Mesoblast - H1 2026

Transcript

Operator (participant)

Hello, and welcome to the Mesoblast financial results for the half year ended December 31st, 2025. 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 those in such forward-looking statements.

In addition, any forward-looking statements represent the company's views only at 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 like to turn the call over to Paul Hughes.

Paul Hughes (Head of Corporate Finance and Investor Relations)

Thank you. Welcome everyone to the Mesoblast financial results call for the period ending 31 December 2025. My name is Paul Hughes. I'm Head of Corporate Finance and Investor Relations. In the room with me today is our CEO, Silviu Itescu, our CFO, James O'Brien, and our CTO, Marcelo Santoro. We have a presentation to run through highlighting the financial results and the operations for the period, then we'll have some time for questions at the end. Now I'll hand over to Silviu to begin.

Silviu Itescu (CFO and Managing Director)

Thank you, Paul. If we could go to slide four, please. This slide highlights the corporate priorities for 2026. We intend to continue to show strong growth in Ryoncil sales driven by market adoption. We will build a strong cash flow with judicious use of funds for operations and an optimal capital structure. Cultural transition is critical so that we can move to an efficient commercial organization.

We will expand Ryoncil label indications and seek to obtain approval for Revascor and Ryoncil products, our second-generation platform. Our manufacturing focus will seek to increase diversification, capacity and cost efficiency for our platforms. We will continue to focus on appropriate commercial partnering backed by demonstrable value drivers, including FDA approvals, strong revenues and advanced clinical programs. Next slide, please. This year was marked by a very successful product launch.

We initially received FDA approval for Ryoncil in December 2024. Ryoncil is the first and only FDA-approved allogeneic mesenchymal stromal cell product. The product was launched in April of 2025, with revenues growing quarter-on-quarter. There's significant unmet need with continued uptake and increasing market adoption. Our net revenue from Ryoncil was $49 million in the first half of FY 26. Next slide, please.

Paul Hughes (Head of Corporate Finance and Investor Relations)

Thanks, Silviu. Jim will take us through the financial slides. Thanks, Jim.

James O'Brien (CFO)

Thank you, Paul. Hi, everybody. I'd like to now review our first half fiscal 2026 operating results. I should mention that all figures are in US dollars. Total revenues for the period were $51.3 million, driven by the successful launch of Ryoncil. Our net product revenues, as Silvio mentioned, were $49 million, and we had a gross margin of a strong 93%. Our R&D expenses for the period were $46.1 million compared to what we reported last year of $5.1 million. Last year's numbers were a bit skewed because we had a $23 million reversal of an inventory provision once we got approval of Ryoncil. Without that adjustment, the prior year number would have been about $18.1 million.

I'm sorry, we would have grown about $18.1 million over the prior year. Again, the spending in the period really related to our adult GVHD trials, back pain, and also our LVAD program, as well as getting ready for the BLA and some manufacturing work. Our sales and general administrative expenses were $28.5 million compared to $18 million the prior year. That increase really related to the sales and marketing effort that Marcelo and the sales team did in terms of driving sales growth. The loss of it during the period this year was $40.2 million compared to $48 million in the prior year period. Again, as I mentioned a few moments ago, that prior year loss was impacted by the $23 million worth of reversal on inventory.

We were down on a net loss about $30 million year-over-year. Just in terms of our operating spend and our cash flows, for the first fiscal quarter, first fiscal half of the year, excuse me, we were at $30.3 million. As we look to the second half of the year, we expect our operating cash flow usage to decline when compared to the first half of fiscal 2026, based upon our projected cash receipts from revenues, as well as maintaining disciplined cost control measures and efficiencies in the operation. On the next slide, just to point out, our profitability and the growth pipeline from Ryoncil. As I mentioned, we had strong revenues for the period.

