Core Insights - Mesoblast Limited has successfully launched Ryoncil, the first FDA-approved mesenchymal stromal cell (MSC) therapy for steroid-refractory acute graft versus host disease (SR-aGvHD) in pediatric patients [1][5] - The company aims to expand Ryoncil's applications to adult SR-aGvHD and inflammatory bowel disease (IBD), alongside advancing its second-generation product, Rexlemestrocel-L [3][6] Company Overview - Mesoblast is a leader in developing allogeneic cellular medicines targeting severe inflammatory conditions, utilizing a proprietary mesenchymal lineage cell therapy technology platform [4] - The company has a robust intellectual property portfolio with over 1,000 patents or applications, providing commercial protection until at least 2041 in major markets [7] Product Development - Ryoncil is currently being developed for additional indications, including adult SR-aGvHD and biologic-resistant IBD, while Rexlemestrocel-L is focused on heart failure and chronic low back pain [6] - The company is actively working to onboard new sites and increase the usage of Ryoncil [2] Manufacturing and Distribution - Mesoblast's proprietary manufacturing processes allow for industrial-scale production of cryopreserved, off-the-shelf cellular medicines, ensuring availability for patients worldwide [8]

Core Viewpoint - Mesoblast Limited has announced a plan to issue up to US$50 million in unsecured convertible notes to support its capital structure and ongoing pipeline growth opportunities, subject to shareholder approval [1][2]. Group 1: Convertible Notes Details - The company may issue the convertible notes in tranches of US$10 million, with a maturity date of 5 years after the first issuance [2]. - The conversion price is set at US$16.25 per ADR, which is a 126% premium over the last closing price on Nasdaq and a 29% premium on the ASX [3]. - The notes will carry a coupon of 5% per annum on the face value [3]. Group 2: Investor Considerations - Investors will receive a commitment fee of US$100,000 and warrants for 2 million ordinary shares upon entering the agreement, with additional warrants for 3 million shares if the option is exercised [4]. - The warrants will have the same exercise price as the conversion price and a maturity date of 4 years from the issuance date [4]. Group 3: Company Overview - Mesoblast is a leader in developing allogeneic cellular medicines for severe inflammatory conditions, utilizing a proprietary mesenchymal lineage cell therapy technology platform [6]. - The company has FDA-approved therapies, including Ryoncil for treating steroid-refractory acute graft versus host disease in pediatric patients [7]. - Mesoblast is also developing additional therapies for various inflammatory diseases and has established commercial partnerships in multiple regions [8]. Group 4: Intellectual Property and Manufacturing - Mesoblast holds over 1,000 granted patents or applications related to its cell therapy technologies, providing commercial protection expected to last until at least 2041 in major markets [9]. - The company has proprietary manufacturing processes that yield industrial-scale, cryopreserved cellular medicines, ensuring availability to patients worldwide [10].

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]

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 [15] Market Data and Key Metrics Changes - The addressable market for Ryoncil in pediatric acute graft versus host disease (GVHD) is significant, with potential label extensions in adult populations and other inflammatory diseases [9][10] - The addressable market for heart failure with reduced ejection fraction and chronic low back pain is estimated to exceed $10 billion each [9] 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 are underway, targeting significant unmet medical needs [41][42] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the commercial launch of Ryoncil and its potential to transform the company from an R&D-focused entity to a commercial biotech organization [87] - The company is focused on building a robust commercial infrastructure to support ongoing sales growth and market access [76][82] 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] Q&A Session Summary Question: Timeline for adult GVHD label extension - Management expects to commence an adult acute GVHD trial this quarter, working with the NIH-funded Bone Marrow Transplant Clinical Trials Network [46][48] Question: Progress on Phase III chronic lower back pain trial - Enrollment is ongoing with nearly 40 sites, and management is optimistic about achieving similar outcomes as in previous trials [50][51] Question: Monthly treatment kits administered and inventory dynamics - Treatment kits are stocked based on weight bands, with replenishment occurring as children are treated [56][57] Question: Gross to net dynamics and adult GVHD trial design - Management expects gross to net adjustments to remain flat and plans to include patients on Jakafi in the adult trial to maximize market potential [59][60] Question: Details on adult study and trial design - The FDA is aligned with the company on trial design, focusing on early intervention in severe adult populations [64][66] Question: Timeline for inflammatory bowel disease trials - A KOL group is designing the trial, with plans to use both local and intravenous delivery methods [68] 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 [82][83]

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]

Financial Performance - Revenue from cell therapy products reached US$172 million, a 191% increase compared to the previous year[30] - Ryoncil's successful launch contributed US$132 million in gross sales and US$113 million in reported net sales after a 146% gross to net adjustment[30] - Net operating cash spend was US$50 million, a 3% increase on prior year[30] - Cash on hand at June 30, 2025, was US$162 million (A$247 million)[30] Ryoncil (remestemcel-L) - Ryoncil became the first FDA-approved MSC product in the US in December 2024 and commercially available on March 28, 2025[24] - The company onboarded 32 US transplant centers, aiming for the top 45 centers (80% of pediatric bone marrow transplants) by the end of the quarter[24] - Ryoncil demonstrated a 70% overall response rate at Day 28 in a Phase 3 trial for SR-aGvHD[41,43] - In children from GVHD001 trial, 49% survival at Year 4, with only 14% (N=7) died due to aGvHD through 4 years[44] Market Opportunities - Steroid-refractory acute GvHD for children & adults represents a ~US$1 billion market[21] - Biologic-refractory inflammatory bowel disease represents a >US$5 billion market[21] - Heart failure with reduced ejection fraction (HFrEF) represents a >US$10 billion market[21] - Chronic low back pain (CLBP) represents a >US$10 billion market[21]

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].