Laboratorios Farmacéuticos ROVI, S.A. (“ROVI”) announces that, on 7 May 2025, the Technological Development and Innovation Centre (CDTI) published the Proposed provisional resolution of the review committee on the call for proposals for grants for direct and associated participants in the Important Project of Common European Interest (Med4cure)[1], which approves the award of 36.3 million euros to ROVI to develop the R&D project IPCEI – ROVI (hereinafter, LAISOLID) within the framework of the Recovery, Transformation and Resilience Plan financed through the European Union Recovery and Resilience Facility, within the scope of the IPCEI Med4Cure, the first Important Project of Common European Interest focusing on health. This financing falls within the framework of the Strategic Project for Economic Recovery and Transformation for Cutting-Edge Healthcare.
ROVI will allocate the entirety of the grant received to the LAISOLID project, with the objective of developing sterile filling technologies for complex polymeric matrices capable of containing cells and biological material in regenerative medicine therapies, as well as active ingredients whose structural characteristics must be preserved in order to ensure proper functionality and appropriate release characteristics in the development of long-acting injectables (LAIs) capable of releasing the active ingredient over several months. With these developments, the Company intends to provide technological solutions that can be applied in tissue regeneration and the development of pharmacological treatments that improve the efficacy of therapies for serious diseases, such as breast cancer.
The project submitted by ROVI likewise proposes a new approach to the development of medicines based on predictive models that will accelerate the development of new pharmacological treatments with improved efficacy through the development and validation of models that establish quantitative relationships between formulation parameters and their clinical efficacy. These developments are particularly addressed to therapeutic areas in which effective treatments are lacking, and it is essential to access and maintain adequate plasma levels to ensure clinical efficacy.
ROVI, as a participant associated to the IPCEI project Medi4Cure Health, will have the support of a number of collaborations with European entities in the development of LAISOLID. The total budget for this R&D Project is 80,521,957 euros and ROVI will receive a grant of 36,341,035.65 euros from the Ministry of Science, Innovation and Universities and the CDTI. This budget is in line with the forecast average annual R&D expense reported by ROVI at the Capital Markets Day on 25 March 2025, which was between 40 and 60 million euros for the next 6 years (2025-2030).
Juan López-Belmonte, ROVI’s Chairman and Chief Executive Officer, said that, “With LAISOLID, we want to reinforce our commitment to healthcare innovation. We are confident that these new long-acting formulations will provide significant clinical improvements and help offer therapeutic solutions for the patients. This grant not only provides important financial impetus but also reinforces our position as a leader in innovation in our sector. Backed by our extensive experience in development new long-acting formulations, our work aims for this technology to allow a significant improvement in both the clinical efficiency and tolerability of the treatments. This European financing will be a key element in accelerating the evolution of our solutions and extending our scope through strategic collaborations with other leading companies in the European healthcare area.”
About IPCEI Med4Cure
IPCEI Med4Cure is the first European project focused on health. It aims to boost research, innovation and the first industrial deployment of healthcare products, in addition to innovative production processes in the pharmaceutical sector, addressing diseases for which there are no satisfactory means of prevention or treatment and enhancing the European Union’s preparedness for emerging heath threats. Likewise, it contributes to the objectives of the European Industrial and Pharmaceutical Strategy, Europe’s Beating Cancer Plan, the new European Research Area and the Green Deal.
Here you can review the new Training Policy of the ROVI Group, in which are described the processes for identifying needs and planning training activities for the ROVI’s workforce.
You can find it on ROVI’s website and in the Documents section of ROVI Rocks.
Laboratorios Farmacéuticos Rovi, S.A. has held its Ordinary General Shareholders’ Meeting, at which it presented an evaluation of the financial year 2023 and its plan for the launch of Risperidone ISM® for Europe and the rest of the world, with which it hopes to achieve potential sales of between 200 and 300 million euros globally in upcoming years.
The Meeting, with quorum on the first call, has passed all the motions on the Agenda that are submitted for its approval, including, among others, the motion to approve the individual and consolidated annual accounts of the company and the respective management reports for the year ended 31 December 2023, as well as the corporate management during the last financial year.
The company has presented its shareholders with consolidated operating revenue of 829.6 million euros in 2023, representing 1% growth on 2022, demonstrating the resilience of its business in the first year of a new endemic scenario.
