Bemiparin sodium

ROVI ACHIEVED OPERATING REVENUE OF 329.3 MILLION EUROS AND INCREASED ITS GROSS MARGIN BY 2.8 PERCENTAGE POINTS Operating revenue in the first half of 2024 was 329.3 million euros, a 14% decrease on the first half of 2023, mainly due to the performance of the CDMO business. This division generated (i) lower revenues from the manufacture of the COVID-19 vaccine in comparison to the first half of 2023, when ROVI (the "Company" or the "Group") 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. Positive evolution of Okedi® (Risperidone ISM®), which sales multiplied the 2023 first-half sales by 141% in the first half of 2024, totalling 12.5 million euros. ROVI expects Risperidone ISM® to reach potential sales of between 200 and 300 million euros globally in upcoming years and to become a significant player worldwide in the field of long-acting injectables to treat schizophrenia. Sales of the heparin franchise (low molecular weight heparins (LMWH) and other heparins) decreased by 2% to 120.7 million euros in the first half of 2024, mainly due to lower orders from enoxaparin partners. However, ROVI expects a greater concentration of orders from enoxaparin partners in the second half of 2024 compared to the first six months of the year. In addition, sales of the heparin franchise increased by 14% to 64.3 million euros in the second quarter of 2024 compared to the first quarter of 2024. Good performance of Neparvis®, sales of which increased by 13%, in the first half of 2024 compared to the same period of 2023, rising to 25.0 million euros. In April 2024, ROVI announced that its subsidiary 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 its 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 impact with an increase ranging between 20% and 45% over 2023 sales. Gross margin was 59.4% in the first six months of 2024, an increase of 2.8 percentage points on the first half of 2023. This increase was mainly due to: (i) the decrease in the contribution to the manufacturing business (CDMO) of revenue relating to activities to prepare the plant to produce medicines under the agreement with Moderna, which contributed lower margins to Group sales; (ii) the increased contribution to the CDMO business by existing customers (excluding Moderna), which contributed higher margins; and (iii) the increased contribution of sales of Okedi®, which added higher margins. Net profit was 44.3 million euros in the first half of 2024. The ROVI General Shareholders Meeting, held on 24 June 2024, approved the payment of a gross dividend of 1.1037 euros per share; which represents approximately a 35% pay-out. This dividend was paid on 10 July 2024. Commitment with shareholders ROVI's General Shareholders Meeting, held on 24 June 2024, approved the payment of a gross dividend of 1.1037 per share. This represents approximately 35% of the 2023 consolidated net profit attributed to the parent company, broken down as follows: Application of profit: the entire profit of Laboratorios Farmacéuticos ROVI, S.A. for 2023, 12,071,013.68 euros, was applied to the dividend distribution; and Additionally, a further 47,546,618.80 euros was distributed as dividends charged to the freely-available reserves accounted for as “Retained earnings”. This dividend was paid on 10 July 2024. End of the share buy-back programme On 11 June 2024, ROVI informed on the completion of the Buy-Back Programme launched on 26 July 2023. Under the framework of this programme, a total of 2,233,466 shares were acquired for an amount of 130.0 million euros, which represents approximately 4.3% of the share capital. As notified when the Buy-Back Programme commenced, the purpose of the programme was to cancel shares of ROVI through a reduction of capital and, at the same time, to contribute to ROVI’s shareholder remuneration by increasing the profit per share. The reduction of the capital will be carried out by cancelling 2,780,395 shares. The latter corresponds to (i) the shares repurchased within the framework of the aforementioned Buy-Back Programme, and (ii) part of the existing treasury shares, which total 546,929. The capital reduction was approved at the Ordinary General Shareholders’ Meeting, held on 24 June 2024. The new amount of the share capital, after the shares mentioned have been cancelled and excluded from trading, will appear in the registers of the National Securities Market Commission and Iberclear a few days after registration of the deed of capital reduction. The Company will provide further information in due course. 