Laboratorios Farmaceuticos Aktie

Hello, everyone. This is Marta Campos, Head of Finance for ROVI. Welcome to our company's review of business results for the first half of 2026.

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 our business performance for the quarter; and Javier Lopez-Belmonte, ROVI's Deputy Chairman and Chief Financial Officer, will then review financial results. The presentation will be followed by a Q&A session. Therefore, if you want to ask any questions during the presentation, please don't hesitate to send them through the question button on the platform.

With that, I thank you for your presence here today, and I will now turn the call over to Juan.

Thank you, Marta, and thanks to everyone for joining us today. I will provide the strategic context, and Javier will then take you through the detailed financials. Let me start with the key highlights of the first half of 2026 and our outlook for the year. Total revenue increased by 13% to EUR 357 million in the first half of the year. Operating revenue reached EUR 344.2 million, representing a 9% increase compared to the first half of 2025, mainly driven by the strong performance of our CDMO business, which grew 38% during the period. Gross profit increased by 21% to EUR 237.1 million, reflecting a gross margin improvement of 6.5 percentage points to 68.9%.

Before moving on, I would also like to highlight that on April 1, we successfully completed the acquisition of the injectable manufacturing facility in Phoenix, Arizona, strengthening our industrial footprint in the United States and reinforcing our position as a global CDMO player. The acquisition generated a bargain purchase gain or badwill of EUR 62.4 million.

EBITDA increased by 85% to EUR 121.2 million. And excluding the impact of the badwill, EBITDA decreased by 10% to EUR 58.8 million. Based on the current evolution of the business and the latest information available, we maintain our 2026 guidance and continue to expect operating revenue to increase by a low to mid-single-digit percentage compared to 2025.

Moving to our Specialty Pharmaceutical business. Sales in this division increased by 0.2% to EUR 237.8 million, driven by strong growth in Okedi, hospital products and Neparvis. I would now like to focus on the performance of the heparin business. A key area accounted for approximately 38% of the group's operating revenues in the first half of this year. Heparin franchise generated sales of EUR 130.1 million, down 4% year-on-year, while low molecular weight heparins sales declined 5% to EUR 125.3 million, mainly due to lower bemiparin sales driven by high inventory levels for international partners.

Within the low molecular weight heparins franchise, sales of enoxaparin biosimilar reached EUR 78.6 million in the first half of 2026, representing a 2% year-on-year decline while bemiparin sales amounted to EUR 46.7 million, down 9% year-on-year. However, it's important to highlight that although international bemiparin sales were weak in the first quarter, they show a strong recovery in the second quarter, increasing by 52% versus Q2 2025 and more than tripling compared with Q1 2026.

As a result of the recovery in international bemiparin sales during the second quarter, we now expect bemiparin sales to grow by a low single-digit percentage in 2026 compared with 2025. In addition, we have seen an improvement in our expectations for the enoxaparin biosimilar, supported by stronger-than-expected performance in several markets. Consequently, we have improved our outlook for the low molecular weight heparin franchise and now expect sales to decline by a mid-single-digit percentage this year compared with our previous guidance of high single-digit decline.

That said, we continue to expect a year-on-year decline, primarily reflecting lower order volumes expected from partners since they hold high levels of stocks from the previous year as well as ongoing pricing pressure across the sector. Preserving and improving the profitability of the heparin franchise remains a key priority for ROVI. To mitigate pricing pressure, we continue to implement efficiency initiatives across the value chain. In parallel, we are advancing our vertical integration strategy through the Glicopepton project, which is expected to improve cost competitiveness, increase self-sufficiency and support the long-term sustainability of the business.

Looking ahead, we remain fully committed to the heparin franchise, which continues to be one of the historical pillars of ROVI. Through operational efficiency initiatives, vertical integration and a broad international footprint, we believe we are well prepared to position -- to strengthen our competitive position and support the long-term profitability of the business.

Turning now to Okedi. The product remains a key growth driver with sales of EUR 34 million, up 27% year-on-year. Its differentiated clinical profile continues to support a strong uptake, and we remain excited to reach potential sales of between EUR 100 million to EUR 200 million in coming years.

Moving on to our CDMO business. The contract manufacturing business performed strongly with revenue increasing by 38% to EUR 106.3 million in the first half of 2026. This growth was driven by the growth in business with existing customers following the restoration of full operational capacity at the Madrid facility after its temporary closure during the first half of 2025 to upgrade some Annex 1 GMP aspects for aseptic manufacturing.

And second, the contribution of revenue generated under the supply agreement with Bristol Myers Squibb entered into in connection with the acquisition of the Phoenix facility, completed on April 1, 2026. Revenue from this customer accounted for approximately 13% of the total CDMO business revenue in the first half of 2026.

We remain committed to our investment plan to strengthen our sterile fill and finish capabilities with ongoing capacity expansions and the recent integration of the Phoenix facility into our industrial network. ROVI is well positioned to capture long-term opportunities in high-value injectable manufacturing.

Finally, our ISM platform continues to progress well. Letrozole SIE has received FDA clearance to proceed with clinical investigations under its investigational new drug application, enabling the initiation of clinical development in the U.S. with Phase III recruitment expected to start in the third quarter of 2026. Risperidone QUAR has also delivered strong Phase I results and is now progressing towards Phase II development with patient enrollment expected to begin in the fourth quarter of 2026.

Together, Letrozole SIE and Risperidone QUAR further strengthen our confidence in the potential of the ISM platform and its ability to generate meaningful long-term growth opportunities for ROVI. With that, I would like to thank you for your attention and hand over to Javier, who will take you through the financial performance for the period in more detail. Javier, over to you.

Thank you, Juan, and good morning, everyone. Before reviewing the financial statements in detail, I would like to briefly highlight 2 nonrecurring items that affected our reported results during the first half of 2026. First, we completed the acquisition of the Phoenix manufacturing facility on April 1. As a result of the preliminary purchase price allocation exercise, we recognized a EUR 62.4 million bargain purchase gain or badwill, which was recorded as a nonrecurring income in the income statement.

Second, during the period, we concluded the tax inspection covering fiscal years between years '20 to 2022. The inspections cover all the major taxes, that means corporate income tax, VAT and certain withholding tax matters and has now been fully completed. Importantly, the process was concluded without any penalty proceedings. The main impacts relate to agreed adjustments concerning the tax treatment of certain investments made to adapt manufacturing facilities, together with certain limited nonrecurring expenses recognized as a result of the inspections.

The outcome also led to the recognition of deferred tax assets that are expected to be recovered in future years. More broadly, the conclusion of this process provides greater visibility and certainty regarding the group's tax positions going forward.

Let me now take you through our financial performance for the first half of the year, highlighting the key drivers behind our results and the progress we've made across the business. Total revenue increased by 13% to EUR 357 million. Operating revenue increased by 9% (sic) [ 9.4% ] to EUR 344.2 million in the first half of '26, mainly supported by the strong performance of the CDMO business.

I will now walk you through the remainder of our P&L. Gross profit increased by 21% to EUR 237.1 million in the first half of the year, with gross margin improving by 6.5 percentage points to 68.9%, partly reflecting the recognition of R&D grant income related to the LAISOLID project. Excluding other income, gross margin increased by 3 percentage points to 65.2%, mainly driven by the growth of the contract manufacturing business, higher contribution from Okedi and lower heparin raw material costs.

Well, now moving on the SG&A expenses. SG&A increased 28% to EUR 145 million in the first half of the year. So let me start now with the personnel cost. Employee benefit expenses, excluding R&D here, increased by 23% year-on-year. This increase was mainly driven by, first, the incorporation of ROIS Phoenix into the group; second, the 3% salary increase under the new chemical industry collective agreement; and third, the hiring of additional personnel to support the continued growth of the CDMO business.

Within this increase, let me highlight to you that we also recorded approximately EUR 1.6 million of nonrecurring personnel-related expenses, the majority of which were associated with the tax inspection process that was concluded during the period. Therefore, excluding these nonrecurring expenses, employee benefit expenses increased by 20% (sic) [ 23% ] year-on-year.

Now if we turn to the other operating expenses, excluding R&D, this increased by 34% year-on-year. The main drivers here were the inclusion again of ROIS Phoenix, a lower comparison base in the first half of 2025 due to the temporary shutdown of the Madrid facility that was done to complete Annex 1 upgrades and certain nonrecurring costs related to asset write-offs and the strategic projects. Excluding these nonrecurring expenses, other operating expenses increased by 28%.

So overall, excluding nonrecurring items, SG&A expenses increased by 24% to EUR 140.5 million in the first half of this year. It's worth noting that ROIS Phoenix represented approximately 9% of SG&A expenses during the period. On a like-for-like basis, analysis, excluding both ROIS Phoenix and nonrecurring expenses, SG&A expenses increased by approximately 12% year-on-year versus the first half of 2025. This increase reflects both the expansion of our industrial and organizational capabilities, again, to support future growth and a less favorable comparison base.

Again, as I mentioned before, our Madrid facility was temporarily shut down during part of the first half of '25 to implement Annex 1 GMP upgrades, resulting, therefore, in lower operating expenses in that period. Following the return to normal operations, these costs were fully reflected again in the first half of this year.

Looking ahead for '26, we continue to expect SG&A expenses, excluding ROIS Phoenix, to increase by a mid- to high single digit percentage growth compared with 2025.

Regarding R&D expenses, increased -- they increased, sorry, by 98% to EUR 33.3 million and were largely related to preparations for the Phase III development program of Letrozole SIE.

