 2% to EUR 219.7 million in 2023, mainly as a result of an increase in expenses due to the Okedi launch in Europe. However, other operating expenses, this is excluding R&D and employee benefit expenses, decreased by 11% to EUR 106.4 million in 2023, thanks to an efficient cost containment policy. EBITDA reached EUR 244.5 million in 2023, a decrease of 12% compared to last year to the previous year, reflecting a 4.6 percentage point decrease in the EBITDA margin, which was down to 29.5% in 2023 from 34.1% in 2022.
EBIT decreased by 14% to EUR 220.1 million in 2023, reflecting a 4.8 percentage point decline in the EBIT margin. The effective tax rate remained stable at 2022 at 22.7%, sorry, in 2023. Meanwhile, net profit decreased by 15% from EUR 199.7 million in 2022 to EUR 170.3 million in 2023. EBITDA pre-R&D, this is calculated excluding R&D expenses in 2023 and 2022, decreased by 11% in 2023. Net profit pre-R&D, calculated the same way, decreased by 13%. Rovi invested EUR 55.2 million in 2023, compared to EUR 51.5 million the previous year.
Of this amount, EUR 42.2 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, which was inaugurated in the fourth quarter of last year, the Glicopepton joint venture for the construction of a plant dedicated to the production of compounds of high biological value from the intestinal mucus of pigs, and finally, the new lines for the Moderna products and the operations expansion for the CDMO business. Apart from this, EUR 13 million relates to maintenance and other CapEx. Cash flow from operating activities decreased to EUR 113.2 million in 2023 from EUR 237.7 million in 2022.
This decrease was mainly due to the booking of EUR -58.4 million under the cash flow from provision of manufacturing services caption, caption in 2023, mainly due to the allocation of more revenue to the income statement than payments received, compared to the EUR 57.1 million recognized in 2022, t he decrease of EUR 23.9 million in the trade and other payables items in 2023, and the decrease of EUR 37.6 million in profit before income tax. Regarding our debt, as of December 31st, 2023, Rovi total debt decreased to EUR 65.4 million from EUR 72.2 million as of December 31st, 2022.
EUR 37.7 million is debt with banks, representing 57% of total debt, while EUR 8.9 million correspond to the debt with public administration related to the development of R&D projects, which is 0% interest rate debt, representing this 14% of total debt. Finally, we have EUR 18.8 million, which correspond to financial liabilities for leases, representing 29% of total debt. As of December 31st, 2023, Rovi had net debt of EUR 38.6 million, compared to net cash of EUR 54.2 million as of December 31st, 2022. Regarding the dividend, Rovi will pay a dividend of EUR 1.1037 per share, with dividend rights on 2023 earnings if the shareholders' general meeting approves the application of the 2023 profit and the proposal of Rovi's Board of Directors.
This proposed dividend represents a 35% payout. Considering the group's cash generation and the market situation, Rovi decided to launch a buyback program for the company shares 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, with the maximum number of shares to be acquired representing 5% of the share capital. As of January 31st, 2024, so this year, Rovi had executed approximately 74.85% of the buyback program for an amount of EUR 97.3 million. Regarding news flow for 2024, we will continue to monitor the evolution of the manufacturing of the Moderna products and the evolution of the CDMO business.
We expect to announce Okedi's launch in more countries, and in addition to that, we expect to inform on new national marketing approvals for the enoxaparin biosimilar outside Europe. With regards to R&D, we expect to obtain the marketing authorization for risperidone ISM in the U.S. With regards to R&D, also, we will monitor our clinical trials for both Letrozole ISM and for our three-month risperidone candidate. That's all regarding our financial results for 2023. Right now, we can now start the Q&A session. Again, if you want to ask any questions, please do not hesitate to send them to the question button on the platform. Thank you.
Thank you very much, Javier. We have received a lot of questions, and we are going to try to answer all of them. If you want to ask any question, please don't hesitate to send them by clicking on the question button on the platform. The first question is from Patricia Cifuentes from Bestinver. Javier, Patricia asks: "Cost control was impressive in Q4 2023. We are aware of the capacity increase and the wage increases agreed for 2024, but consensus SG&A estimate of EUR 248 million implies an annual growth of 13%, that now seems unrealistic. How many people do you plan to hire this year? Is it possible that SG&A costs will be below that level this year?
