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Investor releaseQuarter not tagged2026-08-27Mesoblast H2 Earnings Call Highlights
MarketBeat
Mesoblast H2 Earnings Call Highlights
Interested in Mesoblast Limited? Here are five stocks we like better. RYONCIL generated $115 million in fiscal 2026 revenue, its first full year of commercial sales, while Mesoblast reduced its net loss by 44% to $57.5 million. The company ended the year with $103 million in cash and significantly lower second-half cash burn. Commercial momentum continued, with more than 50 treatment centers onboarded and insurance coverage reaching over 98% of U.S. lives. Mesoblast expects double-digit RYONCIL growth over the next 12 months and is conducting a 180-patient adult GVHD trial that could support label expansion. The pipeline advanced in Duchenne muscular dystrophy, chronic low back pain and heart failure: the FDA cleared a Phase III Duchenne trial, enrollment was completed in a 350-patient back-pain study, and the company is pursuing approval for REVASCOR in high-risk heart-failure patients. Mesoblast (NASDAQ:MESO) reported $115 million in net revenue for fiscal 2026, its first full year of commercial sales for RYONCIL, the company’s FDA-approved allogeneic mesenchymal stromal cell therapy for children with steroid-refractory acute graft-versus-host disease, or GVHD. Chief Executive Officer Silviu Itescu said fourth-quarter net revenue reached $36 million, while gross profit excluding amortization expenses totaled $110 million for the full year. The company described RYONCIL as the first and only FDA-approved mesenchymal stromal cell product in the U.S. → What Rising Delivery Forecasts Say About Rivian's Stock Prospects Chief Financial Officer Jim O’Brien said Mesoblast reduced its net loss after tax by 44% to $57.5 million. The company ended the fiscal year with $103 million in cash and reported net cash usage of $43.8 million for the year. Cash burn in the second half was $13.4 million, compared with $50 million in the corresponding prior-year period. Mesoblast said more than 50 treatment centers have been onboarded for RYONCIL, and insurance coverage now extends to more than 98% of U.S. lives. The company also received a J-code in October 2025, which Itescu said contributed to revenue growth. → NVIDIA Reveals $21 Billion SpaceX Stake: Signal of Confidence or Circular Financing? In real-world use, Itescu said RYONCIL has shown 84% early survival among treated children with acute GVHD. He said the company’s priorities over the next year include increasing adopt…Read full documentShow less
Interested in Mesoblast Limited? Here are five stocks we like better. RYONCIL generated $115 million in fiscal 2026 revenue, its first full year of commercial sales, while Mesoblast reduced its net loss by 44% to $57.5 million. The company ended the year with $103 million in cash and significantly lower second-half cash burn. Commercial momentum continued, with more than 50 treatment centers onboarded and insurance coverage reaching over 98% of U.S. lives. Mesoblast expects double-digit RYONCIL growth over the next 12 months and is conducting a 180-patient adult GVHD trial that could support label expansion. The pipeline advanced in Duchenne muscular dystrophy, chronic low back pain and heart failure: the FDA cleared a Phase III Duchenne trial, enrollment was completed in a 350-patient back-pain study, and the company is pursuing approval for REVASCOR in high-risk heart-failure patients. Mesoblast (NASDAQ:MESO) reported $115 million in net revenue for fiscal 2026, its first full year of commercial sales for RYONCIL, the company’s FDA-approved allogeneic mesenchymal stromal cell therapy for children with steroid-refractory acute graft-versus-host disease, or GVHD. Chief Executive Officer Silviu Itescu said fourth-quarter net revenue reached $36 million, while gross profit excluding amortization expenses totaled $110 million for the full year. The company described RYONCIL as the first and only FDA-approved mesenchymal stromal cell product in the U.S. → What Rising Delivery Forecasts Say About Rivian's Stock Prospects Chief Financial Officer Jim O’Brien said Mesoblast reduced its net loss after tax by 44% to $57.5 million. The company ended the fiscal year with $103 million in cash and reported net cash usage of $43.8 million for the year. Cash burn in the second half was $13.4 million, compared with $50 million in the corresponding prior-year period. Mesoblast said more than 50 treatment centers have been onboarded for RYONCIL, and insurance coverage now extends to more than 98% of U.S. lives. The company also received a J-code in October 2025, which Itescu said contributed to revenue growth. → NVIDIA Reveals $21 Billion SpaceX Stake: Signal of Confidence or Circular Financing? In real-world use, Itescu said RYONCIL has shown 84% early survival among treated children with acute GVHD. He said the company’s priorities over the next year include increasing adoption in the pediatric market, encouraging earlier use of the therapy, and expanding into adult GVHD. Mesoblast is enrolling a 180-patient randomized trial in adults with Grade 3 or 4 steroid-refractory acute GVHD. The study compares ruxolitinib alone with ruxolitinib plus RYONCIL. Itescu said the trial is enrolling across more than 40 U.S. sites and is expected to take about 18 months to complete. → Berkshire Boosts Its Bet: This AI Hyperscaler Is Now a Top-3 Holding The company expects an interim analysis in the fourth quarter of 2027 after approximately 100 patients, or 57% of the planned enrollment, have been enrolled. Itescu said either a successful interim analysis or a positive result from the full trial could support a supplemental biologics license application, or sBLA, for an adult label expansion. Discussing patients who have failed ruxolitinib, Itescu cited compassionate-use results showing 76% survival at day 100 among adolescents and adults treated with RYONCIL, compared with survival of roughly 20% to 30% in reports involving patients treated with other third-line agents after ruxolitinib failure. When asked about revenue expectations, Itescu did not provide formal guidance but said the company expects “double-digit growth” over the coming 12 months. He said management expects to have a clearer view of growth by the middle of the fiscal year. The FDA cleared Mesoblast’s investigational new drug application for a Phase III trial of RYONCIL in pediatric Duchenne muscular dystrophy. Itescu said the company is working with U.S. clinicians, patient groups and families to establish trial sites and begin the study. He said Mesoblast selected Duchenne muscular dystrophy because it believes its cell therapy could address inflammation early in the disease process, including in children as young as 3 or 4. The company expects the treatment could potentially be used alongside gene therapy approaches, according to Itescu. Mesoblast also completed treatment of all 350 patients in its pivotal Phase III trial of rexlemestrocel-L for chronic low back pain associated with degenerative disc disease. The company is following participants through 12 months and expects trial results in the second half of calendar 2027. If successful, Mesoblast plans to file a BLA, with a potential approval timeline in calendar 2028. Itescu said the pivotal study is designed to replicate an earlier Phase III trial in which a single injection produced pain reduction beginning at six months, peaking at 12 months and persisting through at least 36 months. The company said it is targeting patients with moderate-to-severe chronic low back pain who have not responded to medical therapies. Itescu said an outreach effort among pain specialists found that 85% were more likely to recommend rexlemestrocel-L if the prior clinical results were replicated in a commercial product. Mesoblast is also pursuing approval of REVASCOR, a rexlemestrocel-L program for advanced heart failure patients supported by left ventricular assist devices. Itescu said a prior randomized trial showed reductions in major gastrointestinal bleeding and hospitalizations related to right heart failure, along with improved survival among higher-risk ischemic patients. The company plans to seek full FDA approval in patients at risk of right heart failure and life-threatening bleeding. Itescu said a successful approval could potentially support later expansion into the larger Class II and III heart failure population. O’Brien said Mesoblast’s fiscal 2027 cash burn is expected to be lower than in fiscal 2026, supported by anticipated RYONCIL growth and cash receipts. He declined to provide a specific quarter in which the company expects to become cash-flow positive from operations. Mesoblast has a $125 million credit facility carrying an 8% interest rate, with no principal amortization for five years, according to O’Brien. He said the company intends to maintain financial flexibility while funding Phase III programs, manufacturing capabilities, regulatory filings and inventory needed to meet patient demand. Mesoblast Limited is a global leader in allogeneic cellular medicines, focused on developing treatments for inflammatory and immunologic diseases. Founded in 2004 by Dr. Silviu Itescu, the company builds on proprietary mesenchymal lineage cell technology to create off-the-shelf, donor-derived therapies. These therapies are designed to modulate immune responses and promote tissue repair in conditions where existing medical options are limited or ineffective. The company's most advanced product, Alofisel® (darvadstrocel), has been approved in Europe for the treatment of complex perianal fistulas in adults with Crohn's disease. This instant news alert was generated by narrative science technology and financial data from MarketBeat in order to provide readers with the fastest reporting and unbiased coverage. Please send any questions or comments about this story to [email protected]. The article "Mesoblast H2 Earnings Call Highlights" was originally published by MarketBeat. View MarketBeat's top stocks for August 2026.
Investor releaseQuarter not tagged2026-08-27Mesoblast Fiscal 2026 Loss Narrows, Revenue Rises
MT Newswires
Mesoblast Fiscal 2026 Loss Narrows, Revenue Rises
Mesoblast (MESO) reported a fiscal 2026 loss Wednesday of about $0.04 per diluted share, compared wi
TranscriptFY2026 Q42026-08-26FY2026 Q4 earnings call transcript
Earnings source - 67 paragraphs
FY2026 Q4 earnings call transcript
Hello, and welcome to the Mesoblast financial results for the full year ended June 30, 2026. An announcement and presentation have been lodged with the ASX and are also available on the Home and Investor pages at www.mesoblast.com. At this time, all participants are in listen-only mode. Later, we will conduct a question and answer session, and instructions will follow at that time. As a reminder, this conference call is being recorded. Before we begin, let me remind you that during today's conference call, the company will be making forward-looking statements that represent the company's intentions, expectations, or beliefs concerning future events. These forward-looking statements are qualified by important factors set forth in today's announcement and the company's filings with the SEC, which could cause actual results to differ materially from such forward-looking statements.