EBITDA totaled EUR 121.2 million in the first half of the year with a margin of 35.2%. Excluding badwill, EBITDA decreased by 10% to EUR 58.8 million. EBIT amounted to EUR 103.2 million in the first half of this year with a margin of 30%. EBIT excluding badwill decreased by 20% to EUR 40.9 million. Net financial cost reached EUR 1.7 million in the first half of '26 compared with net financial cost of EUR 1.3 million in the first half of '25.

Let me point out that the conclusion of the tax inspection covering, again, fiscal years '20 to '22 also had an impact on the financial result. This increase was mainly driven by higher finance costs as a result of a late payment interest associated with the tax inspection.

Turning to taxes. The effective tax rate stood at 16.9% in the first half of '26 compared with 20% in the same period of last year. The reduction in the effective tax rate was primarily driven by the nontaxable nature of badwill recognized in connection with the Phoenix acquisition. As a result, the net profit reached EUR 84.4 million in the same period, an increase of 113% versus the first half of '25.

Well, let's now move to CapEx and cash generation. In the first half of '26, ROVI invested EUR 30.4 million allocated as follows: EUR 21.9 million dedicated to investments and EUR 8.5 million allocated to maintenance CapEx and other items. At the same time, cash generation was particularly strong this period. Cash flow from operating activities increased to EUR 94.3 million compared with EUR 28 million in the first half of '25. As a result, free cash flow increased significantly to EUR 64.7 million compared to EUR 7.5 million in the same period last year, highlighting both the strength of our underlying business and our ability to convert earnings into cash while continuing to invest in future growth opportunities.

Turning now to our debt position. As of June 30, '26, ROVI's total debt amounted to EUR 107.7 million, while gross cash increased to EUR 130.2 million. As a result, ROVI ended the first half with a net cash positive position of EUR 22.5 million compared with a net debt of EUR 21.9 million at year-end '25. This improvement reflects the strong cash generation of the business during the period. Our balance sheet remains solid, providing us with financial flexibility to continue investing in growth initiatives while maintaining a disciplined capital structure. Furthermore, on July 15, we paid a dividend of EUR 0.9594 per share, representing approximately a 35% payout ratio policy.

So to conclude, we maintain our outlook for '26 and continue to expect operating revenue growth in the low to mid-single-digit percentage compared to '25. Our priorities remain unchanged, continued growth of the CDMO business, successful integration and value creation from Phoenix, further progress in heparin vertical integration and sustained growth of the specialty pharmaceutical franchise led by Okedi.

At the same time, we remain firmly committed to innovation with 2 Phase III clinical programs underway and a clear focus on creating long-term value for shareholders. This approach reinforces our road map and our positioning over the medium to long term.

Well, thank you very much for your attention, and we are now happy to take your questions.

Thanks, Javier. [Operator Instructions] The first questions come from Patricia Cifuentes from Bestinver. Juan, the first one is for you. What is your assessment of the German health care reform starting in 2027? What proportion of your total revenue is exposed to increase rebate requirements?

Thank you, Patricia. I mean, like most of the pharma companies today, we are currently assessing the potential impact of our products on the new German health care reform. When it comes to Okedi, we are right now assessing all the different scenarios, the inclusion in the German reference price system. And to be honest, at present, there is not that much visibility to really quantify precisely the final impact on pricing or revenues.

I mean just to give you at least some broad figures of what would be the impact for the company, please, it will be very limited. It will be only focused for sales in Germany, which when it comes to Okedi represented EUR 8.4 million during the first 6 months of 2026. We definitely -- we're going to continue to monitor developments, and we will communicate to the market any new information that could provide visibility on the impact in our financials.

Regarding low molecular weight heparin, we believe that is excluded from the German health care reform. But again, this is brand new. It was approved, I believe, less than 2 weeks ago. There's been a lot of rumors, different expectations in terms of clawbacks, and we are all the companies right now just waiting to see just after summer in September, which are going to be the detailed impact by product. But again, our limitation would be, we believe, to Okedi and Okedi represents in the first half of the year, EUR 8.4 million, which accounts more or less for 36% of our Okedi sales in the first 6 months of 2026.

Thanks, Juan. The second question from Patricia is also for you. Have generic heparin raw material prices fully stabilized? Do you maintain your 2026 guidance for the low molecular weight heparin franchise?

I mean regarding the heparin raw material prices, as we have mentioned in the different last calls, we've seen a significant improvement in the market environment when it comes to prices. We still believe that there is a continuous downward trend. But the current level, again, we are always buying and we are screening the market quarters in advance before the purchasing happens. We believe that this downward trend is gradually being stabilized. We continue. We speak to our different suppliers. We are scanning the market. But we believe that we are starting or we are close to reach probably the bottom end of this continuous decrease in terms of raw material prices.

Regarding the guidance, we have revised our estimates. And now we expect low molecular weight heparin sales to decline by a mid-single-digit percentage compared with our previous expectations of high single-digit declines. And we are very excited, and we have a lot of expectations when it comes to cost of goods efficiency with different initiatives that they are right now in place, ongoing and as well with the Glicopepton kickoff.

This vertical integration should give us another edge in terms of competitiveness. And we are definitely, as we have mentioned in our presentation, both Javier and myself, we are fully committed to the low molecular weight heparins. It represents 38% of our sales. And we believe that we have all the features really to place ROVI and our portfolio of heparins, both with bemiparin and enoxaparin to be one of the major players worldwide in this essential work.

Thanks, Juan. Javier, the third question from Patricia is for you. What progress is being made in securing new take-or-pay contracts to boost capacity utilization across your 11 Spanish aseptic lines and the upcoming Phoenix Optima line?

Once again, thanks, Patricia, for your question. As everybody knows, our current priority is to complete the integration of the remaining manufacturing lines, and for sure, increase their utilization levels. Optimizing capacity utilization remains our key priority on the CDMO business. And we continue to see a strong commercial activity. And, look, the second quarter for the CDMO business has been very, very strong, and we still see a high level of customer interest.

Unfortunately, new projects typically involve lengthy evaluation and assessment and then qualification and decision-making process. So it takes time. You also know that we are not allowed to make normally press releases and announcement. But I would say that we remain as optimistic as before, and we still see a tremendous tailwind dynamics in the market, if you could say so.

Regarding the future Phoenix Optima line, again, our immediate focus is on completing its installation and validation. It's been only since 1st of April that we could take over from BMS and take control of the actual facility. We expect the line to become operational between end of '27, early '28. At that moment of time, if we are successful on our manufacturing efforts, at that point, we will start manufacturing, and therefore, invoicing from that line from Phoenix.

And for sure, we are already working to secure customers for this future capacity. Let me say, and I think I have repeated this many times, we are reinforcing and hiring more people on our business development team. And I think this is one of the underlying factors that we -- why we are increasing our SG&A there. And we are actively pursuing new opportunities and advancing discussion with potential customers. And again, our main goal is that we have a gradual ramp-up in Phoenix and achieve utilization levels that are good from 2028 onwards.

Thanks, Javier. The next questions come from Juan Ros from ODDO. He has several questions on the contract from April 2024. So the first one is what exactly remains outstanding for PFS regulatory approval? And when is approval now expected? Does 2026 full year guidance include routine PFS manufacturing revenue? And is the original 2027 PFS revenue range still valid? Javier, they are for you.

Yes. Again, I think we stated in our first quarter results that this contract has a delay on the regulatory approval. We are both companies working, I would say, hard to get the regulatory approval. But again, this will not be -- this will be delayed. So this is not going to change this year. And as we said before in our previous quarterly results, we are not expecting any material income from this agreement or at least we are not expecting ongoing or recurrent manufacturing activities from the contract this year as we stated. And this hasn't changed at all.

So our guidance -- our current guidance is not taking into account this recurring manufacturing revenue from this agreement as we explained last time. From next year onwards, we are working on this regulatory approval. We expect for sure that for next year, this agreement will have the regulatory approval. And there's no doubt about that. And again, we are very -- I think we are safe in the sense that we have these take-or-pay clauses, and we expect to start manufacturing next year, at least with this agreement. So there is no change in the outlook that we commented last quarter.

Thanks, Javier. The next questions come from Guilherme Sampaio from CaixaBank. The first one is for you, Javier. Could you provide more details regarding the levers of the organic year-on-year CDMO sales growth acceleration versus Q1? To what extent should this be maintained into H2?

Well, thank you, Guilherme, for your question. And I think it's been -- I said -- as I said before, I think it's been a fantastic quarter for the CDMO business. We are very proud of including ROIS Phoenix for the first time in our P&L and our statements. And the integration of Phoenix is going very, very well. I think this is an important fact. And I think it's an important item for the sales growth for the period as we disclosed revenues from Phoenix were around EUR 13.8 million revenue.

So the main growth came from the existing business. And I think this is very well diversified. There is not one single customer that hasn't been growing. And I would say that most of our main customers are growing in terms of revenues compared to the previous quarter. We also stated that first quarter was a slow quarter. First quarter, I guess, that always is slower in the business. And this second quarter has picked up very well. And again, there is no one customer to select. It's been all the portfolio. And look, we expect to keep the growth in the next coming quarters, and this will help us to achieve the guidance that we have stated.

Thanks, Javier. Juan, 2 questions from Guilherme for you. Could you offer some color on the weaker quarter-on-quarter performance of Okedi? How are you seeing the competitive environment evolving in schizophrenia?

I mean we are extremely satisfied with Okedi's performance. The most important thing is that we are seeing a robust continuous uptake of Okedi by physicians and it's not limited to a country, but definitely it's across most of the countries in which we have commercialized the product. Sales are strong in Spain. Sales are strong in Portugal. Sales are strong in Italy, Germany, Austria with our partners with Orion in the northern countries. I mean we are seeing really a very good momentum.

