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

Good morning to everybody. Warm welcome to all those attending the presentation of ROVI's 2024 financial results, which will start in a moment. I'm Javier Lopez-Belmonte, ROVI's Deputy Chairman and Chief Financial Officer of the company. Joining me on today's call are Juan Lopez-Belmonte, ROVI's Chairman and CEO; and Marta Campos, our Head of Finance. The presentation will be followed by a Q&A session. Therefore, if you want to ask question during the presentation please do not hesitate to send them through the question button on the platform. Before we begin, let me remind you that the information presented in this call contains forward-looking statements based on our current beliefs and expectations. Actual results could materially differ due to the known and unknown risks, uncertainties and other factors, and we undertake no obligation to update or revise any of these statements. With that, I thank you for your presence here today, and I will now hand the presentation over to Juan Lopez-Belmonte. Please go ahead, Juan.

Thank you, Javier, and good morning to everyone in the call. 2024 was a transition year for ROVI, crucial for establishing the basis for ROVI's future. The company is currently undergoing a period where investment is essential to drive our growth and position the company for long-term success. In this context, our operating revenue decreased 7.9% as a result of lower revenues from the manufacturer of the COVID-19 vaccine in comparison to 2023 when ROVI had booked higher income related to the production of the pandemic COVID-19 vaccine and secondly, because of lower revenues related to the activities carried out to prepare the plant for production of the vaccine under the agreement with Moderna. Sales of the specialty pharmaceutical business increased 2% in 2024. Okedi, Risperidone ISM, has continued to grow robustly with 2024 sales doubling those of 2023. The slowdown in sales of our heparin franchise division was mainly due to lower orders for enoxaparin partners throughout the year. However, Bemiparin sales increased by 2% to EUR 96.4 million in 2024. Our gross margin improved by 370 basis points in 2024. For 2025, with the visibility that the company has at this moment, we reiterate our guidance ROVI expects its operating revenue to decrease by a mid-single-digit percentage in comparison with 2024. Let's begin by reviewing the key milestones achieved last year. In April, ROVI announced that its subsidiary, ROVI Pharma Industrial Services entered into an agreement to support the manufacture of prefilled syringes for a global pharmaceutical company. Under the terms of the agreement, ROIS will provide a high-speed production line at the ROIS' San Sebastian de los Reyes facility in Madrid with an estimated annual capacity of 100 million units. Commercial production is expected to be the first to commence in 2026. And as from 2027, which is expected to be the first full recurrent manufacturing year, ROVI's CDMO business expects to have a positive revenue increase impact ranging between 20% and 45% over 2023 sales. After the completion of the share buyback program in June 2024, we informed that the canceled shares have been delisted from the stock exchange on September 13, 2024. As a result, total ordinary shares now amount to 51,235,762. By the cancellation of these shares, the shareholders automatically increased their percentage interest in the share cap. Lastly, in December, for the fifth year running, ROVI improved its ESG risk rating awarded by Sustainalytics, achieved a low risk of 16.1% compared with 16.4% in the previous year. The company was placed fifth in the world ESG risk ranking from among the 424 companies evaluated in the pharmaceutical industry. And now let me give a quick overview of 2024 financials. Total operating revenues fell by 7.9% to EUR 763.7 million versus last year. However, we continue to see good performance within our Specialty Pharma business. Its sales were up 2% to EUR 427.5 million in 2024, positively impacted by Okedi, Neparvis, Bemiparin and the contrast agents and other hospital product division. I will touch upon their performance later on in the presentation. EBITDA stood at EUR 207.4 million, a decrease of 15% compared to last year. Reflecting a 2.3 percentage point decrease in the EBITDA margin, which was 27.2% in 2024. Likewise, net profit stood at EUR 136.9 million, a decrease of 20% in 2024 compared to 2023. Moving on to one of our main pillars of growth, our specialty pharma area. Sales of prescription-based pharmaceutical products remained stable in 2024. Sales of the heparin franchise decreased by 2% in 2024, mainly due to lower orders from enoxaparin partners. Bemiparin had another strong quarter in terms of revenue performance. In 2024, sales were up 2%. Bemiparin international sales grew 16% with a strong contribution from China, Turkey and Greece. And we continue to see momentum for the product. We aspire to become a global leader in this field with Bemiparin and enoxaparin biosimilar. In this context, we are investing not only increase our capacities for the production of heparin, but also to become self-sufficient in obtaining crude heparin and thus becoming a vertically integrated company in all the low molecular weight heparin manufacturing phases. ROVI continues with its internalization plan. Sales outside Spain represented 64% of operating revenue in 2024 versus 67% in 2023. Regarding enoxaparin biosimilar, it is already present in 41 countries, and we continue to sign out licensing agreements to distribute the product in more countries. As I mentioned before, in 2024, enoxaparin biosimilar sales decreased by 6%. However, the fourth quarter was the strongest quarter of the year in terms of sales due to a higher concentration of orders from partners. Enoxaparin sales increased 37% in the fourth quarter of 2024 compared to the third quarter of the same year and rose 10% in the fourth quarter of 2024 compared to the fourth quarter of 2023. The growth drivers of the specialty pharmaceutical business were Okedi, Neparvis and the contrast agents and other hospital products. Now taking each one of the brands