Excellent news: production has resumed
Excellent news: production has resumedLATEST
FACT
Crossject announced that the production issue (due to a mould of a Zeneo component which had been damaged during the summer) has been fixed with production having started again yesterday.
ANALYSIS
As a reminder, the technical issue surrounding a mould of a component was announced together with the release of the H1 results (see our Latest dated 27 September) and (partly) caused a steep fall in the share price which has halved in the last two months. Yesterday’s news is, of course, very good news for the group and this all the more since management is now even more aware of the possible occurrence of such issues, and determined to put greater emphasis on maintenance and invest on substitution production tools to face future potential issues. For the time being, the mould has been repaired and the first products validated. After the whole process has been validated, production for clinical studies will resume in spring 2019. Fair enough. Management also seized this opportunity to confirm it is targeting filings for 2020 for most products, although it also insisted it puts an emphasis on Midazolam (Europe), Naloxone (Europe and US) and Epinephrin (Europe and US). The group also confirmed it is targeting licensing agreements in FY19 for Midazolam, Naloxone and Sumatriptan in Europe and/or the US depending on the drug.
IMPACT
Altogether, this is very good news and Crossject is back on its feet to keep moving towards its ambitious goals. There is no reason for us to change numbers and/or valuation on the news. Thus, our upside remains huge, as is the market potential for Zeneo.
Crossject SA is a France-based company that designs and develops medical injection systems. The Company specializes in needle-free, pre-filled, single-use injection systems for intradermal, subcutaneous and intramuscular applications for pharmaceutical companies. Is also has a pipeline and three drugs in the preclinical or clinical phase of research. The Company's products, which are based on well-known injectable drugs (chemicals and biologics), are designed to enhance patients' safety, compliance and comfort. Crossject's first ZENEO SUPERGENERIC product is expected to reach the market in the year 2015. The Company has industrial partnerships with Hirtenberger and Recipharm.
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