Let me remind how the Okedi sales work out. I mean, obviously, we get new business from the dynamic market. So that means that we are not targeting let's say, the schizophrenia patient population, we are targeting those patients that they have to change medication for whatever reason. That's what we call the dynamic market. And in that sense, we are extremely satisfied. I think the sales force of the commercial team is doing a great job. And that's why we are very -- we are committed to the product, but definitely, we feel that the guidance in terms of sales that we provide, we are going to hit it.

And actually, this is as well something -- regardless of the sales, which is really encouraging for the company is that the product uptake by physicians is really going great. And that's what it makes the difference. I mean the product works, the product fulfills the medical needs of patients and physicians. And again, as I mentioned before, which is also important, and it gives the color of the strong grounds of Okedi, which is that this is across all countries. So it's not something that it may be limited to dynamics in Italy or in Germany or in France, but we are seeing this throughout most of the countries where the product has been commercialized.

So I mean, we're extremely satisfied. Obviously, we are going to see quarter-by-quarter different growth rates. Again, in many cases, as I mentioned before, due to this market dynamic potentiality and as well the schizophrenia patients in general, by nature, they are very fragile patients. So we will see quarters stronger than others because we can imagine by common sense, physicians probably they will choose certain quarters or certain months during the year to start the switch in terms of medication required by the patient just for adherence and follow-ups to supervision.

Regarding the schizophrenia market, the market is -- I mean, it's doing great. We see a continuous growth in the long-acting injectable market. We are seeing that adherence is becoming a more and more important item. We're seeing countries like Portugal where LAIs growth is much faster than other countries or in the case of Spain, which is also growing stronger. Other countries, which is the long-acting injectable market still delivers probably not the best growth that we're expecting in terms of LAIs like Germany.

But in general, as I mentioned before, I think the dynamics are great. And I don't see to date with the information that we have available any issue that might prevent ROVI to obtain the Okedi sales guidance. And that's the reason why we are investing heavily on Risperidone QUAR because probably in other calls, we might have the chance to discuss in more detail the Phase III protocol. But again, I believe this is going to be a boost, and this is going to provide ROVI the perfect portfolio to really become as well like in the low molecular weight heparins to become a major global player in the long-acting injectable schizophrenia market.

Thanks, Juan. The next question comes from Chris Richardson from Jefferies. Javier, is the 13% BMS contribution a valid run rate on a quarterly basis? It is much higher than the previously communicated minimum order value from BMS.

Chris, thanks for your question. Actually, I'm not quite sure about the 13% contribution, which you refer to. What I can tell you is, again, yes, I think you are right. We are -- and I think it's important to highlight it in this conference call, we've just taken over Phoenix, and we are extremely excited about the opportunity, not only because of the price we paid, but also the outstanding opportunities that lay ahead of us in the U.S.

Coming back to your question, I think we stated very clear that the agreement, which is at least a take-or-pay agreement, it's at least USD 50 million revenue per year coming from BMS. And I would say that's the baseline for Phoenix and for this Bristol Myers contribution. So you could take that as a baseline. If you do some numbers, yes, you're right. We have a higher income coming from Phoenix this quarter. And this is exciting because it's just the first quarter. But from cautious side or from a safe side, you can consider this $50 million revenue per year as a baseline. And if news -- good news comes, it will be slightly higher during this first year.

Thanks, Javier. The next questions come from Jaime Escribano from Grupo Santander and are related to heparins. So Juan, they are for you. If heparin outlook improved, why not improving full year 2026 full guidance? And how is the competition environment in heparins same as in the first quarter of 2026, improving, worsening?

Thank you, Jaime, for your question. No, the heparin competitive landscape remains the same. Basically, it's ROVI with Chinese players betting for this market. Sanofi is suffering seeing tremendous sales decline across most markets. In some markets, Sanofi has even almost disappeared like the case of Germany. And we are maintaining this competitive edge versus the Chinese heparin players.

No, the landscape in that sense, it remains very stable. And actually, we don't see that many other players coming into place. Probably we'll see in the near future some raw material Chinese suppliers that they may decide to launch the product in -- outside China.

But again, we don't feel scared or afraid or we don't think that ROVI's position in the market will be jeopardized by the entry of new competitors. The heparin business, the low molecular weight heparin business, I say, in the first part of your question, it's mainly focused on hospitals and retail market. So that's why sometimes we suffer quarterly variations. It's a very dynamic market. It's an acute product. So again, compared to other product portfolios that we have, which attends chronic pathologies like Neparvis or Okedi, which we see a continuous and very stable sales graph or sales evolution.

Low molecular weight heparins by definition, they treat thrombo events. It's a blood thinner product. And so it targets acute symptoms, whether the patient is in the hospital or whether has been discharged to follow the treatment for 10, maximum 30 days at the different health centers. So again, we don't feel that today changing -- we have changed the guidance, as I mentioned before, in terms of growth to the low molecular weight heparins, but we'd rather prefer to remain cautious.

As Javier has mentioned, we see robust evolution in this second quarter in heparins, in the CDMO business. We see as well that Okedi is performing well. But we also have to take into account that we have the Neparvis contract resolution in October this year, which accounts for an important or a significant sales revenue. And again, that altogether, although we do believe that the heparin, as I mentioned before, both bemiparin and enoxaparin, it looks like it's going to remain strong. We prefer to be precautious on the global guidance of the company.

Thank you very much, Juan. Thank you very much for your participation. The ROVI IR team will answer the pending questions as soon as possible. Thank you again for your assistance, and have a very nice summer.

Hello, everyone. This is Marta Campos, Head of Finance for ROVI. Welcome to our company's review of business results for the first quarter of 2026.

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 Chief Executive Officer, will discuss our business performance for the quarter. Javier Lopez-Belmonte, ROVI's Deputy Chairman and Chief Financial Officer, will then review financial results. The presentation will be followed by a Q&A session. Therefore, 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 here today, and will now turn the call over to Juan.

Thank you, Marta, and thanks to everyone for joining us today. Let me start by addressing our outlook for 2026. In light of recent developments and greater visibility in key business drivers, we have revised our expectations for the full year. I will provide the strategic context and Javier will then take you through the detailed financials.

Let me continue what we have seen in the business during the first quarter of 2026. Operating revenues reached EUR 152.5 million, representing a 1.5 percentage decrease compared to the first quarter of 2025, mainly due to the performance of the heparin division. The contract manufacturing business continued to perform well, growing by 5% during the period. Gross profit increased by 5% to EUR 95 million, reflecting an improvement in the gross margin of 3.8 percentage points to 62.3%. And based on recent developments, we have updated our outlook for 2026 and now expect operating revenue to increase by a low to mid-single-digit percentage compared to 2025. I will walk through the key drivers behind this revision over the course of the presentation.

Before moving on, I would also like to highlight the full integration of our Phoenix facility as of April 1, which strengthens our U.S. manufacturing footprint and CDMO capabilities.

Moving on to the Specialty Pharmaceutical business, it declined 3% year-on-year in the first quarter due to bemiparin. Within this segment, growth was driven by Okedi, hospital products, Neparvis and enoxaparin biosimilar.

I would now like to focus on the performance of the heparin business, a key area that accounted for approximately 40% of the group's operating revenues in the first quarter of the year. The heparin division decreased 12%, mainly due to lower bemiparin sales driven by high inventory levels for international partners. This was partly offset by a 2% increase in enoxaparin biosimilar sales, supported by higher order volumes in certain markets. The performance of the heparin business may exhibit significant quarter-to-quarter variability depending on the timing of orders and inventory levels held by our partners.

International sales of bemiparin has shown a good performance in the first quarter of 2026. However, for the full year, we anticipate a more moderate decline. Regarding low molecular weight heparin sales, we expect them to decline by a high single-digit percentage in 2026, reflecting lower order volumes from international partners and an increased pricing pressure in the market, particularly from Chinese players.

In response, we are driving cost efficiency initiatives and continuing our progress towards vertical integration and crude heparin self-sufficiency.

Turning now to Okedi. The product remains a key growth driver with sales of EUR 17.2 million, up 37% year-on-year and a further 10% growth versus the fourth quarter of 2025, which was the strongest quarter of last year. Its differentiated clinical profile continues to support a strong uptake, and we remain excited to reach potential sales of between EUR 100 million to EUR 200 million in coming years.

Moving on to our CDMO business. The contract manufacturing business delivered positive performance during the quarter with revenue increasing by 5% to EUR 37.4 million in the first quarter of 2026. However, based on the most recent information available, we have revised our expectations for the CDMO business for 2026, reflecting a more moderate growth scenario. This adjustment is driven by lower revenues forecast under the prefilled syringe manufacturing agreement with a global pharmaceutical company announced in April 2024, mainly due to a delay in the initially expected commencement of routine manufacturing operations as well as increased uncertainty regarding anticipated demand.

We believe this is a conscious and responsible adjustment, one that reflects the current moment and that we will continue to reassess as the year progresses. Importantly, this adjustment does not change our long-term view of the CMO division. We remain committed to our investment plan to strengthen our sterile fill and finish capabilities with ongoing capacity expansions and the recent integration on the Phoenix facility into our industrial network. ROVI is very well positioned to capture long-term opportunities in high-value injectable manufacturing.

Finally, our ISM platform continues to progress well. Letrozole SIE has received FDA approval of its investigational new drug application, which allows the initiation of clinical development in the U.S. with Phase III recruitment expected to start in the third quarter of 2026. Risperidone QUAR delivered a strong Phase I results and is advancing into Phase II. Together, these programs reinforce the long-term value and innovation potential of ISM technology.

