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Laboratorios Farmacéuticos ROVI

DORIA Phase III trial hits primary endpoint

Flash note | Pharmaceuticals & healthcare | 19 Mar 2019

Laboratorios Farmacéuticos ROVI (ROVI) has announced top-line data from the pivotal Phase III PRISMA-3 trial evaluating DORIA (ISM risperidone) in schizophrenia. DORIA achieved the primary endpoint of a statistically significant reduction (p<0.0001) in PANSS score at week 12 (both 75mg and 100mg doses once-monthly intra-muscular injection). These data not only validate DORIA but also the ISM technology platform developed by ROVI. ROVI plans to file the US NDA in H219. We forecast a potential launch in 2021 in both the US and EU and peak sales opportunities of US$411m (US and EU) in 2027. DORIA has the potential to be highly value enhancing to ROVI’s long-term profit growth. This is in line with our expectations and we leave our forecasts and valuation unchanged at EUR 1.23bn or EUR 21.9 per share.

Laboratorios Farmacéuticos ROVI

Strength in heparins; next up DORIA

Update | Pharmaceuticals & healthcare | 06 Mar 2019

Laboratorios Farmacéuticos ROVI has reported strong revenue growth in FY18, with total revenues up 10% (€304.8m) beating guidance for the year. Its low molecular weight heparin (LMWH) franchise consisting of Becat (enoxaparin biosimilar) and flagship drug Hibor (bemiparin) reported sales of €121.5m (+42%). Hibor sales in Spain rose 14.7%, outperforming our 4% expectation. Becat (enoxaparin biosimilar) reported sales of €30.2m; its performance benefitted in 2018 from the ongoing roll-out in several European countries. Gross proceeds of the €88m capital raise will be used partly to fund the acquisition or in-licensing of additional products and sustain R&D efforts; of importance is Phase III DORIA (LA risperidone for schizophrenia) and data are anticipated in Q219. We value ROVI at €1.23bn.

Laboratorios Farmacéuticos ROVI

Executive interview – ROVI

Edison TV: | Pharmaceuticals & healthcare | 06 Mar 2019

Laboratorios Farmacéuticos ROVI is a fully integrated, profitable Spanish pharmaceutical company established in 1946 which listed on the Madrid Stock Exchange in 2007. ROVI is involved in the research and development, in-licensing, manufacture and marketing of small molecule and speciality biologic drugs. ROVI has a particular expertise in low molecular weight heparins (LMWH), with internally developed assets Hibor (bemiparin) and Becat (enoxaparin biosimilar) being key drivers of near-term revenue and profit growth. Sustainable long-term growth is dependent on successful R&D investment and ROVI’s efforts here lie in its ISM (in situ microimplants) technology. In this video, the company’s vice president & chief financial officer Javier López-Belmonte introduces the company, its LMWH franchise and an overview the commercialisation strategy for with its Phase III asset DORIA (Risperidone ISM).

Laboratorios Farmacéuticos ROVI

Becat on track; guidance uplifted

Update | Pharmaceuticals & healthcare | 14 Nov 2018

Laboratorios Farmacéuticos ROVI (ROVI) has reported 9M18 operating revenue of EUR 218.9m (+7.6% y-o-y), driven by substantial growth in the speciality pharmaceutical business (9M18: EUR 180.3m, +14.7% y-o-y). Management has upgraded FY18 guidance for operating revenue to a high single-digit growth rate (from mid-single digit). ROVI reported EUR 16.7m sales of Becat (enoxaparin biosimilar) in 9M18 and its performance benefits from ongoing roll-out in several European countries during 2018. In October, ROVI raised gross proceeds of EUR 88m from a capital raise, which will be used to fund R&D efforts (DORIA Phase III and Letrozole ISM Phase I) and the ongoing marketing of Becat. We value ROVI at EUR 1.13bn.

Laboratorios Farmacéuticos ROVI

Top-line strength as R&D costs rise

Update | Pharmaceuticals & healthcare | 30 Jul 2018

Laboratorios Farmacéuticos ROVI (ROVI) has reported H118 operating revenue of EUR 146.3m (+5.4% y-o-y), driven by substantial growth in the speciality pharmaceutical business (H118: EUR 123.2m, +14% y-o-y). Flagship product Hibor (bemiparin) sales grew to EUR 48.3m (H117: EUR 42.6m) as ROVI takes advantage of changing market dynamics, notably in Spain (+16% y-o-y). Enoxaparin biosimilar (EB) has now launched in Germany, UK and Italy, with further rollout across Europe ongoing. ROVI continues to expect FY18 sales of between EUR 20m and EUR 30m (H118: EUR 8.9m). Net profit for H118 was down to EUR 7.6m (H117: EUR 15.8m) mainly due to significantly increased R&D costs from the ongoing Risperidone-ISM Phase III trial and Letrozole-ISM Phase I trial. We value ROVI at EUR 1.21bn or EUR 24.1 per share.

