Mesoblast Limited (MESO): Business Model Canvas [Dec-2025 Updated]

You're trying to map out exactly how Mesoblast Limited is turning its breakthrough science into dollars, especially now that Ryoncil® is on the market. Honestly, this business model is a classic biotech pivot: you have a rare, first-and-only FDA-approved product for a specific pediatric condition driving initial sales-think US$11.3 million in net sales for FY2025-but that revenue is currently dwarfed by the significant investment needed to push Rexlemestrocel-L through Phase 3 trials. We need to look closely at their over 1,000 granted patents protecting this platform through 2044 and how their US$162 million cash position (as of June 30, 2025) supports the high R&D costs while they scale that specialized US sales force. Dive in below to see the full nine blocks detailing this high-stakes commercialization strategy.

Mesoblast Limited (MESO) - Canvas Business Model: Key Partnerships

You're mapping out Mesoblast Limited's strategic backbone, and honestly, the key partnerships are where the commercialization engine gets its fuel. These alliances de-risk development and provide the necessary scale for a company dealing with complex, industrial-scale cell therapies. Here's the breakdown of the critical relationships as of late 2025.

The manufacturing relationship with Lonza Group is foundational for long-term supply. This alliance covers clinical and long-term commercial production of Mesoblast Limited's off-the-shelf cell products. Lonza is committed for the long run, and the agreement provides for expansion of Lonza's Singapore cGMP facilities if needed to meet global demand projections. Furthermore, the partnership incorporates Lonza's intellectual property to drive down manufacturing costs and enable development of enhanced second-generation products, aiming for significant increases in yields and efficiencies. This manufacturing security is backed by Mesoblast Limited's intellectual property portfolio, which has commercial protection extending through to at least 2044 in all major markets.

For the crucial adult severe acute graft versus host disease (aGvHD) indication, the collaboration with the NIH-funded Blood and Marrow Transplant Clinical Trials Network (BMT CTN) is a major strategic move. This partnership is significant because the BMT CTN represents U.S. centers responsible for performing approximately 80% of all U.S. allogeneic bone marrow transplants. The pivotal trial for Ryoncil® in adults with steroid-refractory aGvHD (SR-aGvHD) is set to submit its protocol to the FDA to begin enrollment in the first quarter of 2026. This trial targets a population with poor outcomes; for Grade III/IV SR-aGvHD, up to 58% of adults treated with ruxolitinib did not respond by Day 28, and survival for those failing ruxolitinib can be as low as 20-30% by Day 100. Early data from Mesoblast Limited's Expanded Access Program showed a more encouraging 76% survival at Day 100 for similar patients, suggesting a major unmet need that this trial aims to address. The adult market opportunity is noted as being 3-4 times larger than the existing pediatric market.

Geographic expansion relies heavily on established licensees, like JCR Pharmaceuticals Co. Ltd. in Japan. JCR commercializes TEMCELL® (remestemcel-L) for SR-aGvHD in Japan, and Mesoblast Limited receives royalties on those sales across all licensed indications. This partnership has also been expanded beyond aGVHD to include treatment for neonatal hypoxic ischemic encephalopathy (HIE), a condition occurring in about 2.5 per 1,000 live births. The global reach is further cemented by the fact that Mesoblast Limited has established commercial partnerships covering Europe and China, in addition to Japan.

Here is a quick look at the structure of these key external relationships:

Partner Entity	Primary Role/Product Focus	Key Metric/Scope
Lonza Group	Long-term commercial manufacturing capacity for allogeneic cell therapies	Expansion of Singapore cGMP facilities; IP utilization targeting increased yields and efficiencies
NIH-funded BMT CTN	Pivotal Phase 3 trial for Ryoncil® in adult SR-aGvHD	BMT CTN represents 80% of U.S. allogeneic BMT centers; Enrollment targeted for Q1 2026
JCR Pharmaceuticals Co. Ltd.	Commercialization of TEMCELL® in Japan (SR-aGvHD and HIE)	Mesoblast Limited receives royalties on sales; HIE affects 2.5 per 1,000 live births
Commercial Partners (Europe/China)	Market access and distribution for approved/pending products	Established partnerships covering Europe and China markets

The reliance on these partners means Mesoblast Limited's near-term success hinges on their execution, defintely. For instance, the success of the adult aGvHD trial will be measured against the current standard of care, where ruxolitinib shows only 20-30% survival at Day 100 in refractory patients. The exchange rate context for any potential milestone payments or royalties, based on the June 30, 2025 rate, was 1A$:0.655US$.