Thank you very much, and I pass the floor to Javier.

Thank you, Juan. Good morning, everyone, and I will now turn to the financial performance. Total revenues reached EUR 154.7 million, broadly flat year-on-year. Operating revenue declined 1.5% to EUR 152.5 million, mainly reflecting lower international sales of bemiparin. This was partly offset by CDMO business, which increased 5% during the quarter.

I will now walk you through the remainder of our P&L.

So gross profit increased by 5% to EUR 95 million in the first quarter of 2026, with gross margin improving by 3.8 percentage points to 62.3%, partly reflecting the recognition of R&D grant income related to the LAISOLID project. Excluding other income, gross margin increased by 2.5 percentage points to 60.8%, mainly driven by a higher contribution from Okedi, lower low molecular weight heparin raw material costs and the growth of the contract manufacturing business, which contributed higher margins to the group revenues.

SG&A increased 18% to EUR 63.6 million in the first quarter of this year, mainly reflecting higher personnel costs due to the wage adjustments and the addition of CDMO personnel as well as higher other operating expenses. The increase in other operating expenses, excluding R&D, was partially driven by a lower cost base in the first quarter of 2025, following the temporary closure of the Madrid facility to upgrade Annex 1 GMP requirements for sterile manufacturing and by nonrecurring items, mainly related to the write-off of assets that are no longer operational.

Excluding nonrecurring items, other operating expenses, again, excluding R&D, increased by 21% year-on-year. For 2026, ROVI expects SG&A expenses, in this case, excluding ROIS Phoenix from the group to increase by between a mid- to high single-digit percentage compared to 2025. As for the R&D expenses, these increased by 79% to EUR 11.2 million in the first quarter of this year. These expenses are related to the preparation for the development of the Phase III clinical trial of Letrozole SIE.

Moving to EBITDA, EBIT and net profit. EBITDA totaled EUR 20.3 million in this first quarter of '26 with a margin of 13.3%. EBIT amounted to EUR 12.1 million in the first quarter of '26 with a margin of 8%, while net profit reached EUR 9.4 million in the same period.

I won't go into Slide 15 in detail. You have the figures and that shows the pre-R&D basis, and we can move to the next slide, please. So let's now move to CapEx and cash generation. In the first quarter of 2026, ROVI invested EUR 7.7 million allocated as follows: EUR 5.6 million dedicated to investments and EUR 2.1 million allocated to maintenance CapEx and other items.

Turning to cash flow. Operating cash flow came in at EUR 13 million in the first quarter, reflecting 2 main factors. Lower profit before tax compared to the prior year and adverse working capital movements. Free cash flow amounted to EUR 5.6 million in the first quarter of '26. As of March 31, 2026, ROVI's total debt amounted to EUR 114.4 million with gross cash of EUR 99.6 million, resulting in a net debt position of EUR 14.9 million. This solid financial position is fully compatible with our shareholder remuneration policy under which we target a 35% payout of consolidated net profit and will propose, therefore, to the General Shareholders' Meeting a EUR 0.9594 per share dividend to be charged against 2025 results and distributable reserves.

To conclude, I would like to summarize our outlook for '26 and the key strategic drivers. Based on the current evolution of the key business variables, and the most recent information available, ROVI has updated its guidance and now expects operating revenue to grow by low to mid-single digit compared to 2025, reflecting a more moderate growth scenario than previously communicated.

This update is mainly driven by lower revenue forecast for '26 under the prefilled syringe manufacturing agreement entered into with a global pharmaceutical company announced in April '24 due to a delay in the initially expected commencement of routine manufacturing operations, which remains subject to the regulatory authorization as well as an increased uncertainty regarding anticipated demand.

In addition, we continue to see growing competitive pressure on pricing in the heparin division and greater volatility in supply and cost dynamics. Additionally, the heparin business performed better than expected in 2025, mainly due to an increase in orders from international partners. Therefore, we expect lower orders from these partners in '26 since they hold a high level of stocks.

Overall, let me say that the company maintains a prudent approach to its 2026 outlook, reflecting the current competitive environment and the level of visibility across the main -- its main business lines, which we will continue to monitor closely.

At the same time, our strategy remains focused on our key priorities on which we are focusing our efforts. the development and scaling of the CDMO business, value creation from the acquisition of injectable manufacturing facility in the U.S., progress in the vertical integration of the heparin business and the continued momentum of the Specialty Pharmaceutical segment with Okedi as a key product.

In parallel, we maintain a strongly committed to R&D with 2 Phase III clinical trials currently underway, Letrozole SIE and Risperidone QUAR, supported by a clear focus on international expansion and execution excellence. This approach reinforce our roadmap and our positioning over the medium to long term.

Thank you very much for your attention. We are now happy to take your questions. Marta?

[Operator Instructions] So the first question comes from Pablo De Renteria from Kepler. Javier, they are for you. The first one is following the increased uncertainty around demand for the new prefilled syringe manufacturing agreement and the delay in the start of operations, what do you think is a reasonable assumption for 2027 revenues under this contract? Should we think about the minimum contractual commitments as the right baseline at this stage?

Thank you for your question, Marta. I would say that, I mean, today, I think it's still to change our vision or our guidance for the contract or to change any -- or to give any more precise information around the future incomes for next year and the following one. Let me remind to everyone that this agreement, we shared a guidance to the market a couple of years ago when we signed the agreement, and we shared our outlook for revenues for the coming years in the case of this agreement.

I think what is important to highlight is that this is a take-or-pay agreement, meaning that the agreement itself, the contract has some mechanisms and some minimum commitments for both parties, which still gives us a lot of comfort and visibility, and I would say, stability over an important chunk of our revenues for the future. And again, I think we still remain confident about this.

The second question is, does this softer near-term outlook in CDMO alter in any way your long-term ambition presented at the Capital Markets Day of reaching around EUR 700 million in CDMO sales by 2030? Or do you still see that target as achievable?

I would be very clear, not right now, we are still very committed to that figures to those goals. We still believe that those are achievable. We always explained to the market that this was an ambitious target, but it was -- we have very solid foundations from our business and from the CDMO business, especially. So right now, I think it's important to highlight that this entire change of guidance is just stick to this particular agreement. Meanwhile the rest of the business, I think we are seeing a good momentum.

We keep signing important agreements. You know that unfortunately, we are not able to communicate those to the markets because they have very strict confidentiality clauses. But I would say that the tailwind is still there. So we remain confident about the 2030 goals that we still have seen -- or we still see a great market momentum, an important tailwind from the market that we are signing contracts, important ones. although we are afraid that we cannot disclose those to the markets due to confidentiality reasons. And that we are also very excited about the Phoenix acquisition, which I was also mentioning that it has been closed at the agreement in a very quick way.

And the third question from Pablo is regarding the new prefilled syringe line in the U.S. When do you expect to be able to start commercializing the available capacity? And more broadly, are you already seeing interest from potential clients looking to book capacity in the U.S.?

Thank you, Pablo. Yes, yes, for sure. I think it would be great to highlight 2 different things. One is that, as you know, we are setting up a new campus for Biologics. This campus includes a new filling line. That filling line will be ready next year. So it's quite exciting news for us because it's in our business, that's quite quick, I would say. And this is an area or an avenue of growth for the site and for the company.

Apart from that biologic campus, we are starting to market our [indiscernible] potent campus on the cytotoxic campus. And I believe, at least for us, what this very exciting is that in the same campus, we believe we -- not only we can fill a cytotoxic product and a standard high potent drugs, but also I think we are capable of filling ADCs and ADCs, we foresee them or everybody think ADCs as an important driver of growth for pharmaceuticals as a segment or a new modality in the pharmaceutical field. So I think there are very few competitors in the U.S. that can offer the same -- these sort of capabilities.

And I can tell you that the feedback from customers is very robust. And I would say that there are very -- there are less competitors in the U.S. than in Europe. So I think I think could be a transformational driver of growth for us this Phoenix site facility.

The next question comes from Patricia Cifuentes from Bestinver. Javier, it's for you. With the delays in the recruitment of Letrozole SIE and quarterly Risperidone, what level of R&D costs should we expect this year?

Yes. As we announced and commented to in our -- I think it was in our Capital Market Day, the first time we shared with all of you the expansion of the Phase III projects, I think that the first few years will be expanding in terms of R&D, sorry, cost. So I would say that this year, we can assess that we'll be in this higher end of the range that we presented on the Capital Market Day. So probably closer to the EUR 60 million figure for the full year. Let me remind to all of you that we will be starting recruiting patients at the -- hopefully, at the end of the year. So this is for sure, we are spending a lot of money in preparing this crucial moment for the company.

The next question comes from Álvaro Lenze from EDM. Can you provide more detail on the approval process for the April 2024 client line? What is the bottleneck?

I will answer that one. I mean, as you know, the agreement was signed in '24. We had a detailed time line, but at the end of the day, it's been a lot of processes going on, tech transfer, validation batches. And at the end of the day, we are also -- we are working closely with the customer to see how the regulatory approval goes. There are different dynamics there, different causes of delay. And also, I would say that there is no -- I wouldn't say it's a big delay. But at the end of the day, it's a long process. It's been forecasted from 2 years ago.

We depend on a large multinational, and they are quite slow sometimes, quite conservative approach. And what I can tell you is that we are monitoring very closely the different events. And if we find out that there is any relevant update, we'll communicate to the market. Anyhow, we expect that for sure, next year, the product will be approved. And I mean, that's the worst-case scenario that at the end of the year, the product will be approved and will be ready and able to manufacture from next year onwards.

So the last question comes from Joaquin Garcia-Quiros from JB Capital. Juan, this one is for you. Now that competition seems tougher in heparins, how do you see the development of this division in the midterm?

