Author: Gonzalo Alvaro

Juan López-Belmonte, CEO of ROVI and vice-president of Farmaindustria, highlighted at the Spain Investors Day the potential of our country as an investment destination for reindustrialisation, highlighting the pharmaceutical sector for its ability to play a decisive role in this regard. “Spain can become a hub for the production of medicines for Europe,” said Juan López-Belmonte.

The sector’s commitment is clear and forward-looking. Over the next three years, pharmaceutical companies plan to invest more than 2.7 billion euros in Spain alone to strengthen manufacturing capacities for strategic medicines, new therapies and vaccines, the digitalisation of production processes and energy efficiency.

These investments must be added to the 4.5 billion euros that the industry will allocate to research and development for the same period, as well as a further 1 billion euros planned for global activities of technological or strategic content. “At Farmaindustria we are working to make Spain a champion in the chemical sector,” said López-Belmonte.

Laboratorios Farmacéuticos ROVI is positioned as the top-scoring pharmaceutical company in the latest Informe Reporta, the ranking prepared by the consultancy firm DEVA to evaluate the information provided by listed companies to their stakeholders.

In the 2022 edition, with a total of 75.2 points out of 100, ROVI is the leader in the Consumer Goods sector and 15th in the overall ranking, ahead of Inditex (20th), Grifols (30th), Pharma Mar (69th) and Almirall (79th).

This ranking evaluates 110 companies in Spain through its annual reports, classifying them on the basis of four indicators: Transparency, Commitment, Relevance and Accessibility. This year, Banco Santander (85.5 points), CIE Automotive (85.7 points) and Fluidra (84.6 points) lead the ranking.

It should be noted that, despite the fact that the average score of the companies evaluated has reached an all-time high of 48 points, almost half of the companies (49.1%) do not reach the pass mark of 50 points.

Take a look at the overall results at http://informereporta.com/.

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ROVI has completed his first participation in the annual Congress of the German Society of Psychiatry, Psychotherapy, Psychosomatic and Neurology (DGPPN) with a high presence and activity with specialists in the area of Psychiatry.

Present with a team of more than 20 people and with an Okedi ® stand that reflected our high commitment to Psychiatry and schizophrenia, ROVI completed his participation in the congress by attending more than 300 meetings with psychiatrists and carrying out more than 200 practical demonstrations on the management and administration of risperidone ISM®, marketed in Germany, the United Kingdom and Spain since 2022.

In addition, ROVI collaborated with the satellite symposium “Schizophrenia exacerbation: time for change?“, dedicated to the therapeutic approach of non-adherent patients with schizophrenia who have been admitted due to a relapse led by Prof. Dr. Christoph Correll (Berlin, New York), Dr. Daniel Schöttle (Hamburg) and Prof. Dr. Anne Karow (Hamburg), important opinion leaders and national references in schizophrenia. During the symposium, a review of the clinical development of Okedi® was conducted, showing the main short- and long-term efficacy and tolerability results of the phase III clinical trial PRISMA-3 in the treatment of patients with non-adherent schizophrenia who have been admitted for relapse. This symposium was attended by 250 specialists in person and more than a hundred through streaming connection.

The congress, held from 23 to 26 November in Berlin (Germany), is considered one of the reference appointments of Psychiatry, bringing together 8,400 psychiatrists mainly from Germany. “For ROVI, it represents a perfect opportunity to introduce Okedi ®, the new innovative ILD antipsychotic based on our ISM® technology, and our commitment to schizophrenia and psychiatry in the country, since these types of appointments allow for closer ties with psychiatry specialists from central European countries such as Germany, Switzerland and Austria,” said ROVI’s Business Unit Director Psychiatry, Dr. Stefan Peters.

Help the Three Wise Men to get the Christmas presents. Can you answer the following questions correctly?
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ROVI joins the United Nations Global Compact to continue the fight against ABUSE, HARASSMENT and VIOLENCE suffered by women.

Let’s turn #16daysofreflection into 365 days of action

Don’t miss the daily content we will be preparing on the canteen televisions.

Stop violence against women NOW!

Sustained-release drug delivery is a field where significant progress is being made that increases the efficacy of the medicines, improves treatment adherence and attains greater efficiency for the healthcare system. Laboratorios Farmacéuticos ROVI’s goal in launching the LAI Challenge is to redefine the sustained release of injectable drugs.

With this initiative, ROVI wishes to seek and promote innovative solutions that will reinforce and transform injectable technologies for the sustained release of medicines. To this end, it is launching an open innovation challenge, in which sector professionals may submit projects that provide a technological solution.

Ibon Gutierro Adúriz, the company’s R&D Director, says that “ROVI is a competitive company that bets on generating value, expanding knowledge and seeking new and innovative therapeutic solutions, and we know that the best way of doing this is to work with the innovation ecosystem.”

The challenge poses the following question: “How could we improve treatments by using sustained-release injectable drug delivery technologies?” The purpose of this initiative is to encourage progress in the field of sustained-release injectable technologies. Specifically, LAI Challenge seeks solutions that improve sustained-release injectable drug delivery technologies in one of the following three areas:

• Ready-to-use technologies that do not require reconstitution (injectable single-dose technological solutions that are stable at room temperature and do not require handling or intervention by a healthcare professional).

• Injectable technologies to release proteins or other biological products that are technically viable, longlasting and stable.

