Mesoblast (MESO)
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Mesoblast Cell Therapy Products are Designated U.S. Origin and Not Subject to Tariffs
Globenewswire· 2025-09-26 05:49
Core Insights - Mesoblast Limited is a global leader in allogeneic cellular medicines for inflammatory diseases, emphasizing that its products are manufactured from U.S. donors and are not subject to tariffs on imported pharmaceutical products [1][3][6] Company Overview - Mesoblast specializes in developing allogeneic (off-the-shelf) cellular medicines aimed at treating severe inflammatory conditions, utilizing proprietary mesenchymal lineage cell therapy technology [4][6] - The company has a strong intellectual property portfolio with over 1,000 granted patents or applications, providing commercial protection expected to last until at least 2041 in major markets [7] Product Information - Ryoncil® (remestemcel-L) is the only FDA-approved allogeneic mesenchymal stromal cell therapy for steroid-refractory acute graft versus host disease (SR-aGvHD) in pediatric patients aged 2 months and older [2][5] - The company is developing Ryoncil® for additional indications, including SR-aGvHD in adults and biologic-resistant inflammatory bowel disease, while rexlemestrocel-L is being developed for heart failure and chronic low back pain [6] Manufacturing and Distribution - Mesoblast's proprietary manufacturing processes yield industrial-scale, cryopreserved, off-the-shelf cellular medicines, which are planned to be readily available to patients worldwide [8] - The company operates in Australia, the United States, and Singapore, and is listed on both the Australian Securities Exchange and Nasdaq [9]
Mesoblast Cell Therapy Products are Designated U.S. Origin and Not Subject to Tariffs
Globenewswire· 2025-09-26 05:49
Core Insights - Mesoblast Limited is a global leader in allogeneic cellular medicines for inflammatory diseases, emphasizing that its products are manufactured from U.S. donors and are not subject to tariffs on imported pharmaceutical products [1][2]. Company Overview - Mesoblast specializes in developing allogeneic (off-the-shelf) cellular medicines aimed at treating severe and life-threatening inflammatory conditions, utilizing proprietary mesenchymal lineage cell therapy technology [4]. - The company has a strong intellectual property portfolio with over 1,000 granted patents or applications, providing commercial protection expected to last until at least 2041 in major markets [7]. Product Information - Ryoncil (remestemcel-L) is the only FDA-approved allogeneic mesenchymal stromal cell therapy for any indication, specifically for pediatric patients with steroid-refractory acute graft versus host disease (SR-aGvHD) [2][5]. - Ryoncil is also being developed for additional inflammatory diseases, including SR-aGvHD in adults and biologic-resistant inflammatory bowel disease, while another product, rexlemestrocel-L, targets heart failure and chronic low back pain [6]. Manufacturing and Distribution - Mesoblast's manufacturing processes yield industrial-scale, cryopreserved, off-the-shelf cellular medicines, ensuring availability to patients worldwide [8]. - The company operates in Australia, the United States, and Singapore, and is listed on both the Australian Securities Exchange and Nasdaq [9].
Successful Commercial Launch of Ryoncil® Highlighted at Global Healthcare Conferences
Globenewswire· 2025-09-15 01:18
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]
Mesoblast Enters Into Option To Issue US$50 Million Convertible Notes
Globenewswire· 2025-09-04 01:47
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].
Mesoblast (MESO) - 2025 Q4 - Annual Report
2025-08-29 10:58
mesoblast Exhibit 99.2 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; Nasdag: MESO CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS this presentation includes forward-looking statements that relate to future events or our future financial performance and involve rids, uncertainties and other factors tha cesults, levels of activity, performance or activements to differ materially ...