Well, thanks, Patricia. I agree with your view. I think we, the company, did an impressive cost control in 2023, as we said before, a decrease in other operating expenses by 11%. And I believe this 2024 is a little bit more challenging for us, as for one hand, we have to raise salaries around 10.3% to our people due to our collective bargaining agreement. Also, we will be keeping the launch of Okedi in the different European countries. And in addition to all of this, we are adding new capacity and new lines for the CDMO business. So all of this makes again a challenging year for us in terms of SG&A.
As always, we'll do our best to maintain the cost under control and to use all this cost to fuel the future growth of the company. Answering your question, probably, yeah, you're right. We'll foresee a double-digit growth for SG&A next year, no? It seems reasonable, take into account all of these points.
Okay, thanks, Javier. Patricia also asks, given a better mix in the CDMO business, the ramp-up of Okedi and potentially lower costs of low molecular weight heparins in the second half of 2024 already, what kind of gross margin expansion can we expect for 2024?
Okay, I will, I will answer a good one, too. Yeah, I think at least, no, our forecast is that, next year, in terms of, gross margin, we are potentially forecasting an expansion. And basically, I think you have touched the right items, no? From one side, Okedi is growing, and next year or this year, 2024, will add more growth to the company, and Okedi is a high added value product for us, no? We have already mentioned during the presentation also that the cost of the heparins will help us a little bit, at least at the end of the year, and it will be also, a help for improving, the margins, especially and potentially more in the next coming years.
And in addition to all of this, with regards to the CDMO business, we are also forecasting better margins also for the year. Basically, as you know, we try to mention this income related to the activities and investments for customers, which normally bring a lower margin. That number, during this year, is gonna be lower compared to the previous one, so to the previous year. So potentially, all of these item will help us to increase and to expand the margins. I mean, I don't know, potentially 3 percentage points. Let's see how the year evolve, and we can have more visibility on the different items.
Juan, the last question from Patricia is, given the Novo Catalent deal, is it more likely now to sign new clients in the CDMO this year or even higher volumes with Moderna?
Hi, Patricia, thank you for your question. Now, definitely the Novo Nordisk-Catalent deal is a tremendous opportunity for our CDMO business. That means that one significant player on the injectable CDMO business is going to be out of the game. And definitely, we don't know if that's going to conclude the new customers for this year, but definitely that's probably one of the best news for our CDMO business for the future in order to get new customers. Definitely, I think, Rovi is going to leverage from this opportunity, and we do expect that for the next years to come, that's going to bring additional customers and additional volumes to the company.
Taking into account the, h ow long it takes to sign a contract manufacturing agreement with a potential customer, and secondly, the regulatory variation. It's unlikely that this is going to have an impact in 2024. But definitely for the future, this is probably an outstanding news for the company.
Thanks, Juan. Javier, Juan Ros from Oddo BHF asks, c ould you provide some detail regarding the CDMO revenue split between production-related sales and other revenues? Do you expect further non-production revenues in 2024?
As we have tried to explain, thank you, Juan, for your question. I'll try to answer this by heart. We tried to explain that, with some customers, especially with Moderna, we have some activities related to prepare the plans to manufacture their product, and on those, as we said before, we have lower margins. Last year, around EUR 80 million of revenues were devoted to these activities, and these non-production revenues in 2024 will be much lower. Quantities could be around EUR 30 million figure. It's an important decrease, and that is one of the reason we explained before or earlier, that we will help to expand the gross margin of the company.
Thanks, Javier. Juan, Juan Ros, also asks, a re you actively searching for a partner to develop letrozole? If so, would that potential partner be the same for Risvan?
Thank you, Juan, for your question. Now, regarding Letrozole, we are, I mean, we are still as financially strong a company, and we don't need a partner to get funds to really develop Letrozole. Letrozole, this is, I mean, we are fully 100% developing the product with our own resources. And again, as we have mentioned many times before to investors, I believe that, as far as we can financially sustain the development of Letrozole, this is going to be executed by ourselves, and we won't be searching for a partner until we have visibility on potential registration dates. And again, Risvan is a completely different product, completely different market.
Let me remind that, on Letrozole, we are really innovating along with an injectable for a product and a treatment that is nothing similar on the market. While with Risvan, we are following other companies' pathways, specifically in the case of J&J. Letrozole, this is a real innovator product that is, we believe is going to be a landmark on the treatment of breast cancer. And we are not right now engaged in any sort of discussions, conversation, or not even searching for any potential partner for Letrozole.