Gross margin Our amortization expense would have been about $44.2 million. Our direct selling costs were $7.7 million. Again, we have strong operating performance allows us to invest in our R&D programs and our life cycle extensions. We do have a very robust pipeline, and we continue to invest in our manufacturing footprint as well as building inventory where needed and getting our second-generation products to market. On page nine, next slide, please. We had $130 million worth of cash at the end of December of this year. Which you can also note that the reduction in our net spend over the year, as I said, will decline over the second half of this year.

On December 30, 2025, we entered into a $125 million non-dilutive credit line facility. The first tranche of which, the $75 million, was drawn at closing and enabled Mesoblast to replay in full its prior senior secured loan. We also partially repaid the subordinated royalty facility, which will continue to be reduced from ongoing revenue and will be fully repaid by the middle of 2026. The second tranche of $50 million is available to be drawn on our option through June of 2026.

The new facility is a lower cost of capital for the company, freed up its major assets to provide flexibility for strategic partnerships and commercialization. The new facility can be repaid at any time without incurring early prepayment or make-whole fees. It does not include any exit fees.

It does not cover any of Mesoblast's assets, which is a very strong point for the reason why we did this. This is terrific for the company. We have no restrictions on doing additional unsecured debt or any licensing activities. We're very pleased with this line of credit and believe it'll strengthen our balance sheet to support an exciting growth period for Mesoblast. On the next slide, looking ahead to the second half of 2026, we anticipate full year Ryoncil net revenues to range between $110 million and $120 million on a full year basis. With that, I'll turn the call back to Silviu for additional comments.

Silviu Itescu (CFO and Managing Director)

Thanks, Jim. If we can go slide 12, I'd like to bring Marcelo Santoro, our Chief Commercial Officer. Please.

Marcelo Santoro (Chief Commercial Officer)

Thank you very much, Silviu. Next slide, please. Good afternoon, good morning, everyone. We are extremely pleased with the performance of the launch to date, and I couldn't be prouder of the work, the commitment, and the passion that our colleagues at Mesoblast demonstrate every single day towards these children. We have treated numerous patients since we launched, and we also is having a transformational impact in the treatment of these children, according to this re-feedback we received from treatment centers and treatment teams.

In fact, we're on track to achieve 20% market share by the end of year 1 in the market. The commercial performance to date has been exceptional. This holds true not only against our initial expectations, but also when benchmarked against other successful rare disease launches. We have been laser-focused on building the infrastructure needed to ensure Ryoncil reaches its full potential.

I am very happy to report that we have onboarded 49 treatment centers to date. Ryoncil is now listed on the formulary of 30 of those centers, a number that continues to grow steadily as more P&T committees review and approve its use. Formulary inclusion is critical, as you know, as it streamlines the adoption and use of Ryoncil when it's selected for a patient.

Having this many formulary approvals in less than one year demonstrates the outstanding value of this product and the tireless commitment of the team to build the appropriate infrastructure to expand its utilization. 30 hospitals have opted to use Optum Frontier, our specialty pharmacy partner, virtually eliminating their financial responsibilities for the product. On the payer side, we have also made exceptional progress.

Ryoncil is now covered by insurance plans representing over 280 million lives across both commercial and government payers. Medicaid coverage is in place in all states, and a specific J-code for Ryoncil, J3402, went into effect on October 1st, allowing for more efficient billing and reimbursement for both sides of care and payers, along with CMS published rates. Commercial payer support has also been very strong.

All major payers, including Aetna, Cigna, UnitedHealthcare, Anthem, Humana, and Prime Therapeutics covering all Blue Cross plans, have issued favorable coverage policies for Ryoncil. Notably, these policies do not require step therapy, which simplifies patient access significantly. All of this has occurred within the first six months post-launch. Next slide, please. From a strategic priority standpoint, the Ryoncil team is 100% focused on three key strategic pillars.

The first is to proactively identify and prioritize appropriate patients who may benefit from Ryoncil therapy. The second, to reinforce our superior patient outcomes in first-line treatment right after steroids. The third is to empower caregivers to demand Ryoncil for their children. We have been working with several advocacy groups and will soon launch a comprehensive campaign

Silviu Itescu (CFO and Managing Director)

Dedicated to supporting both caregivers and patients. With that, let me turn back to Paul.

