NEW YORK, Feb. 26, 2026 (GLOBE NEWSWIRE) -- Mesoblast Limited (Nasdaq:MESO; ASX:MSB), global leader in allogeneic cellular medicines for inflammatory diseases, today provided financial results and an operational update for the period ended December 31, 2025 (H1 FY2026).
FINANCIAL HIGHLIGHTS FOR H1 FY2026(1)
Performance driven by successful commercial launch of Ryoncil$(R)$
-- Total revenue of US$51.3 million (A$78.3 million),2 up from US$3.2
million.
-- Successful U.S. commercial launch of Ryoncil(R) (remestemcel-L-rknd)
generated gross sales of US$57.0 million and revenue of US$48.7 million
after gross to net adjustment.
-- Ryoncil(R) gross profit, excluding amortization, was US$44.2 million
versus nil in the prior year period. Direct selling costs were US$7.7
million.
-- The strong operating performance in the period allowed us to invest in
R&D, including to support the Phase 3 trial on the blockbuster chronic
low back pain indication, for clinical programs for lifecycle extension,
and for commercial manufacturing of Ryoncil(R) inventory as well as for
launch of second-generation product.
-- Reported net loss of US$40.2 million compared to US$47.9 million, an
improvement of US$7.8 million. Excluding a US$23.0 million inventory
reversal reported in the prior year period, the improvement in net loss
year-over-year would have been US$30.7 million.
-- Net operating cash spend of US$30.3 million. Mesoblast expects to see
reduction in net cash spend over the remainder of the fiscal period based
on projected receipts from quarterly revenues.
-- Period-end cash balance of US$130.0 million. Mesoblast entered into a
US$125.0 million five-year non-dilutive credit-line facility. The second
tranche of US$50.0 million is available to be drawn at our option until
June 30, 2026.
OPERATIONAL HIGHLIGHTS FOR H1 FY2026
Successful Ryoncil(R) commercial launch
-- To date 49 transplant centers have been onboarded, with a target of 64
centers which account for 94% of transplants performed in the U.S.
Ryoncil(R).
-- Coverage by government and commercial payers already extends to 280
million U.S. lives with Federal Medicaid coverage by U.S. Centers for
Medicare & Medicaid Services $(CMS)$ and mandatory fee-for-service Medicaid
coverage in all U.S. states.
-- Issuance on October 1, 2025, of a specific Healthcare Common Procedure
Coding System (HCPCS) J-Code by CMS for billing and reimbursement
resulted in growth of Ryoncil(R) usage under CMS coverage versus
commercial coverage in the last quarter.3
-- 84% of patients in 'real-world' clinical setting able to complete the
initial 28-day treatment regimen as per the FDA approval label and
alive.4
-- These early data are consistent with the prior clinical experience with
Ryoncil(R). The outcomes highlight our focus on getting patients on
Ryoncil(R) therapy as early as possible following steroid resistance to
enable completion of an initial 28-day treatment course and maximize
survival.
-- Ryoncil(R) lifecycle extension: Mesoblast intends to expand the clinical
indications of Ryoncil(R) for life-cycle extension in both adults and
children with life-threatening inflammatory conditions. The final
protocol design for the Phase 3 trial of Ryoncil(R) as part of the
second-line treatment regimen in adults with steroid-refractory acute
graft versus host disease (SR-aGvHD), a population approximately three
times the size of the pediatric SR-aGvHD population, is locked down
following a recent meeting with FDA and will be provided to the
Institutional Review Board (IRB) in March for site initiation.
Mesoblast's second generation product rexlemestrocel-L to create multiple revenue streams in blockbuster indications
-- Mesoblast will seek to use its data from large randomized controlled
trials in chronic discogenic low back pain (CLBP) and inflammatory
chronic heart failure with low ejection fraction to support approvals for
rexlemestrocel-L, aligning with recent announcements by the FDA that a
single pivotal trial is the new default option for FDA approval.5
-- Confirmatory Phase 3 trial for chronic discogenic low back pain (CLBP):
During the period, Mesoblast received positive feedback from FDA on
potential filing of a Biologics License Application (BLA) confirming that
a clinically meaningful reduction in pain intensity in the active arm
versus placebo at 12 months can support product efficacy and stated that
the robust results on opioid reduction from at least one adequate and
well controlled trial could be included in the Clinical Studies section
of product labeling. Mesoblast's second randomized controlled Phase 3
trial in CLBP is on track to complete its 300-patient enrollment target
in March/April this year with the trial actively recruiting across 40
sites in the U.S.