CDMO sales rose 1% in 2023 compared with the preceding year 2022, totalling 409.3 million euros in 2023, mainly due to: (i) the booking of the revenue related to production of the COVID-19 vaccine; (ii) the booking of the revenue related to the activities carried out to prepare the plant to produce the vaccine under the agreement with Moderna; and (iii) the reorientation of the CDMO strategy towards products with a higher value-added.
The specialty pharmaceutical business sales increased 1% in 2023 compared to 2022, totalling 420.2 million euros, mainly driven by Okedi®, Neparvis® and Orvatez®. Sales of Okedi®, ROVI’S first product based on its vanguard drug delivery technology, ISM®, indicated for the treatment schizophrenia in adults for whom tolerability and effectiveness have been established with oral risperidone, were 14.4 million euros in 2023. These sales increased 42% in the fourth quarter of 2023 in comparison with the third quarter of the year. In 2022, the product was launched in Germany, the United Kingdom and Spain and, in 2023, in Portugal, Italy, Austria, Greece and Serbia. It is important to highlight the fact that, in the first quarter of 2024, the product was approved in the United States (under the trademark Risvan®), Canada and Australia.
Sales of Neparvis® grew 16% to 45.5 million euros, compared to 39.1 million euros in 2022. This is a prescription product from Novartis indicated for the treatment of adult patients with symptomatic chronic heart failure and reduced ejection fraction, which ROVI has been distributing in Spain since December 2016.
Ordinary General Shareholders’ Meeting can be seen at this link.
Sales of Orvatez®, a prescription product from the company Organon & Co. (“Organon”) indicated as adjunctive therapy to diet in patients with hypercholesterolemia, increased 8% to 26.5 million euros in 2023, compared with the 24.5 million euros of 2022.
Regarding the heparin franchise, ROVI aspires to become a global leader in the low-molecular-weight heparin (“LMWH”) field. The commitment to this franchise can be seen with the inauguration, in the fourth quarter of 2023, of a new production plant for the active substance of heparins, and the addition, in the second quarter of 2024, of a new sodium heparin facility, both of which are in Escúzar (Granada). Likewise, the company continues with its commitment to the vertical integration of the heparin supply chain by investing in the creation of the first national structure for the self-supply of low-molecular-weight heparins. ROVI expects this investment to contribute to an increase in the future margins of the heparin franchise and believes that the plant is likely to come into operation in 2026. Additionally, LMWH raw material prices dropped 35% in 2023 compared with 2022. This decrease is expected to accelerate during 2024 and to have a positive impact on the group’s gross margin from 2025 onwards.
In 2023, LMWH sales decreased 6% on 2022, dropping to 242.1 million euros in 2023, mainly as a result of the difference between the increase in partners’ orders related to COVID-19 treatment in 2022 and the lower volume of orders from partners in 2023, since they had held higher stocks of the products since 2022.
EBITDA decreased 12% on 2022 to 244.5 million euros in 2023, reflecting a drop of 4.6 percentage points in the EBITDA margin, which was 29.5% in 2023, compared to 34.1% in 2022.
Net profit totalled 170.3 million euros in 2023, showing a 15% decrease on the 2022 figure, which had been 199.7 million euros.
Net profit totalled 170.3 million euros in 2023, with a 15% decrease on the 2022 figure, which was 199.7 million euros.
Research and development (R&D) expenses increased 4% to 24.9 million euros in 2023. These R&D expenses relate mainly to (i) developing the phase 1 of Letrozole LEBE and (ii) developing the phase I of the new formulation of Risperidone ISM® for a three-monthly injection.
Sales, overhead and administration expenses rose 2% to 219.7 million euros in 2023, mainly resulting from the increase in expenses related to the launch of Okedi® in Europe. Notwithstanding, other operating expenses (excluding R&D and employee benefit expenses) decreased 11% to 106.4 million euros in 2023, due to an efficient cost containment policy.
Consolidation and international expansion plan for Risperidone ISM® in Europe and the rest of the world The European Commission authorised the marketing of Okedi® (Risperidone ISM®) in February 2022. Since then, the product has been marketed in a number of European countries. In 2022, Okedi® was launched in Germany, the United Kingdom and Spain and, in 2023, in Portugal, Italy, Austria, Greece and Serbia. These launches have consolidated ROVI’s internationalisation strategy as one of its pillars for future growth.
