- Mesoblast (MSB) tumbles on the ASX today after flagging a wider year-on-year loss for the 2021 financial year
- The company posts a US$98.8 million (A$135.5 million) for the year, 26.8 per cent more than the 2020 financial year
- CEO Silviu Itescu says MSB has made “significant progress” developing its flagship remestemcel-L drug but is still pursuing regulatory approvals
- The company says its “well-established” regulatory process may include a resubmission to the FDA and a six-month review of its lead product
- Mesoblast shares are down 10.2 per cent and trading at $1.78 each at 11:38 am AEST
Mesoblast (MSB) has tumbled on the ASX today after flagging a wider year-on-year loss for the 2021 financial year.
The drug developer tabled roughly US$7.5 million (A$10.3 million) in revenue for the full year — 77 per cent down on the $32.1 million (A$44 million) in revenue the year before.
While research and development costs were marginally lighter than FY20, Mesoblast still deepened its annual loss by roughly 26.8 per cent to US$98.8 million (A$135.5 million). For reference, MSB posted a US$77.94 million (A$106.9 million) loss over the 2020 financial year.
Mesoblast said part of the reason for the lower revenue figure was US$25 million (A$34.29 million) in milestone payments for its rexlemestrocel-L product from Grünenthal and Tasly during the 2020 financial year.
These upfront payments were not reported for the 2021 financial year, hence the difference in revenue figures.
Mesoblast CEO Silviu Itescu reiterated the company made “significant progress” towards developing its flagship remestemcel-L product as it worked towards regulatory approval with the US Food and Drug Administration’s (FDA) Center for Biologics Evaluation and Research (CBER).
“We are pleased with recent recommendations by FDA’s CBER to meet with the review team and address remaining CMC items for remestemcel-L in the treatment of steroid-refractory acute graft versus host disease in children,” Mr Itescu said.
“Additionally, our most recent meeting with the FDA has provided clarity on the pathway towards an emergency use authorisation for remestemcel-L in the treatment of COVID ARDS.”
Mesoblast said it planned to meet with the FDA’s Office of Tissue and Advanced Therapies (OTAT) in the December quarter of this year to discuss potency assays for remestemcel-L in relation to treating steroid-refractory acute graft versus host disease (SR-aGvHD).
The company said this condition had attributes relevant to COVID-19-induced acute respiratory distress syndrome (ARDS).
Meanwhile, Mesoblast is still chasing regulatory approval for using remestemcel-L to treat pediatric aGvHD.
The company said it was still in talks with the FDA, with a “well-established” regulatory process that may include a resubmission and a six-month review of its lead product.
This means shareholders still have some time to wait before Mesoblast can land its necessary approvals for its treatments.
Mesoblast had US$136.9 million (A$187.75 million) cash on hand at the end of the financial year, with some US$21.9 million (A$30 million) of remestemcel-L pre-launch inventory ready to go if it received FDA approval.
Nevertheless, the ongoing regulatory delays and steeper annual loss means Mesoblast shares were down 10.2 per cent and trading at $1.78 each at 11:38 am AEST. The company has a $1.15 billion market cap.