The Mesoblast Ltd (ASX: MSB) share price is in focus today after the company announced a 69% quarter-on-quarter increase in net revenues from its lead product Ryoncil®, reaching US$20.6 million for the September quarter. Cash on hand also remained strong at US$145 million.
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What did Mesoblast report?
- Net revenue from cell therapy products rose to US$20.6 million, up from US$12.9 million in the prior quarter
- Gross sales of Ryoncil® increased by 66% to US$21.9 million, with net sales up 69% to US$19.1 million
- Net operating cash outflow was US$14.9 million, a reduction of US$1.7 million from the previous quarter
- Cash and cash equivalents at quarter-end totalled US$145 million
- Entered into agreements for up to US$50 million in unsecured convertible notes, subject to shareholder approval
What else do investors need to know?
Ryoncil® is now the first mesenchymal stromal cell (MSC) therapy approved by the US FDA, specifically approved for children under 12 suffering from steroid-refractory acute graft-versus-host disease (SR-aGvHD). A new permanent J-Code from Medicare and Medicaid Services, active from 1 October, is expected to further streamline billing and reimbursement, making access easier for hospitals and patients.
Coverage for Ryoncil® has expanded to more than 260 million insured lives across the US with mandatory Medicaid reimbursement. Mesoblast has established a patient support hub, MyMesoblast™, to help families and providers navigate insurance and financial assistance for treatment.
The company is expanding Ryoncil's® reach, now onboarded at 40 US transplant centres and progressing plans to launch a pivotal adult trial in partnership with the Bone Marrow Transplant Clinical Trials Network.
What did Mesoblast management say?
Commenting on the announcement, Mesoblast Chief Executive Dr. Silviu Itescu said:
Revenues from sales of Ryoncil® continue to increase, driven by greater physician adoption with reimbursement from both commercial and government payers. Having a permanent J-Code assigned by Centers for Medicare and Medicaid Services (CMS), which became active October 1, should serve to further enhance product adoption.
What's next for Mesoblast?
Mesoblast plans to build on its recent momentum by expanding Ryoncil's® approved use into adult SR-aGvHD patients, aiming for a pivotal trial with the support of the National Institutes of Health. This group represents a market roughly three times larger than paediatrics.
Meanwhile, the company says it remains well-funded and will consider drawing additional capital from its convertible note facility as it continues to grow sales and broaden its cell therapy pipeline for other inflammatory conditions.
Mesoblast share price snapshot
Mesoblast shares have soared 83% over the past year, far outpacing the S&P/ASX 200 Index (ASX: XJO) which has risen around 8% over the same period.
