Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 ______________________________ FORM 20-F ______________________________ o REGISTRATION STATEMENT PURSUANT TO SECTION 12(b) OR (g) OF THE SECURITIES EXCHANGE ACT OF 1934 OR x ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 o TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 OR o SHELL COMPANY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURIT ...

Core Insights - Mesoblast Limited achieved FDA approval for Ryoncil, the first FDA-approved mesenchymal stromal cell (MSC) product in the U.S., and successfully launched it for treating steroid-refractory acute graft-versus-host disease (SR-aGvHD) in pediatric patients [2][10][34] - The company aims to transform into a commercial biotechnology entity with plans for additional approved indications for Ryoncil and the launch of next-generation platform technologies targeting heart failure and chronic low back pain [2][6] Financial Highlights - Total revenue from cell therapy products reached US$17.2 million, a 191% increase from the previous year, driven by Ryoncil's launch [6][31] - Net operating cash spend was US$50.0 million, a 3% increase year-over-year, reflecting costs associated with the commercial team and product launch [6] - Cash on hand as of June 30, 2025, was US$162 million (A$247 million) [6] Product and Market Opportunities - Ryoncil has a potential annual addressable market of approximately $1 billion for pediatric and adult SR-aGvHD, with additional markets for biologic-refractory inflammatory bowel disease exceeding $5 billion, heart failure with reduced ejection fraction (HFrEF) over $10 billion, and chronic low back pain (CLBP) also exceeding $10 billion [7][35] - The company is developing Ryoncil for additional indications, including adult SR-aGvHD and inflammatory bowel disease, and has a pipeline of therapies targeting unmet medical needs [7][35] Operational Developments - Ryoncil became commercially available on March 28, 2025, shortly after FDA approval [10] - The company has expanded coverage for Ryoncil, with over 250 million U.S. lives insured and federal Medicaid coverage effective July 1, 2025 [11] - Mesoblast has onboarded 32 transplant centers and aims to onboard the top 45 centers that account for 80% of pediatric bone marrow transplants in the U.S. [11] Corporate Governance - The Board of Directors was strengthened with the appointments of Dr. Gregory George and Ms. Lyn Cobley, bringing extensive experience in medical science and financial services [30]

Mesoblast (MESO) H2 2025 Earnings Call August 28, 2025 06:30 PM ET Company ParticipantsSilviu Itescu - Founder, CEO & MDAndrew Chaponnel - Interim CFOMarcelo Santoro - Chief Commercial OfficerConference Call ParticipantsEdward Tenthoff - MD & Senior Research AnalystOlivia Brayer - Director & Senior Biotech AnalystElyse Shapiro - Senior Analyst - HealthcareMichael Okunewitch - Senior Research Analyst - BiotechnologyJohn Hester - Senior AnalystOperatorHello, and welcome to the Mesoblast Financial Results for ...

Financial Data and Key Metrics Changes - Revenue from cell therapy products increased to $17.2 million, up 191% from the prior year, driven by the successful launch of Ryoncil [12][15] - Net operating cash spend for the year was $50 million, consistent with the prior year, despite investments in commercial team build-out and product launch activities [13][15] - Cash on hand as of June 30 was $162 million [13] Business Line Data and Key Metrics Changes - Ryoncil generated $13.2 million in gross sales and $11.3 million in net sales after a 14.6% gross to net adjustment [12] - Cost of revenues related to product sales was $1.2 million, representing 10% of net product sales, resulting in a gross margin of 90% [15] - Selling, general, and administrative expenses rose to $39.3 million, an increase of $14.3 million from FY 2024, primarily due to the commercial team build-out and product launch [15] Market Data and Key Metrics Changes - The addressable market for Ryoncil in pediatric acute graft versus host disease (GVHD) is approximately $1 billion, with potential label extensions in adults and inflammatory bowel disease exceeding $5 billion [8] - The addressable market for chronic low back pain and heart failure with reduced ejection fraction is each over $10 billion [8] Company Strategy and Development Direction - The company aims to expand Ryoncil's label to include adult patients with GVHD and other inflammatory conditions, leveraging existing pediatric treatment centers [24][25] - Plans to initiate pivotal studies for Ryoncil in inflammatory bowel disease and chronic low back pain, targeting significant unmet medical needs [40][41] - The company is transitioning from an R&D-focused organization to a commercial biotech entity, emphasizing the importance of building a robust commercial infrastructure [87] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the successful launch of Ryoncil and the potential for continued revenue growth as more treatment centers are onboarded [76] - The company is focused on addressing the opioid crisis by providing alternatives for chronic pain management through its RexLemistroCell product [32] - Management highlighted the importance of FDA alignment for accelerated approval pathways and ongoing discussions regarding trial designs for heart failure and inflammatory bowel disease [77] Other Important Information - Ryoncil became commercially available on March 28, 2025, shortly after receiving FDA approval in December 2024 [10] - The company has onboarded 32 transplant centers in the U.S. and aims to reach 45 centers that account for 80% of pediatric bone marrow transplants [10][11] - Medicaid coverage for Ryoncil was mandated on July 1, expanding access to over 250 million lives in the U.S. [11][82] Q&A Session Summary Question: Timeline for adult GVHD label extension - Management expects to commence an adult acute GVHD trial this quarter, aiming to add Ryoncil on top of existing second-line agents [45][46] Question: Update on Phase III chronic lower back pain trial - Enrollment is progressing well with almost 40 sites, and management is optimistic about outcomes similar to previous trials [48][50] Question: Monthly treatment kits administered and inventory dynamics - Treatment kits are stocked based on weight bands, and inventory is replenished as children are treated [55][56] Question: Gross to net dynamics and adult GVHD trial design - Management expects gross to net adjustments to remain flat and will target patients on Jakafi for the adult trial [59][60] Question: Details on adult study and trial design - The trial will focus on patients with severe disease on Jakafi, aiming to increase responder rates significantly [64][65] Question: Timeline for inflammatory bowel disease trials - A KOL group is designing the trial, with updates expected this quarter [68] Question: Distribution of initial sales and revenue trajectory - It is too early to project future sales, but management expects continued strengthening of sales as infrastructure is built [73][76] Question: Market access progress - The company has engaged with over 97 payers, achieving coverage for over 250 million lives, with Medicaid coverage in place across all states [81][82]