in turn step by step. Sales of Okedi, the first ROVI product based on its leading-edge drug delivery technology, ISM, for the treatment of schizophrenia in adults reached EUR 28.8 million in 2024, twice as much as in 2023. We have also continued to make good progress with Okedi's launch. In the fourth quarter of 2024, the product was launched in Finland and was approved by Health Canada. In January 2025, it was launched in the rest of the Nordic countries and will also be launched in Australia, Taiwan and the Netherlands. Sales of Neparvis, a specialty product from Novartis indicated for the treatment of adult patients with symptomatic chronic heart failure and reduced ejection fraction increased 13% in 2024. And finally, sales of contrast imaging agents and other hospital products increased by 16% in 2024. Let me mention that in January 2025, ROVI acquired a majority position in Cells IA Technologies a pioneering company in the development of artificial intelligence-assisted diagnosis in the pathological anatomy area. We believe this agreement represents an opportunity for ROVI to contribute to the improvement of health care through the development of artificial intelligence solutions. Regarding CDMO, sales declined to EUR 346.2 million as a result of lower revenues from the manufacture of the COVID-19 vaccine in comparison to 2023 when ROVI had booked higher income related to the production of the pandemic COVID-19 vaccine and lower revenues related to the activities carried out to prepare the plant for production of the vaccine under the agreement with Moderna. We remain excited about the near and long-term potential of our globally leading CDMO business given the attractive market dynamics. ROVI has invested substantial capital to build global leadership in sterile fill and finish capacity and technology services. With such investments and with current expansions underway, ROVI expects to significantly increase its current sterile capacity and its FDA and EMEA EU GMP1 compliant facilities in Spain. And to become one of the largest and most experienced pharmaceutical groups in Spain with 8 fully integrated plants, 3 of which are fully engaged in contract development manufacturing operations. Moving to research and development. We are making good progress with our 2 Phase I clinical trials -- in July 2023, we began the Phase I clinical trial of the new 3 formulation of Letrozole in Europe to evaluate the pharmacokinetics, safety and tolerability of single ascending doses of Letrozole LEBE at different strengths in voluntary healthy postmenopausal women, the LEILA-1 study. In September 2023, we began the Phase I clinical trial of the 3 monthly risperidone injection, which would complement the current 4-weekly formulation of Risperidone ISM for the maintenance treatment of patients with clinically stable schizophrenia. The clinical trial will evaluate the safety, tolerability and pharmacokinetics of various candidate formulations at different dose strengths and injection sites. Proof of ROVI's commitment to a sustainable business model is the recognition obtained by the company to the evaluation by Sustainalytics. In December 2024, ROVI obtained the fifth position in the ESG rating among the 424 companies evaluated in the pharmaceutical industry category. The company was likewise ranked 31st out of a total of 851 companies in the entire sector, which includes biotechnology companies, pharmaceutical laboratories and laboratory equipment companies. Furthermore, ROVI improved its ESG rating to 16.1 points versus the 16.4 points obtained in 2023. Among the actions that allow the rating to improve in 2024, ROVI can highlight the sound management of ESG risks related to product quality and safety, corporate governance, business ethics, human capital, climate change, waste management and anticorruption antibribery practices. In addition, ROVI has been considered by Sustainalytics as top rated among companies in the industry to its involvement in a series of activities such as the Board of Directors involvement in the company's environmental and social aspects. The implementation of the environmental policy and our robust quality and safety program for products and services as well as the integration of ethical practices at all levels of the organization. Additionally, 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 '23 and 2024, 65% 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. And finally, I will provide an overview of the 2025 outlook. As I mentioned earlier, 2025 guidance remains unchanged, and we expect operating revenue to decrease by a mid-single-digit percentage in comparison with 2024. Notwithstanding this guidance is calculated using certain factors that could be relevant to the estimates and that are difficult to specify at the present time. They include, among others, the following: First, as of today's date, the company is unable to forecast how demand and production might evolve for the vaccination campaigns that will take place in 2025. Second, it is hoped that the expansion of the compounding, aesthetic filling, inspection, leveling and packaging capacities at the ROVI facilities in Madrid and the current high market demand for contract manufacturing services will favor obtaining new business with the resulting sales impact. This would have to be considered, but it's impossible to estimate at this time. 2024 and 2025 are clearly transition years. The company is making significant investments that will lay the foundation for ROVI's future growth. We are at an inflection point with a multiyear growth opportunity driven by our established European footprint, which will continue delivering growth within our low molecular weight heparin platform and the successful launch of Okedi and the future avenues of growth that will come from our CDMO business and the investments efforts made in research and development with the development of the quarterly injection of Risperidone, which is nearing completion of a Phase I study. These growth levels 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 CDMO services. And with that, I would like to turn it back 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 meeting.

