Laboratorios Farmaceuticos Rovi, S.A.

Good morning to everybody. A warm welcome to all those attending the presentation of ROVI’s First Half 2024 Financial Results which will start in a moment.

I am Javier Lopez-Belmonte, ROVI’s Deputy Chairman and Chief Financial Officer. Joining me on today’s call are Juan Lopez-Belmonte, ROVI’s Chairman and CEO.

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.

Before we begin, let me remind you that the information presented in this call contains forward-looking statements based on our current beliefs and expectations. Actual results could materially differ due to the known and unknown risks, uncertainties and other factors, and we undertake no obligation to update or revise any of these statements.

With that, I thank you again for your presence here today. And I will now hand the presentation over to Juan Lopez-Belmonte.

Please, Juan, go ahead.

Thank you, Javier, and good morning to everyone in the call. The first 6 months of 2024 have been months of transition crucial for establishing the basis for ROVI’s future.

In this context, our operating revenue decreased 14% to €329.3 million as a result, first, of lower revenues from the manufacturer of the COVID-19 vaccine in comparison to the first half of 2023, when ROVI had booked higher income related to the production of the pandemic COVID-19 vaccine, and as well due to lower revenues related to the activities carried out to prepare the plant for the production of the vaccine and the agreement with Moderna. To-date, Risperidone itself continues to grow in a robust way.

First half 2024 sales multiplied first half 2023 sales by 141%, totaling €12.5 million. The slowdown in sales of our low molecular weight heparins division in the first half of 2024 was mainly due to lower orders from enoxparin partners.

However, we expect greater concentration of orders from partners in the second half of the year, and we remain excited in the continued sustained performance of this division and aspire to become a benchmark player in this field worldwide. Our gross margin for the first half of 2024 improved by 280 basis points to 59.4% versus the first half of 2023.

This increase was mainly due to the decrease in the contribution to the manufacturing business of revenue relating to activities to prepare the plant to produce medicines under the agreement with Moderna, which contributed lower margins to group sales; secondly, the increased contribution to the CDMO business by existing customers, excluding Moderna, which contributed higher margins; and finally, the increased contribution of sales of Okedi, which contributed higher margins. Based on the first 6 months’ performance and the visibility that we currently have, we reiterate our 2024 full year guidance, and we expect operating revenue to decrease by a mid-single-digit percentage in comparison with 2023.

In the first 6 months of 2024, we have achieved some key milestones. In April this year, ROVI announced that its subsidiary, ROVI Pharma Industrial Services, ROIS, entered into an agreement to support the manufacture of pre-filled syringes for a global pharmaceutical company.

Per the terms of the agreement, ROIS will provide a high-speed production line at the ROIS San Sebastian de los Reyes facility in Madrid with an estimated annual capacity of 100 million units. Commercial production is expected to commence in 2026 and as from 2027, which is expected to be the first full recurrent manufacturing year, ROVI’s CDMO division expects to have a positive revenue increase impact ranging between 20% and 45% over 2023 sales.

In June 2024, we completed the buyback program launched in July 26 last year. Under the framework of this program, ROVI acquired a total of 2,233,466 for an amount of €130 million, which represents approximately 4.3% of the share capital.

I’m particularly excited about this one. In our Annual General Shareholders Meeting held in June 2024, we announced that we expect Risperidone ISM potential sales to reach between €200 million and €300 million globally in upcoming years, which we are confident will represent significant growth in our specialty pharmaceutical business.

And now let me give a quick overview of half year 2024 financials. Total operating revenues fell by 14% to €329.3 million versus last year.

As you know, our business was impacted by a drop in contribution of the CDMO business. Sales of this division fell to €118.9 million due to lower revenues from the manufacturer of the COVID-19 vaccine in comparison to the first half of 2023 when ROVI had pulled higher income related to the production of the pandemic COVID-19 vaccine and finally, lower revenues related to the activities carried out to prepare the plant for the production of the vaccine and the agreement with Moderna.

However, I would like to point out the positive performance of our specialty pharma business. Sales were up 1% to an amount of €210.5 million in the first 6 months of the year, positively impacted by Okedi, Neparvis, Bemiparin and the contrast agents and other hospital products division.