Joaquin, thank you for your question. Yes, actually, we are seeing a very rapid erosion in terms of prices. Heparin is a very dynamic market. As I mentioned before in my presentation, we expect variability between quarters. But I mean we're adjusting ourselves. I mean we are still very much optimistic on the long term of the heparin perspectives, investing on Glicopepton to be fully vertical integrated. We still don't know really what is the basis for this rapidly unexpected price erosion that is impacting our business.

But we feel very much confident that the business remains solid, and we expect still to be a driver of growth for the company in the next coming years. And that's the reason why we are fully investing just to make sure that we remain competitive on the market landscape. But unfortunately, we are seeing a very rapidly unexpected erosion in prices that is impacting our partners future orders for 2026. And we just wanted to make sure that we will communicate it accordingly to the market. But Heparin is great business. ROVI has a great knowledge. We have great performance in the past. And again, we are fully committed to this business, and we believe that we are going to be hearing in not that long future, very good news coming from the bemiparin and enoxaparin franchises.

Thanks, Juan. We are out of time. Thank you very much for your participation. The ROVI IR team will answer the pending questions as soon as possible. Thank you again for your assistance, and have a nice day.

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 Lopez-Belmonte, 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. Therefore, 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 I will now turn the call over to Juan.

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 3% 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 year 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 drug manufacturing agreement with an initial 5-year term, including minimum annual payments of USD 50 million. We're 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 LAISOLID 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. And finally, in January 2025, we advanced meaningfully in the field of artificial intelligence. We acquired a majority stake in Cells IA Technologies, 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.

And now let me begin a quick overview of the 2025 financial results. Total revenues fell 3% 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 and 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 a strong performance. Sales increased 4% in 2025, driven by a very strong fourth quarter with sales increasing 53% compared with the third quarter. This growth was supported by the strength of our international, where revenues rose 15% to EUR 43.6 million, mainly driven by 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 to our full vertical integration across all manufacturing stages of low-molecular-weight heparins. 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 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.

Additionally, 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, as specialty product from Novartis, indicated for the treatment of adult patients with symptomatic chronic heart failure and reduced ejection fraction, increased 10% in 2025. Finally, 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 2 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 CDMO 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 a 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 SIE, 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. 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. It's 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 others.

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 led solid foundations for our next phase of growth. In 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 percentage and a low double-digit percentage in comparison with 2025. This outlook reflects several factors. The potential revenue from the manufacturing agreement signed with Bristol-Myers Squibb, closing 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 and lastly, the current competitive pressure on pricing in the heparin division.

To conclude, we are executing strongly across the business, successfully advancing Okedis' 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, and I will now turn the call to Javier.

Thank you, Juan. Good morning to 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, Okedi, 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 LAISOLID 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 2 factors: One, 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 I clinical trials for Letrozole SIE and quarterly Risperidone ISM and also for the preparation for the development of Letrozole SIE's Phase III 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 nonrecurring expenses associated with the strategic projects undertaken in 2024 and 2025. When excluding these nonrecurring 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 Collective Agreement of The Chemical Industry, '24-'26 in the fourth quarter of '24 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 '25. 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. Net profit increased 3% to EUR 140.4 million in 2025.

If we now perform a pre-R&D analysis, EBITDA pre-R&D calculated excluding R&D expenses in '25 increased by 9%, reflecting a 3.6 percentage point increase in the EBIT (sic) [ EBITDA ] 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 is a key focus for our organization. This way, last year, ROVI invested EUR 67.8 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, Glicopepton, 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 2 factors: the collection of the CDTI grant from the LAISOLID 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 '25, ROVI's total debt increased to EUR 121.8 million. So December '25, ROVI had a gross cash position of EUR .9 million and a net debt of only EUR 21.9 million.

Let me end this section with our dividend policy, which 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 '21 profit -- 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.

So moving to the news flows for '26. 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 towards 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. And in R&D, our ISM platform continues to represent a significant value driver with important milestones expected across our later-stage pipeline. Phase III trial of Letrozole SIE and the Phase III program of our quarterly Risperidone formulation. Altogether, '26 is set to be a commercially rich year supported by strong execution, meaningful catalysts 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.

Thanks, Javier. [Operator Instructions] The first question is for Javier, and it comes from Pablo De Renteria Kepler Cheuvreux.

Javier, I understand it may still be early to comment, but could you share any indication on your clients' 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? And as a follow-up, has there been any change to the time line for commissioning the line? Or does September still look like the official target date?

Thanks, Pablo. 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 works, and that will imply regulatory approvals this year. And again, commercial production is expected to commence probably or likely most likely in the second part of the year. With this contract, the client has, at their disposal, a filling line in San Sebastián de los Reyes [indiscernible] plant up to we normally assess 100 million units of prefilled syringes. And the expectations remain the same. '27 is expected to be the first full year manufacturing year, I mean recurrent from full year, from beginning to end. And 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 '23 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.

Thanks, Javier. The next question comes from Guilherme Sampaio from CaixaBank, and Juan, it's for you. Could you comment on the latest trends regarding heparin raw material cost evolution and to what extent this should be able to offset potential pressures in prices in 2026?

Thank you. Thank you, Guilherme. There's not that much info 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 kick of our operations of our new manufacturing plant with the vertical integration of our supply chain. So really, we do believe that we have very positive trends in the future once we can in-house source the crude heparin manufacturing. But 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 the most of our -- in terms of cost efficiency in our supply chain.

Thanks, Juan. Javier, Guilherme also wants to know, what is your view on SG&A evolution in 2026?

Thanks, Guilherme. As we guided the market on '26, 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. So that will mean that we'll need to expand -- that we are expanding our operations. And for sure, this is linked to an increase in people and some expenditure. I want to highlight the tremendous performance that the company did on SG&A last year on '25, where we reduced SG&A. I think this is very difficult to replicate because as long as we are fortunate and 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. You know our policy is to be very strict on cost expansion. So probably -- 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.

Thanks, Javier. The next question comes from Sergio [indiscernible]. Could you talk about reaching Phase III for quarterly Letrozole in 2026? And what do you think the Phase III would last?

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 time lines are pretty much already being shared with the market. I mean this is going to be a long execution Phase III clinical trial. I mean the design is extremely attractive. We are targeting superiority versus the comparative drug. And we don't expect to be the clinical trial finalized before 2030, 2031. But definitely, this is going to be one of the major milestones of the company. And I think it's the best signal how do we -- 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.

Thanks, Juan. Francisco Ruiz from BNP has 2 questions. The first one is for you, Juan. After the excellent year on heparins, what are your expectations for 2026?

Thank you, Francisco. Really, as I mentioned to 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. So that means that our partners right now, they have sufficient stock. So we expect a slowdown in that part of the business.

And secondly, we are seeing -- as I mentioned before in a previous question, we're seeing a tremendous price aggressive strategy from mainly our Chinese competitors. So altogether, we expect that for 2026 sales decline for low-molecular-weight heparin. 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. We -- hopefully, Glicopepton will be very soon works finalized, and we will be able to be fully integrated in the supply chain of the heparin production.

And definitely, I believe that great things are to be delivered by ROVI on this field. We are experts on heparin, 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.

Thanks, Juan. The second question from Francisco. This goes 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?

Yes. Thank you, Francisco, for the question. I mean probably you are right. Last year was a lower R&D expenditure than expected. 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 are expecting to start recruiting patients this year, very soon. And probably recruiting patients in this phase of the clinical trials are the most expensive one. And therefore, we could expect this year to be very intensive on R&D expenditure. At the end of the day, what we -- the guidance that we provided on the Capital Market Day last year around the R&D expenditure for this 5-year terms program from '26 to 2030 don't change at all. So probably we'll be spending EUR 300 million on this year.

So overall, that amount will not change. Probably '26 will be one of the years that we'll spend most on R&D. That's also clear. And we are also looking and pushing to spend as much as possible, but 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 '26, we will account the second part of this aid from this Spanish organization, CDTI that will give us or we will account extra income, let's say, that way, that will be in a substantial amount. So that probably will offset any extra expenditure for the year on R&D. So we are very happy that we were able to collect that grant that will help us to smooth the expenditure on R&D.

Thanks, Javier. Juan, Álvaro Lenze from Alantra Equities asks, can you provide some detail on Neparvis prospects and the timing of the loss of exclusivity?

Thank you for the question. I mean Neparvis has been a tremendous success. I mean, it has proven the skills of our commercial capabilities in Spain. Unfortunately, the product will lose its patent around November this year. But it has proven really the benefits of the combination in terms of commercialization of Entresto and Neparvis, and this has not proven or is not on the market. So it's been a tremendous success. But unfortunately, I mean, November, last quarter this year, the product will go off patent.

Thanks, Juan. The next question, Javier, comes from Joaquin Garcia-Quiros and is related to CapEx. CapEx consensus for 2026 is at around EUR 62 million. Are you comfortable with this number?

Thanks, Joaquin, for the question. As we highlighted during the presentation, we are investing heavily for us on CapEx this year because for us, these investments are setting the foundations to achieve the goals that we internally have for 2030. So as you know, we are expanding our San Sebastián de los Reyes plant. And this year, also, we will set up a new line in ROIS, Phoenix. Apart from that, we are still investing on Glicopepton, which is the JV for the vertically integration heparin plant. So EUR 62 million is similar to the amount that we spend or invest on '25. Depending on how these investments -- the investments that I was sharing with you evolve on '26, depending on how they fall on '26, '27, this figure could be similar to last year figure to EUR 60 million CapEx or it could be slightly even above that figure.

