Laboratorios Farmacéuticos Rovi SA reported its financial results for Q4 2025, highlighting a year of strategic investments and transformative initiatives. Despite a slight decrease in revenue, the company achieved significant improvements in profitability metrics, driven by strong specialty pharmaceutical performance and operational efficiencies. The stock has surged 64% over the past year and is currently trading within 1% of its 52-week high at a market capitalization of $4.8 billion. Yet InvestingPro analysis suggests the stock may be overvalued at current levels, placing it among stocks on the most overvalued list based on Fair Value calculations.
Key Takeaways
* Rovi’s total revenue decreased by 1% to 756.1 million euros, primarily due to a decline in the CDMO business.
* Gross profit rose by 3% to 494.7 million euros, with a notable gross margin improvement of 3.9 percentage points.
* EBITDA increased by 4%, with a margin expansion to 29.1%.
* The company proposed a dividend distribution of over 49 million euros, representing 35% of net profit. According to InvestingPro Tips, Rovi has maintained dividend payments for 18 consecutive years, demonstrating strong commitment to shareholder returns. The platform offers 15 additional ProTips for Rovi, providing investors with comprehensive insights into the company’s strengths and potential concerns.
* Strategic initiatives include vertical integration in the heparin supply chain and expansion of the ISM platform.
Company Performance
Rovi navigated a challenging market environment in 2025, characterized by strategic investments and operational transformations. While total revenue declined slightly, the company succeeded in enhancing profitability through improved product mix and cost efficiencies. The specialty pharmaceutical segment, particularly Okedi, demonstrated robust growth, offsetting declines in the CDMO business.
Financial Highlights
* Revenue: 756.1 million euros, down 1% year-over-year
* Gross profit: 494.7 million euros, up 3%
* EBITDA: 216.2 million euros, up 4%
* EBIT: 185.8 million euros, up 4%
* Free cash flow: 120 million euros, up 57%
Outlook & Guidance
Rovi remains optimistic about its future prospects, with plans to further expand its specialty pharmaceutical portfolio and enhance its CDMO capabilities. The company is investing in vertical integration for its heparin supply chain and advancing its ISM platform with late-stage clinical programs like Letrozole CE and Risperidone Quar, which are expected to drive significant revenue post-2030.
Executive Commentary
Rovi’s CEO emphasized the company’s commitment to enhancing shareholder value through strategic investments and operational efficiencies. “Our focus on high-margin products and vertical integration will position us for sustainable growth,” the CEO stated. The CFO highlighted the strong cash generation capabilities, noting, “Our improved cash flow and conservative debt position provide a solid foundation for future investments.”
Risks and Challenges
* Supply Chain Pressures: Competitive pricing from Chinese heparin producers could pressure margins.
* Regulatory Hurdles: Ongoing regulatory approvals for new products and manufacturing processes pose potential challenges.
* Market Volatility: Economic uncertainties and market fluctuations could impact demand for Rovi’s products.
* Patent Expirations: The upcoming patent loss for Neparvis in 2026 may affect revenue streams.
Q&A
During the earnings call, analysts focused on Rovi’s strategic initiatives, particularly the vertical integration of its heparin supply chain and the commercialization strategy for Okedi. Questions also addressed the company’s R&D investments and potential impacts of regulatory changes on future product launches.
Full transcript – Laboratorios Farmaceuticos ROVI SA (1ROVI) Q4 2025:
Marta Campos, Head of Finance, Rovi: Hello, everyone. This is Marta Campos, Head of Finance for Rovi. Welcome to our company’s review of business results for the full year 2025. Before we begin, let me remind you that today’s presentation and associated documentation are available on the Investor Relations section of Rovi’s website. Please note 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 known and unknown risks, uncertainties, and other factors, and we undertake no obligation to update or revise any of the statements. Moving to today’s agenda, Juan Lopez Belmonte, Rovi’s Chairman and CEO, will discuss on business performance for the full year 2025, as well as our outlook for 2026.
Javier López-Belmonte Encina, Rovi’s Chief Financial Officer, will then review full year financial results and provide an overview of our cash and debt position. The presentation will be followed by a Q&A session. If you want to ask any questions during the presentation, please do not hesitate to send them through the question button on the platform. With that, I thank you for your presence today, and we’ll now turn the call over to Juan.