I will touch upon the performance later in this presentation. In the first 6 months of 2024, profitability was negatively impacted by the lower contribution of revenues from the CDMO business as well as an increase in SG&A and research and development expenses.

EBITDA stood at €69.9 million in the first 6 months, a decrease of 28% compared to the same period of last year, reflecting a 4.3 percentage point decrease in the EBITDA margin, which was down to 21.2% in the first half of 2024. Likewise, net profit decreased by 32% to €44.3 million in the first 6 months of 2024.

Moving on to one of our main pillars of growth, our specialty pharma area, sales of prescription-based pharmaceutical products moderately decreased by 1% to an amount of €183.4 million in the first 6 months of the year. Sales of the heparin franchise, low molecular weight heparin, and other heparins decreased by 2% to €120.7 million in the first half of 2024, mainly due to lower orders for enoxaparin partners.

Bemiparin showed solid revenue performance in the first half of the year with sales up 6% to €47.2 million. Bemiparin international sales grew 32% with a strong contribution from China, Turkey and Greece.

We continue to see momentum for the product. Thus, we expect full year sales of Bemiparin to increase by a low 6% in 2024 compared to 2023.

We aspire to become a global leader in this field with Bemiparin and an Enoxaparin biosimilar. In this context, we’re investing not only increase our capacities for the production of heparins, but also to become self-sufficient in obtaining heparin and thus becoming a vertically integrated company in all the low molecular weight heparin manufacturing phases.

We are therefore proud to announce that, in June 2024, we received the European authority’s approval for the commencement of commercial activity at the new sodium heparin plant in Escuzar. With this new plant, we increase our capacities for the production of heparins, a medicine that is classified as essential by the World Health Organization and among the talks included in the European Juniors Critical Medical Alliance in which ROVI participates.

ROVI continues with its internalization plan. Sales outside of Spain represented 57% of operating revenue in the first 6 months of 2024 versus 63% in the same period of last year.

Sales outside of Spain stood at €188.4 million, reflecting a 22% decrease, mainly due to the lower sales contribution of the CDMO business. Regarding Enoxaparin biosimilar, it is already present in 40 countries, and we continue to sign out license agreements to distribute the product in more countries.

In the first half of the year, Enoxaparin biosimilar sales decreased by 6% to €69.8 million, mainly due to lower orders from enoxaparin partners. However, ROVI spends a greater concentration of focus on Enoxaparin partners in the second half of 2024 compared to the first 6 months of the year.

So let me just summarize the opportunity here. This is a €2 billion market, €1.3 billion in Europe and €700 billion in emerging countries with high entry barriers where biosimilars are likely to reach between 50% to 70% of market share with only 3 other players in the market.

The growth drivers of the specialty pharmaceutical business were Okedi, Neparvis, and the contrast agents and other hospital products. Now, taking each one of the plants in turn step by step, sales of Okedi, the first ROVI product based on its leading-edge drug delivery technology, ISM for the treatment of schizophrenia in others for whom tolerability and effectiveness has been established with oral Risperidone reached €12.5 million in the first 6 months of 2024.

Okedi sales multiplied the 2023 first half sales by 141%. In 2024, the product was approved in the United States, under the brand name of Risvan, Canada and Australia.

In 2023, it was launched in Portugal, Italy, Austria, Greece and Serbia. And in 2022, it was launched in Germany, U.K.

and Spain. The feedback we are receiving from Sekadis is still very positive.

The outlook for this product is, therefore, highly promising. And as previously mentioned, we expect potential sales to increase to €200 million and €300 million in the coming years.

Sales of Neparvis, a specialty product from Novartis launched in December 2016, indicated for the treatment of other patients with symptomatic chronic heart failure and reduced ejection fraction increased 13% to €25 million in the first half of the year compared to €22.1 million in the first half of 2023. Sales of Vytorin and Orvatez, specialty products from Organon, indicated as an injunctive therapy to dieting patients with hypercholesterolemia, decreased 5% to €13 million in the first half of 2024 compared to €13.7 million in the first half of 2023.

