Uncategorized – Page 12

23 February, 202223 February, 2022

ROVI achieved operating revenue growth of 54% in 2021

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”.

16 February, 202216 February, 2022

Moderna and ROVI expand long-term collaboration for the next ten years

Moderna and Laboratorios Farmacéuticos Rovi today announced a long-term collaboration to increase capacities for the compounding, aseptic filling, inspection, labeling, and packaging of ROVI’s facilities located in Madrid, San Sebastián de los Reyes and Alcalá de Henares.

This new agreement, which has a term of ten years, includes a series of investments expected to allow the manufacturing capacity to increase across ROVI’s facilities in Madrid, Spain. In addition to producing Moderna’s COVID-19 vaccine, ROVI’s platform could also be utilized to service future Moderna mRNA vaccine candidates.

“ROVI has been a pivotal partner in supporting the manufacturing of our COVID-19 mRNA vaccine for countries outside of the U.S., and this long-term agreement expands our partnership and allows for further scale-up for future mRNA medicines,” said Juan Andrés, Moderna’s Chief Technical Operations and Quality Officer.

Mr. Juan López-Belmonte Encina, ROVI’s Chairman and Chief Executive Officer, said: “We are delighted to expand our collaboration with Moderna and become a long-term manufacturing partner. At ROVI we are working to contribute all our experience as a high-technological-value contract manufacturer of injectables to the solution of this pandemic and we are confident of our ability to take part in the manufacturing of new mRNA candidates in the future.”

Moderna and ROVI are expected to finalize details of this agreement in the first quarter of 2022.

15 February, 202215 February, 2022

ROVI receives the European Commission’s approval of Okedi® as a treatment for schizophrenia

Today, ROVI has announced that the European Commission has authorised the marketing of Okedi^® (Risperidone ISM^®) for the treatment of schizophrenia in adults for whom tolerability and effectiveness has been established with oral risperidone.

Risperidone ISM^®is a prolonged-release injectable antipsychotic developed and patented by ROVI for the treatment of schizophrenia in adults for whom 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.

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.

“We are very excited about the European Commission’s approval of Risperidone ISM^® because we think our medicine will be able to contribute to the clinical management of schizophrenia patients. Likewise, we hope to launch the product in Europe in the second quarter of 2022”, commented Juan López-Belmonte Encina, ROVI’s Chairman and Chief Executive Officer.

Regarding other territories, ROVI filed the application for marketing authorisation of Risperidone ISM^® 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 the FDA. Recently, the FDA informed ROVI of a delay in making a decision on the grant of said marketing authorisation.

25 January, 2022

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15 January, 202219 January, 2022

President Sánchez visits ROVI’s facilities in Granada

ROVI and Moderna received a visit from Pedro Sánchez this weekend at the ROVI manufacturing plant in Granada, to see the start-up of a new production line for the active ingredient of the mRNA vaccine at this facility.

The President of the Government, together with the Minister of Health, Consumer Affairs and Social Welfare, Carolina Darias, and the Mayor of the city, Francisco Cuenca, were able to tour the facilities accompanied by Juan López-Belmonte, President and CEO of ROVI; Miguel Ángel Ortega, Industrial Director of ROVI; and Juan Carlos Gil, Managing Director of Moderna.

For the first time, a Spanish facility has the potential to not only fill the vials, but to run the entire production of a messenger RNA vaccine, which puts the country in a “key” position in the fight against the pandemic, President Sánchez stressed.

7 January, 2022

Per Diems and Mileage for 2022

We indicate the amounts of allowances and mileage that apply from 1 January 2022:

½ Per diem: 22,22.-€ (One meal out).
Per diem: €44.36 (two meals out).
Full subsistence allowance: €132.64 (two meals and overnight stay away from home).
Mileage for use of own vehicle: €0.403 per kilometre.

7 January, 20227 January, 2022