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On Thursday 26th August, Rovi and Moderna declared that some doses of Moderna''s COVID vaccine in Japan, manufactured by ROVI, had some particle contamination. This has led to the withdrawal of the impacted batch and two adjacent ones, totalling 1.6m doses. Rovi identified the reason (not disclosed), and acknowledged the fault was theirs, identifying an incident in June, which has already been resolved. Production has not stopped at any time since Thursday. News of additional batches
Companies: Laboratorios Farmaceuticos ROVI (ROVI:BME)Laboratorios Farmaceuticos Rovi, S.A. (ROVI:MCE)
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Stronger sales due to Moderna agreement
Sales in Q2 grew 77%, 15% above consensus. Part of this was due to the lower activity in Q2 20 but the main reason for the strong beat came from Toll manufacturing activity, which includes the revenues from the CDMO contract with Moderna and the income received to prepare the plant for manufacturing. Toll manufacturing sales reached EUR58.9m vs EUR42m estimated. The beat in margin was lower. EBITDA grew 75%, 4% above consensus, as heparin raw material cos
Strong figures boosted by Moderna vaccine CDMO
Results were better than expected on a slightly better sales figure (+4%) and better margins despite a raw materials headwind. Heparins grew 15% thanks to Hibor outside Spain, while the main contributor to sales was the services business (+179%), which registered the first impact from the Moderna vaccine contract development and manufacturing organisation (CDMO). Gross margin did not improve, as expected, due to the growing raw material prices of h
Edison Investment Research is terminating coverage on EJF Investments (EJFI), ROVI Laboratorios Farmaceuticos (ROVI) and SDX Energy (SDX). Please note you should no longer rely on any previous research or estimates for these companies. All forecasts should now be considered redundant.
Laboratorios Farmacéuticos ROVI (ROVI) has reported a strong set of FY20 results, with all pillars of the business contributing to revenue growth of 10% and EBITDA margin expansion of 650bp to 22.4%. Total revenues of €421.1m were driven by its LMWH franchise (+14%) and high-value, toll manufacturing business (+39%), which has been catapulted into the international spotlight. In July 2020, ROVI signed a deal with US biotech Moderna to provide finished COVID-19 vaccine mRNA-1273 for supply ex-US.
ROVI has stopped the Doria regulatory process for 6 months
ROVI has announced that it has required a stop the clock in the process on Day 181 of the EMA process for licensing Doria in order to have time to repeat the bioavailability study (BORIS). The issue is not with efficacy but bioavailability, with the EMA requesting a comparison of Doria with oral risperidone in Europe, despite the company having proved the bioequivalence of the US and European versions in its registration dossier and t
Stronger EBITDA despite weaker Enoxaparin sales
Sales came in line with our numbers (but above consensus), with slightly weaker performance by Enoxaparin (-11% in Q4), offset by the rest of the heparin business. In Toll Manufacturing the company included the income from the Moderna technology transfer. With gross margin slightly below expectations due to slower than expected decline in sodium heparin prices, the positive performance in terms of costs helped the company to report 83% growth in E
Stronger Q4 results due to Moderna''s technology transfer
We expect ROVI to end the year ahead of consensus estimates due to the contribution from the Moderna technology transfer during Q4. We quantify this at c.EUR10m. The rest of the business should progress in line with previous quarters, though with some deceleration in heparins (-12% in Q4), due to fewer surgeries and lower price increases in Hibor international. Raw materials will continue to impact in heparins as well, but we expect EBIT
Companies: Laboratorios Farmaceuticos Rovi, S.A.
Laboratorios Farmacéuticos ROVI’s (ROVI’s) recent capital markets day (CMD) highlighted the strong positioning of its three key franchises. Combined unit sales of Becat and Hibor have now overtaken incumbent Clexane sales, establishing ROVI as a leader in low molecular weight heparins (LMWHs). The US DORIA (risperidone ISM) NDA has been filed for schizophrenia. Near-term inflection points include DORIA EU approval and launch (2021e). The COVID-19 opportunity has led to a significant rally in the
Reported 9M20 numbers highlight continual strength in sales across key franchises and ongoing margin expansion. ROVI reported operating revenue of €302.1m (+12%). Within the low molecular weight heparin (LMWH) franchise (+26% to €157.7m), biosimilar enoxaparin (Becat) performed strongly, while the toll manufacturing division (+38% to €62.7m) benefited from the redirection of strategy to high value-added products. EBITDA increased 47% to €69.7m in 9M20, reflecting lower R&D costs and increasing o
Strong beat in sales and margins
Sales grew 19% in Q3 with 2 clear drivers: the strong contribution of Becat (+66% growth vs Q2 19) and the positive toll manufacturing business (+48%). A better mix, with higher toll manufacturing sales and price increases in heparins (mainly in hospitals), drove an increase in gross margin above our expectations (56.6% vs 55.4%). EBITDA grew 30% and NP +18%. The only ''negative'' in the results came from FCF. This was down to higher capex on the new heparin fac
Our fireside chat with Javier Lopez Belmonte, CFO of ROVI: Doria on track in Europe
The CFO reiterated that the company expects EMA approval for Doria by the end of this year or beginning of 2021 in Europe. Rovi is already recruiting sales force in Germany and will do so in the UK in the short term. Filing with the FDA and the way they plan to commercialise Doria in the US will depend on the launch in Europe.
Moderna vaccine: ''It could be very material''
Despite the company maintaining its c
Family-owned pharma company Rovi has a strong position in the heparin market in Europe. It has a ''risk-free'' agreement with Moderna to produce its COVID vaccine outside the US and a potential game-changing new long acting injectable product for schizophrenia (Doria) that could help group sales double by 2025 vs 2019 and EBITDA rise fourfold. We see limited regulatory and leverage risk.