This increase was mostly caused by a deferral of Orvatez wholesaler [Technical Difficulty]. Therefore, Orvatez sales for the year are expected to remain stable in comparison to full year 2023 sales.

ROVI ceased to distribute Vytorin as of 31 January last year. Sales of Volutsa from Astellas Pharma, launched in Spain in February 2015, decreased by 42% to €4.7 million, mainly due to a product price reduction of 47% in the second quarter of 2023.

And finally, sales of contrast imaging agents and other hospital products increased by 12% to €26.4 million in the first half of 2024. Regarding CDMO, sales declined 31% to €118.9 million as a result of, first, lower revenues from the manufacturer of the COVID-19 vaccine in comparison to the first half of 2023 when ROVI had booked higher income related to the production of the pandemic COVID-19 vaccine, and secondly, lower revenues related to the activities carried out to prepare the plant for the production of the vaccine under the agreement with Moderna.

As I reflect on the milestones achieved within this division, I’m very proud of what we have accomplished. Our team’s excellent execution has enabled ROVI to obtain FDA approval with no action indicated for our injectable manufacturing plants in Madrid, San Sebastian de los Reyes and Alcala de Henares for the fill-and-finish of Moderna’s COVID-19 vaccine, which demonstrates ROVI’s commitment to the quality and safety of our service.

As a result of our unique capabilities in syringe fill-and-finish, we are continuing to invest in our plans to expand our production capacity. Specifically, we are conducting an investment project at the San Sebastian de los Reyes plant to increase this site’s capacity to 500 million injectables in the coming years, which the community of Madrid has classified as a strategic project.

We believe our production capacity positions us as one of the largest and most experienced pharmaceutical groups in Spain with 8 fully integrated plants, 3 of which are fully engaged in contract development manufacturing operations. Moving to research and development, we are making very good progress with our two Phase 1 clinical trials.

In July 2023, we began the Phase 1 clinical trial of the new 3-monthly formulation of Letrozole in Europe to evaluate the pharmacokinetics, safety and tolerability of single ascending doses of Letrozole at different strengths in voluntary healthy post-menopausal women, the LEILA-1 study. In September last year, we began as well the Phase 1 clinical trial of the 3-monthly Risperidone injection, which would complement the current 4-weekly formulation of Risperidone ISM for the maintenance treatment of all the patients with clinically stable schizophrenia.

The clinical trial will evaluate the safety, tolerability and pharmacokinetics of various candidate formulations at different dose strengths and injection sites. And finally, moving on to our full year 2024 guidance, our outlook for the remainder of this year remains unchanged, and we expect operating revenue to decrease by a mid-single-digit percentage in comparison with 2023.

Notwithstanding, there are certain factors that have been considered when calculating this guidance. But although they could be relevant estimates are difficult to specify as a percent, including, among others, the following.

First, the situation of the national health systems due to the low vaccination ratios during the 2023 COVID-19 campaign could favor a more successful vaccination campaign in 2024. However, at this date, the company is not in a position to forecast how demand and production might evolve for the remainder of the vaccination campaign in 2024.

Secondly, it is hoped that the expansion of the compounding ascetic filling inspection, leveling and packaging capacities at ROVI’s facilities in Madrid and the current high demand for CDMO services in the market might favor obtaining new business with the resulting sales impact. This will have to be taken into consideration but cannot be estimated at present.

Overall, we are very satisfied with the performance of the company in the first half of 2024. 2024 is clearly a transition year.

The company is making significant investments that will lay the foundation for robust future growth. We are definitely at an inflection point with a multiyear growth opportunity driven by the recently approved ISM base and [indiscernible] Okedi in Europe, Canada and Australia and Risvan in the U.S., our first candidate validating our leading-edge drug delivery technology, ISM, the continued growth of our specialty pharma portfolio and expansion of our low molecular weight heparin franchise, new CDMO agreements which will help strengthen our manufacturing area, the increase in our production capacities that could provide us with a significant growth opportunity, and finally, the investment efforts made in R&D focused on our ISM technology, which we see as a new avenue for ROVI’s future growth.

