Today, 25 November, is the International Day for the Elimination of Violence against Women.
At ROVI we do not tolerate harassment and we reject any form of violence, physical, sexual, psychological or moral harassment, abuse of authority at work or any other form of harassment or conduct that creates an intimidating or offensive environment for the rights of our employees.
ROVI also has an internal information system (Ethics Channel) which allows for fluid and effective communication with the bodies responsible for ensuring compliance with the company’s Code of Ethics, guaranteeing confidentiality and non-retaliation in the event of any type of harassment, abuse or violence suffered by a ROVI employee.
The City Council of Alcalá de Henares, in collaboration with the Official College of Pharmacists of Madrid (COFM), Laboratorios ROVI and the Foundation “España Salud”, have presented the project “Farmacias Cardioprotectoras”, which will allow a total of 24 pharmacies in this city, located in areas where this type of assistance is not forthcoming, to have a defibrillation equipment at the service of anyone who needs it.
This initiative provides for the installation of defibrillators in selected pharmacies, especially those with extended opening hours and away from other health centres. As health professionals closest to the population, community pharmacists will receive the necessary training to act in time, in order to reverse episodes of sudden death or sudden onset of cardiac arrest. The objective is to create a safety network of cardioprotective pharmacies to guarantee the population quick access to these devices, to reduce the number of deaths associated with cardiorespiratory arrests.
Cardiovascular problems are today the first cause of death in women and the second in men in Spain, accounting for 30% of deaths. Defibrillation has been shown to be an effective treatment that involves delivering a controlled electrical shock to the heart with the defibrillator.
“With this project, the pharmacy network once again demonstrates that it offers solutions to improve the care and health of the population; we want to offer greater peace of mind and tell citizens that we are better prepared to face an emergency, where reaction time is key to saving a life,” said the president of COFM, Manuel Martínez del Peral.
I am writing to announce an important transformation in the management of Laboratorios Farmacéuticos ROVI’s most important asset: its employees. As part of our commitment to the continuous improvement and optimisation of our internal processes, we have decided to implement an important change in our human resource management computer system so that we can become swifter and more agile.
To this end, we are going to adopt the Workday programme, a new tool with which we will unify and simplify the people-related administrative and management tasks at ROVI.
This new platform will allow us to centralise human resource management, furnishing each employee with greater autonomy and self-management capacity. When it has been implemented, you will be able to administer aspects related to your time, salary and professional development more directly, with updated information and easily accessible tools.
Impact on the human resources team
With this new computer system, the human resources team will be freed from various administrative tasks, which will allow them to take on a more strategic role in accompanying our workforce and providing advice on their needs. This change will enable the team to focus on supporting the professional development of each colleague and promoting an inclusive and collaborative work environment.
Next step
As of 1 October, Workday will become our partner for day-to-day procedures and may be accessed from both computers and mobile phones. As you know, we have begun/conducted a round of face-to-face sessions to familiarise our employees with the programme and favour their adaptation to the new system and its functionalities.
We firmly believe that this transformation will represent a significant advance for our organisation, allowing us to improve efficiency, autonomy and collaboration at all levels. From the human resources team, we would like to thank you for your commitment and cooperation in making this project a success and we reiterate that we will continue to work with you to enable ROVI to continue growing.
We have the pleasure of announcing that the Board of Directors of Laboratorios Farmacéuticos ROVI has approved the new Human Rights Policy. In this Policy, the Group, as a member of the United Nations Global Compact, reaffirms its commitment to ensuring that the activities conducted in the course of both its own operations and those of its value chain do not violate human rates or the Fundamental Conventions of the International Labour Organisation.
Respect for human rights is one of the basic pillars of ROVI’s values, as set out in its Code of Ethics, Environmental and Social Sustainability Policy and Corporate Social Responsibility Programme, in accordance with the standard SA8000. This new policy supplements these principles with the goal of generating a positive impact on ROVI’s stakeholders (workers, patients, healthcare professionals, suppliers and society) and ensuring that all the Group’s actions are guided by the strictest ethical standards.
In this half-year, special attention should be drawn to the 2.8 percentage point increase in the gross margin when compared with the first half of 2023, rising to 59.4%.
Operating revenue decreased 14%, mainly due to a lower contribution from the CDMO business, sales of which decreased to 118.9 million euros.
Operating revenue generated by the specialty pharmaceutical business increased 1% to 210.5 million euros.
Sales of the heparin division (low-molecular-weight heparins and other heparins) totalled 120.7 million euros in the first half of the year.
Low-molecular-weight heparins decreased 2% to 116.9 million euros in the first half of 2024, mainly due to the drop in enoxaparin sales. However, a greater concentration of orders from partners is expected in the second half of 2024.
Bemiparin sales increased 6%, driven mainly by a higher volume of orders from partners in China, Turkey and Greece.
ROVI expects bemiparin sales to increase by a low-single-digit percentage in 2024 compared with 2023. Risperidone ISM® sales rose 141% in the first half of 2024 versus the same period of 2023, totalling 12.5 million euros.
In 2024, this product has been approved in the United States, Canada and Australia, thus reinforcing ROVI’s internationalisation strategy. Risperidone ISM® is expected to reach potential sales of between 200 and 300 million euros globally in upcoming years. R&D expenses rose 13% to 12.2 million euros. 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 present.
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.
The Investment Accelerator of the Community of Madrid has declared as a strategic project the expansion that Laboratorios ROVI will undertake at its plant in San Sebastián de los Reyes (Madrid), with which it plans to increase its current production capacity, thanks to the commissioning of a new high-speed line with a capacity of 100 million syringes.
The expansion project will involve an investment of around 60 million euros. The group has acquired adjoining land for a total area of 54,715 m2, which will increase production capacity by more than 31.5 percent to a total of 420 million prefilled syringes and 80 million vials by 2027.
To respond to the increase in activity, the group will incorporate new buildings for the expansion of production areas and new lines, a new quality laboratory and office building, and auxiliary storage and maintenance buildings, among others. The project envisages providing the industrial complex with new accesses and improving internal circulation, as well as increasing the number of parking spaces to meet the needs of the current and future workforce.
The various investments to increase the plant’s production capacity between 2023 and 2027 will create 200 new direct skilled jobs.
With this, the ROVI Group is positioned as one of the largest industrial pharmaceutical groups in Spain and among the world leaders in the production of injectables.
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.
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.