Pharma business boosted by enoxaparin biosimilar
Low molecular weight heparins represent 46% of sales. Laun
Laboratorios Farmacéuticos ROVI reported H120 operating revenue of €191.1m (+8% y-o-y), driven by strong growth in heparins (+23% to €104.0m) and in toll manufacturing (+31% to €34.8m), which offset a decrease in sales of low-margin, mature specialty pharmaceuticals. EBITDA increased by 60% to €42.4m in H120, which reflects operational leverage plus a significant benefit from improved gross margin, and reduction in R&D and SG&A. For FY20, ROVI has maintained guidance of mid-single-digit growth i
Laboratorios Farmacéuticos ROVI (ROVI) reported Q120 operating revenue of €101.0m (+23% y-o-y), driven by strong growth both in the speciality pharmaceutical business (+24% to €88.2m) and in the toll manufacturing business (+19% to €12.7m). Top-line growth has, in part, benefited from COVID-19 related stockpiling across all divisions. As a result of operating leverage, EBITDA increased by 68% to €20.0m in Q120 reflecting a 530bp improvement vs Q119. Sales of low molecular weight heparin (LMWH) p
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EKF has reported a strong H1, with revenues of £37.5m and double-digit growth in underlying non-Covid related business. Management reports it is trading in line with expectations for the full year and we make no change to our profit forecasts at this stage. New growth initiatives are proceeding to plan and should lead to accelerated core growth from FY23 onwards. We continue to see substantial upside on successful execution with the shares trading on an FY23 P/E of 13.1x and an EV/EBITDA of just
Companies: EKF Diagnostics Holdings plc
Singer Capital Markets
Kromek reported full-year results to 30 April that were in line with the trading update of 16 May. Record visibility over our FY 2023 revenue forecast of £18m (c.53% of which is already contracted and 37% “Awarded not Contracted”, with the balance from its normal monthly run rate) is a great start for FY 2023 on which the company can build further. We are leaving forecasts unchanged for the moment, despite additional contract wins, and expect to introduce FY 2024 forecasts at the time of its int
Companies: Kromek Group Plc
Kromek announced a £1.7m fundraise by way of the issue of convertible loan notes (8% coupon, 18-month conversion period at 15p per share), which will allow the company to minimise any potential supply-chain disruption to the delivery of contracts during the year. We make only minor changes to forecasts to reflect the additional interest (c.£0.1m) accrued, with adjusted pre-tax loss increasing to £5.0m. We leave our target valuation of £118m (27p) unchanged, with near-term catalysts (e.g. a secon
Ahead of its upcoming results, ECO has issued an update flagging an issue around a sales tax liability and the treatment of certain items of capitalised development, offset by a foreign exchange gain will result in it reporting FY22 Adj EBITDA of ~£6.5m vs SCMe £7.1m. It has also indicated trading in China has been difficult in Q1 FY23, particularly with the large producers, but margins have improved on mix. Trading in the Rest of the World has been strong YTD. Given the proximity to the results
Companies: ECO Animal Health Group plc
Companies: Omega Diagnostics Group PLC
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Unigel Group, intends to join the Aquis Growth Market. Unigel Group is a pioneer in the field of thixotropic gels for the fibre optic cable industry. The Company is also a supplier of laminated steel tapes to the fibre optic cable industry in the US. Thixotropic gels and laminated steel tapes are essential components to the rapidly growing global fibre optic cable market. The Group export
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Smith & Nephew reported mostly in-line Q2 22 numbers, missing the top-line estimates (-0.6%) but beating on the trading profit (+0.5%), albeit marginally.
The Q2 performance was overshadowed by a 100bp margin downgrade for FY22 (-50bps Y-o-Y vs +50bps previously), which sent the stock ~9% lower in the session following the update. The reiteration of the top-line growth outlook of 4-5% was no help either.
We will cut our estimates, largely to reflect the soft margin guidance.
Companies: Smith & Nephew PLC
Companies: PureTech Health PLC
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What’s cooking in the IPO kitchen?**
Unigel Group, intends to join the Aquis Growth Market. Unigel Group is a pioneer in the field of thixotropic gels for the fibre optic cable industry. The Company is also a supplier of laminated steel tapes to the fibre optic cable industry in the US. Thixotropic gels and laminated steel tapes are essential components to the rapidly growing global fibre optic cable market. The Group exports
Companies: UJO FAB HAT HZM SYM TRAC
In Q2, Astra sustained its solid top-line momentum. Like in the past few quarters, this outperformance was again driven by higher COVID-19 business sales and solid growth in Diabetes drug Farxiga. Moreover, the recovering Oncology and much-needed green shoots in Rare Diseases were the icing on the cake. Although, profitability again came under the scanner but should improve in the coming quarters/years as the company completes its ‘growth phase’. Overall, a decent set of results and our positive
Companies: AstraZeneca PLC
Companies: SourceBio International Plc
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Inteliqo Limited, intends to join the Aquis Growth Market. Inteliqo Limited provides sales, marketing and distribution services to technology product owners under long-term distribution agreements. The Company has agreed its first such agreement in respect of the Ipedia iQ product range. The iQ product is a smart translation earphone (earbuds) system which offers integrated real time speech
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Belluscura has announced that it has entered into a Group Purchasing Organisation Product Supply Agreement with VGM Group which further expands its distribution network across the US.
Companies: Belluscura PLC
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