Furthermore, in March 2024, the FDA approved the marketing of Risvan® (Risperidone ISM®) for the treatment of schizophrenia in adults. Additionally, the FDA has required, as a postmarketing requirement following normal market practice, that a pharmacokinetic study be conducted to evaluate exposure to Risvan® similar to the daily administration of 6mg of oral risperidone. The protocol for the clinical study will be previously reviewed and agreed with the FDA and the final report on the study will be submitted before July 2026. This additional study does not affect either the approval or the marketing of Risvan®. Likewise, ROVI remains committed to the company’s international expansion outside Europe as a result of the approval of this product in Canada and Australia, also in 2024.
ROVI expects that, given its differential characteristics, Risperidone ISM® will reach potential sales of between 200 and 300 million euros globally in upcoming years and will become a significant player worldwide in the field of long-acting injectables to treat schizophrenia.
Expansion of ROVI’s industrial presence In June 2024, ROVI has obtained the European authorities’ approval for the commencement of commercial activity at its new sodium heparin plant in Escúzar (Granada). Thus, ROVI is positioned as one of the largest pharmaceutical industrial groups in Spain, with eight fully-integrated plants and a ninth under construction.
The Group has five plants to manufacture its own products and three for contract manufacturing. In Andalusia, it has three plants for its own manufacturing: two engaged in producing the active substance of low-molecular-weight heparins, in Granada and Escúzar, and the new plant that will be producing sodium heparin. ROVI is, therefore, prepared for production of a medicine like sodium heparin, which is classified as essential by the World Health Organisation and is, moreover, among the medicines included in the European Union’s Critical Medicine Alliance, in which ROVI participates.
Additionally, ROVI has two plants in Madrid engaged in the production of medicines based on its ISM® technology, in which 35.6 million euros has been invested in the last five years: at the first plant, the company produces Risperidone ISM®, while the second is used to manufacture products under development that use highly potent active ingredients.
Furthermore, ROVI has three plants engaged in contract manufacturing: in particular, two injectables manufacturing plants, located in San Sebastián de los Reyes and Madrid, and a third in Alcalá de Henares, which is engaged in producing solid oral forms and is a packaging centre of excellence.
Likewise, ROVI remains committed to the vertical integration of its value chain in order to achieve strategic autonomy in its medicine manufacturing process. In this respect, ROVI is making significant investments in the construction of a new plant in Huesca, which will transform pig mucosa into crude heparin and is considered likely to come into operation in 2026.
Laboratorios Farmacéuticos ROVI, S.A. (hereinafter “ROVI”), a specialised pan-European biopharmaceutical company engaged in research, has completed the work on its new plant in Escúzar (Granada) with the expansion of the existing facilities by 1,620 square metres and the inclusion of a new sodium heparin production line. With this operation, in which ROVI has invested an additional 11 million euros, the company continues to advance in the vertical integration strategy for its low-molecular-weight heparin (hereinafter, “LMWH”) franchise. Furthermore, the expansion of the Escúzar facilities is expected to create 15 new jobs, which would raise the total number of employees at these facilities to around 60.
Miguel Ángel Ortega Sánchez, ROVI’s Industrial Manager, said: “At ROVI, we are very proud to announce the completion of the work to expand our new plant in Escúzar, since it reinforces our production capacity significantly and makes our position among the world leaders in the heparin market even stronger.”
Thus, the new Escúzar plant now houses two lines within the LMWH manufacturing process: the production line for the active principle of heparins, which came into operation at the end of 2023 and has a capacity of 673,000 MIU (million international units), equivalent to approximately 134.6 million syringes, and the new sodium heparin production line, with a capacity of 1,200,000 MIU of sodium heparin for 2025, equivalent to 88 million syringes, which has now received authorisation to
commence commercial activity from the Spanish Agency of Medicines and Medical Devices.
The LMWH production process consists of three purification phases: it starts by obtaining crude heparin from pig mucosa, continues with the transformation into sodium heparin (unfractionated heparin), and concludes when the low-molecular-weight heparins are obtained.