• Injectable technologies that allow high doses of drugs or prodrugs to be used in order to reduce the administration frequency while maintaining an injection volume appropriate to the route of administration.

With this project, ROVI opens up a new channel for collaboration with sector professionals.

The following entities may take part in the LAI Challenge:

• Among others, research centres, universities, spin-offs, start-ups and national or international companies who are seeking partners to launch their products in the national and international markets. They must own either a technology under development that has been evaluated by, at least, proof of concept in animals or a developed product..

• Among others, research centres, universities, spin-offs, start-ups and national or international companies that own a product/service that is already on the market whose technology they wish to sell or licence.

• Innovative solutions, projects or technologies capable of addressing the challenge and resolving one or more of the uses proposed in the legal terms and conditions of this initiative.

The winners of the challenge will have the opportunity to develop their idea with the guidance and advice of ROVI professionals, as well as the latter’s knowledge of the regulatory, legal and operational aspects of the sector. Persons and entities who are interested in taking part in the LAI Challenge may consult the terms and conditions and enter through https://laichallenge.rovi.es/en/. The deadline for registration is from November 24 to January 31, 2023.

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. Of particular note were the results obtained in the third quarter, with an increase of 24% in operating revenues and 23% in net profit.

Before investors or representatives of investment groups, Juan López-Belmonte, Chairman and CEO of ROVI, highlighted the main developments in 2022:

• The plan to launch Okedi® in Europe
• Development of a new plant for the self-supply of heparins in Huesca thanks to the collaboration with the agri-food group Costa Food Group and the meat group Càrniques Celrà.
• Extension of the collaboration with Moderna for the manufacture of RNA drugs for the next 10 years.

Javier López-Belmonte, vice-president and CFO of ROVI, has reviewed what will be the growth drivers for the coming year 2023:

• The launch and marketing of Okedi® in Europe
• The Heparin Division
• Distribution licensing agreements, such as Neparvis® and Volutsa®.
• Existing portfolio of speciality pharmaceuticals and new product distribution licences
• Agreement with Moderna
• New contracts and increased capacity in the area of third-party manufacturing

On the 2023 operating income growth rate forecast, although a decrease in the low second decade band is expected over 2022, growth is expected to be between 5% and 10% over 2021.

This will be accompanied by a high level of international investment, with the aim of reaching a presence in 110 countries in the coming years and a sales team specialising in the psychiatric area in Europe, as well as the consolidation of 10 manufacturing plants and the expansion of ROVI’s own key products (Bemiparin, a biosimilar of Enoxaparin, Risperidone ISM®, Letrozol ISM® and quarterly Risperidone ISM®) to 5.

Last Sunday, 6 November, the Madrid También Solidario Race took place, organised by the Fundación También and whose aim is to create an inclusive sporting community and promote educational values through sport. The ROVI team could not miss the event and 41 volunteers set out to run the 1, 5 or 10 km of each of the modalities along the Parque Forestal de Valdebebas.

Our colleagues wanted to encourage us to sign up for the ROVI Volunteers through a video showing their experience. Don’t miss it!

ROVI reports operating revenue growth of 24% and EBITDA growth of 25%

• Operating revenue increased by 24% to 575.5 million euros driven by (i) the strength of the contract manufacturing organization (“CMO”) business, which grew by 49%, and (ii) the specialty pharmaceutical business, where sales rose 9%.
• Sales of the heparin franchise (Low Molecular Weight Heparins (LMWH) and other heparins) increased by 11% to 200.6 million euros. Sales of the enoxaparin biosimilar increased 33% to 119.2 million euros.
• EBITDA increased by 25% to 173.9 million euros.
• Net profit increased by 23% to 121.5 million euros.
• Launch of Okedi® (Risperidone ISM®) in Spain for the treatment of schizophrenia in adults (September 2022).
• On October 4th, 2022, ROVI presented Glycopepton Biotech, S.L., a joint venture with Càrniques Celrà, S.L. and Grupo Empresarial Costa, S.L., that involves the creation of one of the first national structures for self-sufficiency in heparins. The project involves the construction of a facility at the Industrial Logistics Platform of Fraga (Huesca), which will produce compounds of high biological value that derive from the intestinal mucosa of pigs.
• ROVI’s ESG aspects have been evaluated by Sustainalytics, having obtained an “ESG Risk Rating 2021” of 17.3, which places the company at low risk (between 10 and 20). ROVI has attained the first position out of 458 companies in the sub-industry “pharmaceuticals”.
• ROVI General Shareholders Meeting approved the payment of a gross dividend of 0.9556 euros per share on 2021 earnings (+151%). This dividend was paid on July, 7th.

OUTLOOK

In February 2022, ROVI announced it expected the operating revenue for the full year 2022 to increase between 15% and 20%. This guidance was confirmed when the Company released its first quarter and first half 2022 results. With the visibility that the Company has at this moment, ROVI expects to achieve the higher end of this range in 2022.

For 2023, ROVI expects its operating revenue to show low-double-digit negative growth on 2022, although a positive growth of between 5% and 10% is expected in comparison with the 2021 figure.

Notwithstanding, in 2023 ROVI will face a new COVID-19 post-pandemic scenario in which the uncertainty related to the evolution of the disease is very high. It is not, therefore, possible to make a precise assessment of the impact that this new scenario could have on its CMO business. Likewise, under the terms of the agreement