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 match really 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 del Monte, Roviz Chairman and CEO, will discuss our business performance for the quarter, and Javier López Belmonte, Roviz 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 to 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 $357 million in the first half of the year. Operating revenue reached €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 $237.1 million, reflecting a gross margin improvement of 6.5 percentage points to 68.9 percentage. Before moving on, I would also like to highlight that on April 1st, 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 62.4 million euros. EBITDA increased by 85% to €121.2 million, and excluding the impact of the badwill, EBITDA decreased by 10% to €58.8 million. euros. 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 237.8 million euros, driven by strong growth in Okedi, hospital products, and apartments. I would now like to focus on the performance of the happening business. A key area accounted for approximately 38% of the groups operating revenues in the first half of this year. The heparin franchise generated sales of 130.1 million euros, down 4% year-on-year, while low molecular weight heparin sales declined 5% to 125.3 million euros, mainly due to lower bemiparin sales driven by high inventory levels from international partners. Within the low molecular weight heparin franchise, sales of an oxaparin biosimilar reached 78.6 million euros in the first half of 2026, representing a 2% year-on-year decline, while bemiparin sales amounted to 46.7 million, down 9% year-on-year. However, it's important to highlight that although international baby-paring sales were weak in the first quarter, they showed a strong recovery in the second quarter, increasing by 53% versus Q2 2025, and more than tripling compared with Q1 2026. As a result of the recovery in international baby-paring 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 noxaparin 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 HEPANI franchise remains a key priority for Roe. 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 Glicopeptum 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 Heppernin 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 a 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 34 million euros, up 27% year on year. Its differentiated clinical profile continues to support the strong uptake and will remain excited to reach potential sales of between 100 to 200 million euros in coming years. Moving on to our CDMO business, the content manufacturing business performed strongly, with revenue increasing by 38% to 106.3 million euros 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 NS1 GMP aspects for aesthetic manufacturing. And second, the contribution of revenue generated under the Supaya Agreement with Bristol Miles School entered into in connection with acquisition of the Phoenix facility, completed on April 1st, 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 finish facility into our industrial network, Rob is well positioned to capture long-term opportunities in high-value injectable manufacturing. Finally, our ASM platform continues to progress well. Let us all see how 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-Quartz has also delivered some Phase I results and is now progressing toward phase three development, with patient enrollment expected to begin in the fourth quarter of 2026. Together, let us all see and RISPERIDOM QUART further strengthen our confidence in the potential of the AISM platform and its ability to generate meaningful long-term growth opportunities for Roby. With that, I would like to thank you for your attention and hand over to Javier. who will take you to 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 two non-recurrent items that affected our reported results during the first half of 2026. First, we completed the acquisition of the Phoenix Manufacturing Facility on April 1st. As a result of the preliminary purchase price allocation exercise, we recognized a 62.4 million euros bargain purchase gain, or badwill, which was recorded as a non-recurrent 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 non-recurrent expenses recognized as a result of 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 357 million euros. Operating revenue increased by 9% to 344.2 million euros in the first half of 26, mainly supported by the strong performance of the CDMO business.
I will now walk you through the reminder of our P&L.