Juan Lopez Belmonte, Chairman and Chief Executive Officer, Rovi: Thank you, Marta. Good morning, everyone, and thank you for joining us today. 2025 was a transition year for Rovi, but also one characterized by strong execution and solid performance. We operated with clear strategic priorities and delivered our financial commitments. In this context, our total revenue in 2025 amounted to EUR 756.1 million, a 1% decrease compared with 2024. Operating revenue reached EUR 743.5 million, representing a 2% decrease versus 2024. This evolution was better than expected and was mainly driven by the performance of our Contract Development and Manufacturing Organization business. This increase was partially offset by the strong performance of our specialty pharmaceutical business. Our gross margin reached 66.5% in 2025, an improvement of 3.9 percentage points compared to 2024.
It was also a strong years in terms of profitability. EBITDA increased by 4%, and our EBITDA margin expanded by 1.9 percentage points, reaching 29.1 in 2025. With the visibility we have today, we reaffirm our 2026 guidance, and Rovi expects operating revenue to grow by high single digit to low double-digit rates compared with 2025. I’m very pleased with the progress we’ve made in executing transformative initiatives that continue to strengthen our company. Let me begin with our execution in the CDMO business. In November, we announced a collaboration with Roche for the manufacture of a new medicine in development. This agreement reflects the strong momentum we are seeing in new business and the continued expansion of our partnership base. In September, we announced the acquisition of an injectable drug product manufacturing site in Phoenix, Arizona.
We are now integrating the facility, ROIS Phoenix, into our network. As part of the transaction, we signed a total manufacturing agreement with an initial five-year term, including minimum annual payments of $50 million. We are extremely excited about this opportunity, as it enhances our value proposition for biopharma partners by providing U.S.-based manufacturing capabilities and adding highly competitive, high potent OEB5 cytotoxic capacities. Turning to our specialty pharma business. In July, the Technological Development and Innovation Center confirmed the final approval of the EUR 36.3 million aid granted to Rovi for the LySolid project, covering the period from January 2023 to August 2026. In the second half of the year, we collected the full amount and recognized the revenue associated with expenses incurred between January 2023 and December 2025. Finally, in January 2025, we advanced meaningfully in the field of artificial intelligence.
We acquired a majority stake in SALI Technology, a pioneer in AI-assisted diagnostic in pathological anatomy, an area with significant potential from transformation to emerging digital technologies. Looking ahead, we expect these actions to translate into strong financial performance over the coming years and give us confidence in our long-term outlook. Now, let me begin a quick overview of the 2025 financial results. Total operating revenues fell 2% to EUR 743.5 million versus 2024, mainly due to the behavior of the CDMO business. Notwithstanding, sales of the specialty pharmaceutical business were up 11% to EUR 473.9 million, positively impacted by low molecular weight heparins, Okedi, Neparvis, and the contrast agents, and other hospital product division. I will touch upon their performance later on the presentation.
Moving on to one of our main pillars of growth, our specialty pharma area, sales of prescription-based pharmaceutical products increased by 11% in 2025, reaching EUR 414.1 million, driven mainly by the solid performance of our heparin division, which grew 7% in the year. Within the division, Enoxaparin was the main growth contributor. Sales rose 9%, supported by higher order volumes from our international partners. Bemiparin also delivered strong performance. Sales increased 4% in 2025, driven by a very strong fourth quarter, with sales increasing 52% compared with the third quarter. This growth was supported by the strength of our international business, where revenues rose 15% to EUR 43.6 million, mainly driven by a strong performance in China, Greece, and Turkey.
We remain focused on becoming a global leader in the heparin field, with both Bemiparin and our Enoxaparin biosimilar. In line with this ambition, we continue to invest in achieving self-sufficiency in crude heparin sourcing, moving toward full vertical integration across all manufacturing stages of low molecular weight heparins. Our Enoxaparin biosimilar continued to strengthen its global position in 2025, with out-licensing agreements covering 82 territories. Sales performance was solid throughout the year, driven by stronger demand from our international partners. Sales increased 9%, reaching EUR 157.7 million, reflecting higher order volumes and sustained momentum in markets where the product is already well-positioned. The year closed with a particularly strong fourth quarter, the strongest of the year, with sales up 36% versus the previous quarter.
Growth from the specialty pharmaceutical business was also driven by Okedi, Neparvis, and the contrast agents and other hospital products. Okedi, the first Rovi product based on its leading-edge drug delivery technology, ISM, for the treatment of schizophrenia in adults, delivered another year of strong growth. Sales reached EUR 56.7 million in 2025, an increase of 97% compared to 2024, and 84% rise compared to the fourth quarter of 2024. Sales of Neparvis, a specialty product from Novartis, indicated for the treatment of adult patients with symptomatic chronic heart failure and reduced ejected fraction, increased 10% in 2025. Sales of contrast imaging agents and other hospital products increased by 11% in 2025. Moving on to our CMO business, performance in 2025 evolved in line with our expectations.