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 remainder of 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. About ROVI ROVI is a pan-European pharmaceutical company specializing and engaging in the research, development, contract manufacturing and marketing of small molecules and biological specialties. The company, in a continuous international expansion process, has subsidiaries in Portugal, Germany, the United Kingdom, Italy, France and Poland and has a diversified marketing portfolio of more than 40 products, among which its flagship product, Bemiparin, already present in more than 60 countries all over the world, should be highlighted. Likewise, in 2017, ROVI commenced the marketing of its Enoxaparin biosimilar, developed in-house, in Europe and it is already marketed in 40 countries. ROVI continues to develop the ISM® Platform technology, a leading-edge line of research in the field of prolonged drug release with proven advantages. For more information, please visit www.rovi.es. Forward-looking statements This news release contains forward-looking statements. Such forward looking statements involve known and unknown risks, uncertainties and other factors which might cause the actual results, financial condition, performance, or achievements of ROVI or industry results, to be materially different from any future results, performance, or achievements expressed or implied by such forward looking statements. The statements in this press release represent ROVI's expectations and beliefs as of the date of this press release. ROVI anticipates that subsequent events and developments may cause these expectations and beliefs to change. However, while ROVI may elect to update these forward-looking statements at some point in the future, it specifically disclaims any obligation to do so. These forward-looking statements should not be relied upon as representing ROVI's expectations or beliefs as of any date after the date of this press release. Alternative performance measures In addition to the financial information prepared in accordance with International Financial Reporting Standards (“IFRSs”) taken from our financial statements, this document includes certain alternative performance measures (“APMs”) as defined in the ESMA (European Securities and Markets Authority) Guidelines on Alternative Performance Measures of 5 October, 2015 (ESMA/2015/1415), as well as some non-IFRS financial indicators. The financial measures contained in this document that are considered APMs or non-IFRS financial indicators have been prepared on the basis of the ROVI Group’s financial information but are not defined or set out in detail within the framework of the applicable financial information and have not been audited or reviewed by ROVI's auditors. These APMs are considered figures that have been adjusted in respect of those that are presented in accordance with the International Financial Reporting Standards endorsed by the European Union (IFRS-EU), which form the applicable accounting framework for the consolidated financial statements of the ROVI Group. Therefore, the reader should consider them to complement the latter but not to replace them. We use these APMs and non-IFRS financial indicators to plan, oversee and assess our performance. We consider the APMs and non-IFRS financial indicators to be useful to allow the management team and investors to compare the past or future financial performance, the financial situation and the cash flows. Notwithstanding, these APMs and non-IFRS financial indicators are considered complementary and are not intended to replace IFRS measures. Furthermore, other companies, including some in ROVI's sector, may calculate such measures differently, which reduces their usefulness for comparative purposes. To obtain further information on the alternative performance measures (APMs) and non-IFRS financial indicators used, including the definition thereof and a reconciliation between the applicable management indicators and the financial information set out in the consolidated financial statements prepared under IFRSs, please consult the information included on this subject on Appendix 2 (pages 35-39) of the press release on the financial results for the first half of 2024. Said document is available on ROVI’s website and may be accessed on the following link: (https://www.rovi.es/en/shareholders-investors/financial-business-information).