Gross profit increased by 21% to €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 LiarSolid project. excluding other income gross margin increased by three percentage points to 65.2 percent mainly driven by the growth of the contract manufacturing business higher contribution from okay and lower heparin raw material cost well now moving on the sdna expenses sdna increased 28 percent to 145 million euros in the first half of the year. So let me start now with the personal cost. Employee benefit expenses, excluding R&D here, increased by 23 percent year-on-year. This increase was mainly driven by, first, the incorporation of Royce 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 1.6 million euros of non-recurrent personnel-related expenses, the majority of which were associated with the tax inspection process that was concluded during the period. therefore excluding these non-recurrent expenses employee benefit expenses increased by 20 percent year on year now if we turn to the other operating expenses excluding r&d this increased by 34 year year the main drivers here were the inclusion again of royce 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 non-recurrent costs related to asset write-offs and strategic projects. Excluding these non-recurrent expenses, other operating expenses increased by 28%. So, overall, excluding non-recurrent items, SENA expenses increased by 24% to €140.5 million in the first half of this year. It's worth noting that Royce Phoenix represented approximately 9% of SG&A expenses during the On a like-for-like basis analysis, excluding both Royce Phoenix and non-recurrent 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 2025 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 Royce Phoenix, to increase by a mid-to-high single-digit percentage growth compared with 2025. Regarding R&D expenses, they increased by 98% to €33.3 million and were largely related to preparations for the Phase III development program of Letrosol SIE. EBITDA totaled €121.2 million in the first half of the year with a margin of 35.2% excluding badwill EBITDA decreased by 10% to €58.8 million. EBITDA amounted to €103.2 million in the first half of this year with a margin of 30%. EBIT excluding badwill decreased by 20% to 40.9 million euros. Net financial cost reached 1.7 million euros in the first half of 26 compared with net financial cost of 1.3 million euros 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 2016, compared with 20% in the same period of last year. The reduction in the effective tax rate was primarily driven by the non-taxable nature of bad oil, recognizing cognition with the Phoenix acquisition. As a result, the net profit reached 84.4 million euros 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 2016, Robby invested 30.4 million euros allocated as follows. 21.9 million euros dedicated to investments and 8.5 million euros allocated to maintenance, capex and other items. At the same time, cash generation was particularly strong this period. cash flow for an operating activities increased to 94.3 million euros compared with 28 million euros in the first half of 25. As a result, free cash flow increased significantly to 64.7 million euros compared to 7.5 million euros 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 30th, 26, Roby's total debt amounted to 107.7 million euros while gross cash increased to 130.2 million euros as a result roby ended the first half with a net cash positive position of 22.5 million euros compared with a net debt of 21.9 million euros at year end 25. this improvement reflects the strong cash generation of the business during the period. Our balance sheet remained solid, providing us with financial flexibility to continue investing in growth initiatives while maintaining a disciplined capital structure. Furthermore, on July 15th, we paid a dividend of 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 Ocadie. At the same time, we remain firmly committed to innovation with two phase three clinical programs underway and a clear focus on creating long-term value for shareholders. This approach reinforces our roadmap 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. If you want to ask any questions, please don't hesitate to send them through the question bottom of the platform. The first questions come from Patricia Cifuentes from Westinburg. The first one is for you. What is your assessment of the German healthcare reform starting in 2027? What proportion of your total revenue is exposed to increase rebate requirements?
Good morning. 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 healthcare reform. When it comes to OKD, we are right now assessing all the different scenarios, the inclusion in the 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 on pricing or revenues i mean just to give you at least some broad figures or what would be the impact for the company please uh it would be very limited uh it will be only focused for sales in germany which, when it comes to OKD, represented 8.4 million euros during the first six months of 2026. We definitely were 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 separating, we believe that it's excluded from the German healthcare reform. But again, this is brand new. It was approved, I believe, less than two weeks ago. There's been a lot of rumors, different expectations in terms of clovebacks, 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 byproducts. But again, our limitation would be, we believe, to Okedi, and Okedi represents, in the first half of the year, 8.4 million euros, which accounts more or less for 36% of ROKD sales in the first six months of 2026.
Thanks, Juan. The second question from Patrick 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, I mean, 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 separating 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 are right now in place, ongoing, and as well with the Glico-Peptone 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 of heparinx. It represents 38% of our sales. And we believe that we have all the features really to place Robi and our portfolio of heparinx, both with the MIPI and Xaparinx, to be one of the major players worldwide in this essential talk.
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 Fenix Optima line?
Well, good morning 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 um optimizing capacity utilization remains our key priority on the cdmo business and and you know we continue to see a strong commercial activity you know and um i mean 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 assessments 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 an 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 you know, 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 why we are increasing our SENAE 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. Okay, the next questions come from Juan Ros from ODO. He has several questions on the contract from April 2024. So the first one is what exactly remains outstanding for PPS regulatory approval and when is approval now expected? does uh 2026 fully guidance uh include routine pfs manufacturing revenue and is the original 2027 pfs revenue range still valid have you there for you yeah um again i think we we stated in in our first quarter results that um This contract has delayed on the regulatory approval.