Well, thanks, Juan. As Juan has previously mentioned, since the pandemic, we have been in a transition period in which value is being created for the future. In this context, in 2024, operating revenue was EUR 763.7 million, a decrease of 7.9% from 2023 sales, mainly due to the performance of the CDMO business. CDMO sales fell to EUR 336.2 million, mainly due to the lower revenues from the manufacture of the COVID-19 vaccine in comparison to 2023 when ROVI had booked higher income related to the production of the pandemic COVID-19 vaccine and also lower revenues related to the activities carried out to prepare the plant for production of the vaccine under the agreement with Moderna. Furthermore, ROVI invoiced less than forecast in the contract manufacturing business in the fourth quarter of the previous year, basically because of a provision that had not been initially expected that was charged to revenue. At any event, this is a situation limited to 2024 which does not affect or change the forecast for the current year 2025. However, sales of the Specialty Pharmaceutical business increased 2% to EUR 427.5 million compared to EUR 420.2 million in 2023. Sales of low molecular weight heparins slightly decreased by 0.2% to EUR 241.6 million in 2024. Gross profit decreased 2% to EUR 478.5 million in 2024 compared to last year. Gross margin was up 3.7 percentage points to 62.7% in 2024. This increase was mainly due to the decrease in the contribution to the contract manufacturing business of revenue relating to activities to prepare the plant to produce medicines under the agreement with Moderna, which contributed lower margins to group sales. The increased contribution to the CDMO business by existing customers excluding Moderna this time, which contributed high margins and the increased contribution of sales of Okedi, which likewise added high margins. In 2024, raw material prices for low molecular-weight heparins fell 54% compared to 2023. Notwithstanding in spite of the decrease in heparin raw material prices, the impact on the gross margin was negative in 2024. However, a positive impact on the gross margin is expected from 2025 onwards. ROVI continues to be committed to innovation. R&D expenses increased 3% only to EUR 25.8 million in 2024 due to the development of the Phase I of Letrozole LEBE, which began in July 2023 and the development of the Phase I of a new formulation of Risperidone ISM for a 3-monthly injection, which began in September '23. Selling, general and administrative expenses, SG&A increased 12% to EUR 245.2 million in 2024 compared to '23. This increase was a consequence of higher employee benefit expenses, excluding R&D, which increased 10% in '24 versus '23, resulting mostly from a wage increase of 10.3% in accordance with the 20th general collective agreement for the chemical industry '21-'23 and also a 3% wage rise due to the entering force of the 21st collective agreement of the chemical industry, in this case, '24, '26 in November '24. And also an increase of 13% in other operating expenses, excluding again, R&D due to the Arcadis launch in Europe and to nonrecurrent expenses. The latter includes the process for a strategic assessment of the contract manufacturing business and the dismantling of the sodium heparin production plant in San Sebastián de los Reyes subsequent to the investment in a new plant in Escuzar approved by the European authorities in June '24. Nevertheless, other operating expenses, excluding R&D and nonrecurrent expenses only increased by 5% compared to '23. EBITDA totaled EUR 207.4 million in '24, a decrease of 15% compared to '23, reflecting a 2.3 percentage point decrease in the EBITDA margin, which decreased to 27.2% in '24. EBIT decreased 19% to EUR 179.4 million in '24, reflecting a 3 percentage point decrease in the EBIT margin, which decreased to 23.5% in '24. Net profit