AUS
NZ
UK
CA
USA
IND
_10_04_2024_16_38_50_427275.jpg)
Highlights:
- Mesoblast Limited (ASX:MSB) announced its operational and financial results for the quarter ended 31 March 2023.
- In 3Q FY23 results, MSB’s revenue from sales of TEMCELL® HS Inj. sold in Japan by its licensee for 3Q FY23 were US$1.8 million.
- MSB trimmed losses after tax to US$18.6 million in 3Q FY23 versus US$21.3 million in pcp.
The biotechnology company in the area of stem cell technology, Mesoblast Limited (ASX: MSB), increased by 6.249% and was trading at AU$1.105 on Friday, 26 May 2023, at 11:47 am AEST after it announced its operational and financial results for the quarter ended 31 March 2023.
Let’s now go through the ASX healthcare stock-MSB’s 3Q FY23 results in detail.
On Friday, MSB released its 3Q FY23 results, revenue from sales of TEMCELL® HS Inj. sold in Japan by its licensee for 3Q FY23 were US$1.8 million. On a constant currency basis, sales for 3Q FY23 rose 4% to US$2 million against US$1.9 million in pcp.
In the given period, MSB successfully concluded a global private placement mainly to its current major US, UK and Australian stakeholders raising nearly US$40 million, net of transaction costs.
In the reported period, the company trimmed losses after tax to US$18.6 million in 3Q FY23 versus US$21.3 million in pcp. The net loss attributable to ordinary stakeholders was 2.53 US cps for 3Q FY23, against 3.28 US cps in pcp.
As of 31 March 2023, the company’s cash reserves were US$48.8 million (pro forma cash after adjusting) for US$40 million of funds raised in April is US$88.8 million, with up to a further US$40 million available to be taken out from current financing facilities conditional on specific milestones.
During the 3Q FY23, FDA accepted MSB’s filing of the BLA for remestemcel-L for treating children with SR aGVHD concluded and has set a PDUFA target date of 2 August this year.
As a component of its in-progress evaluation of the BLA, FDA conducted the PLI of the manufacturing procedure for remestemcel-L. As per the FDA process, an EIR is anticipated to be issued by FDA in the upcoming weeks giving a thorough summary and concluding evaluation of the inspection.
The FDA gave RMAT designation for rexlemestrocel-L for treating CLBP related to disc degeneration in conjunction with hyaluronic acid as a delivery agent for injection into the lumbar disc. FDA has given its nod to the pivotal trial protocol, and the company anticipate enrolment to begin in the 3Q of 2023.
