Commercial RisksComirnaty (COVID-19 vaccine) market share erosion is increasingly likely due, in part, to Sanofi enabling the commercialization of peptide-based COVID and COVID/flu vaccines under the Sanofi/Novavax partnership.
Financial PerformanceBioNTech recorded a net loss per diluted share of €1.31 per share—meaningfully worse than the previous forecast for net earnings of €1.18 per share; this was primarily due to significantly lower-than-expected COMIRNATY revenues.
Regulatory IssuesBNT326, the company’s HER3 antibody drug conjugate (ADC), was placed under a partial clinical hold by the FDA resulting in an enrollment pause of US patients.