decreased 20% to EUR 136.9 million in 2024. Moving on to the evolution of CapEx and cash flows. As we have been saying, we are on track to becoming a key leading player with the CDMO industry in terms of injectable capabilities. In this context, ROVI invested EUR 62.2 million in '24. Of this amount, EUR 46.6 million relates to investment CapEx regarding our facilities, including important projects such as the ISM industrialization, 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 filling lines and the operations expansions. Lastly, we invested EUR 15.6 million related to maintenance and other CapEx. I'm very pleased to report that cash flows from operating activities has increased to EUR 138.3 million. I would like to mention that ROVI's working capital improved by EUR 9 million in '24, mainly due to the decrease in inventories. We expect inventories to continue decreasing throughout '25 as a result of the fall in the prices of the raw materials of low molecular-weight heparins. Regarding our debt, as of 31st December '24, ROVI's total debt increased to EUR 114.4 million, EUR 86.9 million is debt with banks, representing 76% of total debt, while EUR 16.1 million correspond to financial liabilities for leases representing 14% of total debt. And finally, EUR 11.4 million correspond to debt with public administration related to the development of R&D projects, which is 0% interest rate debt, representing 10% of total debt. At 31st December '24, bank borrowings increased to EUR 49.2 million. The same way as of December 31, '24, ROVI had a gross cash position of EUR 29.3 million and therefore, net debt of EUR 85.1 million. Regarding the dividend, ROVI's Board of Directors will put a proposal to the General Shareholders' Meeting for distribution of a dividend of EUR 47,910,561.05, equivalent to EUR 0.9351 per share entitled to receive it charged to the 2024 profit. This would entail distribution to an amount equivalent to approximately 35% of the consolidated net profit for '24 attributed to the parent company. Considering the group's cash generation and the market situation, ROVI decided to launch a buyback program for the company's shares effective as of 26 July '23. On 11th June '24, ROVI informed of the completion of this buyback under this framework, a total of 2,233,466 shares were acquired for an amount of EUR 130 million, which represents approximately 4.13% of the share capital. As notified when the buyback program commenced, the purpose of the program was to cancel shares of ROVI through our reduction of capital and at the same time, to contribute to ROVI shareholders' remuneration by increasing the profit per share. The reduction of the capital was carried out by canceling 2,780,395 shares. On 12 September '24, ROVI informed that the canceled shares have been delisted from the stock exchange. So regarding news flows for this year, we will continue to monitor the evolution of the manufacturing of the Moderna products and also the rest of our portfolio of customers of the CDMO business unit. We expect to announce Okedi's launch in more countries. The product is currently being marketed, Germany, U.K., Spain, Portugal, Italy, Austria, Greece, Serbia and Finland. In addition, in January this year, it was launched in the rest of the Nordic countries. And as Juan said before, will be followed by Australia, Taiwan and the Netherlands. We also look forward to hearing about the licensing of new products. Regarding our R&D strategy, we are making good progress with the first clinical trial of Letrozole ISM and the new formulation of Risperidone for a 3-monthly injection. Regarding the clinical development of Letrozole LEBE, we will request to meet with the FDA in '25 to discuss the next steps with them. That's all regarding our financial results for 2024. Therefore, we can now start the Q&A session. [Operator Instructions]

