Mesoblast FY26 earnings: Ryoncil revenue up, new trial milestones for ASX:MSB

Mesoblast reported a strong full year with US$115 million in Ryoncil revenue and advanced key clinical trials for future growth.

The Mesoblast Ltd (ASX: MSB) share price is in focus after the company reported Ryoncil® net revenue of US$36 million for the June quarter and US$115 million in its first full year since product launch.

A male doctor and a woman in scrubs in the foreground smile.

Image source: Getty Images

What did Mesoblast report?

  • Ryoncil® net revenue of US$36 million for the fourth quarter
  • US$115 million in Ryoncil® net revenue for the first full year since FDA approval
  • Net operating cash spend of US$43.8 million for FY26
  • US$103 million cash on hand at 30 June 2026 (after extinguishing debt obligations)
  • At least 300 patients treated in pivotal Phase 3 trial of rexlemestrocel-L for chronic low back pain

What else do investors need to know?

Mesoblast is expanding Ryoncil® into new patient groups. Trials have commenced to extend its label from children to adults with steroid-refractory acute graft versus host disease (SR-aGvHD), a market expected to be three times larger. The company is also advancing trials for use in severe inflammatory conditions, including Duchenne muscular dystrophy.

The pivotal Phase 3 trial of rexlemestrocel-L met its target of over 300 chronic low back pain patients, with results to be followed over 12 months. In addition, Mesoblast received clearance to proceed with a registrational trial for Ryoncil® in children with Duchenne muscular dystrophy and filed for a biologic licence for rexlemestrocel-L in heart failure.

Mesoblast unveiled next-generation cell therapy strategies, securing a worldwide licence for chimeric antigen receptor (CAR) technology, aiming to develop new products for conditions such as ulcerative colitis, Crohn's disease, and lupus nephritis.

What did Mesoblast management say?

Mesoblast Chief Executive Dr. Silviu Itescu said:

We are very pleased with the continued momentum in uptake of Ryoncil® in children with life-threatening steroid-refractory acute GvHD across major U.S. pediatric centres, positioning the treatment well for use next in adults with this life-threatening disease. We will continue to build on the strong first full year of Ryoncil® revenue to ensure our judicious use of capital facilitates achievement of key inflexion points for our blockbuster products, including potential FDA approvals.

What's next for Mesoblast?

Mesoblast is focused on extending its lead product, Ryoncil®, into adult SR-aGvHD and other severe inflammatory conditions. The company expects up to 40 U.S. trial sites to enrol adults, representing approximately 60% of the annual U.S. bone marrow transplant population.

Looking forward, Mesoblast will follow patients in its chronic low back pain trial to collect safety and efficacy data, while progressing regulatory filings for both Ryoncil® and rexlemestrocel-L. Management has flagged ongoing innovation and new product opportunities through its CAR technology platform.

Mesoblast share price snapshot

Over the past 12 months, Mesoblast shares have declined 16%, trailing the S&P/ASX 200 Index (ASX: XJO), which has risen 3% over the same period.

View Original Announcement

Motley Fool contributor Laura Stewart has no position in any of the stocks mentioned. The Motley Fool Australia's parent company Motley Fool Holdings Inc. has no position in any of the stocks mentioned. The Motley Fool Australia has no position in any of the stocks mentioned. The Motley Fool has a disclosure policy. This article contains general investment advice only (under AFSL 400691). Authorised by Scott Phillips. This article was prepared with the assistance of Large Language Model (LLM) tools for the initial summary of the company announcement. Any content assisted by AI is subject to our robust human-in-the-loop quality control framework, involving thorough review, substantial editing, and fact-checking by our experienced writers and editors holding appropriate credentials. The Motley Fool Australia stands behind the work of our editorial team and takes ultimate responsibility for the content published by The Motley Fool Australia.

More on Healthcare Shares

Doctor sees virtual images of the patient's x-rays on a blue background.
Healthcare Shares

Could this ASX biotech really jump more than 80% in value?

This company's new technology has one broker impressed.

Read more »

Teamwork, planning and meeting with doctors and laptop for medical, review and healthcare. Medicine, technology and internet with group of people for collaboration, diversity and support in hospital
Healthcare Shares

CSL vs Pro Medicus: Which ASX healthcare share is better?

Both CSL and Pro Medicus have faced recent challenges but have enviable long-term track records. Here's which one I'd buy…

Read more »

Scientists working in the laboratory and examining results.
Healthcare Shares

This ASX biotech could rise almost 50%, Morgans says

Turning science into contracts could unlock value for this company.

Read more »

Doctor with stethoscope using a tablet in a hospital.
Healthcare Shares

Telix Pharmaceuticals wins FDA Fast Track for BiPASS prostate cancer imaging

Telix Pharmaceuticals shares are in the spotlight after the FDA granted Fast Track for its BiPASS pre-biopsy prostate cancer imaging…

Read more »

Three scientists looking at a laptop in a lab.
Healthcare Shares

What would it take for CSL shares to return to $250?

The shares have already recovered strongly, so I wanted to see whether $250 is realistic.

Read more »

Doctor with stethoscope typing on her computer.
Healthcare Shares

Is the ResMed share price a cheap buy?

I look at what the next few years of earnings growth could mean for today’s valuation.

Read more »

Medical workers examine an x-ray or scan in a hospital laboratory.
Healthcare Shares

Expert names 'undervalued' ASX 200 healthcare stock to buy today

A top fundie expects more outperformance from this resurgent ASX healthcare share.

Read more »

A gavel is placed on a stand on a desk with a legal representative wearing a suit in the background.
Healthcare Shares

Cochlear shares fall as investors face another setback

Cochlear shares are back in the red.

Read more »