Mesoblast (MESO) - 2025 Q4 - Annual Report
2025-08-29 10:22
Financial Performance - As of June 30, 2025, the company held total cash reserves of $161.6 million, with net cash usage for operating activities reported at $50.0 million for the year[534]. - Since the launch of Ryoncil in late March 2025, the company achieved net product sales of $11.3 million through June 30, 2025[534]. - Net cash outflows in operating activities increased by $1.5 million from $48.5 million in 2024 to $50.0 million in 2025, attributed to a decrease in cash inflows[536]. - The company reported net cash inflows from financing activities of $147.3 million for the year ended June 30, 2025, an increase of $107.1 million compared to the previous year[540]. - Revenue for FY2025 was US$17.2 million, representing a 191% increase compared to US$5.9 million in FY2024[620]. - The company reported a loss before income tax of US$101.8 million for FY2025, compared to US$88.1 million in FY2024[620]. Product Development and Regulatory Approvals - The company anticipates continued losses in the foreseeable future as it develops and seeks regulatory approvals for its cell-based product candidates, including Ryoncil[543]. - FDA approved Ryoncil in December 2024, marking it as the first mesenchymal stromal cell therapy approved in the U.S. for children aged 2 months and older with SR-aGvHD[572]. - Mesoblast aligned with the FDA on key items for filing a Biologics License Application for Revascor, targeting ischemic heart failure with reduced ejection fraction[575]. - The confirmatory Phase 3 trial of rexlemestrocel-L commenced, with 37 sites enrolling patients across the United States[625]. - The CHF program gained alignment with the US FDA in June 2025 for filing a BLA for Revascor, targeting patients with ischemic heart failure[626]. Executive Leadership and Governance - Joseph Swedish served as Chairman, President, and CEO of Anthem, Inc., growing membership by 4 million (11%) and increasing operating revenue by 39% to over $89 billion during his tenure[555]. - Dr. Eric Rose played a key role in obtaining FDA approval for TPOXX, securing contracts for 1.7 million courses valued at over $1 billion for the Strategic National Stockpile[560]. - Silviu Itescu has been CEO since 2011, with a background in stem cell biology and significant contributions to adult stem cell therapy[559]. - Andrew Chaponnel has 25 years of finance experience, including 13 years at Mesoblast, overseeing NASDAQ IPO and financial reporting[562]. - The board consists of seven members, including five non-executive directors and two executive directors[711]. Employee and Remuneration Policies - Approximately 97% of employees opted for stock options instead of cash for short-term incentives, conserving approximately $6.7 million in cash[576]. - The CEO's remuneration was adjusted, with the maximum short-term incentive increased from 50% to 100% of base salary, while long-term incentives were reduced from 200% to 100% of base salary[584]. - The total statutory remuneration for the CEO in FY25 was A$8,448,247, with 82% being performance-based remuneration[641]. - The total statutory remuneration for the CMO in FY25 was A$4,619,202, with 85% being performance-based remuneration[641]. - The company’s CEO and CMO voluntarily reduced their base salaries by 30% for a 12-month period ending August 31, 2025, in exchange for an option grant approved by shareholders[645]. Shareholder and Market Performance - Total Shareholder Return (TSR) for the year was 68%[575]. - The share price of Mesoblast (ASX:MSB) closed at A$1.66 on June 30, 2025, up 88% from A$0.99 in 2024[620]. - Mesoblast raised US$160 million in January 2025 to strengthen its balance sheet for the commercial launch and ongoing R&D[621]. - The company was added to the Nasdaq Biotechnology Index in December 2024 as part of the annual reconstitution[622]. Risk Management and Compliance - The company has adopted a risk management policy to identify and control material risks associated with its business operations[722]. - The Audit and Risk Committee oversees various auditing and accounting matters, including the selection of independent accountants and the scope of annual audits[718]. - The company follows ASIC guidelines for rounding amounts in financial reports, rounding to the nearest thousand dollars or dollar[709]. - The auditor's independence declaration for the year ended June 30, 2025, is included in the annual report[708]. Employee Structure and Growth - As of June 30, 2025, the company had 81 employees globally, an increase from 73 in 2024, with 62% based in the United States[689]. - The breakdown of employees by category shows 41 in Research & Development, 2 in Commercial, 15 in Manufacturing, and 23 in Corporate[723]. - The majority of employees (27%) are based in Australia, where the corporate headquarters is located[691].
Banner Year for Mesoblast With First FDA Product Approval and Successful Commercial Launch of Ryoncil®
Globenewswire· 2025-08-29 00:24
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) - 2025 Q4 - Earnings Call Transcript
2025-08-28 23:32
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]
Mesoblast (MESO) - 2025 Q4 - Earnings Call Transcript
2025-08-28 23:30
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 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 (MESO) - 2025 H2 - Earnings Call Presentation
2025-08-28 22:30
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]