So '26 is going to 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 '26 very, very intensive on CapEx. That's what I would say right now.

Thanks, Javier. The next question comes from [ Tim Jack ] from Entrepreneurial Investment. 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 plant utilization of the established production capabilities?

Thank you, Tim, for your question. Go ahead, Javier. Go ahead.

No, no. What I was going to say that, I mean, in a public conference like this, we don't comment on other companies' performance. But I could say that the outlook for Moderna for '26 and '27 is better than before. So 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 this can only be positive for us.

But Juan, please add whatever you want.

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 strong as ever. And again, we still feel that there is going to be a tremendous important collaboration between ROVI and Moderna in the future.

The next question comes from Patricia Cifuentes from Bestinver. When do you expect to advance with the Risperidone QUAR trials?

I mean [indiscernible] very similar to those of Letrozole. Our idea is to start recruitment as well in 2026 and to kick off. And 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, 5 years once we got the results. I mean we are targeting something that 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. And I think that will give us a unique differentiation in the market, in the long-acting injectable market. And again, it's already on the execution mode. And hopefully, if we could just open the window 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 Okedi, which is doing extremely good as well.

Thanks, Juan. Javier, the next question comes from Jaime Escribano from Santander. Regarding BMS integration, when do you expect BMS to start contributing in P&L?

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 and things that both companies or both parties have to perform. We are extremely optimistic that this is going to 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 6 years from BMS contribution during '26, at least. And we are working to sign the -- to have the closing as soon as possible so we can take over ROIS Phoenix and start producing for BMS. And more important than that, start -- we want to start deploying all the investments in ROIS Phoenix to be able to produce to other customers as soon as possible.

Okay. Thanks, Javier. Jaime also asks about gross margin. What is your expectation for 2026?

I mean, we don't provide accurate guidance for gross margin for '26. 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. So 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 the CDMO business is highly gross margin driven, too. So positively, if we are increasing the sales of CDMO business on '26, probably this will also contribute in a positive way to the gross margin.

And finally, the heparin franchise, as commented, we are having positive tailwinds on the raw material front. So 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 from a gross margin perspective. But again, that will depend on very much how the pricing pressure will evolve on the different markets.

Thanks, Javier. And 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 2007 -- 2027, sorry, low, mid or high end of the range?

Well, up to now, what we can tell you is that we are working very hard to hit all the different time lines. We started this project back in '24. And I would say that the contract negotiation was even earlier. So it's been a lot of time, what the team is very focused and at least is what we can do right now is to work on this tech transfer to execute as efficient as possible, to be executed as efficient as possible. So 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. And look, we are more focused on this year, trying to get the regulatory approvals to start a routine manufacturing rather than thinking on next year.

As any CDMO contract, that will depend on the customer needs. The good thing about this agreement is that we have some 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. And 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. And again, we need just to wait a few months and see how this contract evolves.

Thanks, Javier. The next question comes from Javier [indiscernible]. 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 III is starting?

Thank you for your question. Really, 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 we have -- 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 -- we like partnerships as we have shown with the rollout of bemiparin, enoxaparin and lately Okedi with the latest launches in Canada, Australia or Taiwan through 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 how on the results of the clinical trials that will define our final strategy. 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 $2 billion, $3 billion to $7 billion, depending on the price strategy.

So again, this is a unique opportunity. We really want to hit perfectly. And that's the reason why we have been aggressive on the clinical trial design. We are targeting superiority, which provide a tremendous competitive advantage if the product finally gets approved. And I think it will be once that the clinical trial advance once we start getting some data that we will start defining which is the strategy to follow. But I think Okedi 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.

Thanks, Juan. The last question comes from Christian Schmidt from [indiscernible]. What is the likelihood of signing an additional CDMO contract in 2026? This one is for you, Javier.

Thank you for your last question. I mean we are truly excited about the business. And again, I know that we reiterate sometimes the same message. We are signing contracts on an 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, unless they are very key for us, and we are forced to publish because it's material for our accounts on a stock exchange regulation or mainly is that -- I think the momentum is still there. Now 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, 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.

Thank you very much, Javier.

So 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 Lopez-Belmonte, for the closure of the presentation.

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 Relations team will answer them in a one-to-one mode. Thank you very much for joining with us for the full year presentations call, and wishing you a pleasant day. Bye-bye.

Good afternoon, and thank you for joining us for this special conference call to discuss ROVI's acquisition of an injectable drug product manufacturing site in Phoenix, Arizona, which we announced yesterday. Joining me on the call today is Juan Lopez-Belmonte, ROVI's Chairman and Chief Executive Officer; and Javier Lopez-Belmonte, ROVI's Deputy Chairman and Chief Financial Officer who will discuss the strategic rationale for the acquisition as well as the key terms of the transaction.

Javier is in Phoenix and he doesn't have a good coverage. So we hope he can stay connected throughout the event. You will see a big presentation deck in the Investors section of our website. We'll work through that deck on the call. And after that, we'll open it up for Q&A. If you want to ask any questions during the presentation, please don't hesitate to send them through the question bottom on the platform.

Before we get started, I note that some statements we may maybe consider 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.

So with that, I thank you for your presence here today. And we'll now hand the presentation over to Juan Lopez-Belmonte, please go ahead.

Thank you, Marta. Good morning, and thank you for joining us today. This is truly an exciting day for ROVI. I'm very pleased to announce our agreement to acquire ROIS Phoenix, a sterile fill & finish drug product manufacturing and packaging site located in Phoenix, Arizona.

This next slide provides a quick snapshot of ROIS Phoenix. The facility has a well-trained and highly experienced workforce, I would also like to mention that there had been significant CapEx investments made in the facility over USD 100 million since 2021. It's a big site. It has a total size of 34,000 square meters, situated on 80,000 square meters of land, which leaves ample room for expansion. It's a state-of-the-art site with cytotoxic area that has been approved by the FDA, EMA, Japanese agency among others. And we will continue to upgrade capabilities within the site.

And as part of the agreement, we will be installing a new optima pre-filled syringe filling line with isolator technology. So this line is expected to be installed in a segregated area in 2027 and will add a capacity of between 65 million to 70 million prefilled syringes per year.

And to end, as part of the agreement, we have entered into a Toll Manufacturing Agreement with Bristol-Myers Squibb and its affiliates from whom we have acquired this site.

Through this agreement, ROIS Phoenix will engage in a 5-year supply agreement for a yearly fee of USD 50 million.

As you can see in this next slide, the facility is divided into three main areas: Building A, which houses all current manufacturing and laboratory facilities, warehouses and administrative offices. Building B, warehouse space. New Shell. This is a new building that has been recently constructed. In this building, we will include the new optima line, thus expanding our PFS filling capacity.

However, as you can see from the figures on the screen, there is still plenty of space for building a segregated area for manufacturing biologic products.

This transaction makes a unique value proposition for our biopharma customers even stronger. It not only offers the ability to manufacture products in U.S. soil, but also adds highly competitive, high potent OEB5 cytotoxic capacities.

In coming years, and in line with ROVI's expertise and long-term strategy, the facility is expected to house the production of many more high value-added products such as obesity products, vaccines, biosimilars or biotech drug products, monoclonal antibodies and ADCs.

And you may be wondering why Phoenix? Phoenix is the fifth largest city in the United States and has been among the fastest growing cities in the U.S. in recent times. There are also several trends that make the city very attractive for the manufacturing site.

First, let me begin with its attractive location. The site is located like 10 kilometers away from downtown Phoenix and 17 kilometers away from Phoenix International Airport. It is also two blocks away from the Interstate 10, a major East West Freeway that runs across the Southern U.S., including to Phoenix and Loop 202, a beltway around the Phoenix metropolitan area that connects to the Interstate 10 multiple times.

The site locations ensures seamless inbound and outbound logistics, which is key for our manufacturing site.

Second, Phoenix is a city with access to talent. Its proximity to universities provides access to specialized professionals. The city is also attracting aviation and semiconductor industries, which are recruiting skilled talent to the area.

Third, Phoenix is a growing life science city, has a life science innovation district with over 550,000 square meters of planned life science development.

And finally, as you all may know, there is a desirable climate with limited risk of earthquakes, floods or landslides. The acquisition of the new U.S. facility represents a significant step in ROVI's long-term strategy to invest in advanced manufacturing infrastructure, equipped to handle commercial scale production of injectable medicines. This site enhances ROIS' ability to offer end-to-end CDMO services across multiple geographies.

ROIS Phoenix is a great strategic fit. With this expansion, ROIS managed to get a broadened global manufacturing network by adding a new state-of-the-art site, enhancing injectable capacity, strengthening partnerships and supporting the supply of medicines.

Expands ROIS high-value injectable capacity to develop and manufacture injectable medicines at commercial scale, enabling the company to serve pharmaceutical and biotech customers directly in U.S. soil, while continuing to build on its strong European base.

Enhances ROIS's know-how and capacity for manufacturing high-potent OEB5 cytotoxic injectable products.

Strengthens ROIS's commitment to innovation and investment in cutting-edge facilities and equipment.

Lastly, scales ROIS's U.S. sales team to capture new growth opportunities.

Today's announcement is a key milestone that enables us to achieve our goals, our vision to be a worldwide player in high value-added injectables.

Javier will now explain the key terms of the transaction.

Thank you, Juan, and good morning to everyone from Phoenix, Arizona. Good morning here and my Internet connection, as Marta was explaining to all of you, it's not very good. I hope it will work during the call. It's a truly exciting day for ROVI.

