Mesoblast Ltd (ASX: MSB) shares are in the spotlight on Tuesday.
In morning trade, the allogeneic cellular medicines developer's shares are up over 1% to $2.36.
This follows the release of the company's annual general meeting update and quarterly sales guidance.
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What did the company announce?
Let's start with its sales performance in the current quarter.
According to the release, Mesoblast's sales are expected to be up strongly quarter on quarter thanks to increasing demand for its Ryoncil (remestemcel-L-rknd) product.
For the quarter ended 31 December, management revealed that it expects gross revenue of more than US$30 million from sales of Ryoncil (remestemcel-L-rknd). This represents an increase of 37% on the US$21.9 million in gross revenue that was record from Ryoncil in the prior quarter ended 30 September 30.
What else?
At its annual general meeting, management spoke very positively about Ryoncil and how its approval by the US FDA has transformed the company forever. The company's chair, Jane Bell, said:
The FDA approval of Ryoncil is not simply a regulatory milestone: it is a turning point in our transition from development to commercialization, and a powerful validation of Mesoblast's scientific platform, manufacturing rigor, and clinical strategy.
The commercial launch of Ryoncil has been executed flawlessly with strong uptake to date and growing sales, which have exceeded our expectations. We are very pleased with the commercial and government reimbursement that is now in place, as we ensure that all children with this devastating disease have access to our life-saving treatment with payor coverage now extending to over 260 million lives in the U.S. as well as successful onboarding and physician adoption.
Bell also highlights that the first approval could be just the start of many more in the future. She highlights that Mesoblast has its eyes on the cardiovascular and back pain markets, adding:
Achieving a first FDA approval and demonstrating successful product commercialization provides important validation for our whole strategy and value chain of our technology platforms. The learnings from Ryoncil are being adapted to the rest of the company's pipeline and will hold us in good stead as we work towards further FDA approvals for our cardiovascular and back pain indications for our second-generation stromal cell technology platform.
Mesoblast shares have been strong performers over the past 12 months. During this time, they are up almost 40%. This compares to a gain of just 1.3% from the ASX 200 index over the same period.
