The operating revenue of Laboratorios Farmacéuticos ROVI increased by 10% to 303.2 million euros in 2018, driven mainly by the strength of the specialty pharmaceutical business, which grew by 16%, strongly outperforming the pharmaceutical market. Total revenue increased by 10 % to 304.8 million euros in 2018.

Sales of prescription-based pharmaceutical products rose 18% to 216.8 million euros in 2018, outperforming the market by 16 percentage points. According to the consulting company QuintilesIMS, the innovative product market in Spain rose by 2% in 2018 in comparison with the preceding year.

In addition, sales of the low-molecular-weight heparin (LMWH) franchise increased by 42% in 2018. LMWH (enoxaparin biosimilar and bemiparin) ) sales represented 40% of operating revenue in 2018, compared to 31% in 2017. Sales of the enoxaparin biosimilar totalled 30.2 million euros,  while those of bemiparin, ROVI’s flagship product, grew 9% in Spain, totalling 91.3 million euros. In Spain, bemiparin sales rose 15%.

In 2018, 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, totalled 13.6 million euros, in comparison with 4.7 million euros in the preceding year. Sales of Hirobriz® Breezhaler® and Ulunar® Breezhaler® of the company Novartis, both of which are bronchodilators administered by inhalations and indicated for patients with respiratory difficulties due to Chronic Obstructive Pulmonary Disease (COPD), rose by 7% to 15.3 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 25% to 11.2 million euros. Sales of contrast imaging agents and other hospital products increased by 4% to 29.7 million euros.

EBITDA “pre-R&D and non-recurring expenses”, calculated excluding R&D expenses in 2018 and 2017 and  the impact of non-recurring expenses in 2018, increased by 8%, from 58.2 million euros in 2017 to 63.0 million euros in 2018. Likewise, ROVI’s net profit “pre-R&D and recurring expenses” increased by 19% to 53.8 million euros.

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

As of 31 December, 2018, all the European Union countries (24 countries) where ROVI had applied for the national registration of the enoxaparin biosimilar had approved said registration, except Greece and Luxembourg.

ROVI commenced the marketing of its enoxaparin biosimilar in Germany in September 2017. Likewise, in 2018, ROVI began to market it in UK, Italy, Spain, France, Austria, Latvia and Estonia in 2018;.

In April 2018, ROVI signed a licensing agreement with Hikma Pharmaceuticals PLC, a quoted multinational pharmaceutical group (LSE: HIK), for the exclusive marketing of its enoxaparin biosimilar in 17 MENA (Middle East and North Africa) countries: Saudi Arabia, Jordan, Algeria, Egypt, Tunisia, Sudan, Syria, Yemen, Iraq, Oman, United Arab Emirates, Kuwait, Qatar, Bahrain, Libya, Palestine and Lebanon.

Likewise, in June 2018 ROVI announced the signature of an agreement with Sandoz, a division of Novartis AG and a global leader in generic pharmaceuticals and biosimilars, to distribute and market its enoxaparin biosimilar in 14 countries/regions (Australia, New Zealand, Philippines, Hong Kong, Singapore, Vietnam, Malaysia, Canada, South Africa, Brazil, Colombia, Argentina, Mexico and Central America).

In addition to the European countries mentioned, as of December 2018, ROVI held marketing agreements for its enoxaparin biosimilar in 64 countries.

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 phase I & II programme of Risperidone ISM®, ROVI started the pivotal phase III trial “PRISMA-3” with the recruitment of the first patient in May 2017. After finishing the recruitment in September 2018, all patients completed the double-blind (main) period of the study in December 2018. Therefore, the company plans to file an NDA (New Drug Application), the registration dossier for the U.S. which is submitted to the FDA (Food and Drug Administration), in the second half 2019.

In addition, in November 2017, ROVI started the clinical development of Letrozole ISM®, 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 [AL1] study, is currently ongoing; this is an open-label, dose-escalation study to evaluate the pharmacokinetics, safety and tolerability of single intramuscular injections of Letrozole ISM® at different strengths 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 completing a Phase III study and we 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 24 countries as of 31 December, 2018. Likewise, we are continuing with the marketing of enoxaparin in Germany, United Kingdom, Italy, Spain and France, five of the main markets in Europe, and have begun to market it in Austria, Latvia and Estonia, with good sales expectations, as shown by the 2018 sales, which totalled 30.2 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

In 2019, ROVI expects a high-single-digit growth rate for the operating revenue. The company hopes to continue to grow at a higher rate than the pharmaceutical spending In Spain in the first nine months of 2018, which, according to the figures published by the Ministry of Health, Consumer Affairs and Social Welfare, was 3%.

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, new products distribution licences and the new contracts in the toll manufacturing area.