ROVI REACHED 201.9 MILLION EUROS OF REVENUE IN THE FIRST POST-PANDEMIC QUARTER

• Operating revenue decreased by 2% to 201.6 million euros in the first post-pandemic quarter. 
• Positive evolution of Okedi® (Risperidone ISM®), which doubled its sales to 2.2 million euros in the first quarter of 2023, compared to the fourth quarter of 2022.
• CMO sales increased by 2% to 97.3 million euros in the first quarter of 2023.
• Heparin franchise sales (low molecular weight heparins or LMWHs and other heparins) decreased by 19% to 61.2 million euros, mostly due to the lower volume of orders from partners in the first quarter of 2023 in comparison with  the same period of the previous year, when sales of the enoxaparin biosimilar peaked at 44.2 million euros, almost 10 million euros higher than the average quarterly sales of the product in the last nine quarters.
• Good performance of Neparvis® and Volutsa®, whose sales increased by 22% and 16%, respectively, in the first quarter of 2023 compared to the first quarter of 2022, rising to 11.3 million euros and 5.0 million euros, respectively.
• Net profit decreased by 11% to 47.5 million euros.
• ROVI decided to commence the clinical development of a new three-monthly formulation of letrozole (hereinafter, Letrozole LEBE), rather than the initially planned annual formulation of Letrozole ISM®. The objective of this new development is to reach bioequivalence in the plasma levels of letrozole in comparison with the daily administration of oral doses of Femara® 2.5 mg.
• Regarding the evaluation process to obtain marketing authorisation for Risvan® (Risperidone ISM®) in the United States, the Food and Drug Administration (FDA) has notified ROVI that the user fee goal date is 27 July 2023. ROVI is awaiting an FDA inspection of its plant before the user fee goal date.

OUTLOOK

For 2023, ROVI expects its operating revenue to show low-double-digit negative growth on 2022, although positive growth of between 5% and 10% is expected in comparison with the 2021 figure.

For 2023, ROVI is assuming a new post-pandemic scenario in which COVID-19 would foreseeably be a seasonal disease and, in principle, the vaccine would be administered once a year. For this reason, ROVI expects a stronger second half of the year compared to the first half regarding the CMO business. The first quarter of 2023 includes revenues linked to the production of vaccines in the fourth quarter of 2022. ROVI expects that the second quarter of 2023 will be the lowest quarter in terms of CMO sales.

Nevertheless, the uncertainty related to the evolution of the disease is very high. It is not, therefore, possible to make a precise assessment of the impact that this new scenario could have on the CMO business. Likewise, under the terms of the agreement signed with Moderna in February 2022, ROVI is still investing in increasing the compounding, aseptic filling, inspection, labelling and packaging capacities at its facilities and expects them to be fully installed by the end of 2024. 

Taking account of the aforementioned guidance on a decrease in operating revenue in 2023, as well as the fact that ROVI will continue with its investment policy as stated, it is reasonable to expect that the Company’s profits may also see a downward adjustment in 2023.