Sales declined 20%, reaching EUR 269.5 million, mainly due to two factors: minimal revenue recognition related to the activities carried out in the year to prepare the plant for Moderna vaccine production, and second, lower production revenues from Moderna during that same period. Despite this temporary contraction, our confidence in the year and long-term potential of our CMO platform remains very strong. We operate in a highly dynamic market where Rovi holds a clear competitive position. To fully capture this opportunity, we are making significant investments to reinforce our global leadership in sterile fill and finish capacity and services. These investments will enable us to continue benefiting from the structural imbalance between the growing demand for injectable products and the limited supply of high-quality manufacturing capacity worldwide.
With expansions underway, Rovi is on track to become one of the largest and most experienced pharmaceutical groups in Spain, operating 8 fully integrated manufacturing sites, 5 of which are dedicated exclusively to contract development and manufacturing activities. This positions us exceptionally well for future growth. We continue to progress on our 2 innovative formulations based on our ISM technology platform. Today, I will provide an update across both programs. First, Letrozole CE, our quarterly prolonged-release formulation of Letrozole for the treatment of hormone-dependent breast cancer. We obtained positive phase I results at the beginning of 2025 and demonstrated superior estrogen suppression compared with Femara. In November 2025, we submitted the investigational new drug application to the U.S. FDA, and we expect to begin recruitment for the first clinical trial in the second quarter of 2026.
Second, Risperidone Quar, our quarterly prolonged-release Risperidone injection for the treatment of schizophrenia in adults. Its unique PK profile is capable of providing clinically relevant plasma concentrations from day 1 onwards. The clinical program intends to achieve the same indications as Okedi and to demonstrate that unlike all the other quarterly formulations, patients being attended for an acute episode can be treated with a single quarterly injection of Risperidone Quar without previous stabilization with monthly medication. We also reported positive phase I results early in 2025, and the phase III clinical program will follow a design similar to the one successfully executed for Okedi. Both programs represent meaningful innovation and reinforce the potential of our ISM platform to deliver long-acting treatments that improve patient outcomes and adherence. To conclude, let’s turn to our outlook for 2026.
As we’ve highlighted throughout today’s presentation, 2025 was a strong year in terms of execution, and we have laid solid foundations for our next phase of growth. 2026, we expect to return to revenue growth. As I mentioned earlier, 2026 guidance remains unchanged, and we expect operating revenue to increase by between a high single-digit % and a low double-digit % in comparison with 2025. This outlook reflects several factors: the potential revenue from the manufacturing agreement signed with Bristol Myers Squibb, closing is still pending, as part of the transaction announced on the 29th of September, 2025. Revenue arising from other agreements related to the contract manufacturing activity. Lastly, the current competitive pressure on pricing in the heparin division. To conclude, we are executing strongly across the business, successfully advising Okedi’s rollout, progressing our clinical programs, and delivering solid performance in our CDMO operations.
At the same time, we are making the strategic investments required to support sustainable growth over the long term. The progress we’ve made this year, combined with the momentum we are carrying forward, reinforces our ability to serve patients effectively while building lasting value for our shareholders. Thank you for your presence, again today. I will now turn the call to Javier.
Javier López-Belmonte Encina, Chief Financial Officer, Rovi: Thank you, Juan. Good morning, everyone. As Juan noted, in 2025, we made meaningful progress on building long-term value for the company. Total revenue in 2025 amounted to EUR 756.1 million, a 1% decrease compared with 2024. Likewise, operating revenue for 2025 totaled EUR 743.5 million, a decrease of 3% on 2024 numbers. This decline was better than expected and mainly driven by the performance of the CDMO business. This decrease was partially offset by the strong performance of our specialty pharma business, which was driven by our heparin division, O케이, Neparvis, and contract agents and other hospital products. I will now walk you through the remainder of our P&L.
Gross profit increased 3% to EUR 494.7 million in 2025 compared to 2024. Gross margin was up 3.9 percentage points to 66.5% in 2025. This increase was mainly impacted by the recognition of revenue associated with the R&D aid awarded by the CDTI for the Lysolide project, which is recorded under the other income line. Excluding the impact of other income, gross margin would have increased by 2.3 percentage points to 64.8%, mainly due to two factors. First, the increased contribution of Okedi sales, which added high margins, and second, the decrease in low molecular weight heparin raw material prices, which had a positive impact on gross margin. Rovi continues to be committed to innovation.
