ROVI joins in the IBEX 35 in December

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.

Join the Race for Enterprise 2021

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

ROVI is once again running for inclusion

Ready…

Steady…

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!

Update 91. COVID-19: Use of microwave ovens

In order to help employees adaptation to the increased presence at headquarters, the use of microwave ovens will be permitted for heating food to be taken at the workstation.

As far as possible, we ask to avoid the crowds in the canteen when microwaves are to be used. In addition, as with other commonly used devices, employees should make use of the hydro-alcoholic gel in the canteens before use.

The microwaves can be used from Monday onwards.

Obligatory use of masks

We insist on the obligatory use of the mask during the whole working day. It can only be removed at the workplace when eating or drinking.

Also, we recommend the employees to follow the same instructions when they go outside during the working day.

Lifts

We remind you that the use of lifts is still restricted to one person per trip.
This committee has been observing systematic non-compliance with these last two rules.

We would like to remind you that any behaviour that does not comply with the COVID-19 prevention measures established at ROVI may be subject to sanctions.

ROVI celebrated its Capital Markets Day

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 increases net profit by 111% to almost 100 million euros

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.

We started vaccination campaign

Next week we will start with the vaccination campaign in ROVI. We will install mobile units in the headquarters, and you will be assigned appointments and times to go in an orderly manner, respecting the safety distances and capacity control.

The Department of Safety and Environment will publish a list in each workplace in which the day and time of vaccination assigned to each employee can be consulted. IMPORTANT: to comply with data protection regulations, this list is encrypted, so the EMPLOYEE NUMBER and the appointment will appear.

If you do not know your employee number, you can easily consult it in ROVIROCKS, following these steps:

You can also see it in TALENTIA, from the “My working data” section.

Sales delegates from Madrid and Granada must go to the ROVI centres to receive the vaccine on the assigned days. For the rest of the members of the commercial network, Quiron will contact them in the coming days to inform them about when and where to receive the vaccine.

The vaccination SHIFTS in the centres are:

Flexibility of measures in ROVI

Taking into account the evolution of the pandemic and the decreasing incidence of COVID-19, we announce the flexibility of the following measures in our work centres, which will be effective as of November 15:

Mandatory mask
The use of the mask continues to be mandatory during the work day, except for the time necessary to eat or drink.

Distances
In order to restore normalcy and to increase the capacity for skilled jobs in our work centres, we are going to review the distances between jobs at 1.5 meters, as established by the Law 2/2021, of March 29, on urgent prevention, containment and coordination measures to face the health crisis caused by COVID-19.

In the coming days, the jobs that become available will be marked with stickers. Those responsible must evaluate whether the positions have the necessary devices and connections, especially in those cases in which there have been hiring of personnel who have not been able to carry out routine work in the offices.

The objective is to occupy the maximum number of positions enabled after this review, trying that each employee does four days a week in person. In those departments that do not have enough positions enabled after this review, they should be organized to guarantee the maximum possible occupancy.

This instruction will be application to all employees, except for risk personnel, who will continue as before.

Working Hours
The transfer schedule remains as before:

  • WHEN THE WORKING DAY IS CARRIED OUT: normal hours (Flexible entry 8-9 am – Departure 5.30 – 6.30 pm, with breaks for lunch and breakfast).
  • WHEN DONE AT THE HEADQUARTERS: the intensive schedule is maintained (flexible entry from 8-9 am and exit from 16-17 hours).

Canteen
The use of canteens, microwaves, toasters and refrigerators remains restricted exclusively to factory personnel who maintain their work shifts and, therefore, are authorized to use it.

Office personnel not linked to the industrial area can use the canteens to use the fountains, vending machines or coffee machines.

Computer
While the risk of confinement is lower, the obligation to bring the computer home every day is eliminated.

In the event that an employee must start quarantine due to having been in contact with a positive or being infected, the company will assume the shipment to the home of the equipment if necessary.

Using Elevators
We remind you that the limitation of the use of elevators in ROVI to one person is still in force.

Meeting rooms
Face-to-face meetings will be allowed. We remember that the use of a mask is mandatory at all times. In addition, we recommend maintaining distances and in rooms that allow it, ventilate.

Travel
Similarly, travel for work reasons is allowed. In both cases, meetings and trips, this committee recommends reducing both to the essential minimum and continuing to use telemetric applications where possible. It will be the responsibility of the department heads to make decisions regarding the meetings and travel that are necessary.

Temperature check
As of November 15, we will abolish access control by temperature. However, we remember that, in case of presenting symptoms, employees must remain at home, communicate the reason for absence to notificationscovid19@rovi.es and contact their health centre.

Mobility between venues
We enable mobility between workplaces. In this case, we ask employees to organize their trips confirming availability of position at the destination headquarters.

The FDA delays its decision on Risperidone ISM®

Laboratorios Farmacéuticos Rovi, S.A. has been informed of the delay in the decision on the granting of marketing authorisation for Risperidone ISM® by the U.S. Food and Drug Administration (“FDA”). The FDA will be taking a number of actions, including an in-situ inspection of the European production plant where the product is manufactured, located in Madrid (Spain). The grant of the marketing authorisation for Risperidone ISM® by the FDA is subject to the result of this inspection.

The delay in the inspection of the manufacturing facilities has been caused by the restrictions on movement due to COVID-19 and, thus, the FDA has not yet fixed the inspection date.

ROVI filed the application for marketing authorisation for Risperidone ISM® with the FDA on 24 November, 2020. On 24 September, 2021, ROVI received a Complete Response Letter from the FDA with outstanding questions on the Risperidone ISM® dossier. The Company has either answered them or will be answering them in the near future since, in its letter, the FDA recognises that it did not review some of the responses submitted during the evaluation process. ROVI expects its responses to clarify the outstanding questions.

In the Complete Response Letter, the FDA states that, due to the exceptional situation caused by the pandemic which has prevented the inspection from taking place within

the term defined in the Filing Communication Letter, all the responses to outstanding questions will be evaluated in accordance with the timeline described in the “2020 Guidance for Industry Review Timelines for Applicant Reponses to Complete Response Letters When a Facility Assessment Is Needed During the COVID-19 Public Health Emergency”, with an estimated review time of 6 months as of the submission of the responses to the questions raised in the Complete Response Letter.

Risperidone ISM® is a novel, once-monthly, injectable antipsychotic, currently in the research phase, for the treatment of schizophrenia, developed and patented by ROVI. As of the first injection, it provides immediate and sustained plasma drug levels of the medicine, without the need for loading doses or supplementation with oral risperidone.

There’s still time to take part in the Madrid También Solidario race

Haven’t you signed up for the Madrid También Solidario race yet?

Run with us on Sunday 7 November at 10am for the inclusion and accessibility of people with disabilities.

Register for the race HERE

We encourage you to participate with your family and friends. There are three modalities:

  • 10km and 5km running, handbike or wheelchair.
  • 1km for inclusion. Ideal to do with the little ones

The funds raised will be donated to the sports programmes of the También Foundation, which works for the inclusion of people with disabilities and promotes education in values through adapted sport.

Do you want to know more about the race? Click HERE