You should track the BMT CTN trial enrollment progress closely. Finance: draft the Q1 2026 cash flow projection incorporating potential milestone triggers by next Tuesday.

Mesoblast Limited (MESO) - Canvas Business Model: Key Activities

You're looking at the core engine driving Mesoblast Limited right now, which is all about turning that FDA approval into real revenue while pushing the next big assets through late-stage development. The key activities are sharply focused on commercial execution and clinical milestones as of late 2025.

Commercial launch and scaling of Ryoncil® sales in the US

The commercial launch of Ryoncil® (remestemcel-L-rknd) for pediatric steroid-refractory acute graft-versus-host disease (SR-aGvHD) started on March 28, 2025. The focus here is on driving adoption and securing payer access, which is definitely showing traction.

Here's the quick math on the initial sales ramp-up through the first two reported quarters post-launch:

Reporting Period End Date	Ryoncil Gross Revenue (US$)	Ryoncil Net Sales (US$)	Key Coverage/Adoption Metric
June 30, 2025	$13.2 million	$11.3 million	Over 250 million US lives insured
September 30, 2025	$21.9 million	$19.1 million	40 transplant centers onboarded

Management is projecting continued strong growth, expecting gross revenue for the quarter ending December 31, 2025, to be more than US$30.0 million. That would be a more than 37% increase over the $21.9 million in gross revenue reported for the September 2025 quarter. Federal Medicaid coverage became mandatory starting July 1, 2025, and a permanent CMS J-Code (J3402) became active on October 1, 2025, which should lower administrative friction.

The commercial team's activity centers on specific targets:

• Complete onboarding across the 45 priority transplant centers, which represent approximately 80% of U.S. pediatric transplants.
• Drive physician adoption following the assignment of the permanent J-Code.
• Expand label indications for Ryoncil®, including for adults with severe SR-aGvHD.

Advanced R&D and Phase 3 clinical trials for Rexlemestrocel-L (heart failure, CLBP)

Mesoblast Limited is actively managing two major Rexlemestrocel-L programs, both leveraging the Regenerative Medicine Advanced Therapy (RMAT) designation.

For Chronic Low Back Pain (CLBP) due to inflammatory degenerative disc disease (DDD), the key activity is the completion of the confirmatory Phase 3 trial:

• The trial is a 300-patient randomized, placebo-controlled study.
• The primary endpoint is 12-month pain reduction, an approvable indication.
• The first Phase 3 trial showed significant pain reduction and opioid cessation.

For Chronic Heart Failure (Revascor®), the activity is focused on preparing the Biologics License Application (BLA) package:

• Mesoblast met with the FDA on June 3, 2025, to align on BLA filing components for accelerated approval in end-stage HFrEF patients with a left ventricular assist device (LVAD).
• Alignment was reached on Chemistry, Manufacturing & Controls (CMC), potency assays, and the proposed design/primary endpoint for the required confirmatory trial post-approval.

Proprietary industrial-scale, off-the-shelf cell manufacturing

A critical underlying activity is maintaining and scaling the proprietary manufacturing platform. The company's processes yield 'industrial-scale, cryopreserved, off-the-shelf, cellular medicines.' Still, management notes a concentration risk, highlighting dependence on third-party manufacturers and certain single-source suppliers which could constrain scale-up or cause service disruptions.

Regulatory filings, including BLA submission for Revascor® (Rexlemestrocel-L)

While the Ryoncil® BLA was approved in December 2024, the next major regulatory filing activity centers on Revascor® for heart failure. Following the June 3, 2025, FDA meeting, the company is working to finalize the data package. The goal is to support a BLA submission for accelerated approval in end-stage HFrEF patients. Furthermore, Mesoblast is pursuing a label extension for Ryoncil® in adults with SR-aGvHD, with a pivotal trial planned with the NIH-funded Bone Marrow Transplant Clinical Trials Network (BMT-CTN).

Finance: draft 13-week cash view by Friday.

Mesoblast Limited (MESO) - Canvas Business Model: Key Resources

You're looking at the core assets Mesoblast Limited is leaning on to drive commercial success and future pipeline value as of late 2025. These aren't just ideas; these are regulated products, protected science, and hard cash reserves.