As Juan has explained, ROVI has acquired via its subsidiary, ROIS Phoenix, the facility located in Phoenix from Bristol-Myers Squibb and its relevant affiliates, for a price, which is not material for ROVI. As a part of the agreement, ROVI has entered into a Toll Manufacturing agreement with BMS, which regulates the conditions under which ROIS will continue to manufacture for BMS at the facility, with the necessary personnel as of the closing date to enable its operability.

This agreement has an initial term of 5 years from the closing of the transaction and provides for a minimum payment to the buyer of USD 50 million for each year of the contract.

Turning to completion consideration. The acquisition price is subject to customary closing conditions, including obtaining regulatory approvals and no material adverse change occurring prior to the completion of the transaction. We expect those completion of conditions to be satisfied in the first half of next year. Leading up to close, we'll be preparing for the integration of ROIS Phoenix into ROVI following a planned integration strategy to facilitate a smooth and seamless transition.

Our strategic view for the midterm future of the Phoenix site is clear, I would say. We will continue to manufacture for BMS. We will implement the new PFS Optima Line in the New Shell. We will conduct a growth assessment of the potential expansion of the New Shell, and we also conduct a growth assessment of expansion alternatives in available areas in Building A and in the rest of the land that we have there.

Please bear in mind that this is going to be possible, thanks to the skills, dedication and talent of ROIS Phoenix workforce, which is very important in the U.S. Thanks to their work, we are equipped to drive the continued growth of our facility. And through the integration of ROIS Phoenix to the ROIS network, we achieved our vision of becoming a global CDMO player.

So ladies and gentlemen, today, we announced the rebranding of our CDMO business to ROIS brand. This move marks a major step in the company's transformation into a truly global contract development and manufacturing organization. So welcome, everybody, to ROIS. ROIS is one of the top 3 largest CDMO injectable companies worldwide and one of the biggest CDMO players in Europe. We have 4 fully invested sites in Spain and now 1 in Arizona, U.S.

We employ more than 1,400 employees through our network, manufacture for more than 30 top-tier global pharma companies, and we are compliant with for all geographical regions where we operate. ROIS has a large experience in the manufacture of vaccines and biosimilar/biotech drug products. What distinguishes us from our competitors? I would say, our scale, speed and quality.

And this is ROIS today, 4 state-of-the-art sites in Spain and 1 in Phoenix, U.S. The expansion into the U.S. underlines the company's vision to be a partner of choice for injectable medicine worldwide, backed by continuous investment in people, technology and infrastructure. We are now better positioned than ever to deliver to our clients' expectations while preparing for the current and future growth of the global injectable market.

Through the integration of ROIS Phoenix, we are -- we will increase our current capabilities. If we turn to the next slide then, we will provide a snapshot of ROIS's capacity post ROIS Phoenix integration. We'll add 2 new aseptic filling lines, a vial line already in operation and a new PFS line with isolator technology. This PFS line already bought is expected to arrive in the last quarter of the year, but will not be operational until 2027, and it will add between 65 million to 70 million, probably millions of PFS units capacity. As part of the current agreement, we also add a new packaging line that is already in operation.

So I would like to conclude by echoing Juan's excitement about the transaction and the benefits we expect to deliver to clients. Today, we reaffirm our support for our partners in the pharma industry. ROIS Phoenix's strong capabilities will significantly strengthen our unique value proposition for these customers. This transaction, sorry, also give us entry into the booming CDMO U.S. market, large and fast growth market that opens exciting opportunities for us.

Before closing, I'm very proud to take a moment to highlight the tremendous value this transaction brings to our stakeholders. Over the last years, we have built a leading presence in the CDMO industry with exciting growth potential. Bringing ROIS Phoenix on board is all about continuing this momentum. I must point out that this achievement wouldn't be possible without the hard work of our talented team. We are confident that this transaction represents the right strategic move and a natural step in our company's evolution. Together with ROIS Phoenix, we will unlock even greater value for our stakeholders. Please remember ROIS Phoenix is a great business in a growing industry. With that, I'll turn the call -- sorry to Marta11 again for Q&A.

[Operator Instructions] So the first question comes from Francisco Ruiz from BNP. Javier, it's for you.

Could you give us an idea on what would be the EBITDA contribution from the USD 50 million -- sorry, for the $50 million in yearly contract with BMS. If the Optima line is already invested, why BMS will give it almost for free once you were asking for a significant valuation for your business last year?

Thank you, Francisco, for your questions. Starting for the first one around the EBITDA contribution of this $50 million contract. I would say that the importance of this agreement with BMS is that will allow the new ROIS Phoenix company and facility to enlarge its operations meanwhile it's working and manufacturing to BMS as it was doing before this transaction.

In terms of economic return, we are not expecting to be accretive during this first couple of years, at least. And once we start offering the facility to new customers, bringing customers will provide significant profitability to the facility. So meaning that this agreement will cover the cost of the operation of the plant meanwhile, we attract new businesses, which we hope that we will be able to do it, thanks to our reputation and well known of the market. And then once we get new customers, we can really leverage the capacity of the facility, and therefore, we will be able to bring operational leverage to the company and add a significant profitability to ROIS Phoenix.

With regards to your second question, we think it's a fantastic deal also because we are adding new PFS equipment and capacity almost since the closing of the transaction, and that will help us to attract new businesses very soon.

Unfortunately, this business, you need to be patient. And I think that's the vision of ROVI and ROIS that we invest for the long term, and we invest for our long-term view. I mean it's clear to me that BMS is in a restructuring mode as a company. They are making different cost containment measures. And probably one of the ideas behind the selling of -- the facility is to decrease the number of sites of their network.

Again, we don't have internal info about BMS. What we can tell you, is it's been very hard to convince the BMS that we were the right partner. And for them, probably price and valuation was not that important. You have to bear in mind that BMS is a multibillion market from a company, a blue chip pharmaceutical company, and we are going to manufacture for them in the next 5 years. So for BMS, what it was more important is to have the right partner in place because they are going to rely on ROVI, at least for the next 5 years for products that they are currently selling and they have an important added value for them.

So I believe the profile of ROVI and ROIS has a worldwide CDMO injectable manufacturing partner was far more important than the valuation of the assets and the valuation of the transaction.

The next question comes from Álvaro Lenze from Alantra. Javier, given the plan imbalance in the injectables fill & finish space, how is an asset like this being sold below its replacement cost? Do you know what other bidders were looking for?

Well, this transaction was conducted with a financial adviser by BMS. So it was a competitive bid and tender. And again, let me highlight that from our point of view, what we had to manage to deliver to BMS to the seller was not that much the price that we were paying for them for the facility, but our capabilities and our strength to commit with BMS needs for the future.

Again, the product or the products that we will be manufacturing, it means, I would say, a lot to BMS and its network. So for them, the continuation of supply.

And again, giving an opportunity for their talented employees to have a career in the injectable world, I think it was far more important than the price that we were paying to them. It hasn't been easy at all. We've been working in this transaction for several months with a full team dedicated to convince BMS and its adviser that we were the right partner for the ROIS Phoenix site or the Phoenix site. So I think, again, overall, our value proposition for the long term, what's more important for BMS that the short-term price that eventually any bidder could place on the table.

Thanks, Javier. Álvaro also asks, should we expect any margin at the EBITDA or EBIT level from the 5-year contract with the BMS?

I mean, which is very important or at least was very important to us in the negotiation process, it's this 5-year agreement allows us to develop the site. And as we were mentioning in the presentation, it provides us with 5 years to install new lines as the PFS one already bought by BMS that will attract new customers also for the current cytotoxic line. So with these potential new businesses, we could add a significant profitability to the site.

With the current agreement, what we make sure is that this site can operate in a normal way and cannot -- and it is not going to be a burden for the rest of the company. So it's a magnificent opportunity that we can keep growing this site as we have done in the past with others. And for sure, the first couple of years, we don't expect this site to bring additional profitability to the business, but it opens a tremendous opportunity for the company in the medium term.

As everybody knows, with the current geopolitical situation, all companies are trying to look also for being their products manufactured in the U.S. -- manufacturing in the U.S. So I think it's a tremendous opportunity for ROVI to offer this site for customers and clients that they want their products manufactured in U.S. soil.

Thanks, Javier. The next question comes from Tim Jeck from Entrepreneurial of Investment. Javier, it's for you. Can you be more precise what not material means, example, less than 1% of market cap?

I mean we would have loved to provide the market with the price. However, our agreement with BMS doesn't allow us to give visibility on the price, which meaning that is not material means that it's not significant to ROVI now. I would say that it's a good assessment that is below 1%. I mean we cannot give transparency on that, but it's not meaningless to us -- it is meaningless to us, sorry.

Thanks, Javier. Juan, the next one is for you. It comes from [indiscernible]. Do you think that there could be a potential to move some of current or future Moderna production into this plant? How do you plan to articulate the marketing of this new capacity with the existing capacity in Spain, namely to U.S. customer?

Thank you for your question. As Javier has mentioned before, and we have reiterated along the call, I think this is a magnificent movement by ROVI on operation to really scale up our contract manufacturing operations to a global level. I mean we like having a facility in U.S. soil, and this is what we get with U.S. Phoenix.

I believe this is going to be a very attractive alternative to all our existing and future potential customers. As Javier has mentioned, and I have emphasized in my initial presentation, we're going to enlarge our commercial team in the U.S. And I think that's going to provide us a tremendous opportunity, probably Moderna, but not only limited to Moderna, but many of our existing customers or future potential customers, having the optionality within ROIS to have their operations and their manufacturing activities done in U.S. soil is a tremendous thing. I mean, I think this is going to be a landmark. This is going to change the evolution of ROIS as a CDMO. And I'm pretty optimistic that this is just going to be the beginning of a very exciting future of ROIS as a CDMO global injectable player.