R&D expenses increased 47% to EUR 37.8 million in 2025, due to the completion of the phase 1 clinical trials for Letrozole LEBE and Risperidone ISM, and also for the preparation for the development of Letrozole LEBE’s phase 3 clinical trial. SG&A expenses decreased by 2% to EUR 240.7 million in 2025 compared to 2024, mainly due to an 8% reduction in other operating expenses, excluding R&D. This item, however, includes non-recurrent expenses associated with the strategic projects undertaken in 2024 and 2025. When excluding these non-recurrent strategic projects and other operating expenses, excluding R&D, would have decreased by 4% in 2025, underscoring the continued effectiveness of the company’s cost containment initiatives.
These efficiencies offset the 4% increase in employee benefit expenses, always excluding R&D, in 2025 versus 2024, driven primarily by a 3% wage increase due to the entry into force of the 21st General Agreement for the Chemical Industry, 2024-2026, in the 4th quarter of 2024, and also by the hiring of additional CDMO personnel. EBITDA totaled EUR 216.2 million in 2025, an increase of 4% compared to 2024, reflecting a 1.9 percentage point increase in the EBITDA margin, which increased to 29.1% in 2025. EBIT increased 4% to EUR 185.8 million in 2025, reflecting a 1.5 percentage point increase in the EBIT margin, which increased to 25% in 2025.
We now perform a pre-R&D analysis, EBITDA pre-R&D, calculated excluding R&D expenses in 2025, increased by 9%, reflecting a 3.6 percentage point increase in the EBIT margin to 34.2% in 2025. Likewise, EBIT pre-R&D increased by 9%, reflecting a 3.2 percentage point increase in the EBIT margin to 30.1% in 2025. Net profit pre-R&D, in the same way, increased by 8% in 2025. Moving on to the evolution of CapEx and cash generation, let me say first that we view CapEx as a key enabler for Rovi’s future growth, and it’s a key focus for our organization. This way, last year, Rovi invested EUR 67. million.
Of this amount, EUR 46.2 million relates to investment CapEx related to our facilities, including key important projects such as the new filling lines and the operations expansion; Glycopepton, our joint venture for the construction of a plant dedicated to the production of compounds of high biological value from the intestinal mucosa of pigs, and finally, the industrialization of our ISM platform. Lastly, we invested EUR 21.6 million in maintenance and other CapEx. In 2025, we increased cash flow from operating activities by 35% to EUR 187.1 million. Increase is mainly explained by two factors: the collection of the CDTI grant from the LySolid project and the improvement in inventory resulting from lower prices of heparin raw materials.
Our cash generation capacity has also evolved positively, with free cash flow reaching EUR 120 million, 57% higher than in 2024. Regarding our debt, as of 31st December 2025, Rovi’s total debt increased to EUR 121.8 million. December 2025, Rovi had a gross cash position of EUR 99.9 million, and a net debt of only EUR 21.9 million. Let me end this section with our dividend policy, which, you know, we consider a key priority for Rovi. Rovi’s Board of Directors will propose to the general shareholders’ meeting a dividend distribution of over EUR 49 million. This is equivalent to EUR 0.9594 per share, entitled to receive it, charged to the 2025 profit, sorry.
This would entail distribution to an amount equivalent to approximately 35% of the consolidated net profit for 2025, attributed to the parent company. Moving to the news flows for 2026, let me say that, first of all, Rovi delivered in 2025, and we are entering 2026 in a very strong position, ready to capture the next wave of growth. The year ahead brings a very attractive news flow across all parts of our business. In Specialty Pharma, we expect to strengthen the heparin division as we advance toward becoming a fully vertically integrated company, securing our supply chain and improving competitiveness. In CDMO business, 2026 will be a pivotal year, with the full integration of ROIS Phoenix into our network and the continued execution of our capital investments, which will expand capacity, enhance capabilities, and support future commercial opportunities.
In R&D, our ISM platform continues to represent a significant value driver, with important milestones expected across our late-stage pipeline. phase III trial of Letrozole SAE and the phase III program of our quarterly risperidone formulation. Altogether, 2026 is set to be a commercially rich year, supported by a strong execution, meaningful catalyst across the portfolio, and the actions we are taking to position Rovi for sustainable long-term growth. That’s all regarding our full year financial results. We can now start the Q&A session, and I will pass the floor to Marta.