Madrid – 2 April, 2024 – Today, Laboratorios Farmacéuticos Rovi, S.A. (“ROVI” or the “Company”) has announced that the U.S. Food and Drug Administration (FDA) has authorised the marketing of Risvan® (Risperidone ISM®) for the treatment of schizophrenia in adults. Risperidone ISM® is a prolonged-release injectable antipsychotic developed and patented by ROVI for the treatment of schizophrenia in adults, which, as of the first injection, provides immediate and sustained plasmatic drug levels and does not require loading doses or supplementation with oral risperidone. This approval is based on the positive results of the pivotal PRISMA-3 study on the efficacy and safety of Risperidone ISM® in schizophrenia patients. The results obtained in this study show that the two different doses (75 mg and 100 mg once a month) have achieved the prespecified primary and secondary efficacy endpoints for treatment of patients with moderate to severe symptoms of schizophrenia. The primary efficacy endpoint, the PANSS total score (mean difference, CI: 95%), improved significantly with Risperidone ISM® 75 mg and 100 mg from the beginning until day 85, with adjusted differences of -13.0 (17.3 to -8-8; p <0.0001) and -13.3 (-17.6 to -8.9; p<0.0001), respectively, in comparison with the placebo. Significantly improved mean changes for the secondary endpoint, the CGI-S score, were also obtained for Risperidone ISM® in comparison with the placebo, -0.7 (-1.0 to -0.5; p<0.0001), for both doses, from the beginning until day 85. The significant statistical improvement for both efficacy results was observed as early as 8 days after the first injection. The most frequently reported treatment-emergent adverse events were increased blood prolactin (7.8%), headaches (7.3%), hyperprolactinemia (5%) and weight increase (4.8%). No important new or unexpected safety information was reported. Likewise, patients who successfully completed the double-blind period were offered the opportunity to continue in a long-term, open-label 12-month extension phase with once every four weeks injections of Risperidone ISM® (75 mg or 100 mg). New, clinically stable patients ("de novo" patients) were also able to enter this open phase of the study. Long-term treatment was observed to be effective, safe and well tolerated in adult patients with schizophrenia, regardless the initial severity of the disease or whether they had been treated previously with Risperidone ISM® during an acute exacerbation or switched from stable doses of oral risperidone. Likewise, Risperidone ISM® provided a swift and sustained improvement in functioning (both social and personal) and health-related quality of life. These findings, together with a quick onset of effectiveness, could help strengthen the therapeutic alliance and possibly lead to an earlier hospital discharge. Furthermore, the patient’s functioning either continued to improve or remained stable with long-term treatment. "We are very excited about the FDA’s approval of Risvan® because we think our medicine will be able to contribute to the clinical management of schizophrenia patients, helping to improve treatment adherence”, commented Juan López-Belmonte Encina, ROVI’s Chairman and Chief Executive Officer. About schizophrenia Schizophrenia is a chronic, serious and disabling mental disorder that affects around 1% of the world population. Schizophrenia patients are characterised by a mixture of symptoms, both positive (delusional ideas, hallucinations, disorganized language and behaviour) and negative (affective flattening, speech poverty, abulia) in nature. The disease usually starts at an age that is critical for personal development, often forcing patients to leave their educational or work activity and resulting in a great deal of suffering for the patients and their family environment, as well as an important loss for society. It is estimated that between 3% and 5% of total global healthcare expenditure is spent on schizophrenia. About the ISM® Technology ISM® is a Technology Platform for the release of drugs, patented by ROVI, which is based on the in situ formation of biodegradable matrices after the administration of a liquid carrier. Its unique characteristics allow therapeutic levels of the medicine to be obtained quickly after its administration, without the need for oral co-administration, additional boosters or loading injections to achieve and maintain the levels in a predictable and sustained manner, thus having a greater likelihood of meeting the patient's clinical needs. About ROVI ROVI is a pan-European pharmaceutical company specializing and engaging in the research, development, contract manufacturing and marketing of small molecules and biological specialties. The company, in a continuous international expansion process, has subsidiaries in Portugal, Germany, the United Kingdom, Italy, France and Poland and has a diversified marketing portfolio of more than 40 products, among which its flagship product, Bemiparin, already present in more than 60 countries all over the world, should be highlighted. Likewise, in 2017, ROVI commenced the marketing of its Enoxaparin biosimilar, developed in-house, in Europe and it is already marketed in 40 countries. ROVI continues to develop the ISM® Platform technology, a leading-edge line of research in the field of prolonged drug release with proven advantages. For more information, please visit ww.rovi.es.