Laboratorios Farmaceuticos Rovi, SA has held its today General Ordinary Shareholders Meeting, in which a valuation of the 2020 financial year, marked by significant growth, has been made. The company increased its sales, both of prescription pharmaceutical products (6%), as well as of low molecular weight heparins (14%) and especially in the third-party manufacturing division (39%). “It has been an essential year for ROVI in which we have demonstrated our commitment to science, life and health of millions of people”, Has assured Mr. Juan López-Belmonte Encina, CEO of ROVI.

The General Meeting, meeting on first call, approved all the resolutions on the Agenda and, among others, the individual and consolidated annual accounts of the Company as well as the respective management reports, corresponding to the year ended December 31, 2020, and social management during the past year.

The company has presented to its shareholders consolidated operating income of 420.0 million euros in 2020, which represents a growth of 10% compared to 2019. ROVI also achieved a 55% increase in EBITDA, from 60.9 million euros in 2019 to reach 94.2 million euros in 2020. Likewise, ROVI’s net profit grew 55% to 61.1 million euros. Research and development (R&D) expenses stood at 23.8 million euros in 2020. These expenses are mainly related to the preparation of the Risperidone ISM® registration dossier for submission to the US authority, the US Food and Drug Administration (FDA); the development of Phase I of Letrozole-ISM®; and  the development of the new formulation of Risperidone ISM® for a quarterly injection.

The great growth in its revenues is mainly explained by the general increase in sales in all its areas. Sales of prescription pharmaceutical products grew 6%, outpacing the performance of the pharmaceutical market for another year.

It is worth highlighting the 14% increase in sales in the Heparin division. Heparin sales (Enoxaparin biosimilar, Bemiparin, and other heparins) accounted for 50% of operating revenue in 2020 compared to 48% in 2019. Specifically, sales of the enoxaparin biosimilar reached 101.4 million euros and those of Bemiparin also stood at 101.4 million euros in 2020.

Sales of other pharmaceutical specialties are also increasing. In 2020, Neparvis® sales grew 34% reaching 29.6 million euros, compared to 22.0 million euros in 2019. This is a prescription product from the Novartis company indicated for the treatment of adult patients with symptomatic chronic heart failure and reduced ejection fraction, which has been distributed by ROVI in Spain since December 2016.

For its part, sales of Volutsa®, a prescription product from the Astellas Pharma company indicated for the treatment of moderate to severe filling and emptying symptoms associated with benign prostatic hyperplasia, increased by 7%, to 14.2%. million euros in 2020.

ROVI, the great international advance

As of December 31, 2020, Bemiparin is already present in 58 countries outside of Spain and sells 5% more than in the previous year. International sales of Bemiparin increased by 21% to reach 33.0 million euros in 2020.

Likewise, in the mentioned year, ROVI has achieved that its enoxaparin biosimilar was present in 19 countries and that its sales increased by 25%.

Sales outside of Spain grew 28% in 2020, representing 46% of operating income compared to 39% in 2019.

Agreement with Moderna

In 2020, ROVI began its collaboration with Moderna for the large-scale manufacturing of the filling and finishing of Moderna’s mRNA vaccine against COVID-19 at ROVI’s facilities in Madrid.

ROVI provides vial filling and finishing capacity through the acquisition of a new production line and equipment for formulation, filling, automatic visual inspection and labelling to support the production of the vaccine, in principle, to supply markets outside the U.S. beginning in early 2021.

In 2021, ROVI strengthens its collaboration with Moderna (i) in filling and finishing the vaccine against COVID-19, increasing its current capacity for these two activities, and (ii) for manufacturing the active ingredient of said vaccine. To this end, new industrial investments will be made in the facilities that the ROVI Group has in Madrid and Granada.

Mr. Juan López-Belmonte Encina has commented: “Our collaboration with Moderna, as manufacturer of injectables, supplying the vaccine against COVID-19 outside the United States, has meant the definitive strengthening of our manufacturing area to third parties. We have assumed this essential mission for the lives of millions of people with responsibility and commitment, and we thank the Government of Spain and the Spanish Medicines Agency for the trust placed in ROVI ”.

Risperidone ISM® in the regulatory process in Europe and the USA

ROVI continues to bet on Research as a guarantee of growth and sustainability and one of the milestones of 2020 is precisely the beginning of the evaluation process to obtain the marketing authorization for Risperidona ISM ® in the European Union and the United States. ROVI has made significant progress in treating schizophrenia and looks forward to the future.

The results of its pivotal phase III clinical trial PRISMA-3, on the efficacy and safety of Risperidone ISM® in patients with schizophrenia 1 , demonstrate that the monthly injectable antipsychotic Risperidone ISM® provides a significant improvement in the symptoms and severity of the disease in patients with an acute exacerbation of schizophrenia.

ROVI consolidates its commitment to research and development as a guarantee for the future of the company. Mr. Juan López-Belmonte Encina has commented that “we have managed to position ourselves as a leading company in the field of low molecular weight heparins worldwide and we will continue to focus on international expansion, fully trusting in our potential to grow and continue saving lives. Likewise, we are confident in the potential of our current portfolio of R&D projects, based on our ISM® technology, in which we are making a significant investment effort as we hope that it will be the growth engine of the company in the future. We remain convinced that research is the way to prosperity and development, and our goal is to find scientific solutions that, today more than ever, become the true hope for millions of suffering people. And we will do all of this with a commitment to responsible management, based on the principles of sustainability. We are especially proud that ROVI has obtained such a good grade in the ESG (environment, social and governance) classification prepared by Sustainalytics, a leading company in the evaluation of Corporate Social Responsibility and Corporate Governance worldwide, achieving the second position out of 360 pharmaceutical industry companies worldwide.

Growth forecast

In February 2021, ROVI announced that it expected operating revenues for 2021 to increase between 20% and 30%, including the production of Moderna’s vaccine against COVID-19. As a result of the expansion of the collaboration between ROVI and Moderna, in 2021 ROVI expects to reach the upper band of the range.

ROVI expects its growth drivers to be Bemiparin, distribution licensing agreements, such as Neparvis® and Volutsa®, the enoxaparin biosimilar, the existing portfolio of specialty pharmaceutical products, the agreement with Moderna and the new contract manufacturing  area.

Mr. Juan López-Belmonte Encina has shown his satisfaction with the results obtained and has declared: “This year we have shown that our business motto, our commitment to Research and development is the engine that moves us and encourages us to continue. We are very aware that our work and our personal and collective commitment have a direct impact on the lives of millions of people. We are ready, prepared and hopeful to continue contributing to save lives”.

The Ordinary General Meeting of Shareholders of Laboratorios Farmacéuticos ROVI, chaired by Mr. Javier López-Belmonte Encina, has also approved at its meeting today the distribution to shareholders of a gross dividend, charged to the results of the 2020 financial year, of 0 , 3812 euros per share with the right to receive it, which represents an increase of 118% compared to the dividend paid out of the results of the year 2019 (0.1751 euros per share) and would imply the distribution of approximately 35% of the consolidated net profit of the year 2020 (vs. 25% of the consolidated net profit of 2019).

Informative details about ROVI’s General Shareholders’ Meeting

• All the resolutions submitted for the approval of the General Meeting have been approved. The results of the voting can be consulted on the Company’s website.
• Notary required attending the Meeting: Mr. Manuel Richi Alberti.
• Secretary of the Board of Directors: Mr. Gabriel Núñez Fernández.