These growth levers are firmly underpinned by a very solid, ongoing business that has delivered year after year based on our leading specialty pharma franchise and our high-value added CDMO services. And with that, I would like to turn it back over to Javier, who will run you through the financials in more detail.

Thank you very much for your attention and for taking the time to participate in this meeting.

Thank you, Juan. As Juan already mentioned, 2024 is emerging as a year of transition, a year in which value is created for the future.

In this context, in the first half of the year, operating revenue was €329.3 million, a 14% decrease on the first half of 2023, mainly due to the performance of the CDMO business and this division’s - as this division generated lower revenues from the manufacture of the COVID-19 vaccine in comparison to first half 2023, where ROVI had booked higher income related to the production of the pandemic COVID-19 vaccine, and also lower revenues related to the activities carried out to prepare the plant for the production of the vaccine under the agreement with Moderna. However, sales from the specialty pharmaceutical business increased 1% to €210.5 million.

Sales of low molecular weight heparins decreased by 2% in the first half of 2024, mostly due to a decrease in enoxaparin sales. However, Bemiparin sales increased 6% to €47.2 million in the first half of this year, mainly linked to higher orders from partners in China, Turkey and Greece.

ROVI expects full year sales of Bemiparin to increase by a low single-digit percentage in 2024 compared to 2023. Gross profit decreased 9% to €195.6 million in the first half of 2024 compared to the first half of last year.

However, the gross margin was 59.4% in the first 6 months of 2024, an increase of 2.8 percentage points on the first half of 2023. This increase is mainly due to the decrease in the contribution to the manufacturing business of revenue relating to activities to prepare the plant to produce medicines under the agreement with Moderna, which, as you know, contributed lower margins to group sales; also, the increased contribution to the CDMO business by existing customers, excluding Moderna, which contributed higher margins; and finally, the increased contribution of sales of Okedi, which contributed higher margins, too.

In the first 6 months of 2024, raw material prices for low molecular weight heparins fell 55% compared to the first half of 2023. ROVI expects this decrease in heparin raw material prices to be confirmed in 2024.

Not withstanding, in spite of the decrease in heparin raw material prices, the impact on the gross margin was negative in the first 6 months of 2024. However, a positive impact on the gross margin is expected from 2025 onwards.

ROVI continues to be committed to innovation. R&D expenses increased 13% in the first months of 2024 due to the development of the Phase 1 of Letrozole LEBE and the development of the Phase 1 of a new formulation of Risperidone ISM for a 3-monthly injection.

Both projects were in the preparation phase in the first half of 2023. Selling, general and administrative expenses, SG&A, moderately increased 5% in the first half of 2024 compared to the same period of the previous year.

This increase was a consequence of higher employee benefit expenses, excluding R&D, which increased 10% in the first half of 2024 versus the first half of 2023, mainly due to a 10.3% wage increase under the general collective agreement for the chemical industry, and second, an increase in other operating expenses, excluding, again, R&D, mainly due to Okedi’s launch in Europe. EBITDA totaled €69.9 million in the first half of 2024, a decrease of 28% compared to the first half of 2023, reflecting a 4.3 percentage point decrease in the EBITDA margin to 21.2% in the first half of 2024.

EBIT decreased by 34% in the first half of 2024, reflecting a 5.2 percentage point decline in the EBIT margin to 17.1% in the first half of 2024. At the same time, net profit decreased by 33% to €44.3 million, sorry, in the first half of 2024.

If we do a pre-R&D analysis, EBITDA, pre-R&D, calculated excluding R&D expenses, in the first half of the year decreased only by 24%. EBIT, pre-R&D, again, decreased by 29%, and net profit, pre-R&D, again, decreased only by 28% in the first half of 2024.

Moving on to the evolution of CapEx and cash flows, ROVI invested €18.7 million in the first half of the year compared to €18.2 million in the same period last year. Of this amount, €15.2 million relates to investment CapEx regarding our facilities, including important projects such as the ISM industrialization, Glicopepton 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 the new filling lines and the operating – operations expansion.

€3.4 million relates to maintenance and other CapEx. Cash flow from operating activities decreased to €29.8 million in the first half of 2024 from €52.5 million in the same period of 2023.