Thanks, Juan. Francisco Ruiz from BNP. Juan asks, regarding manufacturing for U.S., do you expect a positive jump in 2024, or due to the seasonality of the vaccine, the increase will not be significant?
Well, again, I'm extremely positive regarding 2024 and the CDMO perspective. As we have explained in our call before, we believe that 2023 was a transitional year. We were moving from the pandemic to the endemic scenario. 2024 is going to be the first full year on endemic, and I believe, or I got the perception or the wish, that I think vaccination rates are going to increase globally. In our particular case, regarding to Moderna, well, we are positive that 2024 is going to be a good year.
In addition to that, I would like to highlight as well that we are extremely as well positive on the perspectives of the CMO business, not only because of the Catalent deal with Novo, as we have mentioned before in a previous question, but as well, really, injectables today is, I mean, is really a hot topic. I mean, we have many, many products in the pipeline of the big pharma companies that they have been channeled to an injectable device, either a prefilled syringe, either a vial. So definitely, we see the CMO perspective really expanding much more regarding the vaccine segment.
So definitely we see that for the next five years, and pushed as well by the Catalent deal with Novo, we are extremely positive that CMO business and the CMO revenues are going to increase significantly. That's the reason why we are investing to increase capacity in our facility, because we believe that demand of injectables are going to be over the capacity of the market to supply.
Thanks, Juan. Emmanuel Codron of Kepler Cheuvreux asks, w hat is the expected growth rate for Okedi in the next years? When do you expect to reach profitability?
I mean, okay, okay performance is going above our expectations. The third quarter last year and fourth quarter have been extremely positive. We are rolling out the product right now to Europe, with the launches in Germany and Spain, and very recently in Italy and Greece. Hopefully, we'll be launching the product as well in the Nordic countries. So we are extremely positive, and we believe that the performance of the product is really above our expectations. The potential FDA approval is going to be another major milestone, that it can change the dynamics of the product. But definitely, we expect to reach peak sales sometime in the next three to four years.
And that's the reason why we are investing in developing a quarterly injection of risperidone, because we don't want to lose the momentum. And we, at least in our thoughts, is that once we have reached peak sales with the monthly injection, we should be able to have a, we should be very close to the market with the quarterly injection, just to make sure that we can leverage on all the effort that we have done. And I have to say that I'm extremely satisfied with the performance of Okedi, because first we have launched the product, but secondly, which is very important to mention, is that we have rolled out sales force across Europe. I mean, we have been involved in the last two years in hiring people in Germany, sales force, MSL, key accounts.
So, I mean, we have a major, we have done a major, and I think a fantastic job by all the team to really putting together the salesforce capabilities that is really right now delivering the results that we have shared with you before. So we believe that in three to four years, we'll be reaching peak sales. And again, as, a nd we believe that Okedi is going to be a major item that is going to deliver not only sales, but it's going to deliver an increase in our gross margins, KPIs.
Thanks, Juan. Javier. Nicholas Schmidlin from ProfitlichSch midlin asks, when do you expect to receive the results of the LEILA-1 phase I study?
Thank you, Marta, and, and thank you, Nicholas, for your question. I believe that we are planning to have the final report of that clinical trial around, I would say June, July next year. So potentially in 15, 16 months' time.
Thanks, Javier. Juan, Chema Canovas from GVC Gaesco asks, has two questions. The first one is, what utilization rates do you expect to see for Rovi's CDMO business in 2024, 2025 and 2026? That's the first one.
I mean, that's a difficult question really to answer out of the spot. Again, as a CDMO, we live out of capacity. And again, the only way to engage new customers is by showing them that you have available capacity in the short term and in the long term, and that you have the capacity according to the last state-of-the-art technologies. So that's the reason that we are engaging ourselves in upgrading with new equipment and new capabilities in the three facilities, both in Julian Camarillo as San Sebastián de los Reyes for filling capacities and in Alcalá de Henares for the finished packaging capabilities. I cannot share with you exactly utilization rate, because I don't have those figures on top of my head.
But definitely, we believe that we have tremendous opportunities to significantly increase our, our production outputs during the period that you have mentioned. And for that reason, why we are preparing the company right now, is to make sure that we don't lose the second wave of potential opportunities beyond 2026, and we are engaging ourselves in additional capacities to make sure that we have the capacity with the right technology to make sure that we can absorb the tremendous demand that we are listening that the market is, is currently requesting.
