De IV. Aquí está lo que dice un analista que ha hablado con NVAX. Todo lo que se ha dicho por aquí o en el pasado.
Problemas de materiales para el finalizado (filtros...), pero en línea para 150M dosis mes en junio. Sin problema de Matrix.
Retraso en entregar la documentación para los EUA por el cmc, que requiere verificación de varias de las fábricas. Dicen que Q2, esperemos que no tarde mucho en UK porque más de abril en UK y Europa y mayo en usa me parecería malo.
Finalizando el acuerdo con Europa. Por eso están apretando. Ahora la empresa puede ir y decirles, esto no es actuar en buena fe. Habéis tenido meses, ponernos las fábricas en tu territorio y nos haces esto? 1€ más la dosis.
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Note from JPM Analyst:
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We had the chance to connect with Novavax management following the flow of headlines surrounding vaccine production delays due to raw material supply shortages and wanted to pass along some thoughts as it relates to shares.
Indeed the company confirmed challenges are being faced by contract manufacturers and are primarily related to the sourcing of material necessary for the fill / finish process (ie: filters, stoppers, etc.) rather than constituents of the active vaccine substances. That said, while specifics were not provided, the company notes that measures are underway to resolve these delays and is still committed to the previously outlined goal of producing 150M doses/month globally by the end of 2Q. With respect to other aspects of its vaccine manufacturing supply chain (antigen and adjuvant production, co-formulation), the company notes no bottlenecks and retains uninterrupted access to its supply of Matrix-M adjuvant.
On the regulatory front (recall rolling authorization reviews in the UK, EMA, Canada, Australia, and New Zealand underway), finalization of submissions are on track for 2Q, where completion of CMC package (which requires coordination across multiple manufacturing sites) remains the gating item. From the standpoint of company news flow, we would anticipate an announcement upon a completion of submission, prior to any authorization announcement(s) from EMA, MHRA or other jurisdictions. As well, the company continues to engage in discussions with the EU commission towards the finalization of a vaccine supply agreement (hoping to be able to make an announcement “soon”) and notes the process is independent of an EMA authorization.
Bigger picture, looking to a number of potential approvals over the very near term, we note today’s weakness as overdone and continue to see NVAX as undervalued relative to approved peers with current levels presenting an attractive entry-point.