This decrease was mainly due to the decrease of €29.7 million in profit before income tax and the increase of €27.1 million in the trade and other receivables item in the first half of 2024. The decrease of €29 million compared to a decrease in €29 million in the trade and other payables item in the first half of 2024.

Regarding our debt, as of June ‘24, ROVI total debt increased to €121.2 million. €94.6 million is debt with banks, representing 78% of total debt, while €9.1 million correspond to debt with public administration related to the development of R&D projects, which is at 0% interest rate debt, representing 8% of total debt.

And €17.5 million corresponds to financial liabilities for leases, representing this figure, 14% of our total debt. In July of ‘22, ROVI announced that the European Investment Bank had granted a new loan to support its investment in research, development and innovation.

As of June ‘24, ROVI had drawn €10 million against this new facility at a variable rate of Euribor at 3 months plus 0.655%. The interest rate for this first repayment is 4.552%.

Additionally, ROVI has signed three credit policies, one in September of ‘23 for €20 million and another in March ‘24 for €20 million, too, both with conditions of Euribor 3 months plus 0.5%. And in June ‘24, our third policy was signed also for €20 million at Euribor 3 months plus 0.65%, as well as two loans of €25 million each at fixed rates of 3% and 3.49%, respectively.

Let me clarify that. At June ‘24, ROVI had not drawn down on any of the policies.

At June 30, 2024, ROVI had a gross cash position of €46.4 million compared to €26.8 million as of December 31, 2023, and net debt of €74.7 million compared to €38.6 million at end of last year. Regarding the dividend, ROVI’s General Shareholders’ Meeting, held on 24th June ‘24, approved the payment of a gross dividend of €1.1037 per share.

This represents approximately 35% of the ‘23 consolidated net profit attributed to the parent company. This dividend was paid on the 10th of July this year.

Considering the group’s cash generation and the market situation, ROVI decided to launch a buyback program for the company’s shares effective at 26th of July 2023. On 11th of June this year, ROVI informed on the completion of this buyback.

Under the framework of this program, a total of 2,233,466 shares were acquired for an amount of €130 million, which represents approximately 4.3% of the share capital. As notified when the buyback program commenced, the purpose of the program was to cancel sales of ROVI through our reduction of capital and, at the same time, to contribute to ROVI shareholders’ remuneration by increasing net profit per share.

The reduction of the capital will be carried out by canceling 2,780,395 shares. The latter corresponds to shares repurchased within the framework of the mentioned buyback program and part of the existing treasury sales, which totaled 546,929 shares.

The capital reduction was approved at the ordinary General Shareholders’ Meeting held on the 24th June, ‘24. The new amount of the share capital, after the shares mentioned have been canceled and excluded from trading, will appear in the registers of the National Securities Market Commission and Iberclear, a few days after registration of the deed of capital reduction.

The company will provide further information in due course. Regarding news flow for this year, we will continue to monitor the evolution of the manufacturing of the Moderna portfolio products.

We expect to announce Okedi’s launch in more countries. As you know, the product has already been launched in Germany, UK, Spain, Portugal, Italy, Austria, Greece and Serbia.

We also expect to market Risperidone ISM in the different countries already approved, U.S., Canada and Australia. In addition, we expect to inform on new national marketing approvals for the enoxaparin biosimilar outside Europe.

Regarding our R&D, we are making good progress with the first clinical trial of Letrozole ISM and the new formulation of Risperidone for a three-monthly injection. And that’s all regarding our financial results for the first half of the year.

We then can now start the Q&A session. If you want to ask any questions, please do not hesitate to send them through the question button on the platform.

Good morning. The first questions came from Pablo – Pablo de Renteria from Kepler.

So, Juan, the first one is for you. When do you think you will be able to provide more details about the strategy to enter the U.S.

market with Risvan? When do you expect the product launch?

Hi. Thank you.

Good morning again. I mean really, the approval of Risvan has been a – I mean a major milestone for the company.

And I would like to further highlight this – I mean this item. I mean it’s important not only because we have managed to get our product approved in the U.S., but as well because it means that is the validation of our platform by the FDA, which obviously it sets a very positive regulatory pathway to feature the developments.