The inauguration of this new sodium heparin facility represents a further step in the vertical integration of ROVI’s LMWH production. It joins the facilities that are being constructed in Fraga (Huesca) for Glicopepton, ROVI’s joint venture with Costa Food Group and Càrniques Celrà for the first part of the production process, and the already-existing LMWH production line in Escúzar.
With this strategy, ROVI continues to reinforce the guarantee, autonomy and visibility of the production of heparins, a product classified as essential by the European Union and the World Health Organisation and also a strategic business segment for ROVI, in which the company aspires to become a global industry leader.
Laboratorios Farmacéuticos Rovi, S.A. (hereinafter, “ROVI”), a pan-European pharmaceutical company that specialises and engages in the research, development, contract manufacturing and licensing of small molecules and biological medicines, has announced today that its subsidiary ROVI Pharma Industrial Services, S.A.U. (hereinafter “ROIS”) has entered into an agreement to support the manufacture of pre-filled syringes for a global pharmaceutical company.
Under the terms of the agreement, ROIS will provide a high-speed production line at the ROIS’ San Sebastián de los Reyes facility in Madrid, with an estimated annual capacity of 100 million units. The agreement includes the technology transfer for aseptic filling and has a commercial production term of five years subject to the terms of the agreement, beginning on the date of manufacture of the first commercial lot. After the technology transfer and regulatory approval, commercial production is expected to commence in 2026. As from 2027, which is expected to be the first full recurrent manufacturing year, the ROVI´s Group CDMO division expects to have a positive revenues increase impact ranging between 20% and 45% over 2023 sales.
ROIS is well-equipped to support the production of pre-filled syringes given its deep expertise in the current good manufacturing practice (cGMP) production of sterile injectable products across both vials and pre-filled syringes.
Juan López-Belmonte Encina, Chairman and Chief Executive Officer of ROVI, said: “We are delighted to be able to support in the manufacture of medicine that is able to prolong the life of millions of people. Our proven experience in the manufacture of high-valued-added injectables and the expansion of our production capacities have positioned us to help meet the rapidly growing demand, which requires a high degree of technological capability.”
For the second year running, ROVI has obtained the best ranking in the pharmaceutical industry category in the world rating of environmental, social and corporate governance (ESG) risks drawn up by Sustainalytics, a leading independent ESG research, rating and analytics firm that supports investors around the world with the development and implementation of responsible investment strategies. ROVI has revalidated its first place among 431 companies rated in the pharmaceutical industry group and remains in 22nd place among a total of 895 companies rated in the entire sector, which includes “biotechnology companies, pharmaceutical laboratories and laboratory equipment companies.”
In the rating process, Sustainalytics has analysed the company’s performance in sustainability aspects considered material in the pharmaceutical sector, highlighting ROVI’s sound management of ESG risks related to product quality and safety, corporate governance, business ethics, human capital, the fight against climate change and anti-corruption and anti-bribery practices. ROVI has obtained a higher-than-average score in areas such as the board’s involvement in the company’s environmental and social aspects, implementation of the environmental policy and a sound quality and safety programme for products and services, as well as the integration of ethical practices into all tiers of the organisation.
In 2022, ROVI approved its ESG Master Plan 2023-2025, a document that sets out 19 strategic ESG goals. With a three-year horizon, the Group has established a roadmap for attaining the Sustainable Development Goals (SDGs) of the United Nations Agenda 2030, with which ROVI, as a member of the Global Compact, is aligned.
The Group focuses its action on five priority areas:
– Becoming a leader in governance committed to sustainability.
– Commitment to sustainable management to combat the global environmental challenges: fight against climate change, promotion of the circular economy and efficient water management.
– Positioning itself as a key player in caring for persons and integrating specialised and diverse talent.
– Promoting responsible management of the supply chain, ensuring ethical and environmental standards in each one of its links.
– Promoting R&D&I activities by establishing partnerships with key players.
ROVI informs on the evaluation process to obtain marketing authorisation for Risvan® (Risperidone ISM®) in the United States and reports that the United States Food and Drug Administration (FDA) has issued a Complete Response Letter. In this letter, the FDA informs ROVI that it considers the responses to the evaluation of the Risvan® dossier to be complete and makes no additional observations.
Likewise, the letter states that ROVI must close the observations made by the FDA during its inspection in May 2023. ROVI will submit a response to reinitiate the procedure providing details of the responses that have already been filed. ROVI will then await a further notification from the FDA with the estimated User Fee Goal Date for the closure of the procedure, which is expected to be in February 2024.