In addition, any forward-looking statements represent the company's views only as of the date of this webcast and should not be relied upon as representing the company's views of any subsequent date. The company specifically disclaims any obligations to update such statements. With that, I would now like to turn the call over to Dr. Silviu Itescu, Chief Executive of Mesoblast. Please go ahead.
Thank you, operator. Good morning, good afternoon, and thank you all for joining us on Mesoblast's financial results and operational update for the period ended June 30, 2026. With me are our Chief Financial Officer, Jim O'Brien, our Chief Commercial Officer, Marcelo Santoro, and our Head of the Orthopedic Musculoskeletal Program, Roger Brown. If you could go to slide number two, please. Mesoblast is the leader in allogeneic cellular therapies. RYONCIL, our lead product for mesenchymal stromal cells, is the only FDA-approved product of its type, a first-in-class therapy, and has undergone a successful first-year launch with net revenues of $115 million for fiscal year 2026, the first full year post-launch. This is a highly profitable single product on a standalone basis, and the proceeds from revenues generated from this product are being reinvested in our phase III programs and our manufacturing for potential blockbuster opportunities.
We've built a mature commercial capability with an infrastructure that supports product launch, growth, and beyond RYONCIL, multiple expansion indications beyond GVHD and other areas. We've built a specialized sales team focused on hospitals, transplant centers, and specialists. We've built a robust phase III pipeline with multiple blockbuster opportunities, including chronic low back pain that I'll be talking quite a bit on today and inflammatory heart failure. RYONCIL label expansion beyond GVHD is focused on pediatric adults and children, rare inflammatory conditions such as Duchenne. Next slide, please. Our market leadership position is underpinned by our so-called moat. We have a global IP portfolio of more than 1,100 patents and patent applications, which provide commercial protection beyond 2044. Our dominant IP protects our cells, our manufacturing capabilities, and our multiple indications and commercial opportunities.
We have a first-mover advantage in that RYONCIL is the first and only mesenchymal stromal cell product approved by the FDA. We're leveraging FDA guidance on how approved products such as RYONCIL can be expanded to obtain additional label or new indications. We've completed multiple large U.S.-based randomized clinical trials, which continue to provide evidence of efficacy of our platform technologies. We are the leader in complex manufacturing with strong IP protection, significant know-how advantages, and demonstrable FDA alignment, scale-up capability, and ability to leverage across our product pipelines. Finally, we're investing further in our next-generation technology to maintain our leadership position and enhance our tissue-homing characteristics and have new products that leverage our existing development to date. Next slide, please.
This slide is a snapshot of our worldwide leadership in allogeneic mesenchymal stromal cell, using a portfolio that leverages two major platforms, our rexlemestrocel-L platform in green and our remestemcel-L platform in blue. As you can see here, the remestemcel-L platform, branded RYONCIL, is obviously now in the market for children with this life-threatening disease called acute graft-versus-host disease, but is also being expanded in adults in markets that are at least three times bigger than the pediatric market. The total addressable market for the GVHD opportunity in children and adults is in excess of $1 billion. remestemcel-L, or RYONCIL, is also being developed for other rare inflammatory conditions where the underlying mechanism of action can be leveraged beyond GVHD. One of these indications is Duchenne.
Duchenne is a very large unmet need in children as young as two to three years old, and these unfortunate children continue to develop inflammation of their muscles, the muscle destruction, and end-organ damage involving the heart and lungs. On the basis of preclinical data, plus leveraging the approval of RYONCIL and its mechanism of action, the FDA cleared an IND to commence a phase III trial for potential registration of the product in this very large opportunity. The second-generation platform, rexlemestrocel-L, is based on using monoclonal antibodies to isolate an even more potent platform technology of stromal cells that are highly purified and demonstrated significant outcomes across multiple major indications.
This platform has been focused on local delivery in the heart, in inflammatory heart disease, and in the orthopedic applications, particularly intervertebral disc disease, where a single injection into the disc space has resulted in substantial and durable long-term reduction in pain. The total addressable markets for rexlemestrocel-L, just in cardiac disease and in back pain, in aggregate exceed $20 billion. Huge blockbuster opportunities. Next slide, please. Fiscal year 2026 proved to be a successful transition from the R&D company that Mesoblast was to a commercial company with delivery of major milestones. In our first full commercial year, we were successful in demonstrating a U.S. launch of RYONCIL, with fourth quarter net revenue of $36 million, and annual revenue in first year in FY 2026 of $115 million. Our gross profit on total sales, excluding amortization expenses, was $110 million.
The major milestones that were achieved during the fiscal year were registration trial for label extension of RYONCIL into adults with steroid-refractory acute graft-versus-host disease that has commenced and is currently enrolling across more than 40 sites in the U.S. A successful IND submission with clearance by the FDA of our phase III trial for pediatric Duchenne's. A completion of 350 patients treated in the pivotal randomized controlled phase III trial for the blockbuster indication of chronic low back pain. This trial seeks to replicate an earlier trial which achieved more than 12 months reduction in pain from a single injection. The total patient numbers, importantly in this trial, increased from 300 patients to 350 patients as a result of strong demand from the trial investigators to have their patients enrolled in this innovative program for patients who otherwise have no alternatives.
Now let's move to our financial update, which will be presented by our Chief Financial Officer, Jim O'Brien.
Thank you, Silviu, and good day everybody. On slide eight, our income statement for the year ended June 2026 as compared to June of 2025. Important to note here, as Silviu pointed out, we had $115 million of net revenue for the year. A very exciting year for us that we expect to build on in the future. We continued to invest in our R&D programs. Product development cost for the year were $17.3 million. Our continuing R&D investment in our phase III programs were roughly $21.2 million. We did support the revenue growth of RYONCIL with the increased investment, and sales and marketing expenses of roughly about $18 million, with a very strong commercial team now built around the launch, and we continue to penetrate the market and grow market share. Importantly, we reduced our net loss after taxes this year by 44% to $57.5 million.
Next slide, please. Our balance sheet remains very strong. We ended the fiscal year in June with $103 million. For the year, net cash usage was $43.8 million, and importantly, in the second half of the fiscal year, our cash burn was $13.4 million, compared to $50 million in the same period a year ago. We are working towards profitability. We have a very strong cash flow forecast. Plus, we're controlling costs in all areas across the businesses, and we're deploying funds where our operations are most needed to support operations and to continue to grow the company. Our operating plan includes spending money on our phase III programs, building out our manufacturing capabilities, supporting BLA filings, and having the appropriate inventory levels to support patient demand. Earlier this year, as we've reported, we entered into a credit line facility of $125 million, replacing a long-term debt.
That carries an 8% interest rate. There is no amortization of the principal for five years. Our balance sheet is very strong to support our upcoming fiscal year in terms of being able to deploy capital where we need to. Next slide, please. With that, I would like to turn it over to Silviu again to take you through our acute graft-versus-host disease programs and to address the accomplishments that we have reached so far this year.
Thanks, Jim. This next slide summarizes the key accomplishments so far for RYONCIL's commercialization in acute GVHD in children. Importantly, in green, the real-world experience continues to show the difference we are making in these children and their outcomes, with 84% survival early in the disease process with treatment of RYONCIL in children who otherwise would have a very high mortality. As I mentioned earlier, the net revenue exceeded $125 million since launch of last year. We have now got more than 50 centers onboarded. Importantly, insurance coverage shows that more than 98% of U.S. lives across the country are now covered. Medicaid cover federally was in place early, mandatory in every state, and we were very pleased having received a J-code in October 2025, which continued to contribute to the growth in revenues.
Finally, our focus in the next 12 months will be to expand the product adoption in the adult market, and I will talk about that in the next couple of slides. Next slide, please. This is a snapshot of strategic approach to continued growth based on identifying and prioritizing those appropriate patients using various tools at our disposal. Reinforcing the superior outcomes, particularly the earlier the product is used, the better the outcome in these very sick children. We will continue to access reimbursement pull-through and empower caregivers to demand that RYONCIL be used in their children as soon as the disease is diagnosed. Next slide. The adult form of this disease is a huge opportunity for RYONCIL growth. There are more than 2,000 adults annually in the U.S. with steroid-refractory graft versus-host disease.
Of these, 50% approximately have got grade three or four disease, which is associated with high mortality. Ruxolitinib is the only drug that is approved in the U.S. as second-line for adults with acute GvHD. However, only about 42% of patients with the severe form of the disease, grade three or four, actually achieve a response at day 28 to ruxolitinib. These patients who do not respond have a very dismal survival, as low as 20%-30% by day 100. So there is a very large unmet need in adults who are currently being treated with ruxolitinib for steroid-refractory acute graft-versus-host disease. In these adults, mortality remains very high. Importantly, those are the very adults who have been enrolled under expanded IND under compassionate care by Mesoblast for treatment with RYONCIL.
And unlike other therapies which result in, as I said, survival of only 20%-30%, we're seeing a 76% survival at day 100 in these patients with terrible outcomes. Next slide, please. This is a slide that provides a snapshot of, on the left-hand side, survival in patients who have failed ruxolitinib as second-line and who are then being treated with other agents as third-line. On the right-hand side, patients who have failed ruxolitinib and other second-line agents have then been offered RYONCIL under our compassionate care program. What you can see here is on the left-hand side, the day 100 survival where the dotted line is a dismal 20%-30%, roughly 25% in this particular report.
Whereas on the right-hand side, patients who otherwise meet the exact same criteria have a 76% survival, adolescents and adults, when they've been treated for four to eight weeks with a regimen of RYONCIL. Therefore, we believe that this is a treatment that should be offered to these patients, a potential adult market of more than 600 patients annually with grade three or four disease refractory to ruxolitinib or any other agents. Next slide, please. But even more proximal than that is the entire second-line market in adults with acute graft-versus-host disease. As mentioned earlier, there are more than 2,000 adults who annually develop grade three or four disease as part of their disease process after bone marrow transplant.