Paul Hughes (Head of Corporate Finance and Investor Relations)

Thanks, Marcel. I'll hand over to Silviu, who's gonna take us through the rest of the deck, before we open it up to Q&A. Thanks.

Silviu Itescu (CFO and Managing Director)

Thank you. We can move to slide 14. This slide summarizes our plans for label expansion of Ryoncil into adults. A pivotal study of Ryoncil as part of second-line treatment regimen in adults with severe steroid-refractory graft-versus-host disease is underway with our partners at the NIH-funded Blood and Marrow Transplant Clinical Trials Network.

The basis for this trial is that 50% of adults who have severe GvHD fail existing second-line treatments, including predominantly ruxolitinib. These patients who fail have a 25% abysmal survival at 100 days. We have previously used Ryoncil under expanded access in patients aged 12 and older, in many adults as well, 18 and older, who failed ruxolitinib or other second-line agents in use of our product in this patient population was associated with 76% survival at day 100, a remarkable result.

As a result of these results, the final protocol design for the registrational study in adults has been locked down and has been worked through with the FDA recently in a meeting with the FDA agency. We expect that following central institutional review board approval coming up in March, site initiation and patient enrollment will commence. Next slide, please. Further extension strategy for Ryoncil is focused on various opportunities in pediatric and adult inflammatory diseases.

The team is currently evaluating multiple indications to unlock value, including in the inflammatory bowel, neurodegenerative, and respiratory conditions. Our portfolio will be prioritized to maximize shareholder return by utilizing either internal investment strategies versus external partnership initiatives. Next slide 16. Now I'll be updating you on our second-generation platform, rexlemestrocel-L, currently being developed for chronic discogenic low back pain and chronic ischemic heart failure.

Slide 17, our phase III chronic low back pain program. A first 404 patient randomized controlled phase III trial has already completed, and that included about 40% of patients who are opioid-dependent. We met with the FDA recently received positive feedback on potential filing of a BLA, based on achieving a clinically meaningful reduction in pain intensity at 12 months between the treatment arm and placebo arm. The robust results in opioid reduction from at least one adequate and well-controlled trial could be included, according to our meeting with the agency, as part of product labeling, which is a very, very, very important outcome. We in fact do already have an RMAT, Regenerative Medicine Advanced Therapy Designation for rexlemestrocel-L as a potential opioid-sparing therapy in chronic lower back pain. Next slide.

The confirmatory phase III trial is recruiting currently 300 patients across 40 sites in the U.S. with a primary endpoint, 12-month reduction in pain. As I've mentioned on multiple occasions, FDA has confirmed that that is an approvable endpoint. The enrollment of these 300 patients is expected to be completed in March or April. Data readout and BLA filing are expected in calendar year 2027. We have, at the same time, are undergoing commercial manufacturing in order to leverage our existing capacity and cost efficiencies. I'll reinforce that there are many patients who are suffering from this terrible disease. Over 7 million patients, across each of the U.S. and EU 5 are due to degenerative disc disease, patients who are otherwise, have run out of options other than surgery. This is a large unmet need for a potential blockbuster opportunity.

Next slide 19. Now I'd like to update you on Revascor, our product based on our rexlemestrocel-L platform that is being developed for chronic heart failure with reduced ejection fraction and persistent inflammation in either patients with class two, three heart failure or very end-stage heart failure patients who are being kept alive with a ventricular assist device in the left ventricle.

We can go to slide 20. LVAD implantation improves overall survival in these end-stage patients, and that's well-established. However, the underlying causes of heart failure in these patients, notably inflammation, persist. Whilst the left ventricle's improving the left side, the LVAD is improving the left side of the heart, the right ventricular pump function remains vulnerable and continues to deteriorate.