Thanks, Juan. And Juan, the second question from Chema is, has there been any approach from industrial players to license Rovi's ISM technology? Would you be open to such kind of agreements in the coming years?
I mean, definitely. I mean, something that we have, I have always shared with investors is that for us, ISM technology has got like two potential avenues or streams of revenue for the company. The first one was our in-house developed products, like risperidone and Letrozole. And secondly, would be, why not providing lifecycle management for existing products on the market? In that sense, to date, we have been focused on the launch of Okedi and the clinical trial execution of Letrozole LEBE and the quarterly injection of risperidone. But we are right now starting to engage ourselves with discussions with other companies to see how we can help them to really improve and expand their lifecycle management of existing products that they are currently on the market.
We expect 2025, probably, to be able to share with the market news on this regard.
Thanks, Juan. And Joaquín García Quiroz from JB Capital asks, can we expect enoxaparin to continue the growth trend seen in Q4 2023 during 2024?
I mean, enoxaparin, as I explained before, and mostly all low-molecular-weight heparins, like any treatment, adjuvant to treat the COVID-19 pathology, I mean, we're suffering right now because the market is, is not decreasing. The market is adjusting to the volumes they had, pre-COVID-19. So for us, it's still a question mark. We, we have seen that the fourth quarter last year has been very positive compared to the third quarter of 2023 and, and as well, positive from the fourth quarter of 2022. And we do expect that, we will have a continuous growth on the low-molecular-weight heparin franchise.
And, and basically, just to show you our, the commitment that our belief that we want to become a worldwide player, and we believe this is an area in need, which we're expecting a very important growth item, is probably the largest or one of the two largest investments done by the company in the last couple of years. First, the building, and it's already operational, the new API facility in Escúzar, Granada. And secondly, is the JV that we have signed with pig producers, Glicopepton, which we are right now in the course of building the facility and which will enable us to really be 100% vertically integrated in the manufacturing of the API. I mean, from the mucosa intestine to the enoxaparin or bemiparin API.
So again, 2023 probably has been a transitional year. Probably 2024, we will see a slow growth on the low-molecular-weight heparin. But definitely, we believe that low-molecular-weight heparins in general is state-of-the-art standard treatment as a blood thinner. And definitely, we see a significant growth for the next years to come, and that's the reason why the company is investing heavily, just to make sure that we can secure the capacity, and as well, we can improve gross margins as we grow market share on the market.
Thanks, Juan. Javier, Joaquin also asks, can we expect lower inventory levels for 2024 due to the lower heparin's raw material costs?
Thank you, Marta. As I mean, we've been trying to explain to the analysts and investors that the heparin production and its stocks level will take, I mean, the production cycle is very long. So we hold many months in stock in the different steps of production. Meaning that at the end, all the impacts of the decrease of the raw material cost of the heparin, again, the impact on the P&L and therefore on the working capital, it would be gradual, no? And in a gradually way. So basically, I believe that those impacts will started to be noticed at the end of 2024.
So potentially, these lower cost of the raw material of the heparins will see an impact on stocks and on, hopefully, on P&L, rather at the end of 2024. And for sure, it will be in 2025, where hopefully we'll see an important impact, not only in the P&L, but also as potentially Joaquin is suggesting, also in the working capital, working capital levels, so on the stocks. But again, I think it's still early. I think we are very, very excited to see that the raw material costs are decreasing, and not only last year, but also this year. And we see a downward trend, and this will help our P&L and balance on a stocks level in the coming periods, so.
Thanks, Javier. Javier, Álvaro Lenze from Alantra Equities asks, you have maintained the the 35% dividend payout unchanged. Any chance you could increase this in the future instead of opting for share buybacks? Or are there major investments that need retaining such as such a large portion of the earnings?
Well, thank you, Álvaro. I think you in your question answer why the dividend is maintained, no? Basically, the payout rate is maintained, basically, because we decided to go for a share buyback program this year, last year. At the end of the day, if you sum up the dividend we paid last year, plus the ongoing share buyback program, amounts up to EUR 200 million or close or even over EUR 200 million figure, which basically is like 100% of the net profit that we had in 2022 and over the figure that we had in 2023, no?
Meaning that the company, as we disclosed and explained to investors, we didn't find additional investments or additional growth opportunities to invest that money, and we prefer to give it back to our investors, huh? Right now, we are, as we've been trying to explain today, to maintain or to invest on CapEx, basically, on this transformation of our CDMO business, which is underway. And we are maintaining a good CapEx number. And again, potentially next year, if we don't find any other alternative or any other M&A opportunity, we could increase the dividend rather than the pay share buyback or doing another share buyback program, no? I think it's very early to decide that.