This is a market that's three times bigger than the pediatric market, and this is a market that we have currently addressed through a randomized controlled trial of 180 patients, actively enrolling across the U.S. These patients in this trial are being randomized one-to-one to ruxolitinib alone versus ruxolitinib plus RYONCIL. We are hoping to see a significant benefit in terms of a day 28 response and a further benefit in overall survival. If we're successful in this trial, RYONCIL would become part of the second-line treatment regimen in these high-risk patients with grade three or four disease. This trial is expected to take a total of 18 months to complete, but it will have an interim analysis when approximately 57% of patients are enrolled, or close to 100 patients. We expect that interim analysis to be performed in the fourth quarter of 2027.
If successful, that would allow us to move forward with a BLA filing for a label extension. Next slide. Now let me move on to what we think is our largest and most exciting near-term blockbuster opportunity. That's our second-generation pipeline, rexlemestrocel-L, for chronic low back pain. The unmet need is substantial. Of the 35 million patients across the U.S. who suffer from chronic low back pain, about 60% the cause is degenerative disc disease, which is an inflammatory condition. Of these, about 7 million fit into our criteria of moderate to severe disease within the first five years of diagnosis, refractory to all medical therapies, including opioids. The addressable market here is at least $10 billion. The major milestones to commercial launch are a phase III trial that has completed treatment. All 350 patients have completed treatment.
This phase III trial seeks to confirm an earlier phase III trial, which showed pain reduction at 12 months. This is an FDA-approvable endpoint, as supported by various meetings and documents with the FDA. The trial readout is going to be in the second half of calendar year 2027, followed by a BLA filing with potential approval in calendar year 2028. Next slide. This is a diagram that shows what the cause of this severe degenerative disease, back pain, is all about. On the left-hand side, you see what a healthy intervertebral disc looks like. On the right-hand side, you see what a degenerative intervertebral disc looks like. In the middle of that area in red, right in the middle of the intervertebral disc, is inflammation. That is where your immune cells come in to try to restore disc integrity.
In the process of trying to repair, they release a cytokine storm, and many of you are familiar with that term from the COVID period, but a cytokine storm that inadvertently destroys healthy parts of the disc. You lose disc height, and you have severe pain as your outcome. That is what we seek to address with a single injection of our cells right in the middle of that inflamed disc. Next slide, please. What is the patient treatment journey in this disease? Well, after conservative treatments that include non-steroidal anti-inflammatory drugs, there is very little. After patients have failed for three months or more to conservative approaches, many physicians still prescribe opioids. Unfortunately, opioids are very weak agents that reduce pain. They lead to a continued requirement for progressively increasing dosing. There is addiction behavior that is associated with it, and unfortunately, accidental overdosing.
Beyond opioids, there really is not anything else that can address the severe, unremitting chronic pain. Many patients then move on to interventional approaches that are really surgically based, and that includes epidural injections that are guided by radiography, but also radiofrequency ablation, spinal cord stimulation, and intrathecal pumps. Beyond that, all we are left with are severe invasive surgeries. So there is a large unmet market that we are targeting to treat moderate to severe chronic low back pain that is totally unaddressed at this point in time. Next slide, please. In the earlier phase III trial, which this snapshot is taken from, in 202 patients who received a single injection, in blue, of rexlemestrocel-L, or in red, rexlemestrocel-L combined with a carrier, what we see is that significant pain reduction was seen as early as six months, maximal by 12 months, and durable through at least 36 months.
In comparison to a saline injection in green, which shows very little effect. Just to put this into context, a very mild reduction in pain from a saline injection is about equivalent to what you would expect to see with opioids. So this is a dramatic reduction in pain that is long-lasting from a single injection. These are the data that we are aiming to replicate in the 350-patient pivotal trial that has just completed treatment. Next slide, please. Now, who are the physicians that administer this product? Today, the dominant caregiver that provides treatment to these patients are the pain specialists in multidisciplinary clinics, where a patient either goes directly or where the patient is referred to from his primary care physician.
Next slide. When we have done a formal outreach, a commercial outreach to various types of physicians, what you see in this middle panel that is circled, amongst the pain specialists, who are the experts in this space, 85% of them, on reviewing the data from the earlier trial I just showed you, are more likely, on that basis of those results, to recommend rexlemestrocel-L for chronic low back pain than anything else if these results were to be replicated in a commercial product. Next slide, please. Let me move on to our other blockbuster indication, which is chronic heart failure, also from a single injection with rexlemestrocel-L. We are targeting the sickest end-stage patients, because that is where the biggest unmet need is today as we move forward in the broader indications.
Despite an artificial heart, a left ventricular assist device, that is currently implanted in the left ventricle of these patients who otherwise would have a 50% death rate in the first 12 months, the right side of the heart continues to be unprotected, continues to have inflammation, and continues to fail. Right heart failure is the number one cause of death in these end-stage patients, despite the fact that they are being kept alive with an artificial heart in the left side of the heart. Next slide, please. In registry data that cover more than 6,000 patients, this is very recent data from 2021 and continues to, in 2026, be supported by registry data. The number 1 cause of both death, hospitalizations, is right heart failure. You can see as many as 28% get right heart failure in these large registry studies.
When you get right heart failure, you have backup of blood in your liver and your gut, and you have terrible bleeding. So they die of multiple complications, including severe bleeding from the gastrointestinal tract. Next slide, please. A randomized controlled trial was performed in conjunction with the investigators across the U.S. who perform these surgical procedures. In that study, at both six and 12 months, a single injection of rexlemestrocel-L reduced by five fold or more the incidence of major life-threatening gastrointestinal bleeding. This was due to strengthening of the right side of the heart and reduction in right-sided heart failure. Next slide, please.
In addition to reducing bleeding, which was the principal efficacy endpoint in that trial, as you can see here in the top panel, we also reduced hospitalizations from right heart failure by about four fold at 12 months in all patients, and particularly in those patients at highest risk, which were ischemic patients. Most importantly, as you can see in the panel below, survival was improved from a 30% mortality rate in these high-risk patients to about 9%, and this was significant. Next slide. So our strategy is to file for full approval of Revascor in this high-risk patient population at risk of right heart failure and severe life-threatening bleeding. If we are successful to gain FDA approval, then this approval can be extended into the much larger patient segment with Class II and III heart failure, where there is approximately at least 1 million patients in the U.S. alone.
Next slide. In summary, the presentation today has told you what we've done, what we intend to do, and how we're going to do it in the next 12 months. RYONCIL is commercial today, and we seek to have multiple label extensions for this product in order to strongly grow our revenue base. We seek to increase penetration of the pediatric market, maximize early use, and position the product as both a third-line and a second-line treatment for adults with steroid-refractory graft-versus-host disease, markets that are more than three times bigger than the current pediatric market. Our focus beyond that is on additional inflammatory diseases, both in pediatric patients and in adult patients. The first that we're targeting is Duchenne, which is a pediatric disease that's progressive without any cures today, that begins as early as three to four years of age.
In addition, we're pursuing strategic partnering opportunities for inflammatory conditions in both children and adults with various appropriate strategic partners. For our second-generation pipeline platform, rexlemestrocel-L, we've taken the program right to the end and retained full value in the U.S. market for the blockbuster indication of chronic low back pain. The pivotal phase III trial of 350 patients has completed treatment, and we are following these patients through 12 months, with the trial to complete mid-2027 calendar year. If a positive readout positions us for a BLA filing for a blockbuster indication. Our chronic heart failure program is, we seek to complete our BLA filing with the FDA, with the expectation that if approved, that can be expanded into the much larger Class II, III heart failure indication, which will be an opportunity for a strategic alliance.
On that note, I think I'll stop, and we would be delighted to take questions. Thank you.
Thank you. If you wish to ask a question, please press star one on your telephone and wait for your name to be announced. If you wish to cancel your request, please press star two. If you're on a speakerphone, please pick up the handset to ask your question. Your first question comes from Edward Tenthoff with Piper Sandler.
Great. Thank you very much, and it's really exciting to see all the progress you guys are making. I had a question. Great growth from RYONCIL in the current label. Would you hazard a guess to what kind of growth we should be expecting over the next fiscal year? How far do you think we are in terms of penetration of the kids with steroid-refractory GVHD? I guess my second question really came down to, with so many different pediatric inflammatory diseases, and with the backdrop that DMD's been tough, there is some competition there. Why did DMD come to the top of the list in terms of secondary indications for childhood inflammation? Thanks a ton, guys.
Sure. These are all great questions, Ed. Thank you. I think with respect to guidance, I think we've only just completed our first year. The next 12 months we'll assess it in due course. I know that Jim is very keen to review progress, and by mid-year, we'll have a better sense of continued growth. But we certainly expect to see double-digit growth in the coming 12-month period. I think your question pertained also to our potential areas of growth in new inflammatory conditions. Why Duchenne's is a great question. Duchenne's a complete unmet need. To your point, there are various people looking at how to use cell therapy in Duchenne's patients. Most of those people are looking at later stage disease, 10 years and older, at a point in time when the children are already non-ambulatory. At that point, we believe the disease is very late.
That's not where we think we can make the maximal difference and benefit. Maximal benefit, we think should be obtained in children as early as age three or four, well before the age of nine, for example, when there is maximal inflammation by both T cells, macrophages in the muscles, in skeletal muscles, and early on even in the cardiac muscle. The mechanism of action of our cells with graft-versus-host disease lends itself extremely well to targeting the T cell process that is going on in the skeletal muscle of these young children. If we can turn off that disease early, there won't be any need for products later on. Today, there are a number of gene therapy approaches that aim to improve or bring back some of the normal dystrophin protein.
