Operating revenue increased by 21% to 177.5 million euros in the first half of 2019, mainly driven by the strength of the specialty pharmaceutical business, where sales rose 22%, strongly outperforming the pharmaceutical market, and by the toll manufacturing business, which grew by 15%. Total revenue increased by 21% to 177.9 million euros in the first half of 2019.

Sales of prescription-based pharmaceutical products rose 24% to 132.5 million euros in the first half of 2019, outperforming the market by 22 percentage points. According to the consulting company IQVIA, the innovative product market in Spain rose by 2% in the first half 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 43% in the first six months of 2019. LMWH (enoxaparin biosimilar and Bemiparin) ) sales represented 46% of operating revenue in the first six months of 2019, compared to 39% in the first half of 2018. Sales of the enoxaparin biosimilar were multiplied by four, rising to 36.5 million euros in the first half of 2019, while those of bemiparin (Hibor®), ROVI’s flagship product, grew 5% in Spain, totalling 35.5 million euros.

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

In the first half 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 63% to 9.6 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 20% to 6.4 million euros. Sales of contrast imaging agents and other hospital products increased by 9% to 16.7 million euros.

Likewise, toll manufacturing sales rose 15%, representing 26.6 million euros in the first half of 2019, driven by the injectables division, whose sales increased by 53% in the period.

EBITDA grew by 99%, from 13.3 million euros in the first half of 2018 to 26.5 million euros in the first half of 2019. Likewise, ROVI’s net profit rose by 114%% to 16.2 million euros. Research and Development (R&D) expenses were 14.7 million euros in the first half of 2019. These R&D expenses are mainly related to development of the Phase III trial of Risperidone-ISM® and Phase I of Letrozole-ISM®.

Likewise, the General Shareholders’ Meeting of ROVI held on 12 June, 2019 resolved to pay a gross dividend of 0.0798 euros per share to the shareholders, charged to the 2018 profit. This dividend was paid out on 4 July, 2019 and involved the distribution of approximately 25% of the consolidated net profit for 2018.

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

As of 30 June, 2019, all the European Union countries where ROVI had applied for the national registration of the enoxaparin biosimilar (26 countries) had approved said registration.

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 half of 2019.

In addition to the European countries mentioned, as of June 2019, ROVI held 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 concludes Phase III “PRISMA 3” of its Risperidone ISM® project and continues with Phase I “LISA 1” of its Letrozole ISM® project

ROVI has made meaningful progress in the development of its long-acting injectable (LAI) antipsychotic Risperidone ISM®, the first candidate for its leading-edge drug delivery technology, ISM®. In March 2019, the company announced topline results from the pivotal study of Risperidone ISM® “PRISMA-3” 1 , 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.

On 5 July, 2019, Laboratorios Farmacéuticos Rovi, S.A. (“ROVI”) has announced the conclusion of the PRISMA-3 and BORIS studies, thus completing the Clinical Research Program for Risperidone ISM®, which will be included in the registration dossier to apply for marketing authorization for Doria® for the treatment of schizophrenia in the European Union and United States, in a first phase, and, subsequently, in other countries. The final results of the pivotal PRISMA-3 clinical study confirm the superiority of Risperidone ISM® over the placebo.

In addition, in November 2017, ROVI started the human testing with letrozole, which represents the second candidate in clinical development 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 and 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 plans 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.

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; this July we confirmed the positive results of a Phase III study and we are developing a Phase I for another candidate. Likewise, we are 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, Poland and Costa Rica, with good sales expectations, as shown by the sales for the first half of 2019, which were 36.5 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

For the second time this year, ROVI is upgrading its operating revenue guidance for the full year 2019, from a low-teen growth rate (i.e. from approximately 10% to 14%) to a high-teen growth rate (i.e. from approximately 16% to 19%).

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 third quarter of 2019 but, finally, will continue to market them in the fourth quarter of the year.

ROVI expects its growth drivers to be Bemiparin, the latest license agreements (Tetridar®, Neparvis®, Volutsa®, Orvatez® y Ulunar®), the enoxaparin biosimilar, its existing portfolio of specialty pharmaceuticals, the new products acquired recently (Falithrom® and Polaramine®) and the new contracts in the toll manufacturing area.