-- BLA filing for end-stage patients with chronic heart failure with low
ejection fraction (HFrEF): Mesoblast has generated new data showing that
a single administration of rexlemestrocel-L at the time of open heart
surgery and device implantation to support the left ventricle in
end-stage patients with HFrEF, reduces right heart failure
hospitalizations, mortality from right heart failure, and portal
hypertension with major bleeding events. With these new data, existing
Orphan Drug designation for treating this group of patients, and FDA's
stated preference for randomized controlled trials, Mesoblast is moving
from filing for accelerated approval to filing for full FDA approval next
quarter. A confirmatory study would no longer be needed, if approved.
-- Commercial manufacturing: scale-up work for rexlemestrocel-L is well
progressed to support BLA filings for both CLBP and, in the first
instance, for end-stage HFrEF patients with LVADs.
FY2026 Net Revenue Guidance
Mesoblast anticipates full-year fiscal 2026 Ryoncil(R) net revenue to range between US$110 million and US$120 million.
Commentary
Mesoblast Chief Executive Dr. Silviu Itescu, commented on the result: "Today we report strong operational and financial performance for the first half of FY2026, a period that marks an important inflection point in Mesoblast's evolution from clinical development to sustainable commercial execution. Sales momentum for Ryoncil(R) continued to build, driving meaningful revenue and reinforcing the product's value in addressing significant unmet medical need and the strength of our commercial strategy.
Importantly, we have improved the Company's financial position with positive cash flow generated from Ryoncil(R) sales, disciplined cost management, and a strategic refinancing, providing greater flexibility to support expansion and late-stage clinical programs.
As we enter the second half of FY2026, we remain focused on accelerating commercial uptake, advancing regulatory and label expansion opportunities, and maintaining financial discipline to deliver sustainable long-term shareholder value."
Conference Call
There will be a webcast today, beginning at 5.00pm EST (Thursday, February 26); 9.00am AEDT (Friday, February 27). It can be accessed via: https://webcast.openbriefing.com/msb-hyr-2026/
The archived webcast will be available on the Investor page of the Company's website: www.mesoblast.com
Other
Please refer 'Risk Factors' and 'Management's Discussion and Analysis' sections in our Form 6-K filed with SEC and Appendix 4D filed with ASX.
About Mesoblast
Mesoblast (the Company) is a world leader in developing allogeneic (off-the-shelf) cellular medicines for the treatment of severe and life-threatening inflammatory conditions. The therapies from the Company's proprietary mesenchymal lineage cell therapy technology platform respond to severe inflammation by releasing anti-inflammatory factors that counter and modulate multiple effector arms of the immune system, resulting in significant reduction of the damaging inflammatory process.
Mesoblast's Ryoncil(R) (remestemcel-L-rknd) for the treatment of steroid-refractory acute graft versus host disease (SR-aGvHD) in pediatric patients 2 months and older is the first FDA-approved mesenchymal stromal cell $(MSC)$ therapy. Please see the full Prescribing Information at www.ryoncil.com.
Mesoblast is committed to developing additional cell therapies for distinct indications based on its remestemcel-L and rexlemestrocel-L allogeneic stromal cell technology platforms. Ryoncil(R) is being developed for additional inflammatory diseases including SR-aGvHD in adults and biologic-resistant inflammatory bowel disease. Rexlemestrocel-L is being developed for heart failure and chronic low back pain. The Company has established commercial partnerships in Japan, Europe and China.
About Mesoblast intellectual property: Mesoblast has a strong and extensive global intellectual property portfolio, with over 1,000 granted patents or patent applications covering mesenchymal stromal cell compositions of matter, methods of manufacturing and indications. These granted patents and patent applications provide commercial protection extending through to at least 2044 in all major markets.
About Mesoblast manufacturing: The Company's proprietary manufacturing processes yield industrial-scale, cryopreserved, off-the-shelf, cellular medicines. These cell therapies, with defined pharmaceutical release criteria, are planned to be readily available to patients worldwide.
(MORE TO FOLLOW) Dow Jones Newswires
February 26, 2026 19:42 ET (00:42 GMT)