Marta Campos, Head of Finance, Rovi: Thanks, Javier. If you want to ask any questions, please don’t hesitate to send them through the question button on the platform. The first question is for Javier and comes from Pablo de Rentería, from Kepler Cheuvreux. Javier, I understand it may still be early to comment, but could you share any indication on your client’s intentions regarding the 100 million dose capacity expected to be operational this year? Specifically, the agreement is expected to contribute between EUR 80 million and EUR 180 million. Do you have any sense of whether the client is likely to utilize this capacity fully, or whether it is intended more as a backup option? As a follow-up, has there been any change to the timeline for commissioning the line, or does September still look like the official target date?
Javier López-Belmonte Encina, Chief Financial Officer, Rovi: Thanks, Pablo. You know, we cannot comment much on specific contracts for, I mean, for confidentiality reasons. To provide some context, anyway, we are carrying out a technology transfer of works, and that will implies regulatory approvals this year. Again, commercial production is expected to commence probably or likely, most likely in the second part of the year, no? You know, with this contract, the client has at their disposal a filling line in San Sebastián de los Reyes, Padrita plant, up to we normally assess 100 million units of pre-filled syringes. The expectations remain the same. 2027 is expected to be the first full year manufacturing year, so I mean, recurrent from full year from beginning to an end.
If we take into account this potential first full year or this full recurrent manufacturing revenue, the impact in our accounts will range between 20% and 45% over 2023 year, sales year. If you remember, that was the guidance that we provided, when we announced the contract, and, we don’t have, different views, as today.
Marta Campos, Head of Finance, Rovi: Thanks, Javier. The next question comes from Guilherme Sampaio from CaixaBank, Juan, it’s for you. Could you comment on the latest trends regarding heparin raw material costs evolution, and to what extent this should be able to offset potential pressures in prices in 2026?
Juan Lopez Belmonte, Chairman and Chief Executive Officer, Rovi: Thank you. Thank you, Guillermo. There’s not that much info that we can share with you at this moment of time regarding heparin prices. What we are seeing really is a real aggressive price strategies from mostly from the Chinese players. What we are right now working is really on executing our plans to improve cost efficiency and to be able to deliver higher gross margins to make our position in the market more competitive. In this regard, it’s going to be very critical, the kickoff of our operations of our new manufacturing plant with the vertical integration of our supply chain. Really, we do believe that we have very positive trends in the future once we can in-house source the crude heparin manufacturing.
Right now, really, our goal and what it is taking most of our time right now is to make sure that we deliver all our execution plans in terms of making sure that we can make in terms of cost efficiency in our supply chain.
Marta Campos, Head of Finance, Rovi: Thanks, Juan. Javier, Guillermo also wants to know what is your view on SG&A evolution in 2026?
Javier López-Belmonte Encina, Chief Financial Officer, Rovi: Thanks, Guillermo. As we guided the market on 2026, we expect to expand the sales of the company, and that will mean that probably we are having an inflection turning point in our CDMO operations compared to the previous year. That will mean that we’ll need to expand or that we are expanding our operations, and for sure, it is linked to an increase in people and some expenditure, no? I want to highlight the tremendous performance that the company did on SG&A last year, on 2025, where we reduced SG&A.
I think this is very difficult to replicate because as long as we are forced, no, I’m happy to increase salaries to our people by the Collective Agreement, the trend normally is to increase at least as an inflection, as the inflation levels, no? You know our policy is to be very strict on cost expansion. Probably what, I mean, what I foresee, that we will expand our operations, and that will mean that we will need to expand probably our SG&A, but hopefully in a very moderate way.
Marta Campos, Head of Finance, Rovi: Thanks, Javier. The next question comes from Sergio Barrado from Fimarge. Juan, could you talk about reaching phase three for quarterly letrozole in 2026? What do you think the phase three would last?
Juan Lopez Belmonte, Chairman and Chief Executive Officer, Rovi: I mean, that’s really our plan. As both Javier and myself, we have shared with you earlier in our presentations, our target to start recruitment in second quarter this year of letrozole quarterly injection. The timelines are pretty much already been shared with the market. I mean, this is going to be a long execution phase 3 clinical trial. I mean, the design is extremely attractive. We are talking superiority versus the comparative drug, and we don’t expect to be the clinical trial finalized before 2030-2031. Definitely, this is going to be one of the major milestones of the company, and I think it’s the best signal, how are we trying to execute the long-term perspective of the company?
I think we have tremendous, very interesting short-term drivers of growth, while we are already establishing the foundations of the growth of the company for the next decade.
Marta Campos, Head of Finance, Rovi: Thanks, Juan. Francisco Ruiz from BNP has two questions. The first one is for you, Juan. After the excellent year on heparins, what are your expectations for 2026?