None of those are going to be curative, and all of those will continue to be accompanied by severe T cell-mediated inflammation of the skeletal muscles. So we think that we have a unique product built on the mechanism of action in GVHD, and we've demonstrated this in pre-clinical studies, that is both likely to have a major impact early on in the disease and be additive to the gene therapies that are out there.
That's very helpful. Thank you, Silviu.
Thank you.
Your next question comes from Olivia Saunders with Cantor.
Hi. Thank you for the question. What can you guys tell us at this stage just around how enrollment is going in the adult GVHD study? For that interim analysis later next year, is that alone enough for a potential sBLA filing, or is there anything else the FDA has actually asked for as part of that adult submission? Also just wanted to ask about powering for that trial design, if you guys have disclosed that, and how you ultimately decided on a treatment effect on top of Jakafi, just in terms of effect size. Really just trying to get a better sense for your overall confidence level around enrolling the right patients that will produce a high enough response rate to hit your stats goal.
Yeah. These are great questions. Let me see if I can take those one at a time. The basis for starting this trial, and this trial is being recruited across more than 40 sites in the U.S., and it's performed in collaboration, in partnership with the Blood and Marrow Transplant Clinical Trial Network, BMT CTN, which is a network of 80% of all the top bone marrow transplant centers across the U.S. So it's been validated by this group, which is an NIH-funded organization, which tells you where the unmet need is because they're driving this indication. The unmet need is in patients with grade three, four disease who are currently being treated by the only approved drug, ruxolitinib.
In that group of patients, which is about 50% of the adult GVHD market, in that group of patients, ruxolitinib does not perform very well, has not demonstrated a survival benefit with overall response rates in the 50% range. There is a big unmet need because these patients, if 50% of patients fail ruxolitinib, I showed you earlier, these patients have nothing else beyond that, with a 25% survival at day 100, once they've failed ruxolitinib. That's where the big unmet need is. We're addressing this market in two different ways. I showed you data where RYONCIL, once ruxolitinib fails, can rescue these patients and get a 76% survival outcome. That's great, but it's a sequence that we and the physicians believe should be addressed even earlier.
The trial design here is a trial in that group of patients, grade three, four disease, randomized one-to-one to ruxolitinib only, where we expect a 50% failure rate, versus ruxolitinib plus RYONCIL, where based on a single center pilot study, we would expect to see an overall treatment benefit of at least 75% day 28 response. That's how the trial has been powered, with a powering approximately 85%-90%. Your question was then. Actually, I'm sorry. I believe the expectation is that it'll be about from 50% to about 70% overall response rate. Our interim analysis on 57% of patients is based on the assumption that we might do better than that, actually, and achieve a responder rate north of 75%. If we're successful and do achieve that, then 100 patients will be sufficient to declare success.
Both of those, the full powering of 180 patients and the interim analysis to declare early success, have been vetted with the FDA. Both of those, if we overachieved at the early interim or if we achieved the expected outcome at the full study, both of those would support an sBLA filing.
Okay, great. Thank you. Are you able to disclose the percent or the number of patients that you've enrolled at this point?
Look, we've enrolled.
Or suffice it to say you're still feeling good about the interim.
Patients have been enrolled, treated. We expect the sort of hockey stick effect as we enroll more by the end of this year. Then we expect to have a substantial number on a monthly accrual basis from January onwards, such that we will have achieved 100 patients roughly by the fourth quarter of next year. We're on track to do that.
Great. Thank you, Silviu.
Your next question comes from Madeleine Williams with Canaccord.
[inaudible], thanks for taking my question. Just as it relates to just off the back of the expansion into the adult population. You have mentioned that you have treated adults and adolescents, and there has obviously been some good data that has come out as it relates to that. What have the conversations been with the FDA about your capacity to treat the later stage patients at an earlier time point, and sort of how feasible that might be?
Yeah, look, as you can imagine, those discussions are very active. What I would say is that there is a new leadership at the FDA, and we are very pleased with the new leadership, both at the level of the most senior leadership of the FDA, as well as at the CBER level, as well as the cell and gene therapy level. There has been evident flexibility shown by the new leadership in other areas of cell and gene therapy. We are in discussions, and we will have meetings this quarter with the agency to discuss some of these new potential areas of label extension.
Thanks for that. Just as it relates to the timeline associated with DMD, you sort of touched on it, but do you sort of have any clear plans to initiate the pivotal trial in that space in the next 12 months?
Well, we certainly do, absolutely. We, at the moment, are in discussions with a group of clinicians across the U.S. to put in place what the appropriate sites need to be and in discussions also with the stakeholders of the parents and children to ensure that we have the right groups that can recruit most rapidly and most efficiently. As soon as all that's in place, the study is ready to begin.
Great. Just finally from me, I'll jump back in the queue. Just for the next 12 months and sort of growing RYONCIL in the pediatric business, do you foresee that there'll need to be additional spend in that sort of core business to continue growing the revenue?
Hey, Madeline, it's Jim O'Brien. Let me try to address that. I think we've got a good, clear line of sight in our spending on our important phase III programs over the next 12 months. The capital allocation that we have and the plan to do so is crystal clear to us, and execution is of utmost importance in terms of achieving our milestones as we laid out today, as well as controlling costs and reducing our cash burn. So our plan for the new fiscal year is to be able to fund the programs that we've outlined today in a very judicious way.
Great. Thank you.
Once again, if you wish to ask a question, please press star one on your telephone and wait for your name to be announced. Your next question comes from John Hester with Bell Potter.
Good morning. A question for Jim. Jim, just looking at balance sheets. You've got cash of $103 million, net debt of about $15 million, and your cash burn in the second half, you said, reduced to about $13 million. What is your expectation of the need to raise additional capital at this time?
Well, I think we want to keep all of our options open. With that being said, my expectation is that our cash burn in fiscal 2027 will be less than it is in fiscal 2026, given the growth of the RYONCIL franchise and the market growth that we expect, cash receipts that we expect. Our budgets are very clear in terms of where we're allocating capital. We'll keep our options open, but at this time, our balance sheet is very supportive of. Recall that our debt is all long-term. It's got a five-year balloon on it. So when I look at the cash balance that we have, our strong working capital, the company's balance sheet can support the growth that we've spoken about today. We will always look to continue to invest in growth opportunities and be supportive of that from a financial standpoint.
And perhaps just to follow up, at what quarter do you expect to go cash flow positive from operations?
Yeah, I'd rather steer away from that question at this point. It's early in our fiscal year, and as you know, when you talk about spending on R&D programs and enrollment, we're doing a number of projects around manufacturing processes. We are the leader in this space. Quarter by quarter fluctuations can happen. But we have a clear line of sight in terms of what our priorities are, and Silviu and I are guiding the company towards profitability for the next fiscal year and beyond. So quarter by quarter, I think it's a little tough to pin me down on that, but I would expect to see in our future filings this year, certainly a lower cash burn than we experienced in 2026.
Okay. Thanks. That's all.
Okay.
That brings us to the end of today's call. I'll now hand back to Dr. Itescu for closing remarks.
Great. Thank you, everybody, for joining us today and for the very insightful questions. We hope we've given you a very clear trajectory of the company. We've had a terrific year the last 12 months. We think the next 12 months are going to be even more exciting on multiple areas, including growth of our revenue stream for RYONCIL and most excitedly about our back pain blockbuster opportunity. We look forward to speaking with you all in the short term. Thank you, everybody.
That does conclude our conference for today. Thank you for participating. You may now disconnect.