mesoblast Global Leader in Allogeneic Cellular Medicines for Inflammatory Diseases Financial Results and Operational Update for the Full Year Ended June 30, 2025 August 2025 ASX: MSB; Nasdaq: MESO For personal use only CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS This presentation 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 activit ...

Company Overview - Mesoblast Limited (MESO) currently holds a Momentum Style Score of A, indicating strong momentum characteristics [2] - The company has a Zacks Rank of 2 (Buy), suggesting a favorable outlook compared to the market [3] Price Performance - MESO shares have increased by 40.59% over the past week, while the Zacks Medical - Biomedical and Genetics industry remained flat during the same period [5] - Over the past month, MESO's price change is 44.19%, significantly outperforming the industry's 6.79% [5] - In the last quarter, MESO shares rose by 28.34%, and over the past year, they gained 94.04%, compared to the S&P 500's increases of 22.7% and 15.9%, respectively [6] Trading Volume - The average 20-day trading volume for MESO is 302,528 shares, which serves as a bullish indicator when combined with rising stock prices [7] Earnings Outlook - In the past two months, one earnings estimate for MESO has been revised upward, while none have been revised downward, improving the consensus estimate from -$0.45 to -$0.36 [9] - For the next fiscal year, one estimate has also moved upwards with no downward revisions [9] Conclusion - Considering the strong momentum indicators and positive earnings outlook, MESO is positioned as a 2 (Buy) stock with a Momentum Score of A, making it a potential candidate for near-term investment [11]

Core Insights - Mesoblast Ltd's shares surged nearly 38% following the successful commercial launch of its FDA-approved treatment, Ryoncil®, for steroid-refractory acute graft-versus-host disease (SR-aGvHD) in children, with gross revenue of US$13.2 million reported for the first quarter post-launch [1][2] Financial Performance - The company reported a strong financial foundation with US$162 million (A$247 million) in cash at the end of the quarter, positioning it for continued expansion [3] - Mesoblast received US$1.6 million in royalties from the sale of TEMCELL® HS Inj. in Japan through its licensing agreement [3] Regulatory Exclusivity - Ryoncil® received seven years of orphan-drug exclusivity from the FDA for SR-aGvHD in pediatric patients, protecting it from competition in the US market during that period [4] - The company holds biologic exclusivity preventing competitors from referencing Ryoncil®'s biologic license application (BLA) until December 2036, effectively barring biosimilars from entering the market for more than a decade [4] Commercial Launch and Market Coverage - The company has onboarded more than 25 transplant centers, with plans to complete onboarding at 45 priority centers this quarter [6] - Ryoncil® is now insured for more than 250 million US lives through both commercial and government payers, including federal Medicaid, effective from July 1 [6] Future Expansion Plans - Mesoblast is focused on expanding the use of Ryoncil® in adults with SR-aGvHD and has met with the FDA to discuss a pivotal trial for this population [7] - The company is also advancing its second-generation allogeneic MSC therapy, rexlemestrocel-L, for chronic inflammatory diseases, with recent meetings aligning the company and regulators on the pathway to filing for biologics license approval (BLA) [8] Market Reaction - Despite a promising week, investor sentiment has moderated, with shares trading at A$2.32, down 3.73% from Friday highs [9] - The company's long-term prospects remain strong, supported by Ryoncil®'s commercial launch and a robust cash position as it enters the next growth phase [9][10]