And this is something that I will keep on highlighting on every single call because it has been many years of hard working. And therefore, with Risvan, we just want to make sure that we are going to do it the right way.

The U.S. market compared to Europe, probably is a much more dynamic market.

And therefore, what we are currently doing is continuously investing to have all the adequate market data and intelligence to make sure, as I mentioned before, that when we decide to whom to partner, decide to launch, we do it in the right way. Besides, as well, we are trying to really understand or to better understand the rationale why Perseris has been withdrawn from the market.

And what can I say currently is it’s really our top priority. And hopefully, we expect to be able to announce our strategic decision before the end of the year.

This is also for you. What is your view on the discontinuation of Perseris marketing in the U.S.?

Well, as I mentioned, I mean we currently make a guess. We don’t have much intel than that has been published by the proprietary company of the product.

If I have to make a guess, and again, as I mentioned before, we are just now dedicating our time and resources to fully understand. What is well known is that I mean they do not own the technology.

So, I guess therefore, they will have – they must have to pay significant royalties towards Stifel, which is the owner of the technology. In that case, just to make it a comparison, Roy, I mean, we do own our asset [ph] technology.

As well, it’s important to highlight that, at least from our view, the market perception is that Perseris has got a lower efficacy due to certain viability problems. Just to make some – just to make a summary, I mean the doors that really provides the personal levels to the oral Risperidone of 4 milligrams is a dose of 120 milligrams, which is – that’s not the case with and with Okedi, or Risvan in this case, which has a similar dose of 100 milligrams.

And therefore, as well as results show that we are as fast as the oral medicine, and we provide immediate and sustained dose levels daily 8 milligrams with no need for loading dose or supplementation with oral Risperidone. So, I guess as well the efficacy trials of Perseris probably just faced a problem of this low viability, which when we compare to efficacy values, significantly performs worse than doses of Okedi [indiscernible] patients.

But as I mentioned before, we can only make a guess that probably from a financial point of view and as to where the market perception of this lower efficacy may be. And again, we can only talk in a conditional way – maybe the rationale behind this drastic decision by the company-owned Perseris.

Thanks Javier – Juan, sorry. Javier, Pablo also asks, do you anticipate fully allocating the ongoing capacity expansion in the CDMO business anytime soon?

Thanks Marta. Thanks Pablo.

Good morning again. Well, as we have been mentioning in the presentation, we have even decided to keep expanding our capacity from manufacturing more injectables.

And basically it’s that the CDMO injectable market is growing at a very high rate and all the analysis remarks, but also the biopharma market and all these injectables, new products will keep growing at an incredible speed also in the coming years. Let me say that, in addition to that, as everybody knows, the last acquisition of Catalent by Novo Nordisk will also make this opportunity even bigger.

As the current customers of Catalent, they will probably need to find another manufacturer once the transaction is approved by the authorities. So, all-in-all, the market is going to keep growing in a very high growth rate.

We already announced this year and secured a massive contract. And therefore, for all these reasons, we are very optimistic that we will be able to sell our current spare capacity, but also the new one that we are building in the new – in the coming years.

So, we are having more talks and more conversation with different customers more than ever, more than ever before. And therefore, we are really, really optimistic to field this spare capacity.

Thanks Javier. Guilherme Sampaio from CaixaBank has two questions for you, Javier.

The first one is, how are you seeing vaccination campaign this year? You are still mentioning in your 2024 guidance potential news again with contracts?

How optimistic are you regarding potential new contracts still having an impact in 2024 figures?

Yes, I mean vaccination campaign this year, it’s still early for us to finally have a better view. We are right now manufacturing potentially the U.S.

campaign. In the U.S., the authorities changed the strains selected for the vaccine profile in the last minute, and that has moved all production or has stressed the production efforts to a new variant, to the KP.2 variant.

And this has stressed all the manufacturing supply chain for all the players. So, therefore, we don’t have that much visibility right now how the campaign will end.

We are very optimistic that Moderna is preparing well and probably better than other players. Apart from that, we still see a clear vaccination opportunity in the market still from the pandemic times.