Progressive right heart failure continues to occur in up to 30% of patients and is the primary cause of multi-organ failure and death in this group of patients, mortality occurring within the first 12 months. In addition, life-threatening major mucosal bleeding due to progressive right heart failure and portal hypertension occurring in up to 30% of patients and is a major morbidity in this group, the main cause of recurrent hospitalization. Next slide. We've performed two randomized controlled studies in this patient population. The more recent study was called LVAD study two, and that randomized 159 patients in a 2-to-1 randomization to provide primary evidence of Revascor's efficacy in reducing major bleeding events.

A second study, LVAD study one, an earlier study, is a supportive study for LVAD 2, randomized 30 patients in a 2-to-1 fashion and provided supportive evidence also of Revascor's efficacy in reducing major bleeding events. Intramyocardial injections in both of these studies of either Revascor or control were performed at the time of LVAD implantation. Importantly, both trials, both randomized controlled trials, showed that Revascor reduced cumulative incidents of major bleeding events, life-threatening GI bleeding, the trial's primary efficacy and safety endpoint, and related hospitalizations through 6 months. Both were significant. Can we go to the next slide? Slide 22. This provides you with some new data that we have not previously presented.

This slide demonstrates the total number of major bleeding events resulting in hospitalizations over six months on the left-hand side and over 12 months compared to controls, in the entire study, LVAD 2. As you can see both on the left-hand side and panel B on the right-hand side, Revascor reduced major bleeding events and hospitalizations by about five-fold.

A very significant reduction throughout a 12-month period compared to MPC treatment, compared to control treatment. Next slide, please. Moreover, particularly in the ischemic group of patients, what you can see is that on the left-hand side, in controls, in red, the ischemic controls had approximately a three to four-fold increase in hospitalizations due to right heart failure. The non-ischemic had a very low incidence of and risk of heart failure hospitalizations.

In contrast, on the right-hand side, by 12 months, you can see that the MPC treatments reduced the right heart failure hospitalization events in ischemic patients back to background levels. The same levels as are seen in non-ischemic controls. Again, those reductions of hospitalization from right heart failure were significant. Next slide, please. This slide focuses on the risk of death from right heart failure in controls on the left and in Revascor-treated patients on the right. As you can see in panel A on the left, amongst patient controls who had at least one hospitalization from right heart failure, the presence of sorry.

Amongst controls, the presence of right heart failure hospitalization, at least one right heart failure hospitalization in red, was associated with a mortality risk and a hazard ratio of seven or more than seven compared to patients who did not have right heart failure. In controls, particularly early within the first four months after LVAD implantation, the presence of a right heart failure hospitalization was a very strong predictor of death.

In contrast, what you can see on the right-hand side, amongst Revascor-treated patients, the risk of death, particularly in that early period, four-month period, is almost completely abolished. You can see that the overall survival over a 12-month period in Revascor-treated patients was the same irrespective whether they had a right heart failure hospitalization or not.

What this means is that treatment with Revascor not only reduces the incidence of hospitalization rates but protects these patients against death from right heart failure. Can you go to the next slide, please? The summary of these new data that I haven't shown you here but we have also observed, is that Revascor reduces inflammatory cytokines and through inflammation reduction protects the at-risk right ventricle in these patients.

The same right ventricle that continues to fail despite the fact that there's an LVAD in the left ventricle. The strengthened right ventricle reduces hospitalization rates in the intensive care unit due to right heart failure and improves survival. The strengthened right ventricle decreases the risk of portal hypertension and therefore decreases GI bleeding events.

This leads us to think very carefully about how Revascor, beyond its potential use in patients with left heart failure problems, also has the potential to be used to improve right heart failure function in patients not only with ischemic heart disease, but other causes of right heart failure, including primary pulmonary hypertension and chronic lung diseases.

Next slide, please. Slide 26. Let me give you an update on our CHF program, particularly our plans to file for approval. With these new data and our existing orphan drug designation for treating this group of high-risk patients with high mortality, as well as FDA's stated preference for randomized controlled trials, Mesoblast is moving from filing for an accelerated approval to filing for a full approval.

