Louise Chen

Edward Tenthoff

John Hester

Sami Corwin

Elyse Shapiro

Michael Okunewitch

Olivia Brayer

- Mesoblast Limited achieved **FDA approval** for its lead product **Ryoncil®** (remestemcel-L-rknd) in **December 2024** for pediatric steroid-refractory acute graft-versus-host disease (SR-aGvHD), marking its transition to a commercial organization.  **[1345099_0001345099-25-000090_exhibit991annualreportno.htm:0]** **[1345099_0001345099-25-000090_exhibit991annualreportno.htm:196]** 
- The commercial launch of Ryoncil® in the US, which began **March 28, 2025**, generated **US$11.3 million in net sales** for the fiscal year ended June 30, 2025.  **[1345099_0001345099-25-000090_exhibit991annualreportno.htm:5]** **[1345099_0001345099-25-000090_exhibit991annualreportno.htm:159]** **[1345099_0001345099-25-000090_exhibit991annualreportno.htm:196]**  Total revenue for FY 2025 increased **191%** to **US$17.2 million** compared to the prior year.  **[1345099_0001345099-25-000090_exhibit991annualreportno.htm:5]** **[1345099_0001345099-25-000090_exhibit991annualreportno.htm:159]** **[1345099_0001345099-25-000090_exhibit991annualreportno.htm:196]** 
- The company reported strong sales momentum, with gross sales for the first quarter of fiscal year 2026 reaching **US$21.9 million**, a **66% increase** compared to the quarter ended June 30, 2025.  **[1345099_0001345099-25-000090_exhibit991annualreportno.htm:5]** 
- Mesoblast strengthened its financial position with a **US$161 million capital raise** in **January 2025** and held **US$162 million in cash on hand** as of June 30, 2025.  **[1345099_0001345099-25-000090_exhibit991annualreportno.htm:5]** **[1345099_0001345099-25-000090_exhibit991annualreportno.htm:196]**

Mesoblast Reports FDA Approval and Strong Initial Ryoncil Sales

- **Mesoblast Limited** reported **revenue from cell therapy products of US$20.6 million** for the quarter ended September 30, 2025, with **Ryoncil® net sales increasing 69%** to **US$19.1 million** compared to the previous quarter.  **[1345099_0001345099-25-000088_exhibit991q1fy26appendix.htm:0]** 
- The company had **US$145 million in cash on hand** as of September 30, 2025, and an estimated **9.7 quarters of funding available** based on its **US$14.9 million net operating cash spend** for the quarter.  **[1345099_0001345099-25-000088_exhibit991q1fy26appendix.htm:0]** **[1345099_0001345099-25-000088_exhibit991q1fy26appendix.htm:7]** 
- A permanent **J-Code (J3402) was assigned to Ryoncil®** by the Centers for Medicare and Medicaid Services (CMS), which became active on October 1, 2025, to facilitate billing and reimbursement.  **[1345099_0001345099-25-000088_exhibit991q1fy26appendix.htm:0]** 
- Mesoblast entered into convertible note subscription agreements for up to **US$50.0 million** of unsecured convertible notes, pending shareholder approval, and had an outstanding loan balance of **US$41.7 million** with Oaktree Capital Management, Inc. as of September 30, 2025.  **[1345099_0001345099-25-000088_exhibit991q1fy26appendix.htm:0]** **[1345099_0001345099-25-000088_exhibit991q1fy26appendix.htm:6]**

Mesoblast Reports Q1 FY26 Financial and Operational Highlights

- Mesoblast Limited announced **gross revenue of US$21.9 million** from Ryoncil® sales for the quarter ended September 30, 2025.  **[1345099_0001345099-25-000084_exhibit991ryoncilsalesup.htm:0]** 
- This represents a **66% increase** in Ryoncil® revenue compared to the prior quarter ended June 30, 2025.  **[1345099_0001345099-25-000084_exhibit991ryoncilsalesup.htm:0]** 
- The company expects further adoption of Ryoncil® following the **permanent J-Code assigned by Centers for Medicare and Medicaid Services (CMS)**, which became active on October 1.  **[1345099_0001345099-25-000084_exhibit991ryoncilsalesup.htm:0]**