Core Viewpoint - Mesoblast Limited has reported strong initial sales of its FDA-approved product Ryoncil, generating gross revenue of US$13.2 million from March 28 to June 30, 2025, following its launch for treating steroid-refractory acute graft-versus-host disease in pediatric patients [1][6][10]. Financial Highlights - Gross revenue from Ryoncil sales reached US$13.2 million (unaudited) from March 28 to June 30, 2025 [6]. - The company reported US$1.6 million in revenue from royalties on sales of TEMCELL HS Inj. in Japan [6]. - Net operating cash spend for the quarter was US$16.6 million [6]. - Cash on hand as of June 30, 2025, was US$162 million (A$247 million) [6]. Operational Highlights - More than 25 transplant centers have been onboarded since the product launch, with plans to complete onboarding across all 45 priority centers that account for approximately 80% of U.S. pediatric transplants [6]. - Ryoncil's coverage is expanding, with over 250 million U.S. lives insured by commercial and government payers, and mandatory Medicaid coverage effective July 1 [6]. - A patient access hub, MyMesoblast™, has been established to assist patients with insurance coverage and access to Ryoncil [6]. Regulatory and Exclusivity Status - Ryoncil received seven years of orphan-drug exclusive approval from the FDA for treating SR-aGvHD in pediatric patients aged 2 months and older [6]. - Mesoblast holds biologic exclusivity preventing another sponsor from referencing Ryoncil's biologic license application until December 2036 [6]. - The company has a strong U.S. intellectual property position on MSC technology, providing commercial barriers to entry against competitors through 2044 [6][12]. Future Developments - Mesoblast held a Type B meeting with the FDA to discuss a pivotal trial for Ryoncil in adults with SR-aGvHD, aiming to extend the product's label [6].

Core Insights - Mesoblast is making progress with the FDA regarding the accelerated approval pathway for Revascor and label extension for Ryoncil [1][2][3] Group 1: FDA Interactions and Approvals - A Type B meeting was held with the FDA to discuss the potential filing for a Biologics License Application (BLA) for Revascor, with alignment on key components [2] - An upcoming meeting with the FDA is scheduled to discuss a pivotal trial of Ryoncil in adults with steroid refractory acute graft versus host disease (SR-aGvHD) [3] Group 2: Commercial Launch and Market Coverage - Ryoncil became commercially available in the U.S. on March 28, 2025, with over 20 transplant centers onboarded by the end of the quarter, exceeding expectations [4] - The company has expanded Ryoncil's coverage to over 220 million U.S. lives insured, with 37 of 51 states providing Medicaid coverage [4] Group 3: Company Overview and Future Developments - Mesoblast is a leader in developing allogeneic cellular medicines for severe inflammatory conditions, utilizing proprietary mesenchymal lineage cell therapy technology [6][8] - The company is committed to developing additional cell therapies for various indications, including inflammatory bowel disease and chronic low back pain [8]

Core Insights - Mesoblast has received seven years of orphan-drug exclusive approval from the FDA for Ryoncil (remestemcel-L) to treat steroid-refractory acute graft versus host disease (SR-aGvHD) in pediatric patients aged 2 months and older [1][5] - The FDA's approval grants Mesoblast statutory exclusivity, preventing the approval of other mesenchymal stromal or stem cell products for this indication during the exclusivity period [2] - Mesoblast holds biologic exclusivity that prevents other sponsors from referencing the Ryoncil biologic license application until December 2036, providing a barrier against biosimilar market entry [2] - The company has a strong U.S. intellectual property position on MSC composition, manufacturing, and indications, providing commercial protection against competitors through 2044 [3][7] Company Overview - Mesoblast is a leader in developing allogeneic cellular medicines for severe inflammatory conditions, utilizing proprietary mesenchymal lineage cell therapy technology [4] - Ryoncil is the first FDA-approved MSC therapy for SR-aGvHD in pediatric patients [5] - The company is also developing additional cell therapies for other inflammatory diseases and has established commercial partnerships in Japan, Europe, and China [6] Intellectual Property and Manufacturing - Mesoblast has over 1,000 granted patents or patent applications covering various aspects of MSC technology, expected to provide commercial protection through at least 2044 [7] - The company's proprietary manufacturing processes yield industrial-scale, cryopreserved, off-the-shelf cellular medicines, ensuring availability to patients worldwide [8]