And we can see that from – also from the flu vaccine – from the flu vaccine data and campaigns. So, it’s still early to see how the campaign is going to end.

But again, I think Moderna is well prepared, and we are optimistic of the potential in a new – in the next coming weeks, we will have more visibility, and we can provide even better news to the market. I don’t know if he wants another question, Marta?

Yes. The second one, Javier is, is low-double digit growth in SG&A, a good reference for the second half of the year?

Yes. As you know, we expect more growth in the second part of the year for the company.

That is related to the CDMO business mainly and the vaccination campaigns that we are producing the vaccines right now. And therefore, potentially, we will see a slight increase in SG&A in the second part of the year.

So, you are right. Potentially, I would say, maybe a high-single digit growth in SG&A would be a target, yes.

Okay. Thanks Javier.

James Vane-Tempest from Jefferies has a question for you, Juan. Can you clarify that the €200 million, €300 million for Risvan is your sales, so in-market sales would be much higher?

Hi James. Good morning.

No, when we made peak sales and we made this guidance on Okedi, Risvan, we are talking about the sales of the product – the sales of the product. That’s – but again, we are extremely enthusiastic.

I think the market acceptance in Europe for the product has been magnificent. We already have very good intel on the markets that we have launched the product, not only Spain, but Germany, Italy, Portugal, Austria, UK, and the feedback is extremely positive.

We know that it’s going to take some years before we reach that peak sales. As I always like to remind that these are current patients, so we are always working on the dynamic market of those patients, they have to change treatments for whatever reasons, or naïve patients.

And that will take some years, but definitely, the first intel of the product and the initial feedback that we are hearing from the market is really beyond our expectations, much better.

Okay. Thanks Juan.

Javier, James Vane-Tempest also wants to know if actually there may be limited amounts, you can say, what update can you give us on the CDMO strategic review and when we could get an update on the outcome from this?

Thank you, James. Good morning again.

I mean as probably through the appropriate channels, as you know, we announced at ROVI, in the context of the assessment entrusted to [indiscernible] on total strategic alternatives are to put in value of our assets. We have received from various entities non-binding offers for the acquisition of our CDMO business, this subject to several conditions, as usual in this sort of transaction, such as carrying out financial and legal due diligence and the negotiation of satisfactory agreements for us, as always.

As of today, the process is ongoing and ROVI continues assessing the convenience of potential transaction and interacting with the potential buyers. Right now, in any event, if ROVI decided to go ahead with any proposal, and as I have said before, if the applicable conditions are met, and we finally agreed on the contracts, the transaction anyhow will remain subject to the approval by ROVI’s general shareholders’ meetings and where appropriate by the competent antitrust and foreign investment control authorities.

Again, just I will highlight that there are no final decisions taken yet, and we will keep updating everybody in the channels that are appropriate. Thank you.

Thanks Javier. And the last question comes from Alvaro Lenze from Alantra Equities.

Juan, it’s for you. Do you expect to sign more large contracts like the one announced earlier this year, or are you now looking to smaller contracts and a more diversified client base in CDMO?

I mean the CDMO business, as Javier has mentioned before, is really, at least to me, bullish right now. I mean we believe we have a historic opportunity.

And we are looking both in terms of customers. We are aiming at smaller contracts.

We are also aiming at large contracts. I think there is going to be a tremendous opportunity, especially in the second half or in the first half of next year, once the Novo Nordisk now holding Catalent acquisition is cleared by authorities and is closed.

I think there is going to be a tremendous opportunity for companies like us. We do have the spare capacity.

We have the technical skills. We have the regional quality approvals.

So, we are right now preparing and working just to make sure that we can capture this opportunity. I am being completely honest, we are not going to disregard any sort of potential commercial agreement, whether it is a smaller quantity, a smaller player, or larger quantities when it comes to a contract.

I believe the opportunity probably is a one lifetime event. Definitely ROIS and ROVI, we are just working hard just to be sure that we are prepared to capture as much as possible this opportunity.

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. Let me now hand the floor over to our CFO, Mr.

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

Thank you. Thank you, Marta.

Just we are ending this conference call results. Thank you for joining us today and have a nice summer break for all of you.

Thank you and goodbye.