Actualidad de ROVI
We are pleased to inform you that you have at your disposal the new version of the ROVI Group’s Environmental and Social Sustainability Policy, approved on 24 June 2024.
This document sets out the basic principles of the company’s sustainable behaviour in relation to its stakeholders.
As well as attached in this e-mail, you will find the policy on ROVI’s web site.
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.
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.
Clean-up team…Let’s go! The ROVI Team put on its gloves to clean up the Casa de Campo of rubbish on Saturday 15 July. Together with the Fundación Deporte y Desafío, the 15 ROVI volunteers organised themselves into teams to sweep the reclaimed area of the Manzanares River, starting at the fountain and the viewpoint of the Huerta de La Partida and continuing on to the Palacio de los Vargas.
But it wasn’t all about cleaning up, as we took the opportunity to learn a little more about the history behind both locations, while doing recycling workshops with members of the foundation. Mission accomplished!
We would like to share with you the video of the activity and encourage you to take part in the ROVI Team’s volunteering activities.
Do you have an efficient way to recycle that you would like to share with your colleagues? Any tips on how to use less electricity? Do you do any environmentally friendly activities? Submit it to THE GREEN IDEAS and enter the competition.
The competition entries will be presented to ROVI employees so that they can choose their favourite. The 3 most voted will be awarded with:
1st Prize: Gift Card 300€.
2nd Prize: Gift Card 150€.
3rd Prize: Gift Card 50€.
To enter the competition, please send an email to galvaros@rovi.es with:
Deadline: 25 June
The ROVI Granada Team armed themselves with helmets and bicycles to tackle last Saturday’s bike ride with the Fundación Deporte y Desafío. During the 16-kilometre ride, the 15 ROVI volunteers were able to accompany the members of the foundation on their way to the adventure, completing the La Laguna route while enjoying the good weather and the views that accompanied them.
The starting point of the route was the Aura de la Naturaleza El Aguadero, where the volunteers were able to take the bikes provided by the foundation and set off. From there, a circular route awaited them, passing by the Ermita de la Virgen de la Cabeza (Cozvijar, Granada) and then continuing on to the Cascada del Río Dúrcal. A route with a low gradient and accessible to all participants.
Say goodbye to Diverclick. The new ROVI Discounts platform will bring more and better offers for ROVI employees.
If you are registered on the old Diverclick platform, you will have received an email where you can register on the new one. If you have accumulated money, don’t worry, as it will remain open for a while so you can spend it.
REGISTER FOR ROVI DISCOUNTS
Enter the platform by CLICKING HERE
Take advantage of exclusive offers for ROVI employees. On the website you’ll find discounts in restaurants, supermarkets, cinemas, travel agencies, hotels, fashion, perfumery, homeware… and much more.
Effort, healthy competition and lots of laughter came together on 27 and 28 April at the ROVI Padel Tournament. A total of 42 pairs competed to see who was the best on the courts, dividing the participants into 3 categories according to their level: beginners, intermediate and advanced.
The championship took place at Club Fuencarral A La Par, where 12 padel courts were reserved to make the different phases of the tournament more dynamic. The competition started with a group stage on Saturday 27th, where only the best 4 pairs of each one would go through. On Sunday 28th the final tournament took place, where each pair fought to win their category.
WINNERS OF THE ROVI PADEL TOURNAMENT
Laboratorios Farmacéuticos ROVI announces the financial results obtained in the first quarter of 2024, that is critically important in establishing the bases for ROVI’s future growth.
The company closed the first quarter of 2024 with operating revenue of 151.2 million euros, EBITDA of 25.9 million euros and a net profit of 15.0 million.
Revenue from the CDMO business decreased 48% to 50.1 million, mainly due to lower revenue from manufacture of the COVID-19 vaccine in comparison with the first quarter of 2023, when ROVI booked higher revenue from production of the ”pandemic” vaccine and lower revenue related to the activities to prepare the plant for production of the vaccine under the agreement with Moderna.
Sales of the heparin franchise (low-molecular-weight heparins and other heparins) fell 8% to 56.3 million euros in the first quarter of 2024, due to a lower volume of orders from partners, since they held a higher level of stocks of these products from the fourth quarter of 2023. Sales of Risperidone ISM® evolved positively upwards to 5.4 million euros in the first quarter of the year, multiplying the 2023 first quarter figure by 2.4. In March 2024, ROVI received FDA approval for the marketing of Risperidone ISM® in the United States to treat schizophrenia in adults.
This is a historic milestone for the company as this is the first of its own product to receive marketing authorisation in the United States, the most important market worldwide for long-acting injectable antipsychotics.
Additionally, in the first quarter of 2024, ROVI approved marketing authorisation for this product in Canada and Australia. Research and development expenses rose 17% to 6.1 million euros and were mainly related to the development of phase 1 of Letrozole LEBE and the development of phase 1 of the new formulation of Risperidone ISM® for a three-monthly injection. Additionally, we were able to decrease operating expenses, excluding R&D and employee benefit expenses, by 11% as the result of an efficient cost containment policy.
Regarding guidance for 2024, ROVI expects its operating revenue to decrease by a mid-single-digit percentage, although this guidance considers certain factors that could affect the estimates but are difficult to specify at the present time. ROVI is in a new phase of growth and has confidence in the development potential of its specialty pharmaceuticals division and its CDMO business.
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.”