Thank you very much, Javier. So Patricia Cifuentes has 3 questions. The first one is for you, Javier. Could you tell me about the nature of the miss in EBITDA in Q4? Assuming that only part of it came from sales, I would like to know why there are additional costs or provisions that put pressure on the 2024 EBITDA. And in particular, how much did the strategic review project cost you?

Sure. Thank you very much for your questions, Patricia. As we announced a couple of weeks ago, in the context of the preliminary closing of the last year results and in relation to the closing of EBITDA levels forecasted by the market consensus. The company, as all of you know, made an announcement that the EBITDA levels would be lower than expected, probably or that the market consensus expected, lower below a range of between 10% and 15%. And as we've been commenting this morning, the closing EBITDA figure was EUR 207 million, and that is approach 13% lower than the market consensus at that time. And basically, this was due and as we have tried to explain several times that we invoiced less than expected in the contract manufacturing business, the CDMO business unit in the last quarter of '24. And it was mainly due to booking a provision with an impact on the sales figures that had not initially been forecasted by us. As we said this morning, as we have said this morning in the press release, this is a situation only affecting '24, which although contributed to an 8% reduction in our operating revenue. which was more or less in guidance with our -- in line with our guidance forecasted for 2024. So therefore, this -- and this is important, does not affect or change the forecast for the current year for this 2025. With regards to your other question, additionally in the fourth quarter of 2024, operating expenses increased due to, I would say, a series of nonrecurring elements, which were related to the process -- mainly to the process of this strategic evaluation of the contract manufacturing business. In this case, we informed the market that this amount was around EUR 4.3 million. And we have also dismantled our facility for sodium -- small facility though for sodium heparin manufacturing. This was in San Sebastian de los Reyes. And this has been done due to the approval of the Escuzar plant approved by the European authorities in June '24. And we have closed down the facility in San Sebastian de los Reyes, which amounted to -- was a write-off of around EUR 4 million because we wanted to focus on Escuzar and in this way to allow us to have more synergies and to reduce the operating cost in the future.

Javier. The second question from Patricia is for you, Juan. What are your growth prospects for heparin for 2025?

For your question. Regarding enoxaparin, we expect flat or slightly decrease in terms of sales. Regarding Bemiparin, we have expressed during our presentation Javier and myself, we see a good momentum from international sales. So we do expect some growth, especially coming from the countries that we have mentioned before, China, Greece and Turkey. So we see that still Bemiparin is a growth item that it will be delivered this year in 2025.

Patricia also asks, how much could the ex-Moderna business grow this year?

I mean before answering the question, let's go back to 2024. I mean, the ex-Moderna business in the CDMO franchise, it grew at double digit. One of the reasons of that incremental growth was because as we have shared with the market, we temporarily shut down the Julian Camarillo facility just to do some upgrading. I mean the facility is already Annex 1 compliant, but we want -- we had to upgrade certain equipment, and we have added a new line. And that made us to shut temporarily the manufacturing plant in the first quarter in 2025. So that means that we have to bridge and to increase the capacity and the output during 2024. So again, for that reason, we expect that part of the production for 2025 was produced during the last quarters of 2024, we expect that the Moderna sales in the CDMO franchise will slightly decrease in 2025.

Thanks, Juan. Francisco Ruiz from BNP has 2 questions. The first one, Javier is for you one of the reasons lower sales in Q4 that is no longer to be in 2025, why maintain the guidance in sales instead of increasing?

