Hello, everyone. This is Marta Campos, Head of Finance for Roby. 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 Roby'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 matter, 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 López Belmonte, Roviz Chairman and Chief Executive Officer, will discuss our business performance for the quarter. Javier Lopez 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 do not hesitate to send them through the question button on the platform. With that, I thank you for your presence here today, and we'll now turn the call over to 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 to the detailed financials. Let me continue what we have seen in the business during the first quarter of 2026. Operating revenues reached 152.5 million euros, representing a 1.5 percentage decrease compared to the first quarter of 2025, mainly due to the performance of the HEPA division. The contract manufacturing business continued to perform well, growing by 5% during the period. Gross profit increased by 5% to $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 to 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 the 1st, which stresses 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 beviparing. Within this segment, growth was driven by Okedi, Hospital Products, Neparvis, and the Noxaparin 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 from international partners. This was partly offset by a 2% increase in anoxaparin 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 hemiparine have shown a weak performance in the first quarter of 2026. However, for the full year, we anticipate a more moderate decline. Regarding low molecular weight heparine 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 toward vertical integration and crude heparin self-sufficiency. Turning now to Okedi, the product remains a key growth driver with sales of 17.2 million, up 37% year-to-year and a farther 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 100 to 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 $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 Prefield 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 finish facility into our industrial network. Roby is very well positioned to capture long-term opportunities in high-value injectable manufacturing. Finally, our ISM platform continues to progress well. Letrozole C 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 Quartz delivered a strong Phase I results and is advancing into Phase III. Together, these programs reinforce the long-term value and innovation potential of IISM technology. Thank you very much, and I pass the floor to Javier. Thank you, Juan.
Good morning, everyone, and I will now turn to financial performance. Total revenues reached 154.7 million euros, broadly flat year-on-year. Operating revenues declined 1.5% to 152.5 million euros, mainly reflecting lower international sales of Bemiparin. This was partly upset by CDMO business, which increased 5% during the quarter.
I will now walk you through the reminder of our P&L.
So gross profit increased by 5% to €95 million in the first quarter of 2026, with gross margin improving by 3.8% points to 62.3 percent, partly reflecting the recognition of R&D grant income related to the LIOS Elite project. Excluding other income, gross margin increased by 2.5 percentage points to 60.8 percent, 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 sgna increased 18 to 63.6 million euros in the first quarter of this year mainly reflecting higher personal 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 non-recurrent items, mainly related to the write-off of assets that are no longer operational. Excluding non-recurrent items, other operating expenses, again excluding R&D, increased by 21% year-end year. For 2026, Robby expects SENA expenses, in this case excluding Royce Phoenix from the group, to increase by between a mid-to-high single-digit percentage compared to 2025. As for the R&D expenses, this increased by 79% to $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 Letrosol SIE. Moving to EBITDA, EBITDA net profit. EBITDA totaled 20.3 million euros in this first quarter of 26 with a margin of 13.3%. EBITDA amounted to 12.1 million in the first quarter of 26 with a margin of 8%, while net profit reached 9.4 million euros in the same period. i won't go into slide 15 in detail you have the figures and that was the pre-rnd 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 7.7 million euros allocated as follows 5.6 millions dedicated to investments and 2.1 million euros allocated to maintenance capex and other items turning to cash flow operating cash flow came in at 13 million euros in the first quarter reflecting two main factors lower profit before tax compared to the prior year and adverse working capital movement. Free cash flow amounted to 5.6 million euros in the first quarter of 2016. As of March 31, 2026, Roby's total debt amounted to 114.4 million euros with gross cash of 99.6 million euros, resulting in a net debt position of 14.9 million euros. 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 shareholder's meeting a 0.9594 per share dividend, euro 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, Roby has updated its guidance and now expects operating revenue to grow by low to mid-single digit compared to 2025, might, reflecting a more moderate growth scenario than previously communicated. This update is mainly driven by lower revenue forecasts for 26 under the Prefield Syringe Manufacturing Agreement entered into with a floral pharmaceutical company, announced in April 24 due to a delay in the initially expected commencement of routine manufacturing operations which remain subject to the regulatory authorization as well as an increased uncertainty regarding anticipated demand in addition we continue to see growing competitive pressure and pricing on 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 is in orders for 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 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 US, progress in the vertical integration of the Hebering business and the continued momentum of the specialty pharmaceutical segment with Okedi as a key product. In parallel, we maintain a strongly committed R&D with two phase three clinical trials currently underway, Letrosol SIE and Risperidone Core, supported by a clear focus on international expansion and execution excellence.
This approach reinforced our road roadmap 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 thanks javier if you want to ask any questions please don't hesitate to send them through the question button on the platform So, the first questions come from Pablo de Renteria from Kepler, Javier, the FOEU. The first one is, following the increased uncertainty around demand for the new profile series 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. Thank you for your question, Marta. I would say that up to date, 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 served a guidance to the market a couple of years ago when we signed the agreement. And we served 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, So, we are 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 near-term outlook in CDMO alter in any way your long-term ambition presented at the capital market stage of reaching around 700 million euros in CDMO sales by 2030 or do you still see that target target as achievable i would be very clear no right now we are still very committed to that figures to those goals we still believe that those are achievable we always explain to the market that this was an ambitious target but it
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 it, 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 pre-filled syringe line in the US when do you expect to be able to start commercializing the available capacity and more broadly are you already seen interest from potential clients looking to book capacity in the u.s thank you paulo um yeah yeah for sure no i think uh i think it would be great to highlight two different things one is that as you know we are setting up a new campus for phalogics 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, you know, 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 spurt high potent campus on the cytotoxic campus. And I believe, at least for us, what is very exciting is that in this same campus, we believe we not only we can feel a cytotoxic product and a standard high potent drugs, but also I think we are capable of feeling ABCs and ABCs. We foresee them or everybody think ABCs as an important driver of growth for pharmaceuticals, as a segment or as a new modality in the pharmaceutical field. So I think there are very few competitors in the U.S. that can offer this 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 US than in Europe. So I think it could be a transformational driver of growth for us, this Phoenix side facility.
Thanks, Javier. The next question comes from Patricia Tifuentes from Vestiver. Javier is for you. with the delays in the recruitment of Letros Olsia and quarterly risperidone, what level of R&D costs should we expect this year?
Yeah, as we previously announced and commented 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 3 projects I think that these 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 60 million euro figure for the full year. Let me remind to all of you that we will be starting recruiting patients the hopefully at the end of the year so so this is for sure um we are spending a lot of money uh in in prepare in preparing um this uh crucial moment for the company okay thanks javier the next question comes from alvaro lense from edm can you provide more detail on the approval process for the april 2024 client line what is the bottleneck i will i will answer that one i mean you know the uh the agreement was signed in 24 we had a detailed timeline but at the end of the day it's been a lot of uh 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 are different causes of delay and also I would say that there isn't 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 two years ago we depend on a large multinational and they are you know quite slow sometimes quite a 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 from next year onward thanks javier so the last the last question comes from uh joaquin garcia quiros from gb capital
one this one is for you now that competition seems tougher in heparines how do you see the development of this division in the midterm hi good morning joaquin thank you for your question yeah actually we are seeing a very rapidly erosion in terms of prices heparin is a very dynamic market and as i mentioned before in my presentation we expect variability between between quarters but i mean we're adjusting ourselves i mean we we are still very much optimistic on the long term of the heparin perspectives investing on 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's 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 communicated accordingly to the market but Heparin is a great business Roy has security knowledge we have a great performance in the past and again we are fully committed to this business and we believe that we are going to hear in not that long future very good news coming from the 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.