We are both companies working, I would say, hard to get the regulatory approval. But again, this is 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. I think there's no doubt about that. and and again we are very we uh uh i think uh we are safe in the in the sense that we have this um take or pay clauses and and we expect to start manufacturing next year uh at least with this agreement so there is no no change in in the outlook that we commented uh last quarter thanks javier the next question uh questions come from guillermo santayo from cash bank uh 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 uh 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 um we are very proud of including uh royce phoenix for the first time in in our pnl and our statements and the integration of phoenix is going very very well no i think this is an important fact and i think it's an important item for for the sales growth for the period as we disclosed revenues from phoenix were around 13.8 million euro revenue so the main growth came from the existing business and i think this It's 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, two questions from Guilherme for you. Could you offer some color on the weaker quarter-on-quarter performance of Ocaddy? How are you seeing the competitive environment evolving in schizophrenia?
Thank you, Guilherme. Good morning for you, Quinto. I mean, we are extremely satisfied with Ocaddy's performance. The most important thing is that we are seeing a robust continuous uptake of Ocaddy 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, to all our partners, with Orion in the northern countries. I mean, we are seeing really a very good momentum. Let me remind how the OKD 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, I mean, 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, I mean, 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, I mean, it's 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 Ocaddy, 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 we obviously we 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 schizophrenia patients in general by nature, they are very fragile patients, so we will see quarters stronger than others because, as we can imagine by common sense, physicians probably, they will choose certain quarters or certain months in the year to start the switch in terms of medication required by the patient just for adherence and follow-ups to supervision. regarding this corsofrenia market the market is is i mean is is 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 lies growth is much faster than in other countries or in the case of spain which is also growing stronger other countries which the long-acting injectable market still delivers probably not the best growth that we're expecting in terms of of lives like like 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 robin to to obtain the the okd sales guidance and that's the reason why we're investing heavily on risperidone quartz because probably in other calls we might have the chance to discuss in more detail the phase three protocol but again i believe this is going to be a boost and this is going to to provide uh rovi um the perfect product portfolio to really become
as well like in the low molecular with the prince 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 hi uh hi chris thanks for your question um actually i'm not quite sure about the 13 contribution which uh
do you refer to uh what i can tell you is again yeah i think you are right um we are and i think it's important to to highlight it in this conference call we just taken over phoenix and we are extremely excited about the opportunity not only because of the price we paid but also the i mean the outstanding um opportunities that lay ahead of us in in the us 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 a 50 at least 50 million us dollars 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, it's all right. We have a higher income coming from Phoenix this quarter, and this is exciting because it's just the first quarter but i mean from a cautious side or from a safe side you can consider this 50 million dollar revenue per year as a baseline and if news good news comes it will be slightly higher uh during this uh first year thanks javier the next uh questions come from uh
Jaime Escribano from Grupo Santander, and I related to heparin, so one day for you. If heparin outlook improved, why not improving 4-year 2006 full guidance? And how is the competition environment in heparin, same as in the first quarter of 2026, improving, worsening?
Thank you, Jaime, for your question. No, I mean, the happening competitive landscape remains the same. Basically, it's Roby with Chinese players betting for this market. Sanofi is suffering since 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, but we will see in the next future some raw material Chinese suppliers that they may decide to launch the product outside China. But again, we don't feel scared or afraid. We don't think that Roby's position in the market will be jeopardized by the entry of new competitors. The Haparin business, the Lomolec product of Haparin business, answering your first part of the question, I mean, 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 heparinins, by definition, they treat thrombo events, it's a blood thinner product, and so it targets acute symptoms, whether the patient is fed on the hospital or whether it 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 non-molecular with heparinids, but we rather prefer to remain cautious. As Javier has mentioned, we see robust evolution in this second quarter in heparinids, in the CMO business. We see as well that OKD 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 significant sales revenue. And again, that altogether, although we do believe that the heparines, as I mentioned before, both the MEPARING and Oxaparin, It looks like it's going to remain strong. We would prefer to be cautious on the global guidance of the company.
Thank you very much, Juan. Thank you very much for your participation. The Rovi Aria team will answer the pending questions as soon as possible. Thank you again for your assistance and have a very nice summer.
