ROVI ACHIEVED OPERATING REVENUE GROWTH OF 1% IN THE FIRST POST-PANDEMIC YEAR

• Operating revenue increased 1% to 829.5 million euros in 2023 driven by the CDMO business, which grew 1% to 409.3 million euros, and the specialty pharmaceutical business, where sales rose 1% compared to 2022.
• 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.
• In September 2023, the FDA approved the company's CDMO's1 plants for injectables in Madrid, San Sebastián de los Reyes and Alcalá de Henares for the fill-and-finish syringe manufacturing of Moderna's COVID-19 mRNA vaccine.
• ROVI also expects to produce Moderna vaccines for supply in the United States from 2023 onwards.
• Positive evolution of Okedi® (Risperidone ISM®), which reached sales of 14.4 million euros in 2023. Okedi® sales increased by 42% in the fourth quarter of 2023 compared to the third quarter of the year.
• Sales of the heparin franchise (low molecular weight heparins (LMWH) and other heparins) decreased by 5% to 250.6 million euros in 2023, mostly due to the increase in orders from partners in 2022 related to the treatment for COVID-19, which has led to a lower volume of orders from partners in 2023, since they still hold a high level of stocks from 2022.
• Good performance of Neparvis® and Orvatez®, of which sales increased by 16% and 8% respectively, in 2023 compared to 2022, rising to 45.5 million euros and 26.5 million euros respectively.
• Gross margin showed a decrease of 4.5 percentage points mainly due to (i) the higher contribution to the CDMO business of the income related to the activities to prepare the plant for drug production under the agreement with Moderna, which added lower margins to Group sales; and (ii) the lower margin from the manufacture of the COVID-19 vaccine in 2023 compared to 2022.
• Net profit decreased by 15% to 170.3 million euros in 2023.
• Regarding the evaluation process to obtain marketing authorization for Risvan® in the United States, on 27 July 2023, ROVI reported that the FDA had issued a Complete Response Letter. In this letter, the FDA informed ROVI that satisfactory resolution of the deficiencies from the last inspection was required before the approval of the application and that there were no outstanding questions related to the dossier. On 21 September 2023, ROVI received the Establishment Inspection Report from the FDA with 4 outstanding observations from the FDA inspection of the facility. ROVI provided responses on 29 September 2023 and the FDA established a new Goal Date of 29 March 2024.
• In July 2023, ROVI achieved first place in the Sustainalytics world ESG risk ranking for the second year running. The company has improved its ESG risk rating by almost one point, improving its “Low Risk” rating to 16.4 versus 17.3 in 2022 and remains in first place among the 431 companies rated in the pharmaceutical industry category.
• ROVI will propose to the General Shareholders' Meeting a dividend of 1.1037 euros per share charge to the 2023 profit and retained earnings, This proposed dividend represents 35% of the net profit for 2023 attributed to the parent company.

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 customers, with the resulting sales impact. This would have to be taken into consideration but cannot be estimated at present.

Last, ROVI expects to obtain marketing authorisation for Risvan® from the United States Food and Drug Administration (FDA) in March 2024 and to market the product on the United States market, probably through a partner. The potential sales of this product in 2024 will depend on the terms of the agreement reached with the potential partner, which could likewise affect the estimates for 2024.

LAUNCHING OF A SHARE BUY-BACK PROGRAMME

ROVI informed that the Company launched, effective as of 26 July, 2023, a share buyback programme (the “Buy-back Programme”), in accordance with the following terms (see further information on page 28):

1. Purpose and scope: the Buy-back Programme’s purpose is to redeem own shares of ROVI (share capital reduction) while, at the same time, boost the remunerationof the ROVI shareholder by increasing the profit per share.
2. Term: from 26 July 2023 for a period of 12 months.
3. Maximum monetary amount: up to 130,000,000 euros.
4. Maximum number of shares to be acquired: 2,700,000 shares of the Company, representing approximately 5% of the Company’s share capital on 26 July 2023.

As of 31 January 2024, ROVI had executed approximately 74.85% of the buy-back programme, having acquired 1,808,392 shares for an amount of 97.3 million euros.