Mesoblast reports Q1 2026 Ryoncil® revenue increase

- Mesoblast Limited announced that its product, **Ryoncil® (remestemcel-L-rknd)**, received a specific Healthcare Common Procedure Coding System (HCPCS) **J-Code (J3402)** from United States Medicare & Medicaid Services (CMS).  **[1345099_0001345099-25-000081_exhibit991ryoncilcmsj-co.htm:0]** 
- The new permanent J-Code became active for billing and reimbursement on **October 1, 2025**, establishing a standardized billing pathway for Medicaid and influencing commercial payers.  **[1345099_0001345099-25-000081_exhibit991ryoncilcmsj-co.htm:0]** 
- This development is considered a **critical element for successful commercialization** of Ryoncil®, facilitating reimbursement and broader patient access for children with life-threatening steroid-refractory acute graft-versus-host disease (SR-aGvHD).  **[1345099_0001345099-25-000081_exhibit991ryoncilcmsj-co.htm:0]**

Mesoblast's Ryoncil® Receives J-Code from CMS

- Mesoblast Limited announced on **September 26, 2025**, that its allogeneic cell therapy products, including **Ryoncil® (remestemcel-L)**, are designated as **U.S. origin** and are **not subject to tariffs** on imported branded or patented pharmaceutical products.  **[1345099_0001345099-25-000079_a2025-09x29productsnotsubj.htm:0]** **[1345099_0001345099-25-000079_exhibit991.htm:0]** 
- **Ryoncil®** is the **only allogeneic mesenchymal stromal cell therapy approved by the U.S. FDA** for any indication, specifically for the treatment of **pediatric patients 2 months and older** with steroid-refractory acute graft versus host disease (SR-aGvHD).  **[1345099_0001345099-25-000079_exhibit991.htm:0]** 
- The company ensures all its products are manufactured from **U.S. donors at U.S. sites**.  **[1345099_0001345099-25-000079_exhibit991.htm:0]** 
- Mesoblast holds a global intellectual property portfolio with **over 1,000 granted patents or patent applications**, providing commercial protection extending to **at least 2041** in major markets.  **[1345099_0001345099-25-000079_exhibit991.htm:0]**

Mesoblast confirms U.S. origin status for cell therapy products, exempting them from tariffs

- Mesoblast Limited announced the **successful commercial launch of Ryoncil® (remestemcel-L-rknd)**, the only FDA-approved mesenchymal stromal cell product, for pediatric steroid-refractory acute graft versus host disease (SR-aGvHD).  **[1345099_0001345099-25-000076_exhibit991successfulcomm.htm:0]** 
- The company reported **strong first quarter product sales** for Ryoncil® and is focused on onboarding new sites and increasing product usage.  **[1345099_0001345099-25-000076_exhibit991successfulcomm.htm:0]** 
- Mesoblast plans to **expand Ryoncil® into additional indications**, including adult SR-aGvHD and inflammatory bowel disease (IBD), and highlighted key Phase 3 milestones for its second-generation product, Rexlemestrocel-L.  **[1345099_0001345099-25-000076_exhibit991successfulcomm.htm:0]**

Mesoblast Highlights Successful Ryoncil® Commercial Launch and Expansion Plans

- Mesoblast reported **revenue from cell therapy products of US$17.2 million** for the full year ended June 30, 2025, representing a **191% increase** over the prior year, primarily driven by the successful commercial launch of **Ryoncil®**.  **[1345099_0001345099-25-000068_exhibit991.htm:0]** **[1345099_0001345099-25-000068_exhibit992.htm:7]** **[1345099_0001345099-25-000068_exhibit991.htm:4]** 
- The company recorded a **net loss after tax of US$102.1 million** for FY2025, with a **net loss attributable to ordinary shareholders of 8.46 US cents per share**.  **[1345099_0001345099-25-000068_exhibit991.htm:4]** **[1345099_0001345099-25-000068_exhibit991.htm:8]** 
- **Ryoncil®**, the first and only FDA-approved mesenchymal stromal cell product, became commercially available on **March 28, 2025**, for the treatment of steroid-refractory acute graft-versus-host disease (SR-aGvHD) in pediatric patients.  **[1345099_0001345099-25-000068_exhibit991.htm:0]** **[1345099_0001345099-25-000068_exhibit991.htm:1]** **[1345099_0001345099-25-000068_exhibit992.htm:4]** 
- As of June 30, 2025, Mesoblast had **US$162 million in cash on hand**.  **[1345099_0001345099-25-000068_exhibit991.htm:0]** **[1345099_0001345099-25-000068_exhibit992.htm:7]** 
- The company is pursuing label expansion for Ryoncil® in adults with severe SR-aGvHD and inflammatory colitis, and plans Biologics License Application (BLA) submissions for **Revascor®** in end-stage heart failure and **Rexlemestrocel-L** for chronic low back pain.  **[1345099_0001345099-25-000068_exhibit991.htm:1]** **[1345099_0001345099-25-000068_exhibit991.htm:2]**

MESOBLAST (MESO)