The most tangible asset right now is the U.S. Food and Drug Administration (FDA) approved product, Ryoncil^® (remestemcel-L-rknd). This is the first and only FDA-approved mesenchymal stromal cell (MSC) therapy in the United States, specifically for the treatment of steroid-refractory acute graft versus host disease (SR-aGvHD) in pediatric patients 2 months of age and older. This approval, which came in early 2025, is a massive de-risking event for the entire platform.

Underpinning this product and the pipeline is the proprietary mesenchymal lineage cell therapy technology platform. This platform is what allows Mesoblast Limited to create these allogeneic (off-the-shelf) cellular medicines designed to respond to severe inflammation by modulating the immune system. This technology is the engine for their other candidates, like Rexlemestrocel-L for heart failure and chronic low back pain.

To defend this technology, Mesoblast Limited has built a formidable intellectual property fortress. Here's a snapshot of the IP and product status as of the mid-2025 reporting period:

Asset/Metric	Status/Value	Key Date/Period
Granted Patents/Applications	Over 1,000	As of June 30, 2025
Commercial Protection Expiry (IP)	Extending through at least 2044	Global Major Markets
Ryoncil® Orphan-Drug Exclusivity	Seven years from approval	From May 2025
Ryoncil® Biologic Exclusivity	Until December 2036	Prevents biosimilar referencing

Financially, you need to know where the working capital stands to support the Ryoncil^® commercial launch and ongoing Phase 3 trials. As of the end of the second quarter, Mesoblast Limited reported a solid liquidity position.

• Cash on hand: US$162 million as of June 30, 2025.
• Gross revenue from Ryoncil^® sales (post-launch March 28 to June 30): US$13.2 million.
• Revenue from TEMCELL^® royalties (Japan): US$1.6 million.
• Net operating cash spend for the quarter ended June 30, 2025: US$16.6 million.

This cash position is vital because the company is in a commercialization phase, which inherently requires upfront investment to build out sales and distribution. Honestly, having US$162 million in the bank right after a major product launch gives them significant runway to execute on the onboarding of the 45 priority transplant centers.

Mesoblast Limited (MESO) - Canvas Business Model: Value Propositions

You're looking at the core value Mesoblast Limited (MESO) offers to its customer segments, which is built on pioneering allogeneic (off-the-shelf) cell therapy technology. This is where the rubber meets the road for their market position.

First and only FDA-approved allogeneic (off-the-shelf) MSC product.

This is the headline, the first mover advantage. Ryoncil® (remestemcel-L-rknd) is the first mesenchymal stromal cell (MSC) product to secure U.S. Food and Drug Administration (FDA) approval for any indication. The commercial launch began on March 28, 2025. This approval sets a precedent for their entire platform.

The early commercial traction is visible in the revenue figures:

Metric	Period Ended June 30, 2025	Period Ended September 30, 2025
Ryoncil® Gross Sales	US$13.2 million (partial quarter post-launch)	US$21.9 million
Cell Therapy Products Revenue	N/A	US$20.6 million

The growth is sharp; revenue from cell therapy products for the quarter ended September 30, 2025, was over ten times greater than the first quarter of fiscal year 2025. The full fiscal year 2025 revenue ended June 30, 2025, was $17.2 million.

Treatment for life-threatening, severe steroid-refractory acute GvHD in children.

For this indication, the value is measured in life-saving potential, which translates to premium pricing and economic benefit. The wholesale acquisition cost is set at US$194,000 per infusion. Given that a standard course may require 8 infusions, the full treatment cost approaches $1.55 million per patient. The economic value proposition is further supported by the fact that total benefits, based on health economic models, range from US$3.2 million to US$4.1 million per patient.

Key clinical data underpinning this value include:

• 70% overall response rate (ORR) at day 28 in Phase 3 trials.
• 49% survival through 4 years in the Phase 3 cohort.
• Approximately 375 pediatric patients in the U.S. are diagnosed with SR-aGvHD annually.

Market access is solidifying, with coverage expanding to over 250 million US lives insured by commercial and government payers as of June 30, 2025. Mandatory federal Medicaid coverage became effective across all US states on July 1, 2025.

Potential for a non-opioid, single-injection treatment for chronic low back pain.

The value here is disrupting a massive market segment-discogenic back pain accounts for about 50% of prescription opioid usage in the US. The investigational product, rexlemestrocel-L, has Regenerative Medicine Advanced Therapy (RMAT) designation from the FDA.

