Operating revenue was 151.2 million euros in the first quarter of 2024, a 25% decrease on the first quarter of 2023, mainly due to the CDMO business. This division generated (i) lower revenues from the manufacture of the COVID-19 vaccine in comparison to the first quarter of 2023, when ROVI had booked higher income related to the production of the "pandemic" COVID-19 vaccine; and, (ii) lower revenues related to the activities carried out to prepare the plant for the production of the vaccine under the agreement with Moderna.
In April 2024, ROVI announced that its subsidiary ROVI Pharma Industrial Services, S.A.U. (“ROIS”) 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. 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 March 2024, the U.S. Food and Drug Administration (FDA) approved the marketing of Risvan® (Risperidone ISM®) in the United States to treat schizophrenia in adults. Additionally, following normal practice, the FDA has required that, as a post-marketing commitment, a pharmacokinetic study be conducted to evaluate exposure to Risvan® approximately equivalent to the daily administration of 6 mg of oral risperidone. The clinical protocol for the study will be reviewed and agreed previously with the FDA and the final report on the clinical study will be submitted by July 2026. This additional study does not affect approval or commercialization.
ROVI has likewise obtained approval for the marketing of Okedi® (Risperidone ISM®) for the treatment of schizophrenia in adults in Canada and Australia.
In March 2024, ROVI announced the creation, jointly with Insud Pharma S.L. and Innvierte Economía Sostenible SICC, SME, S.A. (the investment company of Centro para el Desarrollo Tecnológico Industrial EPE – CDTI) of Terafront Farmatech, a limited company (Sociedad de responsabilidad limitada) engaged in the research and development of advanced therapies. This alliance reinforces ROVI's commitment to innovation by expanding its R&D product pipeline beyond its ISM® technology.
In January 2024, the FDA inspected the company's active substance manufacturing plant in Granada with a satisfactory result. The inspection focused on the processes of manufacture and control of the active substance to be used in the manufacture of Moderna's mRNA COVID-19 vaccine. This result authorises Moderna to market the vaccine manufactured by ROVI in the United States.
Positive evolution of Okedi® (Risperidone ISM®), which had total sales of 5.4 million euros in the first quarter of 2024. Okedi® sales in the first quarter of 2024 were 2.4 times those of the first quarter of 2023.
Sales of the heparin franchise (low molecular weight heparins (LMWH) and other heparins) decreased by 8% to 56.3 million euros in the first quarter of 2024, mostly due to the decrease in orders from partners in the first quarter of 2024, since they still hold a high level of stock from the last quarter of 2023.
Good performance of Neparvis® and Orvatez®, of which sales increased by 8% and 2% respectively, in the first quarter of 2024 compared to the same period of 2023, rising to 12.2 million euros and 6.6 million euros respectively.
Gross margin was 56.6% in the first three months of 2024, which represents a decrease of 5.5 percentage points mainly due to the decrease in sales generated from the manufacture of the COVID-19 vaccine in the first quarter of 2024 compared to the same period of 2023, when they added higher margins to the Group.
Net profit was 15.0 million euros in the first quarter of 2024.
OUTLOOK
For 2024, ROVI expects its 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 that, although they could be relevant to the estimates, are difficult to specify at present, including, among others:
First, the saturation of the National Health Systems due to the low vaccination ratios during the 2023 COVID-19 campaign could favour a more successful vaccination campaign in 2024. However, as of today’s date, the Company is not in a position to forecast how demand and production might evolve for the vaccination campaign in 2024.
Second, it is hoped that the expansion of the compounding, aseptic filling, inspection, labelling and packaging capacities at ROVI’s facilities in Madrid and the current high demand for CDMO services in the market might favour obtaining new business, with the resulting sales impact. This would have to be taken into consideration but cannot be estimated at present.
Finally, subsequent to the granting of marketing authorisation for Risvan® by the United States FDA in March 2024, it is expected to start marketing the product on the United States market through a partner. The potential sales of this product in 2024 will depend on the terms of the agreement that ROVI establishes with its potential partner, which could also affect the estimates for 2024.
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