Unlike an accelerated approval, a full approval does not require a confirmatory study. Aligned with FDA on items required for filing the BLA regarding CMC potency, assays, and product release and commercial manufacturing, we now have these activities well and truly underway. We expect to file our BLA for full approval for this indication in the next quarter.

Let me summarize our highlights and our upcoming milestones. Ryoncil is the first and only FDA-approved MSC product. It delivered net revenues of $49 million in the first half of FY 2026. As you heard, 49 centers have been onboarded. 64 centers account for 94% of the entire pediatric bone marrow transplant population, we're well underway to achieve that in record time. We're initiating label expansion to adults, acute GVHD, a market that is three times larger than the pediatric market.

We are currently prioritizing our portfolio, which includes the potential to go into the inflammatory bowel disease, neurodegenerative diseases, and respiratory conditions, and we will update the market as we focus on certain areas in priority over others. Our second generation of rexlemestrocel-L is enrolling the second trial in back pain, with full enrollment expected to complete by the end of March or end of April.

BLA filing next quarter is in line for full approval for patients with right heart failure and end-stage heart failure with LVADs. And we're actively optimizing manufacturing logistics to support commercialization, both of the rexlemestrocel-L pipeline and obviously to have further inventory for the projected growth in Ryoncil sales.

With $130 million in cash on-hand as of December 31 and the new credit line that you heard about, which still has the potential for $50 million available to draw down, we're in a very strong financial position. As you heard earlier, we are projecting full year fiscal 2026 Ryoncil net revenue to range between $110 million and $120 million. I think I'll stop there, and hopefully there are some questions that we can all address. Thank you.

James O'Brien (CFO)

Operator, if you could please open the lines for questions. Thank you.

Operator (participant)

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 are using a speakerphone, please pick up the handset to ask your question. Your first question comes from Edward Tenthoff with Piper Sandler.

Edward Tenthoff (Managing Director and Senior Research Analyst)

Great. Thank you very much. Congrats on all the great progress across the board. Could you just repeat the guidance? You broke up a little bit for this coming year.

James O'Brien (CFO)

Yes. Yes. What we're projecting for the full fiscal year, our net revenue's ranging from $110 million-$120 million, again, on a full year fiscal basis, 2026, ending June 2026.

Edward Tenthoff (Managing Director and Senior Research Analyst)

That's great. All right. Excellent. I'll get back in the queue.

Operator (participant)

Your next question comes from Olivia Brayer with Cantor Fitzgerald.

Olivia Brayer (Director and Senior Biotech Analyst)

Hi, guys. Thank you for the questions. I have a few, if you don't mind. Maybe just first on Ryoncil in peds. You all mentioned potentially hitting 20% penetration of that pediatric population by the... I think it was by the end of your fiscal year, if I heard that correctly. Can you maybe just run through what those assumptions include to get to that 20%? How high of penetration do you think you can realistically reach in this specifically peds population over time? Then I've got two more on your pipeline programs.

Silviu Itescu (CFO and Managing Director)

Yeah. Thank you. Let me start with the second one and then go to the first, right? The second one, we assume a 40% peak share. You have to understand, we believe it should be 100%. This is a product that should be used by everyone. Let's be responsible and realistic. A 40% share is reasonable, right? If you assume a range of patients, and obviously that's dynamic, of 300 patients-375 patients, that's what the 20% is based on. It's 20% until the end of our fiscal year. That what we aim on achieving at that point.

Olivia Brayer (Director and Senior Biotech Analyst)

Is that specifically for the fourth quarter of your fiscal year? Like if I'm kinda doing the math.

Silviu Itescu (CFO and Managing Director)

Yes.

Olivia Brayer (Director and Senior Biotech Analyst)

Okay. Okay, that's helpful. Thank you.

Silviu Itescu (CFO and Managing Director)

Yes.

Olivia Brayer (Director and Senior Biotech Analyst)

For your Revascor BLA next quarter, how is the FDA viewing the ischemic versus non-ischemic phenotypes? Have they given any input onto, or around potential labeling language around the ischemic etiology or inflammation biomarkers?

