Mesoblast (ASX:MSB) reports profit dive on rough start with US watchdog

Company News

by Melissa Darmawan

Regenerative medicine developer Mesoblast (ASX:MSB) has reported a downturn in earnings, as revenue plunged during the three months ended 31 March this year.

The $1.3 billion biotech’s revenue tumbled 84.4 per cent to US$1.9 million compared to US$12.2 million for the same quarter last year.

Their losses before income tax extended from US$17.2 million last year to US$26.6 million in the first quarter of this year notching a $9.4 million loss.

The cellular medicine maker told investors it may need to resubmit its application to the US FDA for its flagship product designed to help treat steroid-refractory acute graft versus host disease in children. The company gave an outline on how they are still discussing approvals with the US watchdog. The company met with FDA’s Center for Biologics Evaluation and Research review team to address outstanding items such as certain chemistry, manufacturing and controls items, including potency assay validation.

The biotech company also noted the successful completion of US$110 million private placement led by US investor group SurgCenter Development, one of the largest private operators of ambulatory surgical centres in the US specializing in spine, orthopaedic and total joint replacement.

Shares in Mesoblast (ASX:MSB) last traded 1.04 per cent lower at $1.90.