Juan Lopez Belmonte, Chairman and Chief Executive Officer, Rovi: Thank you, Francisco. Really, heparins, as I mentioned you before, we expect. I mean, 2025 was a great year. I mean, sales grew 9% on Enoxaparin, Bemiparin performance was also solid, especially in international markets. For 2026, we expect a decline in terms of sales, basically because the last quarters of last year were very strong in international markets. That means that our partners right now, they have sufficient stock, so we expect a slowdown in that part of the business. Secondly, we are seeing, as I mentioned, before in a previous question, we’re seeing a tremendous price and aggressive strategy from mainly our Chinese competitors. All together, we expect that for 2020-2026, sales decline for low molecular weight heparins.
We are, as I mentioned before, we’re investing heavily in making sure that we improve our cost efficiency in our supply chain, and we remain I mean, very much excited that we can still become a global player. We’re investing heavily. Hopefully, Glycopepton will very soon, works finalized, and we will be able to be fully integrated in the supply chain of the heparin production. Definitely, I believe that great things are yet to be delivered by Rovi on this field. We are experts on heparins, and we have demonstrated in the past that we do have the skills, the products, and expertise, and we’re just working on the long term to make sure that we continue increasing our sales.
Marta Campos, Head of Finance, Rovi: Thanks, Juan. The second question from Francisco is for you, Javier. After the lower R&D in 2025 versus expectations, could you update if in 2026, it should go above the range of EUR 40 million-EUR 60 million commented?
Javier López-Belmonte Encina, Chief Financial Officer, Rovi: Yeah. Thank you, Francisco, for the question. I mean, probably you’re right. Last year was a lower R&D expenditure than expected. You know, at the end of the day, the expenditure of R&D is linked to the evolution of the clinical trials, and as we’ve been mentioning in today’s call, we’re expecting to start recruiting patients this year, very soon. Probably recruiting patients on this phase of the clinical trials are the most expensive one. Therefore, we could expect this year to be very intensive on R&D expenditure. At the end of the day, the guidance that we provided on the capital market day last year around the R&D expenditure for this five-year terms program, from 2026 to 2030, don’t change at all.
Probably we’ll be expending EUR 300 million on this R&D on these years. Overall, that amount will not change. Probably, 2026 will be one of the years that we will spend most on R&D, and that’s also clear, and we are also looking and pushing to spend as much as possible, that will mean that we are progressing in the right direction. On the other hand, and on the positive front, let me remind all of you that on 2026, we will account the second part of this aid from this Spanish organization, authority, CDTI, that will give us or we will account an extra income, let’s say that way, that will be in a substantial amount. That probably will offset any extra expenditure for the year on R&D, you know?
We are very happy that we were able to collect that grant, that will help us to smooth the expenditure on R&D.
Marta Campos, Head of Finance, Rovi: Thanks, Javier. Juan Alvaro Lence from Alantra Equities asks, “Can you provide some detail on Neparvis prospects and the timing of the loss of exclusivity?
Juan Lopez Belmonte, Chairman and Chief Executive Officer, Rovi: Thank you. Thank you for the question. I mean, Neparvis has been a tremendous success. I mean, it’s, it has proven the skills of our commercial capabilities in Spain. Unfortunately, the product will lose its patent, around November this year. It has proven really, the benefits of the combination in terms of commercialization of Entresto and Neparvis, and this has not proven or not this on the market. It’s been a tremendous success, but unfortunately, I mean, November, or last quarter this year, the product will go off patent.
Marta Campos, Head of Finance, Rovi: Thanks, Juan. The next question, Javier, comes from Joaquín García-Quirós, and is related to CapEx. CapEx consensus for 2026 is at around EUR 62 million. Are you comfortable with this number?
Javier López-Belmonte Encina, Chief Financial Officer, Rovi: Thanks, Joaquín, for the question. As we highlighted during the presentation, we are investing heavily for us on CapEx these years, because for us, these investments are, you know, setting the foundations to achieve the goals that we internally have for 2030. As you know, we are expanding our San Sebastián that already is planned, and this year also, we will set up a new line in ROIS Phoenix. Apart from that, we are still investing on Glycopepton, you know, which is the JV for the particle integration heparin plant. EUR 62 million is similar to the amount that we spend or invest on 2025.
Depending on how these investments, the investments that I was sharing with you, evolve on 2026, depending on how they fall on 2026, 2027, this figure could be similar to last year figure, to 60 million EUR CapEx, or it could be slightly even above that figure. 2026 is gonna be a key year for the investments of the company. We are acquiring ROIS Phoenix, and probably, this acquisition, coupled with the current CapEx projects ongoing, will make 2026 very, very intensive on CapEx. That’s what I would say right now.