Silviu Itescu (CFO and Managing Director)

Well, I think it's important to note that in the 159 patient trial, we achieved the principal endpoint in the full patient population without having to go to any subgroups in terms of the cumulative incidence of major bleeding events over six months. Also we achieved a significant reduction in hospitalizations from major bleeding events across the entire patient population without having to go to subgroups.

Our position is that we will be seeking a label for the entire patient population, especially given that the confirmatory study, LVAD 1, also achieved the same endpoint across all patients. There's no question that the patients at greatest risk are those with ischemic etiology. Those patients have a higher level of inflammation. They have a higher risk for bleeding, right heart failure, and death.

Interestingly, we saw the very same sort of thing in the larger trial in Class two three heart failure, where again, we saw patients with ischemic heart disease as an etiology, had higher levels of inflammation, greater risk for three-point MACE, and greater treatment benefit. We will be providing the FDA with the totality of the data that comes out of the supportive trials, demonstration that ischemic patients are at greater risk, and treatment with ourselves, is even more effective in that subgroup. We've achieved the endpoint, the endpoint around the pre-specified bleeding endpoint and hospitalization endpoint across the entire population. That remains to be negotiated.

Olivia Brayer (Director and Senior Biotech Analyst)

That's helpful. Understood. Then last question is just on the chronic back pain. Can you just clarify what data you're submitting to the FDA? Is it just a new analysis of the pre-existing data? Is your ongoing phase III not actually going to be part of that submission package? Maybe just some clarity around, you know, that update, 'cause I do think that is a new disclosure.

Silviu Itescu (CFO and Managing Director)

No, no. I didn't mean to say that we wouldn't be submitting the data from the new trial. The new trial, the second trial, which completes enrollment over the next month to six weeks is the plan to complete enrollment. That trial becomes the primary dataset. The previous trial becomes a supportive dataset. That's certainly our intention. We have spoken with the FDA about looking at the subgroup of patients who are opioid-dependent. That's a discussion that is ongoing with the agency. With respect to the primary endpoint in all comers of pain reduction, we will be using the two trials to present full datasets.

Olivia Brayer (Director and Senior Biotech Analyst)

Okay. That additional phase III readout is coming in 2027, correct? Will you...

Silviu Itescu (CFO and Managing Director)

That's correct.

Olivia Brayer (Director and Senior Biotech Analyst)

You're kicking off the filing before actually having that data?

Silviu Itescu (CFO and Managing Director)

No. The objective is to complete that trial, get the readouts, and move to a filing with those data in the primary file.

Olivia Brayer (Director and Senior Biotech Analyst)

Okay. Okay. Understood. Thank you.

Operator (participant)

Your next question comes from Madeleine Williams with Canaccord.

Madeleine Williams (Equity Research Analyst)

Hi, team. Thanks for taking my question. Just in regards, just coming back to the pediatric Ryoncil, and just the FY 2026 guidance. Can you speak a little bit to, you know, how you're seeing repeat utilization amongst centers or, just how that kind of shakes out over the remaining portion of the year and get sort of just trying to dig into more?

Silviu Itescu (CFO and Managing Director)

Yeah. No, I'd be happy to do that. Yeah. Yeah. We see the continuous growth in the centers, continuous adoption, not only by more centers, but also repeated use by the current centers we already have, which shows that they are finding utility in the products and repeating the treatment in other children, right? That's one component.

The second component, we're also seeing very big, very large centers coming on board, which will substantially increase our confidence in this guidance. You know, it's a reality. It's happening every day. I would add to that I think, you know, a major additional component as moving forward is continued physician education.

Madeleine Williams (Equity Research Analyst)

Yeah.

Silviu Itescu (CFO and Managing Director)

You know, we've shown both in our previous phase III trials and in the real-world data that the earlier this product is used, the greater the survival. It's, it's unquestionable. A lot of the effort by the team will be to educate physicians. You know, physicians have their own practice habits, and they all believe that their particular way of doing things.