Thanks Juan. The next question comes from Charles Weston from Royal Bank of Canada. Javier, it's for you. You described the $50 million per year as a minimum. Could it be materially higher?

Yes, why not? I mean, BMS, it's a great blue-chip company. What it was important to us is that we have a minimum commitment that whatever happened to BMS or the products, we have this minimum income coming in on annual basis.

Again, but as Juan has just mentioned, our focus will be to expand to new customers. That will be the main goal. But yes, why not to say, it could -- this figure could be increased in the next years, which is also -- or it was very important to us is that with this new transaction, we are adding a tremendous and important customer to our company, which is Bristol-Myers Squibb, which is a multibillion pharmaceutical company. So whenever you start working with a company of such size, you never know the opportunities that lies ahead of you.

Thanks, Javier. The next 3 questions come from Jaime Escribano from Santander Group. The first one, Javier, is CapEx left to unlock the new Optima capacity?

Yes. Thanks, Jaime. This is -- we are working on that evaluation. One of the things that we have to do, as described in the presentation, is to assess the future of the facility. For sure, we are going to invest on this new PFS line. For that purpose, we need to do some investments to install the line. Again, I don't see those as a major investment. But again, we need to reassess once we close the transaction, the CapEx for this site for the next year.

But what I believe right now, it's given for us is that in order to install this line, we'll need to implement some investments, which could be between USD 20 million to USD 30 million, but still the fine number, we still have to work it around with the people there in the next coming months.

Thanks, Javier. The next question from Jaime is potential peak revenues of the new Optima line. What will be the key challenges of this project?

I mean what we are truly excited is that this line could be in operation from -- as Juan mentioned or I believe I mentioned since 2027, meaning that we can offer the line to the customers, I think, since today. Since today, our salespeople will start offering this line to our -- first to our current customers and second to the potential new customers.

You know that time is very -- in our industry, companies move in a very slow motion in the sense that everything has to be anticipated by a few years in advance. So probably, as we have done with our lines in Madrid, in the next coming months, we'll start trying to negotiate with customers for this new line. Big line peak sales is always very difficult to predict with this capacity and with the current conditions of the market and our current customers.

I mean, it's easy for us to predict that this line could eventually have revenues I would say, easily more than USD 100 million of revenue. But again, it's very premature to say the revenues that potentially come from a line that is not yet -- that has not yet arrived. So it will depend on the market situation and the current conditions, but we are really, really excited about the potential of this line. And I'm sure that we'll have a queue of customers trying to book some millions of syringes for the future coming from this line.

Thanks, Javier. Juan, Jaime also asks, did you work with Bristol before? Can leadership lead for future collaboration, example, being a customer of CDMO in Spain?

I mean, as Javier has mentioned before, I mean, BMS is one of the largest pharmaceutical innovative companies worldwide. I mean, to some extent, probably it happened many years ago, we did a similar deal with Merck, the American company back in 2010. And Merck is still a customer of ours with different products that we initially contracted with them when we bought the Alcala facility.

So definitely, I mean, we never worked before with BMS, but definitely working with BMS, trying to be partnered with them, being proud to be, as Javier mentioned, to be chosen by BMS to be their partners and acquiring a manufacturing facility. That means that they really praise our company and our business continuity model for their production of one of their key products. So again, we're very excited because getting a new site, cytotoxic line, vials with additional prefilled syringe capacity and on top of that, having a 5-year contract with BMS, which is also a tremendous added value. And definitely, we will work hard to try to build up this relationship and try to enlarge our existing relationship with BMS to additional products for contract manufacturing.

Thanks, Juan. Javier, the next question is from Javier [indiscernible] What is the estimated investment required to add a new line at this site?

Again, we have done a global evaluation of the potential of the site. Let me rephrase as Juan was saying before, that it is not only about the potential new lines, but also the current capacity, which we are including or adding cytotoxic capabilities to our network and lyophilization capabilities. These are key for us because we were lacking in these sort of capabilities in our current network. So let me highlight it, not to visualize wrongly from our investors that the current capacities are great. And on top of that, we are adding this new PFS line for biological production, which you know we are experts on that currently.

And on top of that, the importance and the strategic view of the site is that it's a huge site. So we internally talked that we see this site as the current Alcala site, just to visualize for our investors, the -- how big the site is. So it's a huge land and a huge buildings that we are buying. So we have plenty of space, plenty of room to add new capabilities and services.

Again, the U.S. market is different than Europe and Spain. So any investment there need to be reassessed because the numbers in the U.S. are higher in terms of cost than in Europe and in Spain for sure. But this is the process that we'll be doing again once since today that we have closed the transaction or announced the transaction.

So first, we have the current capabilities; second, this new line. And third, we need to do a fine-tune of what we lack in our network or what is -- what our customers want from us. And I think we have the opportunity to deploy that in Phoenix because we have the people, the room and with ROVI and ROIS, we have also the capital and the money. So it's something that we'll need to further evaluate and probably we'll be updating everybody in the next coming months.

Thanks, Javier. Juan, the next question is for you. It comes from Chris Richardson from Jefferies. Is it fair to assume this site was being run below an optimal level like the Roche site purchased by Lonza? Do you plan to phase out BMS products? Or do you hope to phase BMS products out and bring in third parties?

Again, I mean, I think this is a very exciting opportunity. I mean BMS is a fantastic partner and potential future customers. I think we now have to work hard to gain the trust of BMS beyond this agreement. As I put example before of Merck in 2010, today is one of our major customers. I think we have to really work out the trust on BMS management to prove them that we can run the company with -- I mean, with the efficacy and the efficiency that they did prior to the operation.

I cannot then tell you, how did BMS run the facility, whether it was at an optimal level in terms of capacity. But definitely, we do believe that the added value of this transaction is really very significant for ROVI. I don't want to repeat ourselves, but prefilled syringes, again, we have installed several similar lines very recently in our facilities in Madrid. We know the landscape. We know the customers. We know the markets is on Optima.

I don't want my memory to fail me, but probably it's the fourth or the fifth Optima line that we have installed in our manufacturing network. I mean the line is going to be delivered in the next coming weeks. So that's as well a major positive thing. And again, we -- I mean, we know this landscape very well. So we are going to start offering our services on prefilled syringes from today. And I'm pretty optimistic. I think this is going to be a tremendous landmark and it's going to be a turning point and the perception of ROIS as a real global CDMO operation.

As well as Javier has highlighted, having the cytotoxic vial line with lyophilization capacity, it offers as well the broad of our services. In nowadays, supply chains are getting completely redesigned. Big pharma companies, they want to work with very few contract manufacturers. It takes a lot of money and time and dedication to have different contract manufacturers.

And I think this operation works positively on that sense. The concept of one shop, we can offer different services. We can offer those services in the 2 major or largest pharmaceutical markets, the U.S. and Europe with a top quality level. I mean, we cannot forget this facility is already being approved not only by the FDA, but by EMA, by the Japanese agency, by most of the major geographical regions. So I think altogether, it's really a jackpot. I mean I think definitely for ROIS, this is going to be a real landmark in our CDMO history. And we're just very excited and looking forward to providing more substantial good news in the next coming weeks and months to our investors.

Thanks Juan. The next question comes from [indiscernible] Javier it is for you. Bold move guys, congratulations. Are you seeing higher interest from your clients now that you have the factory in U.S. soil and BMS as another large client?

I mean we just announced the transaction yesterday. So what I can share with all of you is that we've been congratulated by many people. And apparently, so far, nobody has told us that we are wrong in our view or in our assessment. It's still early to talk about new customers because this has been very strictly confidential transaction.

So I hope that this is new for everybody, also for the customers and for the manufacturing industry. But I'm sure that from today, we have already started to communicate our customers that there is an opportunity to book a capacity in the U.S. soil and that they can trust on our ROIS capabilities to bring new products to this new site.

Thanks, Javier. The next question comes from Joaquin Garcia-Quiros from JB Capital. Javier, this is for you. Does BMS has an optionality to renew the contract after the 5 years? Or will you be free to offer that capacity to other players?

I mean the contract/agreement, I'm afraid, is very, very strictly confidential. What I can tell is that BMS has the ability -- I mean, we have to manufacture for BMS for 5 years, and that's a fixed agreement and with minimum quantities and value. And from that period onwards, let's say that it has to be agreed between parties.

The last question is for you, Javier. It comes from Pablo De Renteria from Kepler. I understand it's difficult to assess the potential revenue and profitability of the Phoenix plant at this stage. However, in the long run, would you expect margins at the site to be broadly comparable to those you project for your CDMO business in Spain by 2030?

Well, thanks, Pablo, for your question. I mean, what we are working right now or since we started to analyze the transaction is that we can enlarge the output of the facility firstly, from the current line and second, from the new equipment that is coming. And as we have shared today, once we increase the output of the facility, we can deliver a very strong, I would say, massive operational leverage as it's how this business works.

Once you start adding additional revenue, the additional revenue is very profitable. Again, it's difficult to make such a statement, but we believe so that once this facility is working with -- at a full speed or with more customers on board, we do believe that this business can be very profitable and probably as comparable as our Spanish business.

Thanks, Javier. We are out of time. Thank you very much for your high participation. The IR team will answer the outstanding questions as soon as possible. I'll turn the call over to Javier for the closure of the presentation.

Thank you, Marta. It's been a pleasure to be with all of you today. For us, the acquisition of this facility in Phoenix, it's for sure a turning point in our history and a landmark. So I'm very happy or we are very happy to share with you this call and to comment on the details of the transaction. And there is no more time. So thank you for joining the call today, and have a good day. Thank you. Bye-bye.