Furthermore, there are no observations that have not yet been resolved by ROVI’s suppliers.
Therefore, ROVI will continue to report on the milestones deemed significant in the process to obtain authorisation of Risvan® from the FDA.
In just one week of life, our ROVI Forest has already had 948 trees activated. Below, we share with you the main data on the progress of our forest. If you haven’t activated your QR code yet, don’t wait and join the challenge!
We also share a tutorial for you to plant the seeds at home.
ROVI has published the financial results recorded in the first quarter of 2022. Among the main indicators obtained, the following stand out:
Operating revenue increased by 57% to 205.6 million euros driven by (i) the strength of the contract manufacturing organization (“CMO”) business, which grew by 167%, and (ii) the specialty pharmaceutical business, where sales rose 16%.
EBITDA increased by 113% to 74.3 million euros and Net profit increased by 123% to 53.0 million euros.
Sales of the heparin franchise (Low Molecular Weight Heparins (LMWH) and other heparins) increased by 19% to 75.9 million euros.
Sales of prescription-based pharmaceutical products rose 17% to 100.5 million euros in the first quarter of 2022.
Sales of the enoxaparin biosimilar increased 50% to 44.2 million euros in the first quarter of 2022 mainly because of (i) the launch of the product in four new countries in the first quarter of 2022 and (ii) the increase in the demand for the product in countries where we are already present.
In April, Okedi® (Risperidone ISM®) was launched in Germany for the treatment of schizophrenia in adults for whom tolerability and effectiveness has been established with oral risperidone.
ROVI is in a new phase of growth, supported by the strength of the third-party manufacturing business and the pharmaceutical specialties business, and exptects its operating revenue to increase by between 15% and 20% for 2022.
In recent days, health authorities have established a new surveillance and control strategy against covid-19 after the acute phase of the pandemic in Spain which implies that:
For the general population, the compulsory isolation of both positive cases and those suspected of being positive due to mild symptoms compatible with the infection has been eliminated.
The suppression of quarantines are maintained in case of having had close contact with a positive case.
In case of presenting symptoms, it is no longer mandatory to perform confirmatory tests (self-diagnostic test or PDIA[1]) or to notify the channels provided by the autonomous communities. Diagnostic tests are restricted to:
o People related to vulnerable areas (linked to health centers, social-health centers, day-care centers, prisons, etc.).
o Cases with severe symptoms requiring hospital admission.
o Persons who have been in the last 14 days in a region where a variant of interest or concern is circulating.
This new strategy of the Spanish health authorities implies accepting a certain level of SARS-CoV-2 transmission as long as a sufficiently high level of general vaccination has been achieved to minimize the severity of infections that may occur. For this reason, this new strategy makes it necessary to modify the case management established by ROVI so that, as of next Monday, March 28:
Employees will no longer report SARS-CoV2 infections or suspected SARS-CoV2 infections to ROVI.
The notificacionescovid19@rovi.es mailbox will be disabled.
Persons with symptoms consistent with covid-19 infection should contact their health center and follow their physician’s instructions. In case of sick leave, it will be processed through the usual channels through HR and, as in the case of common illness, they shall no communicate the origin of the illness causing the sick leave.
In addition, we will maintain until further notice the current 50% attendance rate for office personnel, as well as the mandatory use of masks at the workstation and the minimum separation of 1.5 meters between workstations.
As up to now, these measures may be revised if the indications of the health authorities are modified.
Thank you and best regards,
[1]Diagnostic Test for Active SARS-CoV-2 Infection (PCR or rapid test for detection of SARS-CoV-2 antigen, both in nasopharyngeal exudate).
– Immunosuppressed persons due to intrinsic or extrinsic causes (hematopoietic progenitor transplant recipients or CAR-T, within two years after transplantation/treatment, on immunosuppressive treatment or who have graft-versus-host disease (GVHD), regardless of time since transplantation; solid organ transplant recipients (less than two years or on immunosuppressive treatment for rejection events); primary immunodeficiencies: combined and B-cell in which absence of vaccine response has been demonstrated; persons who have received in the previous three months (six months in case of rituximab) anti CD20 drugs or belimumab; Down’s syndrome aged over 40 years.
