Mesoblast Ltd (NASDAQ:MESO, ASX:MSB) reported $US35.1 million ($52.4 million) in gross revenue from Ryoncil sales in the December quarter, up 60% on the prior period.
Mesoblast has reported $US35.1 million ($52.4 million) in gross revenue from sales of its cell therapy Ryoncil during the December quarter, representing a 60% increase on the prior period.
Ryoncil is the first US Food and Drug Administration-approved mesenchymal stromal cell product and is currently cleared for use in paediatric steroid-refractory acute graft-versus-host disease.
The company said it plans to evaluate the treatment in a pivotal trial in adults, targeting a market it estimates to be roughly 3 times larger than the paediatric segment.
Mesoblast also pointed to balance sheet improvements after securing a $US125 million, 5-year, interest-only facility from its largest shareholder.
It said the funding enabled full repayment of its senior secured loan and partial repayment of a subordinated royalty facility.
Chief executive Silviu Itescu said the strengthened financial position provided “greater flexibility for strategic partnerships and pursuit of label expansion for Ryoncil”.
What is RYONCIL
RYONCIL (remestemcel-L) is an allogeneic, bone marrow-derived mesenchymal stromal cell (MSC) therapy indicated for the treatment of steroid-refractory acute graft-versus-host disease (SR-aGvHD) in paediatric patients aged two months and older.
The recommended dose is 2 × 10^6 MSC per kilogram of body weight per intravenous infusion, administered twice weekly for 4 consecutive weeks. Treatment response is assessed 28 ± 2 days after the first dose, with additional therapy given where appropriate.