The operating revenue of Laboratorios Farmacéuticos ROVI increased by 8% to 82.2 million euros in the first quarter of 2019, mainly driven by the strength of the specialty pharmaceutical business, which grew by 12%, strongly outperforming the pharmaceutical market. Total revenue increased by 8% to 82.4 million euros in the first quarter of 2019.

Sales of prescription-based pharmaceuticals rose 12% to 62.7 million euros in the first quarter of 2019, outperforming the market by 10 percentage points. According to the consulting company QuintilesIMS, the innovative product market in Spain rose by 2% in the first quarter of 2019 in comparison with the same period of the preceding year.

In addition, sales of the low-molecular-weight heparin (LMWH) franchise increased by 34% in the first quarter of 2019. LMWH (enoxaparin biosimilar and bemiparin) ) sales represented 46% of operating revenue in the first quarter of 2019 compared to 37% in the first quarter of 2018. Sales of the enoxaparin biosimilar totalled 16.5 million euros, while those of bemiparin, ROVI’s flagship product, grew 4% in Spain, totalling 17.6 million euros.

In the first quarter of 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 60% to 4.3 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 22% to 3.1 million euros. Sales of contrast imaging agents and other hospital products increased by 8% to 8.2 million euros.

EBITDA grew by 17%, from 10.2 million euros in the first quarter of 2018 to 11.9 million euros in the first quarter of 2019. Likewise, ROVI’s net profit rose by 1% to 6.9 million euros.

ROVI will propose to the General Shareholders’ Meeting that part of the 2018 profit should be allocated to the reserves on the company’s statement of financial position, while the other portion should be allocated to the distribution of a dividend of 0.0798 euros per share entitled to receive it, which would represent a pay-out of approximately 25% of the consolidated net profit for 2018.

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

As of 31 March, 2019, all the European Union countries where ROVI had applied for the national registration of the enoxaparin biosimilar (25 countries) had approved said registration, except Luxembourg.

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 and Costa Rica in the first quarter of 2019.

In addition to the European countries mentioned, ROVI holds marketing agreements for its enoxaparin biosimilar in 65 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 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).

 (Destacar en verde) ROVI continues with Phase III “PRISMA 3” of its Risperidone ISM® project and h Phase I “LISA 1” of its Letrozole ISM® project

ROVI has made meaningful progress in the development of Risperidone ISM®, the first candidate of its leading-edge drug delivery technology, ISM®, for a prolonged release of risperidone, a second-generation antipsychotic medicine, the use of which has become consolidated, for the treatment of schizophrenia.

After successfully completing the programme for Phases 1 and II of Doria®, ROVI commenced the Phase III pivotal study, “PRISMA-3”, recruiting the first patient in May 2017. In March, 2019, ROVI announced the positive topline results of the Phase III study. These topline results of the pivotal study with its once-monthly injectable antipsychotic showed that primary and key secondary endpoints were achieved with both doses tested for the treatment of patients with acute exacerbation of schizophrenia. The application for registration with the FDA (Food and Drug Administration) in the United States is planned for the second half of 2019.

In addition, in November 2017, ROVI began the clinical development of Letrozole ISM®, the first long-acting aromatase inhibitor to treat hormone-dependent breast cancer. The first Phase I clinical trial, the LISA1 study, is currently underway. It is an open-label, single-dose, dose-escalation study to evaluate the pharmacokinetic profile, safety and tolerability of intramuscular injections of Letrozole ISM®, with different concentrations, in healthy post-menopausal women.

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 are close to knowing the final clinical report of a Phase III trial and are developing a Phase I for another candidate, both with our ISM® technology. Likewise, we are continuing with the national phase of the registration of our enoxaparin biosimilar in Europe, having obtained approval in 25 countries as of 31 March, 2018. We are also continuing with the marketing of enoxaparin in Germany, United Kingdom, Italy, Spain, France, Austria, Latvia and Estonia and we have begun to market it in Portugal and Costa Rica, with good sales expectations, as shown by the sales for the first quarter of 2019, which were 16.5 million euros. The enoxaparin biosimilar represents an excellent growth opportunity for ROVI, considering the size of the European enoxaparin market, which totals around 1,000 million euros. We aspire to become one of the global leaders in the low-molecular-weight heparin field”.

Growth forecasts

ROVI has upgraded its operating revenue guidance for 2019 from a high-single-digit range to the low-teen range.

This upgrade is mainly due to the positive behaviour of bemiparin in Spain and the good sales prospects of the enoxaparin biosimilar. Likewise, ROVI expected to stop distributing the Merus Labs products (Sintrom®, Salagen®, Cordiplast® and Estraderm®) in the first half  of 2019 but, finally, will continue to market them in the third quarter of the year. Furthermore, ROVI announced the acquisition of Falithrom® and Polaramine® in January and February 2019, respectively, and the distribution agreement for Tetridar® in April 2019. The revenue from these three products was not included in the operating revenue guidance for 2019 published in the press release with the results for the nine-month period ended 30 September, 2018.