Madeleine Williams (Equity Research Analyst)

Yes

Silviu Itescu (CFO and Managing Director)

is standard. Nothing is standard in this disease, especially given that only Ryoncil is approved by FDA-

Madeleine Williams (Equity Research Analyst)

Yeah

Silviu Itescu (CFO and Managing Director)

...for treatment in children under 12. I think a major focus and an area of growth is to educate for the majority to use the product as early as possible after serious failure. Do you agree with that?

Madeleine Williams (Equity Research Analyst)

For sure. I would add one more, right? As a father, you know, if unfortunately my child had something like this horrible disease, I would like to know the softness of it. It's our obligation to empower them, to empower the caregivers, make sure that they understand that this product is available, and it's the only FDA-approved product, so that they can talk to the treatment teams and ask for this as a potential therapeutic option for their children. Thank you. That's helpful. Just maybe one more from me, just in regards to Revascor and the full approval, filing for full approval rather than accelerated.

I'm just interested, you know, you've obviously discussed the additional data. I'm assuming there's sort of been some sort of constructive discussions with the FDA, and just sort of, you know, if you can provide more color about what your confidence is in receiving that full approval.

Silviu Itescu (CFO and Managing Director)

Well, we've had multiple discussions with the agency. We understand what they wanted to see and the data that I've highlighted to you today, particularly as it relates to mortality, is the number one area of focus. The recent guidance by the agency to focus on randomized controlled trials rather than single arm trials, where major endpoints are being targeted, like mortality, give us the sort of confidence that particularly in an orphan disease indication where a single trial should be viewed as sufficient for approval or approved.

Operator (participant)

Got it. 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 Michael Okunewitch with Maxim Group.

Michael Okunewitch (Biotechnology Senior Research Analyst)

Hey, guys. Thank you so much for taking my questions today. Congrats on all the progress. I guess just to kick things off, there's obviously been a lot of changes at the FDA since you first launched the phase III in chronic lower back pain. I wanted to see if you've received confirmation from the current FDA administration that the 12-month pain only endpoint is sufficient for approval.

Silviu Itescu (CFO and Managing Director)

Yes, we have. Absolutely. That's exactly why we had the meeting recently to gain confirmation from the current administration that endpoint is an approvable endpoint, and that's exactly what we received. Moreover, the recent guidance from the FDA that a single well-conducted randomized controlled trial is sufficient for approvals in various indications also gives us great confidence that if we achieve that endpoint, this is an approvable trial and approvable endpoint.

Michael Okunewitch (Biotechnology Senior Research Analyst)

Thank you. Just one more from me, and I'll hop back into queue. I wanted to ask, when it comes to the upcoming filing in the Class 4 heart failure programs, are there any outstanding items that FDA has requested that you need to finalize before you can submit that next quarter?

Silviu Itescu (CFO and Managing Director)

Well, commercial manufacturing is always a very important component of this, that is something that we are, you know, heavily engaged in. The product rexlemestrocel-L and its phase III trials was all made at Lonza in the same facility where Ryoncil was made and which was approved for Ryoncil. We believe that the vast majority of the manufacturing process is quite similar to the Ryoncil process. I think that will be an advantage in our filing, but that remains... We need to get some more confirmation from the agency. Nonetheless, we expect that the long history of manufactured product for back pain trials, failure trials will hold us in good stead.

Michael Okunewitch (Biotechnology Senior Research Analyst)

All right. That's great to hear. Lots to look forward to up ahead. Thank you so much for taking my questions today.

Operator (participant)

That brings us to the end of today's call.

Silviu Itescu (CFO and Managing Director)

Thank you.

Operator (participant)

I'll hand back to Paul. Pease.

Paul Hughes (Head of Corporate Finance and Investor Relations)

Thank you. As you heard today, we're in a strong position with a number of significant milestones in this current second half of the approval period. We look forward to keeping you updated on the progress and the achievements. I'd like to thank everyone for their interest in Mesoblast and participation in the call today. Thank you, and have a great day.