Mesoblast Limited

Hello and welcome to the Mesoblast financial results for the full year ended June 30, 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 a 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 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 like to turn the call over to Dr. Silvio Itescu, Chief Executive of Mesoblast. Please go ahead.

Good afternoon. Good morning to the Mesoblast Financial Results and Operational Update for the full year ended June 30th, 2025. My name is Silvio Itescu. I'm Chief Executive of Mesoblast. On the line with me are Andrew Chaponelle, our Interim Chief Financial Officer, and Marcello Santoro, our Chief commercial officer. We can go to slide four, please. This slide is a snapshot of our company profile. VisaBlast has an FDA-approved product, Rioncil, which is the first and only FDA-approved mesenchymal stromal cell in the United States. We have over 1,100 patents and patent applications globally. for our platform technology. We have two additional assets in phase three trials. We have FDA commercial scale manufacturing capabilities, and we've built out a US commercial organization. Next slide, please. Our platform technology is based on a shared mechanism of action across all of our products. Our mesenchymal lineage stromal cells respond to and are activated by multiple inflammatory cytokines through surface receptors on these cells, which result in orchestration of an anti-inflammatory cascade as a result of multiple factors that the mesenchymal stromal cells secrete. That's the basis for our products, which address major diseases of inflammation. Next slide, please. On this slide is a snapshot of our the Zancamil stromal cell product portfolio. We have two platform technologies. One is called RemiStemCell, our first-generation technology, and our second-generation technology, which is called RexLemiStroCell. Bryoncil, a branded product approved for pediatric steroid refractory acute graft-versus-host disease and launched in the past quarter, is a lead product on the RemiStemCell platform technology. It is also being developed for adult steroid refractory acute graft-based host disease and inflammatory bowel disease. The RexlimiStrem StroCell platform technology, which uses monoclonal antibodies to isolate a purer, more homogeneous cell population, is in Phase III in two large areas, inflammatory chronic heart failure and chronic low back pain. due to inflammation of the intervertebral discs. More about that later. Next slide, please. This slide identifies the addressable annual market opportunity for our product portfolio. Rioncil, the first mesenchymal stromal cell MSC therapy approved by the FDA, is on the market, has been launched for treatment of children with acute GVHD and with the potential for a label extension in adults with acute GVHD of high severity. This addressable market is approximately $1 billion. Biologic refractory inflammatory bowel disease, which represents an extension of the label opportunity, has more than $5 billion in an addressable market. Heart failure with reduced ejection fraction for our Rexlamy stro-cell product has a more than $10 billion addressable market. Chronic low back pain is similarly positioned for more than $10 billion as an annual market opportunity. And of course, we have multiple additional multi-billion opportunities from existing future product pipeline based on our technology platforms. Next slide, please. We're very pleased with a successful commercial launch to date of Rioncil. In December 2024, Rioncil became the first and only FDA-approved MSC product in the United States. Rioncel became commercially available for purchase March 28, 2025, within a quarter of receiving FDA approval. Since launch, we've onboarded 32 transplant centers across the United States. We aim to, by the end of this quarter, have onboarded the top 45 centers that account for 80% of pediatric bone marrow transplants in the United States. Coverage for Rioncel continues to expand, with over 250 million lives in the U.S., insured by commercial and government payers. Importantly, Medicaid coverage exists for both federal and all states and it was mandated on July 1 of this year. Next slide, please. Now I'd like to move to our financial results. The period ended June 30, 2025. Next slide. Financial highlights for this year are as follows. Revenue from self-therapy products was $17.2 million, up 191% on the prior year. We're delighted that this growth in revenue was driven by the successful launch of Rioncel in the final quarter of the year, with $13.2 million in gross sales and $11.3 million in reported net sales, after a 14.6% gross to net adjustment. Net operating cash spent for the year was $50 million, very similar to the prior year, and this is despite the fact that we've invested in costs related to the commercial team build-out and activities around product launch. Our cash on hand as of June 30th was $162 million US or $247 million Australian. Now I'd like to have Andrew take us through some details on the financial results.

Thanks, Phil. Next slide. Turning to slide 11, we have the financial results for the year ended June 30, 2025. All numbers are reported in US dollars. Total revenues on self-therapy products are up 191% on the prior year. Cost of revenues related to product sales for $1.2 million, which is 10% of net product sales and a gross margin of 90%. Additionally, cost of revenues also included $3.9 million of expenses related to non-cash amortisation of the intangible value of our prior MSC asset acquisition. Selling general and admin expenses were $39.3 million for FY2025, an increase of $14.3 million on FY2024. This increase related to our commercial team build and product launch. For revaluation of contingent consideration, we recognise the loss of $14.9 million in FY2025, a non-cash revaluation of potential future third-party payments. The re-evaluation of warrant liability as a result of FDA approval of RIONCIL and the consequential share price appreciation resulted in us recognising a warrant re-measurement loss of $5 million in FY2025 compared to a gain of $0.8 million for FY2024. Back to you, Sylvie.