ROVI Rocks!

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 Alcalá de Henares plant was visited by the mayor of the city, Javier Rodríguez Palacio, accompanied by the councillor responsible for Urban Planning, Alberto Blázquez Sánchez, and the manager of the Ente Público Empresarial Alcalá Desarrollo, Pilar Fernández Herrador.

Accompanied by the vice-president and CFO, Javier López-Belmonte; the director of the Industrial Area, Miguel Ángel Ortega; and the director of the plant, Pilar García-Morato, the mayor was shown the production activity of the plant, which has an annual production capacity of 3,000 million tablets per year, 100 million final packaged units and 150 million packaged syringes.

During the visit, ROVI management showed the state-of-the-art facilities, highlighting the 12 packaging lines (seven dedicated to injectables) that make it a packaging centre of excellence for in-house and third-party manufacturing. The mayor was also interested in the increased investment in the Alcalá plant and the development of new projects there.

The plant had previously received a visit from the city council of Alcalá de Henares, specifically from the councillor for equality, Patricia Sánchez, who also praised its social initiatives, as well as its participation in the “Empléate desde la Igualdad” programme for reintegrating women into the labour market.

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 Race for Enterprise 2021 is here!

Make your team of 2, 3 or 4 runners and show your teammates who is the fastest. If you don’t have a team, don’t worry: we’ll find you one.

If you are not in Madrid but you want to participate in the race, you can sign up in the virtual mode.

What are you waiting for?

• Date: 19 December at 09:00 am
• Place: Plaza San Juan de la Cruz (Madrid)
• Distances: 6.5 km and 10 km

SIGN UP HERE

You have until 10 December

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GO!

On Sunday 7 November we once again put on our running shoes for a good cause: the inclusion of people with motor disabilities. Our ROVI colleagues ran together in the Madrid También Solidario race, organised by the También Foundation, which this year celebrated its tenth edition.

This event brought back good feelings and, above all, the pleasure of being reunited after the pandemic. Our colleagues were able to run 1, 5 or 10 km and wanted to share their experience with us.
Don’t miss the video!

ROVI held its Capital Markets Day where it explained to investors and analysts its strategic vision on the evolution of the business, its R&D plans and the main financial figures. It highlights the operating income forecast for this year, which stands at between 588 and 609 million euros, which would bring forward the achievement of the 2023 target by two years.

Another of the main developments announced at this meeting was the resumption of the regulatory process for Risperidone ISM in Europe, following the successful repetition of the clinical bioavailability study and the submission of the information to the European Medicines Agency.

In front of approximately 60 investors or representatives of investment groups, Juan López-Belmonte, President and CEO of ROVI, reviewed what will be its growth drivers for 2022:

• Low molecular weight heparins, bemiparin and the biosimilar enoxaparin.
• Distribution licensing agreements, such as Neparvis® and Volutsa®.
• The existing portfolio of speciality pharmaceuticals
• The agreement with Moderna for the manufacture of the COVID-19 vaccine.
• New contracts in the area of third-party manufacturing.

This will be accompanied by a high level of investment in the international arena, with the aim of reaching a presence in 120 countries in the coming years and a sales team specialising in the psychiatric area in Europe, as well as the consolidation of the new plant for the active ingredient Low Molecular Weight Heparins in Granada and the new Moderna manufacturing lines.

ROVI reports operating revenue growth of 53% and doubles its ebitda

• Operating revenue increased by 53% to 463.5 million euros driven by (i) the strength of the contract manufacturing organization (“CMO”) business, which grew by 187%, and (ii) the specialty pharmaceutical business, where sales rose 18%.
• Sales of the heparin franchise (Low Molecular Weight Heparins (LMWH) and other heparins) increased by 15% to 181.5 million euros. Sales of the enoxaparin biosimilar increased 17% to 89.9 million euros and sales of Bemiparin increased 13% to 86.3 million euros.
• EBITDA doubled to 139.5 million euros.
• Net profit increased by 111% to 98.9 million euros.
• ROVI’s ESG aspects have been evaluated by Sustainalytics, having obtained an “ESG Risk Rating 2021” of 18.4, which places the company at low risk (between 10 and 20). ROVI has attained the second position out of 432 companies in the sub-industry “pharmaceuticals”. ROVI General Shareholders Meeting approved the payment of a gross dividend of 0.3812 euros per share on 2020 earnings (+118%). This dividend was paid on July, 7th.