Author: Beatriz García Suárez

ROVI reports the financial results obtained in 2021, a historic year for the group in terms of the figures achieved and the capabilities it demonstrated to adapt to the needs of the pandemic.

ROVI achieved operating revenue growth of 54% compared to 2020. This result was mainly driven by the strength of the contract manufacturing organization business, which grew by 189% and by the specialty pharmaceutical business, where sales rose 17%.

Net profit totalled 153.1 million, 151% up on the preceding year. EBITDA rose by 115% to 202.9 million euros in 2021, reflecting a 8.8 percentage point increase in the EBITDA margin, which rose to 31.3% in 2021 from 22.4% in 2020.

Sales of prescription-based pharmaceutical products rose 17% to 347.2 million euros in 2021.

Juan López-Belmonte, Chairman and Chief Executive Officer of ROVI said that “the 2021 results are historic for ROVI and demonstrate our company’s ability to continuously adapt”.

Laboratorios Farmacéuticos Rovi, a pan-European pharmaceutical company specializing and engaging in the research, development, contract manufacturing and marketing of pharmaceutical products, has announced that the Committee for Medical Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion recommending approval of ROVI’s product Risperidone ISM® -commercially known as Okedi®- for adult patients with schizophrenia.

This medicine is a monthly injectable antipsychotic developed and patented by ROVI for the treatment of schizophrenia in adults for whom the tolerability and effectiveness has been established with oral risperidone, since, as of the first injection, it provides immediate and sustained plasmatic drug levels and does not require loading doses or supplementation with oral risperidone. “We are very excited and satisfied at receiving the favourable recommendation of the CHMP because we believe that our product can contribute to the clinical management of schizophrenia patients”, commented Juan López-Belmonte Encina, ROVI’s Chairman and Chief Executive Officer.

The positive opinion of the CHMP is based on the positive results of the PRISMA-3 study on the efficacy and safety of the treatment. The results obtained in this study show that the prespecified primary and secondary efficacy endpoints were achieved with two different doses (75mg and 100 mg monthly) for the treatment of patients with acute exacerbation of schizophrenia. The primary efficacy endpoint improved significantly with the treatment from the beginning until Day 85. Significantly improved mean changes for the secondary endpoint were also obtained with the two doses. The significant statistical improvement for both efficacy results was observed as early as 8 days after the first injection.

The European Commission usually follows the recommendations of the CHMP (EMA), issuing its final decision on the basis thereof. The approval of this new drug is expected in approximately 60 days’ time and it could be launched in Europe in the

second quarter of 2022. Regarding other territories, ROVI filed the application for marketing authorisation for Okedi® with the United State Health authorities, the U.S. Food and Drug Administration (“FDA”), on 24 November, 2020 and the dossier is currently being reviewed by this agency. The new Risperidone ISM® product will increase the diversified portfolio of more than 40 products currently marketed by ROVI.

In Spain, there are around 600,000 people with schizophrenia or associated disorders. Schizophrenia is a chronic, serious and disabling mental disorder 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 a critical age for personal development, forcing patients in many cases to leave their educational or work activity, resulting in a great deal of suffering for the subjects and their family environment as well as representing an important loss for society at large. It is estimated that approximately 3% to 5% of total global health expenditure is devoted to schizophrenia.

The Technical Advisory Committee (CAT) has approved this Thursday the inclusion of Laboratorios Farmacéuticos ROVI in the IBEX 35, the main stock market index in Spain. Inclusion in the IBEX is a decision taken on purely technical criteria. As of 20 December, ROVI’s share price will be included in the Spanish selective index, replacing Viscofan.

As a company, being part of the main index of the Spanish Stock Exchange is a stimulus and an incentive for all the professionals who make up ROVI to continue with the work and dedication that has already led us to be considered as one of the world’s leading companies in the pharmaceutical sector.

The Andalusian Minister of Health and Families, Jesús Aguirre Muñoz, took part in the informative act organised by the Granada newspaper Ideal and sponsored by Laboratorios Farmacéuticos ROVI. During his speech, the Minister reviewed the data on vaccination against covid-19 in the region, where more than 90% of those over 12 years of age have completed the vaccination schedule.

Aguirre Muñoz also reviewed his plans to strengthen the region’s healthcare services in the coming years, with a commitment to increasing investment in primary care, as well as the forecasts for the recruitment of healthcare professionals.

ROVI released today its financial results for the first half of 2021. Below, we share some of the main indicators:

• Operating revenue increased by 52% to 290.1 million euros in the first half of 2021, driven by the strength of the toll manufacturing business, which grew by 172%, and the specialty pharmaceutical business, where sales rose 25%.
• Total revenue increased by 52% to 290.6 million euros in the first half of 2021.
• Sales of the heparin franchise (Low Molecular Weight Heparins (LMWH) and other heparins) increased by 26% to 131.4 million euros in the first half of 2021.
• Heparin sales represented 45% of operating revenue in the first half of 2021 compared to 54% in the first half of 2020.
• Sales of LMWH (Enoxaparin biosimilar and Bemiparin) increased by 27% to 127.8 million euros in the first half of 2021. Sales of the enoxaparin biosimilar increased 27% to 62.7 million euros in the first half of 2021 and sales of Bemiparin increased 26% to 65.1 million euros.
• EBITDA increased by 75%, from 42.4 million euros in the first half of 2020 to 74.0 million euros in the first half of 2021, reflecting a 3.3 percentage point rise in the EBITDA margin to 25.5% in the first half of 2021.
• Net profit increased by 72%, from 29.6 million euros in the first half of 2020 to 51.0 million euros in the first half of 2021.
• As a result of the expansion of the collaboration agreement with Moderna and the current visibility of ROVI’s business areas, the company has again upgraded its forecast for growth in operating revenue in 2021, raising it to between 35% and 40%

The Board of Directors of ROVI, at its meeting held today, has unanimously and acting
on a report from the Appointments and Remunerations Committee, agreed to appoint
the current Chief Executive Officer, Mr. Juan López-Belmonte Encina, as new Chairman
of the Board of Directors of ROVI.
The Board of Directors has expressed the profound gratitude and respect of the
Company and all of its employees towards the former Chairman, Mr. Juan López-Belmonte López.
The Appointments and Remunerations Committee has considered that according to
the career of Mr. Juan López-Belmonte Encina it is clear that he has unquestionable
knowledge to perform the functions as Chairman of the Board, as well as a deep and
extensive expertise in the Company, the Rovi Group and the sector in which it develops
its activity, making him the suitable candidate to occupy such position.
Mr. Juan López-Belmonte Encina will continue to act also as a Chief Executive Officer
(Consejero Delegado).