Investor releaseQuarter not tagged2026-08-24Mesoblast Financial Results and Corporate Update Webcast
GlobeNewswire
Mesoblast Financial Results and Corporate Update Webcast
NEW YORK, Aug. 24, 2026 (GLOBE NEWSWIRE) -- Mesoblast Limited (ASX:MSB; Nasdaq:MESO), global leader in allogeneic cellular medicines for inflammatory diseases, will host a webcast to discuss operational highlights and financial results for the full year ended June 30, 2026. The webcast will begin at 6.30pm EDT, Wednesday, August 26; 8.30am AEST, Thursday, August 27, 2026. It can be accessed via: https://webcast.openbriefing.com/msb-fyr-2026/ The archived webcast will be available on the Investor page of the Company’s website: www.mesoblast.com 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® (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® 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. The…Read full documentShow less
NEW YORK, Aug. 24, 2026 (GLOBE NEWSWIRE) -- Mesoblast Limited (ASX:MSB; Nasdaq:MESO), global leader in allogeneic cellular medicines for inflammatory diseases, will host a webcast to discuss operational highlights and financial results for the full year ended June 30, 2026. The webcast will begin at 6.30pm EDT, Wednesday, August 26; 8.30am AEST, Thursday, August 27, 2026. It can be accessed via: https://webcast.openbriefing.com/msb-fyr-2026/ The archived webcast will be available on the Investor page of the Company’s website: www.mesoblast.com 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® (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® 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. Mesoblast has locations in Australia, the United States and Singapore and is listed on the Australian Securities Exchange (MSB) and on the Nasdaq (MESO). For more information, please see www.mesoblast.com, LinkedIn: Mesoblast Limited and X: @Mesoblast Release authorized by the Chief Executive. For more information, please contact:
Investor releaseQuarter not tagged2026-07-30Mesoblast Reports Ryoncil® Net Revenues of US$36M for the Quarter and US$115M for First Full Year of Product Launch
GlobeNewswire
Mesoblast Reports Ryoncil® Net Revenues of US$36M for the Quarter and US$115M for First Full Year of Product Launch
Expanding indications for RYONCIL in children and adults with life-threatening inflammatory diseases Achieved target of at least 300 Patients treated in Pivotal Phase 3 trial for Chronic Low Back Pain Activity Report for Quarter Ended June 30, 2026 (Appendix 4C) NEW YORK, July 29, 2026 (GLOBE NEWSWIRE) -- Mesoblast Limited (Nasdaq:MESO; ASX:MSB), global leader in allogeneic cellular medicines for inflammatory diseases, today provided highlights of its recent activities for the fourth fiscal quarter ended June 30, 2026. “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 centers, 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.” said Mesoblast Chief Executive Dr. Silviu Itescu. FINANCIAL HIGHLIGHTS FOR THE FULL YEAR ENDED JUNE 30, 2026, THE FOURTH QUARTER AND THE SECOND HALF1 Ryoncil® net revenue for the fourth quarter was US$36 million. For the first full year post-FDA approval Ryoncil® net revenue was US$115 million, with US$66.5 million for the second half. Net operating cash spend for the full year was US$43.8 million, with operating cash spend of US$13.4 million for the second half. Mesoblast had US$103 million of cash at June 30, 2026, after having drawn down US$50 million from the existing five-year facility to extinguish all maturing debt obligations. OPERATIONAL HIGHLIGHTS FOR THE FOURTH QUARTER RYONCIL (remestemcel-L-rknd) The Company is executing on its strategy to extend its FDA-approved label for its flagship product Ryoncil® beyond children with steroid-refractory acute graft versus host disease (SR-aGvHD) to adults with SR-aGvHD, a market three times larger, and to both children and adults with other severe, life-threatening inflammatory conditions. The registration trial for label extension of Ryoncil® into adults with SR-aGvHD has commenced and is currently enrolling patients, with up to 40 sites across the U.S. expected to be activated this year representing approximately 60% of the ~8,500 annual U.S. allogeneic adult bone marrow transplant population. Mesoblast receiv…Read full documentShow less
Expanding indications for RYONCIL in children and adults with life-threatening inflammatory diseases Achieved target of at least 300 Patients treated in Pivotal Phase 3 trial for Chronic Low Back Pain Activity Report for Quarter Ended June 30, 2026 (Appendix 4C) NEW YORK, July 29, 2026 (GLOBE NEWSWIRE) -- Mesoblast Limited (Nasdaq:MESO; ASX:MSB), global leader in allogeneic cellular medicines for inflammatory diseases, today provided highlights of its recent activities for the fourth fiscal quarter ended June 30, 2026. “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 centers, 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.” said Mesoblast Chief Executive Dr. Silviu Itescu. FINANCIAL HIGHLIGHTS FOR THE FULL YEAR ENDED JUNE 30, 2026, THE FOURTH QUARTER AND THE SECOND HALF1 Ryoncil® net revenue for the fourth quarter was US$36 million. For the first full year post-FDA approval Ryoncil® net revenue was US$115 million, with US$66.5 million for the second half. Net operating cash spend for the full year was US$43.8 million, with operating cash spend of US$13.4 million for the second half. Mesoblast had US$103 million of cash at June 30, 2026, after having drawn down US$50 million from the existing five-year facility to extinguish all maturing debt obligations. OPERATIONAL HIGHLIGHTS FOR THE FOURTH QUARTER RYONCIL (remestemcel-L-rknd) The Company is executing on its strategy to extend its FDA-approved label for its flagship product Ryoncil® beyond children with steroid-refractory acute graft versus host disease (SR-aGvHD) to adults with SR-aGvHD, a market three times larger, and to both children and adults with other severe, life-threatening inflammatory conditions. The registration trial for label extension of Ryoncil® into adults with SR-aGvHD has commenced and is currently enrolling patients, with up to 40 sites across the U.S. expected to be activated this year representing approximately 60% of the ~8,500 annual U.S. allogeneic adult bone marrow transplant population. Mesoblast received Investigational New Drug (IND) clearance from U.S. Food and Drug Administration (FDA) to proceed directly to a registrational trial evaluating Ryoncil® in ambulatory children aged 5-9 years with Duchenne muscular dystrophy (DMD), which affects approximately 15,000 children in the U.S. REXLEMESTROCEL L Mesoblast achieved its target of at least 300 patients treated in the MSB-DR004 pivotal Phase 3 randomized controlled trial of rexlemestrocel-L for chronic low back pain (CLBP) associated with degenerative disc disease; these patients will be followed through the trial’s twelve-month primary endpoint to assess reduction in pain from baseline between rexlemestrocel-L and placebo-treated groups. Received a Biologics License Application (BLA) filing number from FDA and has requested a modular review of its BLA for rexlemestrocel-L in prevention of life-threatening gastrointestinal bleeding due to right ventricular dysfunction in end-stage heart failure patients with a left ventricular assist device (LVAD). Other activities Held inaugural R&D day on April 8th in New York. A replay of the event is available here and presentation materials here. At the R&D day, Mesoblast unveiled next generation mesenchymal stromal cell (MSC) strategies including announcing the acquisition of an exclusive worldwide license to a patented chimeric antigen receptor (CAR) technology platform for precision-enhanced augmentation of therapeutic MSC products. This CAR technology provides Mesoblast with an immediate opportunity to generate products with even greater potency for ulcerative colitis or Crohn's disease. In addition, Mesoblast plans to use CAR-MSCs engineered to express CD19 on their surface to induce remission in Lupus Nephritis and other B cell autoimmune diseases where durable, effective and safe immunomodulation is highly desirable. CorporateFees to Non-Executive Directors were US$185,862, consulting payments to Non-Executive Directors were US$100,000, and salary payments to full-time Executive Directors were US$400,206, detailed in Item 6 of the Appendix 4C cash flow report for the quarter.2 A copy of the Appendix 4C – Quarterly Cash Flow Report for the fourth quarter FY2026 is available on the investor page of the company’s website www.mesoblast.com. 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® (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® 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. Mesoblast has locations in Australia, the United States and Singapore and is listed on the Australian Securities Exchange (MSB) and on the Nasdaq (MESO). For more information, please see www.mesoblast.com, LinkedIn: Mesoblast Limited and Twitter: @Mesoblast References / Footnotes The revenues included in this press release are based on management’s initial analysis of operations for the fourth quarter and full year ended June 30, 2026, and are subject to completion of Mesoblast’s financial closing procedures and audit. As required by ASX listing rule 4.7 and reported in Item 6 of the Appendix 4C, reported are the aggregated total payments to related parties being Executive Directors and Non-Executive Directors. Forward-Looking StatementsThis press release includes forward-looking statements that relate to future events or our future financial performance and involve known and unknown risks, uncertainties and other factors that may cause our actual results, levels of activity, performance or achievements to differ materially from any future results, levels of activity, performance or achievements expressed or implied by these forward-looking statements. We make such forward-looking statements pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 and other federal securities laws. Forward-looking statements should not be read as a guarantee of future performance or results, and actual results may differ from the results anticipated in these forward-looking statements, and the differences may be material and adverse. Forward-looking statements include, but are not limited to, statements about: the initiation, timing, progress and results of Mesoblast’s preclinical and clinical studies, and Mesoblast’s research and development programs; Mesoblast’s ability to advance product candidates into, enroll and successfully complete, clinical studies, including multi-national clinical trials; Mesoblast’s ability to advance its manufacturing capabilities; the timing or likelihood of regulatory filings and approvals, manufacturing activities and product marketing activities, if any; the commercialization of Mesoblast’s RYONCIL for pediatric SR-aGVHD and any other product candidates, if approved; regulatory or public perceptions and market acceptance surrounding the use of stem-cell based therapies; the potential for Mesoblast’s product candidates, if any are approved, to be withdrawn from the market due to patient adverse events or deaths; the potential benefits of strategic collaboration agreements and Mesoblast’s ability to enter into and maintain established strategic collaborations; Mesoblast’s ability to establish and maintain intellectual property on its product candidates and Mesoblast’s ability to successfully defend these in cases of alleged infringement; the scope of protection Mesoblast is able to establish and maintain for intellectual property rights covering its product candidates and technology; estimates of Mesoblast’s expenses, future revenues, capital requirements and its needs for additional financing; Mesoblast’s financial performance; developments relating to Mesoblast’s competitors and industry; and the pricing and reimbursement of Mesoblast’s product candidates, if approved. You should read this press release together with our risk factors, in our most recently filed reports with the SEC or on our website. Uncertainties and risks that may cause Mesoblast’s actual results, performance or achievements to be materially different from those which may be expressed or implied by such statements, and accordingly, you should not place undue reliance on these forward-looking statements. We do not undertake any obligations to publicly update or revise any forward-looking statements, whether as a result of new information, future developments or otherwise. Release authorized by the Chief Executive. For more information, please contact:
Investor releaseQuarter not tagged2026-07-10Ryoncil® Delivers Net Revenue of US$36M for the Fourth Quarter Ended 30 June 2026
GlobeNewswire
Ryoncil® Delivers Net Revenue of US$36M for the Fourth Quarter Ended 30 June 2026
Continued Growth Underpins First Full Year Net Revenue of US$115M NEW YORK, July 09, 2026 (GLOBE NEWSWIRE) -- Mesoblast Limited (Nasdaq:MESO; ASX:MSB), global leader in allogeneic cellular medicines for inflammatory diseases, today announced Ryoncil® (remestemcel-L-rknd) net revenue of US$36 million for the quarter and US$115 million for the full year ended June 30, 2026. “We are very pleased with the strong uptake of Ryoncil® since launch, and with revenues that have already exceeded our initial projections,” said Mesoblast Chief Executive Dr. Silviu Itescu. Dr. Itescu added: “We anticipate continued revenue growth in the coming fiscal year in line with momentum we are seeing across major U.S. pediatric centers. Our capital position is strong, operational activities are well funded through revenue growth, and the new five-year facility has freed up our label extension and blockbuster products for strategic initiatives.” Ryoncil® is the first mesenchymal stromal cell (MSC) product approved by the U.S. Food and Drug Administration (FDA) for any indication and is the only FDA-approved product for children under age 12 with steroid-refractory acute graft-versus-host disease (SR-aGvHD).1 The results presented herein are based on management’s preliminary estimates and remain subject to completion of customary year end closing and audit procedures. 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® (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® is being developed for additional inflammato…Read full documentShow less
Continued Growth Underpins First Full Year Net Revenue of US$115M NEW YORK, July 09, 2026 (GLOBE NEWSWIRE) -- Mesoblast Limited (Nasdaq:MESO; ASX:MSB), global leader in allogeneic cellular medicines for inflammatory diseases, today announced Ryoncil® (remestemcel-L-rknd) net revenue of US$36 million for the quarter and US$115 million for the full year ended June 30, 2026. “We are very pleased with the strong uptake of Ryoncil® since launch, and with revenues that have already exceeded our initial projections,” said Mesoblast Chief Executive Dr. Silviu Itescu. Dr. Itescu added: “We anticipate continued revenue growth in the coming fiscal year in line with momentum we are seeing across major U.S. pediatric centers. Our capital position is strong, operational activities are well funded through revenue growth, and the new five-year facility has freed up our label extension and blockbuster products for strategic initiatives.” Ryoncil® is the first mesenchymal stromal cell (MSC) product approved by the U.S. Food and Drug Administration (FDA) for any indication and is the only FDA-approved product for children under age 12 with steroid-refractory acute graft-versus-host disease (SR-aGvHD).1 The results presented herein are based on management’s preliminary estimates and remain subject to completion of customary year end closing and audit procedures. 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® (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® 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. Mesoblast has locations in Australia, the United States and Singapore and is listed on the Australian Securities Exchange (MSB) and on the Nasdaq (MESO). For more information, please see www.mesoblast.com, LinkedIn: Mesoblast Limited and Twitter: @Mesoblast References / Footnotes Please see the full Prescribing Information at www.ryoncil.com Forward-Looking StatementsThis press release includes forward-looking statements that relate to future events or our future financial performance and involve known and unknown risks, uncertainties and other factors that may cause our actual results, levels of activity, performance or achievements to differ materially from any future results, levels of activity, performance or achievements expressed or implied by these forward-looking statements. We make such forward-looking statements pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 and other federal securities laws. Forward-looking statements should not be read as a guarantee of future performance or results, and actual results may differ from the results anticipated in these forward-looking statements, and the differences may be material and adverse. Forward-looking statements include, but are not limited to, statements about: the initiation, timing, progress and results of Mesoblast’s preclinical and clinical studies, and Mesoblast’s research and development programs; Mesoblast’s ability to advance product candidates into, enroll and successfully complete, clinical studies, including multi-national clinical trials; Mesoblast’s ability to advance its manufacturing capabilities; the timing or likelihood of regulatory filings and approvals, manufacturing activities and product marketing activities, if any; the commercialization of Mesoblast’s RYONCIL for pediatric SR-aGVHD and any other product candidates, if approved; regulatory or public perceptions and market acceptance surrounding the use of stem-cell based therapies; the potential for Mesoblast’s product candidates, if any are approved, to be withdrawn from the market due to patient adverse events or deaths; the potential benefits of strategic collaboration agreements and Mesoblast’s ability to enter into and maintain established strategic collaborations; Mesoblast’s ability to establish and maintain intellectual property on its product candidates and Mesoblast’s ability to successfully defend these in cases of alleged infringement; the scope of protection Mesoblast is able to establish and maintain for intellectual property rights covering its product candidates and technology; estimates of Mesoblast’s expenses, future revenues, capital requirements and its needs for additional financing; Mesoblast’s financial performance; developments relating to Mesoblast’s competitors and industry; and the pricing and reimbursement of Mesoblast’s product candidates, if approved. You should read this press release together with our risk factors, in our most recently filed reports with the SEC or on our website. Uncertainties and risks that may cause Mesoblast’s actual results, performance or achievements to be materially different from those which may be expressed or implied by such statements, and accordingly, you should not place undue reliance on these forward-looking statements. We do not undertake any obligations to publicly update or revise any forward-looking statements, whether as a result of new information, future developments or otherwise. Release authorized by the Chief Executive. For more information, please contact:
Investor releaseQuarter not tagged2026-07-10Exchange-Traded Funds, Equity Futures Mixed Pre-Bell Friday Amid Renewed US-Iran Tensions Ahead of Q2 Earnings Season
MT Newswires
Exchange-Traded Funds, Equity Futures Mixed Pre-Bell Friday Amid Renewed US-Iran Tensions Ahead of Q2 Earnings Season
The broad market exchange-traded fund SPDR S&P 500 ETF Trust (SPY) was up 0.03%, and the actively tr
Investor releaseQuarter not tagged2026-07-10Mesoblast Reports $36 Million Ryoncil Revenue for Fiscal Q4
MT Newswires
Mesoblast Reports $36 Million Ryoncil Revenue for Fiscal Q4
Mesoblast (MESO) reported late Thursday that sales of its steroid-refractory acute graft-versus-host
Investor releaseQuarter not tagged2026-04-30Mesoblast Reports Ryoncil® Net Revenues of US$30.3m and Improved Net Operating Cash Spend for the Quarter to US$4.1 Million
GlobeNewswire
Mesoblast Reports Ryoncil® Net Revenues of US$30.3m and Improved Net Operating Cash Spend for the Quarter to US$4.1 Million
Achieved Patient Recruitment Target in Pivotal Phase 3 Trial for Chronic Low Back Pain Activity Report for Quarter Ended March 31, 2026 (Appendix 4C) NEW YORK, April 29, 2026 (GLOBE NEWSWIRE) -- Mesoblast Limited (Nasdaq:MESO; ASX:MSB), global leader in allogeneic cellular medicines for inflammatory diseases, today provided highlights of its recent activities for the third fiscal quarter ended March 31, 2026. “We’ve had a busy and exciting March quarter marked by a series of major achievements. Ryoncil® revenues are now approaching US$100 million since last year’s launch, we have substantially improved our net operating cash spend, our pivotal trial in inflammatory back pain has successfully achieved its patient recruitment target, and we have bolstered our long-term leadership in the field by acquiring genetically modified technology for precision-enhanced cell therapy products,” said Dr. Silviu Itescu, Mesoblast Chief Executive. FINANCIAL HIGHLIGHTS FOR QUARTER ENDED MARCH 31, 20261 Ryoncil® gross sales for the quarter were US$35.3 million, and net revenues were US$30.3 million.1 Strong sales in February and March offset holiday seasonality in January. Revenue generated during this first year of Ryoncil® launch approaches US$100 million. Net operating cash spend for the quarter was US$4.1 million. The reduction in net operating cash spend was driven by receipts of US$34.6 million and tight control of operating expenses. Mesoblast had US$122 million of cash at March 31, 2026. OPERATIONAL HIGHLIGHTS Achieved patient recruitment target in pivotal phase 3 trial of second-generation product rexlemestrocel-L for chronic low back pain (CLBP). Held inaugural R&D day on April 8th in New York. A replay of the event is available here and presentation materials here. At the R&D day Mesoblast highlighted its label extension strategy for Ryoncil® in adult and pediatric rare diseases, provided an update on near- and mid-term blockbuster opportunities in inflammatory back pain and heart failure, showcased leadership in allogeneic cell therapy innovation, and outlined commercial strategies for continued revenue growth. The trial for label extension of our flagship product Ryoncil® in adults with SR-aGvHD was cleared to begin by FDA, by data safety monitoring board (DSMB), and by central institutional review board (IRB) with first sites to be activated this quarter. FDA gra…Read full documentShow less