Yes. Thank you, Marta. Well, basically, as we tried to explain earlier this morning, the forecast for the guidance and the '24 was very similar that we expected and slightly very minor miss compared to our guidance. So for '25, we expect to maintain the guidance that we provided in November last year. So it's in the same direction, and it's aligned with our forecast that's and we expect that the guidance for '25 to be a mid-single-digit decrease.

Thanks, Javier. Juan also asks, you booked EUR 19 million investment in Terafront project. Do you expect further investment of this kind in the future?

I mean the Terafront is a very -- I mean, interesting project. I mean it gives the chance to really to set a foot on advanced therapy, cell therapies and personalized medicine. That was the initial first milestone that we had committed to invest on the company. We are right now assessing all the different projects that have been -- that the different academic groups have approached and have proposed us to fund it. We don't expect at least in 2025 to make any additional milestone payments. And again, it's going to depend on the quality, the number of projects and the investment requirements to take it to commercial phases or even to licensing out phases. So it's very difficult to forecast at this moment of time. But definitely in 2025, we don't see any need for any additional funding to Terafront.

The next question is from Guilherme Sampaio from CaixaBank. Javier, how do you expect SG&A and R&D to grow in 2025?

Thank you, Guilherme, for your question. As we've been trying to deliver in today's presentation, we are in a transitional period where we are trying to prepare ourselves to become a leading CDMO player, and we are also investing for the projects for the next coming years. In this sense for 2025, as you are asking us in terms of SG&A, we expect that we need to increase the number of people in the CDMO business units as we are adding new lines. As you know, that we had an important agreement that we signed last year. And for that agreement, we are adding -- or we are adding a new line that will be booked by that agreement. So we need people to manufacture to run the lines and to be involved on the manufacturing process. So I would say that also with the launch of Okedi in the countries in Europe and the different projects alongside the company, we expect that an increase of SG&A that could be I would say, a mid-single-digit growth at least. And in terms of R&D, I believe that it's still early to assess the forecast for the year. As we said before, we need to meet with the FDA for the Letrozole project. And depending on how we ended up the Phase I clinical trials, we'll probably need to enter on new phases. And therefore, we could be coping with more or incremental R&D costs. I think that probably in the Capital Market Day, we can provide more visibility on the R&D front and therefore, to explain and devote much more time on R&D and explain the future of the projects.

Thanks, Javier. The next question comes from Carlos Garcia from [indiscernible]. The contract that Javier -- the contract that you mentioned for a customer in CDMO, can you clarify how do you expect production to ramp up? You mentioned full year impact in 2027, but should we assume 50% impact in 2026?

Yes. As I was explaining before, this agreement implies a new line, which is already in our site of San Sebastián de los Reyes. We are -- we have already validated the line, and we are starting to do the technical tech transfer with the customer. it's always difficult to have a clear or a very accurate assessment of when we are going to start the routine manufacturing business with the customer. That's why we assess that '27 will be our full year -- first full year of routine manufacturing business, depending on how quick and/or how fast is the tech transfer done and how the regulatory process in the different regions is approved, our manufacturing line is approved. We could even start routine manufacturing business, as Carlos mentioned, at half of '26. So in the middle -- during the middle of '26. Still at this point, it's early to forecast it. But yes, you can bear in mind that it will be either midyear '26 or beginning '27.

Thanks, Javier. So the next 2 questions come from Mark Profitlich. So the first one is for you, Javier. You state that you hope to gain some new CDMO contracts in 2025 and realize revenues from those new revenues. Is this realistic given the long lead times in the CDMO business?

I mean what I can tell you right now is that we are extremely excited and optimistic about the prospect of getting new customers. I think I mentioned before that we believe that there is a current imbalance between supply and demand in the injectable market. And ROVI is well positioned to take advantage of the current situation of the market. We believe that we are gaining and winning customers. And these clients are quite confidential, and we cannot disclose news or break out news about these sort of customers. Again, it's difficult to quantify or to visualize the impact on '25. But I'm sure that at least next year onwards, we could visualize and we could materialize most of these new customers that we are winning right now. And I think we could provide more visibility as long as the year goes by. And again, we are terribly optimistic and excited, and that's why we keep investing on adding new capabilities on the CDMO business unit.