Marta Campos, Head of Finance, Rovi: Thanks, Javier. The next question comes from, Tim Jack, from, Redburn Atlantic. Juan or Javier, can you comment on the public information regarding the smaller pipeline and lower R&D spending of Moderna? How does this affect the planned utilization of the established production capabilities?
Juan Lopez Belmonte, Chairman and Chief Executive Officer, Rovi: I mean, thank you, Tim, for your question. Go ahead, Javier. Go ahead.
Javier López-Belmonte Encina, Chief Financial Officer, Rovi: What I was going to say that, I mean, in a public conference like this, we don’t comment on other companies’ performance. I could say that the outlook for Moderna for 2026 and 2027 is better than before. We are truly excited about our partnership with Moderna, and take into account that the last past years for Moderna has not been the best for them, and that’s public knowledge. If, according to their latest comments, they have an uplift of revenues for the coming years, I think that can this can only be positive for us. Juan, please add whatever you want.
Juan Lopez Belmonte, Chairman and Chief Executive Officer, Rovi: No, just reinforcing what Javier has mentioned. I don’t think it’s up to us to comment on Moderna’s guidance, but the only thing that we can express is that the partnership is as stronger as ever, and again, we still feel that there is going to be a tremendous important collaboration between Rovi and Moderna in the future.
Marta Campos, Head of Finance, Rovi: Well, thanks. The next question comes from Patricia Cifuentes, from Bestinver. When do you expect to advance with the risperidone for trials?
Juan Lopez Belmonte, Chairman and Chief Executive Officer, Rovi: I mean, the are very similar to those of our Letrozole. Our idea is to start recruitment as well in 2026 and to kick off. Again, this is already very much in place. I mean, the clinical trial is extremely interesting, and it’s going to, as well, to lay the foundation for tremendous growth for the company, probably in the next 4 or 5 years once we got the results. I mean, we are targeting something that it will provide us a commercial competitive advantage, is the fact that patients could start right away with our quarterly injection instead of being stabilized with a monthly treatment. I think that will give us a unique differentiation in the market, in the long-acting injectable market.
Again, it’s already on the execution mode, and hopefully, if we could just open the window, and once the clinical trial is finished, there is going to be a tremendous growth and it’s a tremendous life cycle management of the existing business, which is doing extremely good as well.
Marta Campos, Head of Finance, Rovi: Thanks, Juan. Now, Javier, the next question comes from Jaime Escribano from Santander. Regarding BMS integration, when do you expect BMS to start contributing in P&L?
Javier López-Belmonte Encina, Chief Financial Officer, Rovi: Thanks, Jaime, for your question. The BMS potential revenue for the year, it is linked to the acquisition of ROIS Phoenix. Basically, we signed the acquisition of the plant in Phoenix last year. There is an interim period, and it will be a closing day. This closing day depends on several conditions, some things that both companies or both parties have to perform. We are extremely optimistic that this is gonna be easy, and we don’t expect that much delay on the acquisition of ROIS Phoenix. However, it’s still early to predict when this acquisition will take place or will this closing take place. We’ve been. I think we can understand that at least we’ll have six years from BMS contribution during 2026, at least.
We are working to, you know, to have the closing as soon as possible, so we can take over ROIS Phoenix, start producing for BMS, and more important than that, is we want to start deploying all the investments in ROIS Phoenix to be able to produce to all the customers as soon as possible.
Marta Campos, Head of Finance, Rovi: Okay, thanks, Javier. Jaime also asks about gross margin: What is your expectation for 2026?
Javier López-Belmonte Encina, Chief Financial Officer, Rovi: I mean, we don’t provide accurate guidance, no, for gross margin for 2026. What we are saying that is, with the different drivers that we handle at the company, I think we are positive around gross margin for next year. Again, Okedi is growing. We have commented several times that Okedi is a high added value product for us, so meaning that we have higher gross margin in Okedi than in the rest of the portfolio, so this is a very positive contribution. We try to comment also that CDMO business is highly gross margin-driven, too. Positively, if we are increasing the sales of CDMO business on 2026, probably this will also contribute in a positive way to the gross margin.
Finally, the heparin franchise, as commented, we are having positive tailwinds on the raw material front. In this area, it will depend on the competitive pricing pressure on the selling side, and depending how the market evolves, we could even have a positive tailwinds on the heparin franchise too, from a gross margin perspective. Again, that will depend very much how the pricing pressure will evolve on the different markets.