Which I would like to highlight is that the company decided to do additional share buyback program and for that reasons we stress on the share buyback program importance, and we maintain the same payout rate, you know. So we don't know what we will do in the next coming years.
Thanks, Javier. Javier, James Vane- Tempest from Jefferies, has three questions. The first one is, looking at your revenue guidance, please, can you give us, some more information on your assumptions to get to a revenue decline when you now have access to the U.S. market for Moderna this year, and as you highlight the Moderna agreement as a growth lever for 2024?
Well, basically, the U.S. approval from our injectables facilities, fill and finish facilities, were already approved last year in 2023. So last year, we already enjoyed sales to the U.S., and I think that was one of the main reasons behind the good performance of the CDMO business last year. We have shared with all of you that the API facility has been also approved by the FDA, that this is an additional potential source of revenue. But our main business on the CDMO is on the fill and finish front, no? As Juan has explained today, we don't know yet how the revenue evolution will go in 2024, especially that related to the vaccines and how the vaccination rates will evolve in the U.S. and in the rest of the countries.
And potentially, if vaccination rates increases during the year, potentially we can update the guidance. But right now, our most accurate assumption is this decline of the revenue for the year, no? But we are sure that the new projects that we are doing with Moderna, the new products that Moderna is performing and/or developing, like the RSV, the flu vaccine, the combo, will, and obviously the COVID-19 vaccine, will pay off sooner than later, no? We don't know if the revenue will come or the revenue will grow this year or the next coming years, no.
But, according to Moderna's outlook and the analyst and investors' outlook, it seems that their portfolio will grow in the next coming year, and that's why we remain so optimistic with the business with our business with Moderna. So, so let's hope that the Moderna business will grow again, and we can benefit from that, no.
Thanks, Javier. James also asks, for your guide on revenues, can you give us an indication of growth and EBITDA margins and some of the push-pull factors compared to 2023 on cost items?
Yeah. Basically, as we explained earlier, 2024, we expect to have an expansion potentially of the gross margins, which it will help us on the EBITDA levels. On the other hand, however, as we discussed, we expect the SG&A figure and expenditure growing up, potentially a double-digit growth, no? Basically, as I said before, we must raise salaries in our company around ten, at least 10.3% to our employees, and we are adding more lines in the CDMO business, no? Potentially meaning that we need to hire some people. In addition to that, we are launching Okedi in Europe, and meaning that still Okedi is not contributing in a positive way, and that meaning that the still the EBITDA outlook for the 2024 is still unclear, no.
For one side, we expect an expansion of margins from the gross margin levels. On the other side, SG&A will grow also, no? So let's see how the year evolves, and we can comment more as the year goes by.
Thanks. Thanks, Javier. The third question and the last one, from James, y ou have spent more than EUR 50 million a year on CapEx, the last two years. How should we think about CapEx this year if there is sustained demand for your fill and finish CDMO services?
Well, potentially, we see 2024 as the last year that we are coping with this transformation CapEx and capability plan for the CDMO business. As we disclosed several times, we are more than doubling our capacity in the segment, in the business, in the CDMO business, thanks to the investments performed by the company within these last three years and the investments that some of the customers help us doing some of them. And potentially 2024, we envisage to have a similar CapEx figure, no, or CapEx number, no? Let me highlight that from this CapEx number, we believe that maintenance is only EUR 13 million, no?
So, it's a big amount of CapEx devoted to the expansion of the capabilities, and we do believe that this is the right thing, the right thing to do for the expansion and transformation of the business. As we said today, we are really, really excited about the outlook of the CDMO business in the next coming years. And as Juan said, even now, with Catalent out of the game, we do believe that our opportunities are even bigger, no, in the segment, no? So, potentially this 2024 will be the latest expansive year in terms of CapEx.
Thank you very much, Javier. We are out of time. Thank you very much for your high participation. The Rovi IR team will answer the pending question as soon as possible. Let me now turn the floor over to our Deputy Chairman and CFO, Mr. Javier López-Belmonte, for the closure of the presentation.
Well, thanks, Marta, for your help. As Marta said, our IR team is available to answer and explain any remaining or additional questions. And now we are going to end this 2023 results call. Thank you very much for being with us today. Thank you. Bye-bye. Thank you.