Achieved Patient Recruitment Target in Pivotal Phase 3 Trial for Chronic Low Back Pain Activity Report for Quarter Ended March 31, 2026 (Appendix 4C) NEW YORK, April 29, 2026 (GLOBE NEWSWIRE) -- Mesoblast Limited (Nasdaq:MESO; ASX:MSB), global leader in allogeneic cellular medicines for inflammatory diseases, today provided highlights of its recent activities for the third fiscal quarter ended March 31, 2026. “We’ve had a busy and exciting March quarter marked by a series of major achievements. Ryoncil® revenues are now approaching US$100 million since last year’s launch, we have substantially improved our net operating cash spend, our pivotal trial in inflammatory back pain has successfully achieved its patient recruitment target, and we have bolstered our long-term leadership in the field by acquiring genetically modified technology for precision-enhanced cell therapy products,” said Dr. Silviu Itescu, Mesoblast Chief Executive. FINANCIAL HIGHLIGHTS FOR QUARTER ENDED MARCH 31, 20261 Ryoncil® gross sales for the quarter were US$35.3 million, and net revenues were US$30.3 million.1 Strong sales in February and March offset holiday seasonality in January. Revenue generated during this first year of Ryoncil® launch approaches US$100 million. Net operating cash spend for the quarter was US$4.1 million. The reduction in net operating cash spend was driven by receipts of US$34.6 million and tight control of operating expenses. Mesoblast had US$122 million of cash at March 31, 2026. OPERATIONAL HIGHLIGHTS Achieved patient recruitment target in pivotal phase 3 trial of second-generation product rexlemestrocel-L for chronic low back pain (CLBP). Held inaugural R&D day on April 8th in New York. A replay of the event is available here and presentation materials here. At the R&D day Mesoblast highlighted its label extension strategy for Ryoncil® in adult and pediatric rare diseases, provided an update on near- and mid-term blockbuster opportunities in inflammatory back pain and heart failure, showcased leadership in allogeneic cell therapy innovation, and outlined commercial strategies for continued revenue growth. The trial for label extension of our flagship product Ryoncil® in adults with SR-aGvHD was cleared to begin by FDA, by data safety monitoring board (DSMB), and by central institutional review board (IRB) with first sites to be activated this quarter. FDA granted Investigational New Drug (IND) clearance to proceed directly to a registrational trial evaluating Ryoncil® in Duchenne’s muscular dystrophy (DMD), which affects approximately 15,000 children in the U.S. In addition, at the R&D day, Mesoblast unveiled next generation mesenchymal stromal cell (MSC) strategies including announcing the acquisition of an exclusive worldwide license to a patented chimeric antigen receptor (CAR) technology platform for precision-enhanced augmentation of therapeutic MSC products. This CAR technology provides Mesoblast with an immediate opportunity to generate products with even greater potency for ulcerative colitis or Crohn's disease. In addition, Mesoblast plans to use CAR-MSC engineered to express CD19 on their surface to induce remission in Lupus Nephritis and other B cell autoimmune diseases where durable, effective and safe immunomodulation is highly desirable. Other Fees to Non-Executive Directors were US$156,048, consulting payments to Non-Executive Directors were US$150,000, and salary payments to full-time Executive Directors were US$399,070, detailed in Item 6 of the Appendix 4C cash flow report for the quarter.2 A copy of the Appendix 4C – Quarterly Cash Flow Report for the third quarter FY2026 is available on the investor page of the company’s website www.mesoblast.com. 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® (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® 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. Mesoblast has locations in Australia, the United States and Singapore and is listed on the Australian Securities Exchange (MSB) and on the Nasdaq (MESO). For more information, please see www.mesoblast.com, LinkedIn: Mesoblast Limited and Twitter: @Mesoblast References / Footnotes Forward-Looking Statements This press release includes forward-looking statements that relate to future events or our future financial performance and involve known and unknown risks, uncertainties and other factors that may cause our actual results, levels of activity, performance or achievements to differ materially from any future results, levels of activity, performance or achievements expressed or implied by these forward-looking statements. We make such forward-looking statements pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 and other federal securities laws. Forward-looking statements should not be read as a guarantee of future performance or results, and actual results may differ from the results anticipated in these forward-looking statements, and the differences may be material and adverse. Forward-looking statements include, but are not limited to, statements about: the initiation, timing, progress and results of Mesoblast’s preclinical and clinical studies, and Mesoblast’s research and development programs; Mesoblast’s ability to advance product candidates into, enroll and successfully complete, clinical studies, including multi-national clinical trials; Mesoblast’s ability to advance its manufacturing capabilities; the timing or likelihood of regulatory filings and approvals, manufacturing activities and product marketing activities, if any; the commercialization of Mesoblast’s RYONCIL for pediatric SR-aGVHD and any other product candidates, if approved; regulatory or public perceptions and market acceptance surrounding the use of stem-cell based therapies; the potential for Mesoblast’s product candidates, if any are approved, to be withdrawn from the market due to patient adverse events or deaths; the potential benefits of strategic collaboration agreements and Mesoblast’s ability to enter into and maintain established strategic collaborations; Mesoblast’s ability to establish and maintain intellectual property on its product candidates and Mesoblast’s ability to successfully defend these in cases of alleged infringement; the scope of protection Mesoblast is able to establish and maintain for intellectual property rights covering its product candidates and technology; estimates of Mesoblast’s expenses, future revenues, capital requirements and its needs for additional financing; Mesoblast’s financial performance; developments relating to Mesoblast’s competitors and industry; and the pricing and reimbursement of Mesoblast’s product candidates, if approved. You should read this press release together with our risk factors, in our most recently filed reports with the SEC or on our website. Uncertainties and risks that may cause Mesoblast’s actual results, performance or achievements to be materially different from those which may be expressed or implied by such statements, and accordingly, you should not place undue reliance on these forward-looking statements. We do not undertake any obligations to publicly update or revise any forward-looking statements, whether as a result of new information, future developments or otherwise. Release authorized by the Chief Executive. For more information, please contact:
Investor releaseQuarter not tagged2026-04-08Mesoblast Reports Ryoncil Net Sales for March Quarter
MT Newswires
Mesoblast Reports Ryoncil Net Sales for March Quarter
Mesoblast (MESO) said late Monday Ryoncil net sales were $30.3 million for the quarter ended March 3
Investor releaseQuarter not tagged2026-04-07Ryoncil® Continues Successful First Year Launch with Net Sales of US$30.3M in March Quarter
GlobeNewswire
Ryoncil® Continues Successful First Year Launch with Net Sales of US$30.3M in March Quarter
Strong growth in February/March following January seasonality Net revenue approaches US$100M since launch NEW YORK, April 06, 2026 (GLOBE NEWSWIRE) -- Mesoblast Limited (Nasdaq:MESO; ASX:MSB), global leader in allogeneic cellular medicines for inflammatory diseases, today announced Ryoncil® (remestemcel-L-rknd) net sales were US$30.3 million for the quarter ended March 31, 2026.1 Strong sales in February and March offset holiday seasonality in January. Revenue generated during this first year of Ryoncil® launch approaches US$100 million. Ryoncil® revenue strengthens Mesoblast's balance sheet and supports label extension and late-stage blockbuster programs. Ryoncil® is the first mesenchymal stromal cell (MSC) product approved by the U.S. Food and Drug Administration (FDA) for any indication and is the only FDA-approved product for children under age 12 with steroid-refractory acute graft-versus-host disease (SR-aGvHD).2 “Revenue for Ryoncil® continues to be impressive,” said Mesoblast Chief Executive Dr. Silviu Itescu. “We will outline our growth strategy for Ryoncil® as well as our robust late-stage product pipeline at our inaugural R&D event this week.” Mesoblast will host its inaugural R&D Day on Wednesday, April 8, 2026, in New York City. The event will be webcast live from 8:00am to 11:00am EST and will include presentations from Mesoblast’s senior leadership team and from key opinion leaders. The webcast can be accessed via: https://webcast.openbriefing.com/msb-inv-2026/ A replay of the webcast will be available shortly after the conclusion of event on the Company’s website: www.mesoblast.com 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® (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 Informa…Read full documentShow less
Strong growth in February/March following January seasonality Net revenue approaches US$100M since launch NEW YORK, April 06, 2026 (GLOBE NEWSWIRE) -- Mesoblast Limited (Nasdaq:MESO; ASX:MSB), global leader in allogeneic cellular medicines for inflammatory diseases, today announced Ryoncil® (remestemcel-L-rknd) net sales were US$30.3 million for the quarter ended March 31, 2026.1 Strong sales in February and March offset holiday seasonality in January. Revenue generated during this first year of Ryoncil® launch approaches US$100 million. Ryoncil® revenue strengthens Mesoblast's balance sheet and supports label extension and late-stage blockbuster programs. Ryoncil® is the first mesenchymal stromal cell (MSC) product approved by the U.S. Food and Drug Administration (FDA) for any indication and is the only FDA-approved product for children under age 12 with steroid-refractory acute graft-versus-host disease (SR-aGvHD).2 “Revenue for Ryoncil® continues to be impressive,” said Mesoblast Chief Executive Dr. Silviu Itescu. “We will outline our growth strategy for Ryoncil® as well as our robust late-stage product pipeline at our inaugural R&D event this week.” Mesoblast will host its inaugural R&D Day on Wednesday, April 8, 2026, in New York City. The event will be webcast live from 8:00am to 11:00am EST and will include presentations from Mesoblast’s senior leadership team and from key opinion leaders. The webcast can be accessed via: https://webcast.openbriefing.com/msb-inv-2026/ A replay of the webcast will be available shortly after the conclusion of event on the Company’s website: www.mesoblast.com 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® (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® 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. Mesoblast has locations in Australia, the United States and Singapore and is listed on the Australian Securities Exchange (MSB) and on the Nasdaq (MESO). For more information, please see www.mesoblast.com, LinkedIn: Mesoblast Limited and Twitter: @Mesoblast References / Footnotes Forward-Looking Statements This press release includes forward-looking statements that relate to future events or our future financial performance and involve known and unknown risks, uncertainties and other factors that may cause our actual results, levels of activity, performance or achievements to differ materially from any future results, levels of activity, performance or achievements expressed or implied by these forward-looking statements. We make such forward-looking statements pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 and other federal securities laws. Forward-looking statements should not be read as a guarantee of future performance or results, and actual results may differ from the results anticipated in these forward-looking statements, and the differences may be material and adverse. Forward-looking statements include, but are not limited to, statements about: the initiation, timing, progress and results of Mesoblast’s preclinical and clinical studies, and Mesoblast’s research and development programs; Mesoblast’s ability to advance product candidates into, enroll and successfully complete, clinical studies, including multi-national clinical trials; Mesoblast’s ability to advance its manufacturing capabilities; the timing or likelihood of regulatory filings and approvals, manufacturing activities and product marketing activities, if any; the commercialization of Mesoblast’s RYONCIL for pediatric SR-aGVHD and any other product candidates, if approved; regulatory or public perceptions and market acceptance surrounding the use of stem-cell based therapies; the potential for Mesoblast’s product candidates, if any are approved, to be withdrawn from the market due to patient adverse events or deaths; the potential benefits of strategic collaboration agreements and Mesoblast’s ability to enter into and maintain established strategic collaborations; Mesoblast’s ability to establish and maintain intellectual property on its product candidates and Mesoblast’s ability to successfully defend these in cases of alleged infringement; the scope of protection Mesoblast is able to establish and maintain for intellectual property rights covering its product candidates and technology; estimates of Mesoblast’s expenses, future revenues, capital requirements and its needs for additional financing; Mesoblast’s financial performance; developments relating to Mesoblast’s competitors and industry; and the pricing and reimbursement of Mesoblast’s product candidates, if approved. You should read this press release together with our risk factors, in our most recently filed reports with the SEC or on our website. Uncertainties and risks that may cause Mesoblast’s actual results, performance or achievements to be materially different from those which may be expressed or implied by such statements, and accordingly, you should not place undue reliance on these forward-looking statements. We do not undertake any obligations to publicly update or revise any forward-looking statements, whether as a result of new information, future developments or otherwise. Release authorized by the Chief Executive. For more information, please contact:
Investor releaseQuarter not tagged2026-02-27Mesoblast H1 Earnings Call Highlights
MarketBeat
Mesoblast H1 Earnings Call Highlights
Ryoncil launch drove strong early sales with $51.3 million total revenue in H1 (including $49 million net product revenue) and a 93% gross margin; management reiterated full-year Ryoncil net revenue guidance of $110–$120 million and the company ended December with $130 million in cash. Operating costs rose—R&D jumped to $46.1 million—and Mesoblast posted an operating loss of $40.2 million with H1 operating cash usage of $30.3 million, but it closed a $125 million non-dilutive credit facility ( $75 million drawn) to repay prior debt and has an additional $50 million tranche available. Commercial rollout shows momentum with 49 treatment centers onboarded, coverage across plans representing >280 million lives and a reimbursement code (J3402) in place; key clinical/regulatory milestones include adult GVHD pivotal sites starting after central IRB approval (anticipated March), a confirmatory Phase III low back pain trial completing enrollment in Mar/Apr with BLA/data expected in 2027, and a planned BLA filing next quarter for Revascor in LVAD patients as the company pursues full approval. Interested in Mesoblast Limited? Here are five stocks we like better. Mesoblast (NASDAQ:MESO) executives highlighted strong early commercial momentum for its cell therapy Ryoncil and outlined multiple regulatory and clinical milestones ahead during the company’s financial results call for the half year ended Dec. 31, 2025. Chief Executive Officer Silviu Itescu said fiscal 2026 to date has been marked by a “very successful product launch” following U.S. Food and Drug Administration approval of Ryoncil in December 2024. Ryoncil, which management described as the “first and only FDA-approved allogeneic mesenchymal stromal cell product,” launched in April 2025 and has shown quarter-on-quarter revenue growth. → SoundHound’s New Sales Assist Agent Put Voice AI Back in the Spotlight Chief Financial Officer James O’Brien reported total revenue of $51.3 million for the first half of fiscal 2026, including $49 million in net product revenue from Ryoncil. O’Brien said gross margin was 93%. On operating expenses, O’Brien said research and development expense was $46.1 million, compared with $5.1 million in the prior-year period. He noted the prior-year figure was “skewed” by a $23 million reversal of an inventory provision tied to Ryoncil’s approval; without that adjustment, he said prior-ye…Read full documentShow less
Ryoncil launch drove strong early sales with $51.3 million total revenue in H1 (including $49 million net product revenue) and a 93% gross margin; management reiterated full-year Ryoncil net revenue guidance of $110–$120 million and the company ended December with $130 million in cash. Operating costs rose—R&D jumped to $46.1 million—and Mesoblast posted an operating loss of $40.2 million with H1 operating cash usage of $30.3 million, but it closed a $125 million non-dilutive credit facility ( $75 million drawn) to repay prior debt and has an additional $50 million tranche available. Commercial rollout shows momentum with 49 treatment centers onboarded, coverage across plans representing >280 million lives and a reimbursement code (J3402) in place; key clinical/regulatory milestones include adult GVHD pivotal sites starting after central IRB approval (anticipated March), a confirmatory Phase III low back pain trial completing enrollment in Mar/Apr with BLA/data expected in 2027, and a planned BLA filing next quarter for Revascor in LVAD patients as the company pursues full approval. Interested in Mesoblast Limited? Here are five stocks we like better. Mesoblast (NASDAQ:MESO) executives highlighted strong early commercial momentum for its cell therapy Ryoncil and outlined multiple regulatory and clinical milestones ahead during the company’s financial results call for the half year ended Dec. 31, 2025. Chief Executive Officer Silviu Itescu said fiscal 2026 to date has been marked by a “very successful product launch” following U.S. Food and Drug Administration approval of Ryoncil in December 2024. Ryoncil, which management described as the “first and only FDA-approved allogeneic mesenchymal stromal cell product,” launched in April 2025 and has shown quarter-on-quarter revenue growth. → SoundHound’s New Sales Assist Agent Put Voice AI Back in the Spotlight Chief Financial Officer James O’Brien reported total revenue of $51.3 million for the first half of fiscal 2026, including $49 million in net product revenue from Ryoncil. O’Brien said gross margin was 93%. On operating expenses, O’Brien said research and development expense was $46.1 million, compared with $5.1 million in the prior-year period. He noted the prior-year figure was “skewed” by a $23 million reversal of an inventory provision tied to Ryoncil’s approval; without that adjustment, he said prior-year R&D expense would have been about $18.1 million. Spending in the current period was attributed to adult graft-versus-host disease (GVHD) trials, the chronic low back pain program, the left ventricular assist device (LVAD) program, preparation for a biologics license application (BLA), and manufacturing work. → Diamondback Sees Resilient Demand Despite Cautious Guidance Sales and general administrative expense rose to $28.5 million from $18 million a year earlier, which O’Brien attributed to sales and marketing efforts supporting the launch. Mesoblast posted an operating loss of $40.2 million for the half, compared with $48 million in the prior-year period, which was also impacted by the prior-year inventory provision reversal. → Keurig Dr Pepper’s Split Plan Could Unlock Hidden Value O’Brien said operating cash flow usage was $30.3 million for the first half, and management expects cash usage to decline in the second half of fiscal 2026 based on projected revenue receipts and “disciplined cost control measures and efficiencies.” The company ended December with $130 million in cash, O’Brien said. O’Brien also detailed a financing transaction completed late in the period. On Dec. 30, 2025, Mesoblast entered into a $125 million “non-dilutive credit line facility.” The first $75 million tranche was drawn at closing and used to repay the prior senior secured loan in full, while the company also partially repaid a subordinated royalty facility that management expects will be fully repaid by mid-2026 from ongoing revenue. The remaining $50 million tranche is available at Mesoblast’s option through June 2026. O’Brien characterized the facility as a lower cost of capital that can be repaid at any time without early prepayment or make-whole fees and without exit fees. He also said the facility does not cover Mesoblast’s assets and has no restrictions on additional unsecured debt or licensing activities. Looking ahead, O’Brien said Mesoblast anticipates full-year fiscal 2026 Ryoncil net revenue of $110 million to $120 million. Management reiterated the guidance during the Q&A after an analyst asked for it to be repeated. Chief Commercial Officer Marcelo Santoro said the company is “extremely pleased” with launch performance and that Mesoblast has treated “numerous patients” since launch. He said the company is on track to achieve 20% market share by the end of year one in the market. Santoro reported operational metrics around rollout and access: 49 treatment centers onboarded to date Ryoncil listed on formulary at 30 of those centers 30 hospitals have opted to use Optum Frontier, the company’s specialty pharmacy partner Coverage in place across insurance plans representing over 280 million lives, across commercial and government payers Medicaid coverage in all states A specific reimbursement code, J3402, went into effect on Oct. 1 to support billing and reimbursement, along with published CMS rates He said major payers including Aetna, Cigna, UnitedHealthcare, Anthem, Humana, and Prime Therapeutics (covering Blue Cross plans) have issued favorable coverage policies and that these policies do not require step therapy. In response to an analyst question on the 20% share target, management said the goal is to reach 20% by the fourth quarter of the fiscal year, and Itescu said internal assumptions include a patient range of roughly 300 to 375 and a 40% peak share assumption over time, while noting the company believes the product “should be used by everyone.” Executives also said they are seeing both new centers adopt and “repeated use” at existing centers, alongside efforts focused on physician education and caregiver awareness. Beyond the pediatric indication, Itescu outlined plans to expand Ryoncil into adults. A pivotal study in adults with severe steroid-refractory GVHD is underway with partners at the NIH-funded Blood and Marrow Transplant Clinical Trials Network. Itescu said the protocol has been “locked down” after a recent FDA meeting, and the company expects site initiation and patient enrollment to begin after central IRB approval anticipated in March. Mesoblast also discussed its “second-generation platform,” rexlemestrocel-L, in chronic discogenic low back pain and chronic ischemic heart failure. Itescu said the company received positive FDA feedback on potential BLA filing for low back pain based on a clinically meaningful reduction in pain intensity at 12 months in a completed Phase III trial. He added that FDA confirmed 12-month pain reduction is an approvable endpoint, including under the current FDA administration, and noted the program has RMAT designation as a potential opioid-sparing therapy. A confirmatory Phase III trial is recruiting 300 patients across 40 U.S. sites, with enrollment expected to complete in March or April, and data readout and BLA filing expected in calendar 2027. For Revascor in end-stage heart failure patients supported by LVADs, Itescu reviewed results from two randomized controlled studies, including a 159-patient trial (LVAD study 2) and a supportive 30-patient trial (LVAD study 1). He said both trials showed Revascor reduced cumulative incidence of major bleeding events and related hospitalizations through six months. He also presented what he described as new data indicating reductions in major bleeding events and hospitalizations over 12 months, as well as effects on right heart failure hospitalizations and mortality risk. With orphan drug designation and ongoing work on chemistry, manufacturing, and controls, Itescu said Mesoblast is moving from an accelerated approval strategy to pursuing full approval for the LVAD indication and expects to file the BLA in the next quarter. In Q&A, management said it intends to seek a label for the overall LVAD patient population while providing FDA with data showing ischemic patients are at higher risk and may see greater benefit. Mesoblast Limited is a global leader in allogeneic cellular medicines, focused on developing treatments for inflammatory and immunologic diseases. Founded in 2004 by Dr. Silviu Itescu, the company builds on proprietary mesenchymal lineage cell technology to create off-the-shelf, donor-derived therapies. These therapies are designed to modulate immune responses and promote tissue repair in conditions where existing medical options are limited or ineffective. The company's most advanced product, Alofisel® (darvadstrocel), has been approved in Europe for the treatment of complex perianal fistulas in adults with Crohn's disease. The article "Mesoblast H1 Earnings Call Highlights" was originally published by MarketBeat.