Thanks, Javier. The second question from Mark is for you, Juan. In January 2025, Rovi acquired an AI diagnostic company aiming to improve health care through AI. Could you elaborate further on the strategic fit of this acquisition?

I mean this is a start-up that we identified some quarters ago. We thought it had a perfect fit within our hospital product portfolio. I mean anatomic pathology departments nowadays worldwide are getting digitalized. So new equipment is being bought by hospitals in order to enhance and also to speed up the process of diagnosis and the reports regarding the millions of biopsies and pathological samples that they are processed at a regularly basis on all hospitals worldwide. It does fit perfectly with our strategy because we have a stronghold in Spain and a very well knowledge of the central departments of any hospital setting. I mean radiology is a hospital department that provides services to the rest of the medical departments. So anatomy/pathology works in the same way. At the end of the day, this company has developed what we believe is extraordinary technology in producing algorithms to that provides more reliability, flexibility and a faster report time for something that is becoming crucial within the oncological setting and the biopsy setting worldwide. Again, it has been a very minor investment, but it fits perfectly with our strategy. It's a good fit for our hospital sales force and as well it's a good fit for our European footprint. I mean it's very easily to scale up for a European perspective. We just bought the company in January. And as the year goes by and probably in the next forthcoming quarters, we could provide more visibility in terms of launching and in terms of all the commercial activities, a potential stream of revenues for the company.

Thanks, Juan. The next question comes from Joaquin Garcia-Quiros from JB Capital. Javier, could you provide us a bit more color on 2025 EBITDA with sales declining by 5% gross margin improving and costs going up, is it correct to assume a similar to slightly decline in EBITDA for 2025?

Thank you. Thank you. As we have confirmed this morning, our operating revenue guidance for 2025 has not changed other previous prior guidance. And although we do not provide the market with guidance on the EBITDA, right now at ROVI, we are in a moment of -- which is essential to invest on the company in order to drive our growth for the future as we've been telling in today's conference call. We are concentrating our efforts in increasing our production capacities in the CDMO business and reinforcing the company's internationalization strategy through across the different subsidiaries in Europe. All this means an increase in expenditures. And we are hiring, as I said before, talent to support the development of our new production lines, which will come into operation this year and also in '26 and '27. And as I said before, the routine manufacturing business will not be fully running until '27 or even '26, hopefully, before. So this year also, we are ending the Phase I of Letrozole and the quarterly risperidone. And we hope to begin the following phases, as I said before, also on the different projects, which again will also mean significant financial effort. Although these expenses would be significant, we believe that this will set the basis necessary for solid and sustainable growth in the next coming years. And that's why we invite you all of you for the Capital Market Day next month in order to give you more visibility for the growing prospects of the company.

Thanks, Javier. The second question is, what levels of CapEx should we assume for the upcoming years?

Yes. Basically, as I said before, on '25 and '26, we are expanding our manufacturing capabilities. We are also ending the facility with our joint venture, Glicopepton for the manufacturing of biological products. So I believe that for '25, we could expect a similar CapEx than in '25. And again, this is always an investment for the future for -- due to the exciting situation that the company is at the moment.

Javier next question comes from Alvaro Lenze from Alantra Equities. Do you consider launching another share buyback program considering your solid balance sheet, positive cash flow generation and the fall in the share price?

Thank you, Alvaro. I mean, for us, the remuneration of our shareholders is a key criteria. And this is always in our minds when we need to do capital criteria investment decisions. So you know that we believe in organic investments and inorganic growth. So we don't foresee the use of capital for M&A purposes or at least transformative M&A inorganic growth. So whenever we need to think about the future and about the capital needs, share buybacks is always on the table. So I cannot confirm at this point if we are going to do a share buyback program in the future because it's not on my only criteria, but it's always on the table. And I think that balance sheet will be reinforced this year. I mean we cannot disregard that option. But again, it's not in our short-term plans anyway right now.

