Operating revenue increased by 26% to 381.3 million euros in 2019, mainly driven by the strength of the specialty pharmaceutical business, where sales rose 27%, strongly outperforming the pharmaceutical market, and  the contract manufacturing business, which grew by  19%. Total revenue increased by 25% to 382.5 million euros in 2019, more than tripling the total revenue of 2007, which was the year of ROVI’s IPO.

Sales of prescription-based pharmaceuticals rose 30% to 281.0 million euros in 2019, outperforming the market by 28 percentage points. According to the consulting company IQVIA, the innovative product market in Spain rose by 2% in 2019 in comparison with 2018.

In addition, sales of the low-molecular-weight heparin (LMWH) franchise increased 46% in 2019. Sales of LMWHs (enoxaparin biosimilar and bemiparin) represented 47% of operating revenue in 2019 compared to 40% in 2018. Sales of the enoxaparin biosimilar were multiplied by 2.7, reaching 80.9 million euros, while those of bemiparin, ROVI’s flagship product, increased 6% to 96.8 million euros.

ROVI increases sales of its prescription-based products and contract manufacturing

In 2019, sales of Neparvis®, a prescription-based product from the company Novartis indicated for the treatment of adult patients with symptomatic chronic heart failure and reduced ejection fraction, which ROVI has been distributing in Spain since December 2016, increased 62%, totalling 22.0 million euros. Sales of Volutsa®, a prescription-based product from the company Astellas Pharma indicated for the treatment of moderate to severe storage symptoms and voiding symptoms associated with benign prostatic hyperplasia, increased by 18% to 13.3 million euros. Sales of contrast agents for diagnostic imaging and other hospital products rose 10% to 32.6 million euros.

Likewise, contract manufacturing sales rose 20%, totalling 65.6 million euros in 2019, driven mainly by the repositioning of the strategy of the contract manufacturing activity towards products with higher value-added.

EBITDA grew by 106%, rising from 29.5 million euros in 2018 to 60.9 million euros in 2019. Likewise, ROVI’s net profit increased 119% to 39.3 million euros. Research and development expenses (R&D) were 29.3 million euros in 2019. These  R&D expenses were mainly related to the development of the Phase III trial of Risperidone-ISM® and the Phase I of Letrozole-ISM®.

ROVI continues growing outside Spain through its subsidiaries and distribution agreements with third parties

ROVI commenced the marketing of its enoxaparin biosimilar in Germany in September 2017 and in UK, Italy, Spain, France, Austria, Latvia and Estonia in 2018;. Likewise, ROVI began marketing it in Portugal, Poland, Costa Rica, Finland and Sweden in 2019.

In addition to the European countries mentioned, as of September 2019, ROVI holds marketing agreements for its enoxaparin biosimilar in 85 countries. Among them, we can highlight the agreements with Hikma Pharmaceuticals PLC, a listed multinational pharmaceutical group (LSE:HIK), for the exclusive marketing of the enoxaparin biosimilar in 17 MENA (Middle East and North Africa) countries and the agreement with Sandoz, a division of Novartis AG and one of the world leaders in generic medicines and biosimilars, for the distribution and marketing of the products in 14 countries/regions (Australia, New Zealand, Philippines, Hong Kong, Singapore, Vietnam, Malaysia, Canada, South Africa, Brazil, Colombia, Argentina, Mexico and Central America).

ROVI registers its long-acting injectable antipsychotic, Doria®, in Europe and continues with the clinical development of Letrozole ISM®

The company has recently announced that a very important milestone has been achieved with its long-acting injectable (LAI) antipsychotic Doria® (Risperidone ISM®). After the conclusion of the validation phase, the European health authorities have commenced the assessment process to grant marketing authorisation for this first product based on ROVI’s leading-edge drug delivery technology, ISM®. In March 2019, the company announced topline results from the pivotal study of Risperidone ISM® “PRISMA-3”, which showed that primary and key secondary efficacy endpoints were achieved with both doses tested for the treatment of patients with acute exacerbation of schizophrenia. Likewise, in July 2019, the company announced the completion of the Clinical Trial Program that will support the application for marketing authorization for Doria® for the treatment of schizophrenia. In addition, an open-label extension of the PRISMA-3 study 2 has already been completed and will provide clinical data on the long-term use of Risperidone ISM® (12 additional months).

Furthermore, ROVI informed of the decision to expand its industrial capabilities for the manufacture of Doria® with the incorporation of a second line for the manufacture of the syringe containing the solvent. The addition of this second line also provides the company with the necessary flexibility to initiate the preparation of the industrial filling processes of Letrozole ISM®, which will require the installation of a specific filling line. As a result, ROVI has prioritized the submission of the Doria® dossier in Europe (already done) and, subsequently, filing in the USA, targeting the second half of 2020.

In addition, the company has already announced the commencement of the clinical development of Letrozole ISM®, which represents the second candidate using ROVI’s ISM® technology platform. This new investigational medicine is, to the best of our knowledge, the first long-acting injectable aromatase inhibitor intended for the treatment of hormone-dependent breast cancer. The first phase I clinical trial (the LISA-1 study) of Letrozole ISM® is currently ongoing but, due to the study design (“dose escalation”) and its exploratory nature, the finalisation date cannot be known in advance. Nevertheless, preliminary data confirm that this ISM® formulation provides a prolonged release of letrozole which produces a sustained suppression of oestrogenic hormones. The company will be gathering more clinical data from this trial during the following months to better characterise the pharmacological profile of Letrozole ISM®. Subsequently in 2020, ROVI is planning to share these results with the regulatory authorities and discuss the next steps in order to continue with the clinical development of this novel long-acting injectable aromatase inhibitor.

Lastly, ROVI’s R&D team has recently started development of a new formulation of Risperidone ISM® for a 3-monthly injection, which would complement the current formulation of Doria® for the maintenance treatment of patients with clinically stable schizophrenia. This development is still in an initial phase.

ROVI is betting on research and development as the company’s future growth driver. Juan López-Belmonte Encina, ROVI’s Chief Executive Officer, said that, “we will continue to grow over forthcoming hears due to the potential of ROVI’s R&D product portfolio. We are excited about the potential of ISM® technology; we have concluded a Phase III trial, the dossier of which we have just filed in Europe and are planning to file in the United States in the second half of 2020. Likewise,  we are developing a Phase I for another candidate also with our ISM® technology. At the same time, we are continuing to market enoxaparin in 13 countries and reached sales of 80.9 million euros in 2019, practically two years after the product was launched. We are in an international expansion phase and hope that our enoxaparin biosimilar will allow us to be present in more than 120 countries in the long term. We are excited at the potential of our LMWH franchise and aspire to become a global benchmark player in this field”.

Growth forecasts

For 2020, ROVI expects a mid-single-digit growth rate for the operating revenue The company expects to continue growing faster than the growth rate of pharmaceutical spending in Spain in 2019, which was 3.0%, according to the figures published by the Ministry of Health, Consumer Affairs and Social Welfare.

ROVI expects its growth drivers to be bemiparin, the latest license agreements, such as Neparvis® and Volutsa®, the enoxaparin biosimilar, its existing portfolio of specialty pharmaceuticals, the new products acquired recently (Falithrom® and Polaramine®) and the new contracts in the contract manufacturing area.