Mesoblast (ASX: MSB) Revenue Jumps to US$120.3 Million on Ryoncil Launch

Mesoblast’s annual revenue surged seven-fold as the first full year of US sales for Ryoncil began reshaping the biotechnology company’s financial profile.

Revenue reached US$120.3 million for the year ended June 30, up from US$17.2 million a year earlier, driven overwhelmingly by product sales.

The stronger commercial performance helped narrow Mesoblast’s net loss, although rising clinical development spending means the company continues to consume cash as it pursues broader indications for its cell therapies.

Ryoncil Transforms Revenue Base

Net product sales climbed to US$115.2 million from US$11.3 million in fiscal 2025, with Ryoncil accounting for the entire amount after a 13.4% gross-to-net adjustment.

Reported gross profit increased to US$103.6 million. Excluding amortisation, gross profit was US$109.7 million, compared with US$16 million a year earlier.

That growth was partly offset by a sharp increase in research and development expenditure, which rose to US$97.5 million from US$34.8 million as Mesoblast funded Phase 3 trials, regulatory work and development across its cell-therapy platforms.

The full-year net loss narrowed 44% to US$57.5 million from US$102.1 million. The improvement accelerated in the second half, when the loss fell 68% to US$17.3 million.

US Commercial Rollout Expands

Ryoncil is approved in the US for children with steroid-refractory acute graft-versus-host disease and is the first mesenchymal stromal cell therapy cleared by the US Food and Drug Administration.

More than 50 transplant centres have now been onboarded, including 14 of the 15 largest US centres, which account for almost half of paediatric transplant volumes.

Payer coverage has expanded to more than 280 million covered lives, while the median time between patient identification and treatment has fallen from 29 days at launch to eight days.

Mesoblast is now seeking to extend Ryoncil into adults. A registration trial evaluating the therapy alongside ruxolitinib as second-line treatment is enrolling, with up to 40 US sites expected to be activated this year.

Those centres account for about 60% of the estimated 8,500 adult allogeneic bone-marrow transplants performed annually in the US.

Back-Pain Trial Approaches Key Readout

Mesoblast has also completed treatment of 350 patients in its pivotal Phase 3 trial of rexlemestrocel-L for chronic low back pain, after expanding enrolment from an initial 300 patients.

The primary endpoint measures durable pain reduction 12 months after a single intra-discal injection, with secondary measures covering function, quality of life and pain-medication use.

Top-line results are expected in mid-2027. Mesoblast estimates the potential market for the indication exceeds US$10 billion.

Cash Supports Next Stage

Net operating cash outflow improved to US$43.8 million from US$50 million, with second-half operating cash use falling to US$13.4 million.

Cash stood at US$102.9 million at June 30, down from US$161.6 million a year earlier.

During the year, Mesoblast established a US$125 million five-year non-dilutive credit facility and retired two higher-cost facilities, giving it additional funding flexibility as it expands Ryoncil and advances its late-stage pipeline.