Thanks, Javier. The next question comes from Pablo De Renteria from Kepler Cheuvreux. You mentioned that despite the 50% decline in raw material prices for low molecular weight heparins, the impact on gross margin in 2024 was negative. Which I presume was due to inventories built at higher prices. Could you please provide more details or quantify the expected savings impact for 2025? Additionally, should we expect the lower raw material costs to result in reducing pricing for in-licensed agreements in the International segment?

Yes. With regards to your first question, I think we are really, really looking forward to this year results in the sense that after a few years of constraint on the margin due to the increase of the sodium -- the sodium heparin raw material prices, this '25 is the first year that we are going to see a very positive contribution or a positive contribution from the decrease of the heparin raw material prices. Again, and this is -- as you were mentioning in your question, as we have very long stocks and the manufacturing process, very large stocks as the manufacturing process is very long. It's also difficult to quantify very accurately the impact in a given year. But I could think that we can assess that the impact on the raw material and the gross margin positive impact due to the heparin raw material prices would be, I would say, between 2 to 3 percentage points, 2 to 3 percentage points on the gross margin, so a positive additional gross margin for the company. which following your second question is correct, somehow in the sense that if prices are -- material prices are going down or raw material prices are going down, it is easy to expect that the market -- the selling market prices in the tender front of the heparins could be impacted. So maybe we also need to have that to bear in mind that we will have a negative contribution on the selling prices of the heparin due to a price competition pressure. And probably, therefore, we will need to decrease somehow the transfer pricing to our partners. But overall, I would say that we could think a 2% -- maybe a 2% increase on the gross margin.

Thanks, Javier. The last question is for you, Juan, from Chris Richardson from Jefferies. Could you please give us an idea of expected growth ex CDMO growth?

I mean, thank you for the question. I mean ex CDMO growth, I mean, really, we're expecting a very important growth mainly coming from Okedi. I mean the launch of Okedi has been a success. We are just really still launching the product in many countries. So we do expect we doubled sales versus last year. So we expect to have a tremendous organic growth in Okedi, not only coming from new launches, but as well coming from the existing countries. So we do expect still being far away from peak sales in countries like Spain, Germany, Italy, just been launched in the Nordic countries, Taiwan, Australia and Canada will follow shortly. So again, the expectations of Okedi in terms of growth for the company are still very high. And that's a really positive thing, not only for the sales itself, but as well because it validates our technology and the prospect of our follow-up products that we have in our research and development programs. Heparin as well, we do expect growth. Bemiparin -- we believe, as I mentioned before that we'll have still a strong contribution in the following -- following years, not only from Spain, but as well from the international sales that they grew 16% last year. And we expect that China, Turkey and Greece will still bring additional growth to the company. And I believe, as Javier has mentioned in his presentation, the pharma business in Spain is also going pretty well, pretty solid. We do -- we have already faced the price decrease related to the generic launch in is showing strong growth as well as the hospital products in general. And we do expect to -- let's say, we are optimistic as well on new in-licensing agreements coming into place in the next coming quarters. So I think the good thing about the company is that not only CDMO has got a very bright future, but as well the pharmaceutical part of the business represents slightly over 50% of our revenue line. Really, we have a very important organic items yet to be delivered with almost no uncertainty. So there is -- I cannot give you an exact figure because I don't have it on top of my head, but really the predictability in terms of organic growth in the pharma business is strong right now.

Thanks, Juan. We are out of time. Thank you very much for your high participation. The ROVI IR team will answer the pending questions as soon as possible. Let me now turn the floor over to Javier for the closure of the presentation.

Well, thank you, Marta. As you were saying, we -- unfortunately, we are out of time. As we said before, our IR team will help you if you have any pending further questions. Thank you very much for joining us in this ROVI's '24 financial results call, and have a nice day all of you.