Laboratorios Farmacéuticos ROVI

DORIA on target for US NDA in H219

Flash note | Pharmaceuticals & healthcare | 10 May 2018

ROVI has announced its pivotal Phase III PRISMA-3 trial continues on track and it expects to file an NDA with the FDA in the second half of 2019. The pre-specified DORIA interim analysis on the pivotal PRISMA-3 study has demonstrated that the study sample size (number of patients enrolled) does not need to be increased. We forecast efficacy data from the Phase III PRISMA-3 trial will be available in Q219 with a potential launch in 2021 in both the US and EU. We forecast peak sales opportunities of US$411m (US and EU) at a high gross margin, which has the potential to be highly value enhancing to ROVI’s long-term profit growth. We value ROVI at EUR 1.16bn or EUR 23.3/share.

Laboratorios Farmacéuticos ROVI

DORIA low risk, high reward

Outlook | Pharmaceuticals & healthcare | 09 May 2018

Laboratorios Farmacéuticos ROVI’s (ROVI) investment case rests on the growth opportunities in its speciality pharmaceuticals portfolio, in particular the ongoing European roll-out of its biosimilar enoxaparin. However, over the next 12-18 months we expect increased investor interest in the proprietary ISM-patented R&D pipeline. Risperidone ISM or DORIA, a long-acting injectable (LAI) for schizophrenia, is due to read out data in Q219 from the ongoing Phase III PRISMA-3 trial. DORIA’s potential US and EU approval (2020) and launch (2021) will validate ROVI’s long-acting formulation capabilities. With peak sales opportunities of US$411m (US and EU), this high gross margin product will be highly value enhancing to ROVI’s long-term profit growth. We value ROVI at EUR 1.16bn or EUR 23.3/share.

Laboratorios Farmacéuticos ROVI

Stunning growth in speciality pharmaceuticals

Update | Pharmaceuticals & healthcare | 27 Apr 2018

Laboratorios Farmacéuticos ROVI (ROVI) reported Q118 operating revenue of EUR 75.8m (+12% y-o-y), driven by strong growth in the speciality pharmaceutical business (+23%). Flagship drug Hibor (bemiparin) grew 19% (y-o-y) and the majority of the portfolio of drugs posted robust growth. Biosimilar enoxaparin reported sales of EUR 4.1m (despite only being available in Germany since September 2017 and the UK since March 2018), and ROVI has announced a distribution and marketing agreement in the MENA region with Hikma. This asset remains a key driver of near-term top-line growth and medium-term operating profit growth. Toll manufacturing sales declined 23% y-o-y, but we note that Q117 was an exceptionally buoyant year for the injectables division. We value ROVI at EUR 956.7m.

Laboratorios Farmacéuticos ROVI

Steady as she grows

Update | Pharmaceuticals & healthcare | 27 Feb 2018

Laboratorios Farmacéuticos ROVI (ROVI) reported FY17 operating revenue of EUR 275.6m (+ 4%), driven by strong growth in the toll manufacturing business (+8%). The speciality pharmaceutical business grew 3%, within which biosimilar enoxaparin reported fledgling sales of EUR 1.5m despite only being available in Germany since September 2017. This asset remains a key driver of top-line growth in the near term and operating profit growth in the medium term. The R&D pipeline progressed in 2017 with the long-acting DORIA (schizophrenia) and letrozole (breast cancer) having entered Phase III and Phase I clinical-stage development respectively. Our revised valuation is EUR 0.96bn.

Laboratorios Farmacéuticos ROVI

Biosimilar enoxaparin launches

Update | Pharmaceuticals & healthcare | 14 Nov 2017

ROVI reported operating revenue of EUR 203m for 9M17 (+ 6%), driven by exceptionally strong growth in the toll manufacturing business (+20%). The speciality pharmaceutical business grew 3%, aided by sales growth in newer product launches offsetting declines in the mature portfolio. ROVI has launched its internally developed biosimilar enoxaparin into the first European market (Germany) ahead of any competition; this is a key driver of sales and operating growth in the medium term. R&D progress continues with the long-acting DORIA (schizophrenia) and letrozole (breast cancer) having entered Phase III and Phase I of clinical-stage development respectively. Our revised valuation is EUR 0.98bn.

Laboratorios Farmacéuticos ROVI

Ace of Spain

Initiation | Pharmaceuticals & healthcare | 12 Jul 2017

ROVI, a profitable, speciality healthcare company, markets ~30 proprietary and in-licensed products across nine core franchises mainly in its domestic Spanish market. ROVI is at a major inflection point; its internally developed biosimilar enoxaparin could be first to launch in key European markets (launch expected end 2017), transforming the sales growth and operating margins of the business. ROVI has a strong presence in the Spanish heparin market (and select international markets through partners), where it has been manufacturing and marketing its flagship product Hibor (second-generation LMWH) since 1998. Other top-line drivers include further product in-licensing and the potential launch (2021) of Risperidone-ISM (schizophrenia). We value ROVI at EUR 1.0bn (EUR 20.1/share).

Rovi

Enoxaparin biosimilars - natural evolution

QuickView | Pharmaceuticals & healthcare | 15 Jun 2017

Rovi, a Spain-domiciled, speciality pharma company, plans to launch an enoxaparin biosimilar (originator: Sanofi Clexane/Lovenox) into key European markets by year end. Rovi currently markets Hibor (bemiparin), its proprietary second-generation low molecular weight heparin (LMWH) anticoagulant, in Spain and select international markets. We expect Rovi to benefit from the vertical integration opportunities that an enoxaparin biosimilar launch would bring as it continues to evolve into a European leader in LMWH anticoagulants.