Marta Campos, Head of Finance, Rovi: Thanks, Javier. The last question from Jaime is: What is Rovi’s base case scenario for the EUR 80 million-EUR 180 million revenue contract range in, sorry, in 2027, sorry. Low, mid, or high end of the range?
Javier López-Belmonte Encina, Chief Financial Officer, Rovi: Well, up to now, what we can tell you is that we are working very hard to hit all the different timelines. We started this project back in 2024. I would say that the contract negotiation was even earlier. It’s been a lot of time. What the team is very focused, and at least it’s what we can do right now, is to work on this tech transfer to execute as efficient as possible. We are more focused on those tasks. I believe that so far we’ve been extremely efficient. The line was deployed on time. The different work streams has been hitting the different milestones. Look, we are more focused on this year, trying to get the regulatory approvals to start routine manufacturing rather than thinking on next year.
As any CDMO contract, that will depend on the customer needs, no? The good thing about this agreement is that we have some an important, as we discussed several times, minimum commitments. In this case, it’s a full line, and that’s what is really key for us, no? At the end of the day, what is important for us is that we deliver the best service to the customer, and this turns into the most profitable scenario to us, no? Again, we need just to wait a few months and see how this contract evolves.
Marta Campos, Head of Finance, Rovi: Thanks, Javier. The next question comes from Borja Pinedo, from Torreal. Juan, it’s for you. A question for Juan about Letrozole, please. To better understand the commercialization strategy, are you planning to launch it with a partner to reduce risk? Are you already in negotiations, or when would you begin negotiating now that phase 3 is starting?
Juan Lopez Belmonte, Chairman and Chief Executive Officer, Rovi: Thank you. Thank you for your question. I mean, I think it’s too early to really provide a clear strategy of how we’re going to move to the market with Letrozole. I think what we can share with you is that what we have done with Okedi, that definitely we are setting up our commercial capabilities in Europe, and obviously, the obvious case forward would be to leverage those commercial capabilities in Europe. With Okedi, we have shown that we like partnerships, as we have shown with the rollout of Bemiparin and Enoxaparin, and lately, Okedi, with the latest launches in Canada, Australia, or Taiwan, two partnerships. Right now we are focusing on really getting the clinical trial moving forward. Our scope is global.
We want to get the approval in the U.S., in Europe, and it will depend on the results of the clinical trials.
Javier López-Belmonte Encina, Chief Financial Officer, Rovi: … that will define our final study. The market is extremely attractive, as we have shared to the market in several occasions. We are talking in terms of treatment, close to 3 million treatments, so the market can be between EUR 2 billion, EUR 3 billion to EUR 7 billion, depending on the price strategy. Again, this is a unique opportunity. We really want to hit it perfectly, and that’s the reason why we have been aggressive on the clinical trial design. We are targeting superiority, which would provide a tremendous competitive advantage if the product finally gets approved. I think it will be once that the clinical trial advance and once we start getting some data, that we will start defining which is the strategy to follow.
I think, okay, as an example of our previous way of doing things, could be taken as an example of what is our thoughts in terms of the commercialization study.
Marta Campos, Head of Finance, Rovi: Thanks, Juan. The last question comes from Christian Schmidt from Liberum. What is the likelihood of signing an additional CDMO contract in 2026? This one is for you, Javier.
Javier López-Belmonte Encina, Chief Financial Officer, Rovi: Thank you for your last question. I mean, we are really excited about the business, again, I know that we reiterate sometimes the same message. We are signing contracts on a important way or in a very recurrent way, I would say. The only thing is that we do not publish or do not make public these contracts because they are private, and our partners don’t want them to be public anyway, no. Unless they are very key for us, and we are forced to publish because it’s material for our accounts, from a stock exchange regulation or mainly is that. I think the momentum is still there. We are acquiring ROIS Phoenix, and I’m sure that will speed up closing agreements in the next coming months.
As I said before, we are really excited about the momentum of the business. We are getting there to be known as one of the largest injectable CDMO player in the world, and I think that the pipeline is full of opportunities.
Marta Campos, Head of Finance, Rovi: Thank you very much, Javier. Thank you very much for your participation. The Rovi IR team will answer the pending questions as soon as possible. Let me now turn the floor over to our CFO, Javier López-Belmonte Monforte, for the closure of the presentation.
Javier López-Belmonte Encina, Chief Financial Officer, Rovi: Well, thank you, Marta. This concludes our presentation of the full year results. As Marta was saying, if there are further questions, which I believe there are, our investor relation team will answer them in a one-to-one mode. Thank you very much for joining in with us for the full year presentation call. Wishing you a pleasant day. Bye-bye.
This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.
Read more on Investing.com South Africa