Data from the first Phase 3 trial (MSB-DR003) involving 404 patients, where 168 were on opioids at baseline, showed that treated patients had more than 3-fold higher numbers able to cease all opioids by 36 months compared to saline controls (p=0.008). The FDA has agreed that the 12-month pain reduction endpoint is approvable. A confirmatory 300-patient Phase 3 trial is currently recruiting across 40 US sites.

Scalable, cryopreserved cellular medicines with defined release criteria.

The manufacturing process is designed for industrial scale, yielding cryopreserved, off-the-shelf products that meet defined pharmaceutical release criteria. This operational capability supports the commercialization efforts for Ryoncil® and the pipeline for rexlemestrocel-L. Financially, the company is managing its cash position to support this infrastructure. Cash on hand at June 30, 2025, was US$162 million (A$247 million). The net loss for the fiscal year ended June 30, 2025, was $0.0846 per share, with trailing 12-month earnings at -$102.1 million. This is a capital-intensive business, but the commercial revenue stream is now active. Finance: review Q3 2025 cash burn against projected Ryoncil® sales run-rate by next Tuesday.

Mesoblast Limited (MESO) - Canvas Business Model: Customer Relationships

You're looking at how Mesoblast Limited builds and maintains its relationships with the specialized, high-stakes customers in the US transplant and specialty care markets following the Ryoncil® launch in March 2025. The focus here is on direct, high-touch support and ensuring patient access to a novel, high-cost therapy.

The commercial strategy centers on deep engagement with a defined set of high-volume centers. This requires a specialized, dedicated team to manage the complexity of product ordering, infusion logistics, and reimbursement hurdles for a product with a Wholesale Acquisition Cost (WAC) of US$194,000 per intravenous infusion.

High-touch, specialized commercial team supporting US transplant centers

Mesoblast Limited deployed a focused team to onboard the centers responsible for the vast majority of pediatric bone marrow transplants in the United States. The relationship management is intensive, given the product's niche use for steroid-refractory acute graft-versus-host disease (SR-aGvHD) in children.

The structure and progress of this engagement as of mid-2025 included:

Metric	Value/Status	Reporting Period Reference
Key Account Manager (KAM) Team Size	Nine full-time KAMs	Commenced activities in the last week of April 2025
Target Priority Transplant Centers	45 centers	Account for approximately 80% of U.S. pediatric transplants
Transplant Centers Onboarded (to date)	32 centers	As of the quarter ended June 30, 2025
Transplant Centers Onboarded (since launch)	More than 25 centers	As of the quarter ended June 30, 2025
Onboarding Expectation (Current Quarter)	Complete onboarding across all 45 priority centers	As of the quarter ended June 30, 2025

The goal was to accelerate onboarding of these key sites to drive utilization of Ryoncil®.

Patient assistance programs for Ryoncil® access and reimbursement support

To overcome payer friction, Mesoblast Limited established a dedicated hub to shepherd patients and institutions through the access process. This is critical for a novel therapy where payer policies are still maturing.

• Established patient access hub named MyMesoblast™, managed by Cencora, to facilitate patient enrollment, shipment, logistics, and support.
• Total US lives with Ryoncil® coverage expanded to over 250 million insured lives by commercial and government payers as of the quarter ended June 30, 2025.
• Mandatory fee-for-service Medicaid coverage became effective in all US states on July 1, 2025.
• As of March 31, 2025, 37 of the 51 States provided fee-for-service Medicaid coverage via Orphan Drug Lists or medical exception/prior authorization (PA) process.
• By June 30, 2025, 15 infusion kits had been purchased for patients to start or continue treatment since the March 28, 2025, commercial availability date.

Direct engagement with key opinion leaders and regulatory bodies (FDA)

Maintaining an active, transparent dialogue with the U.S. Food & Drug Administration (FDA) is central to both current product lifecycle management and future pipeline advancement. This includes specific interactions for Ryoncil® label extension and for the Revascor® program.

• Mesoblast Limited held a Type B meeting with the FDA on June 3, 2025, to discuss components of a potential Biologics License Application (BLA) for Revascor®.
• An upcoming meeting with the FDA in early July 2025 was scheduled to discuss a pivotal trial of Ryoncil® in adults with SR-aGvHD, to be conducted with the NIH-funded Bone Marrow Transplant Clinical Trials Network (BMT-CTN).
• The company is seeking to extend the Ryoncil® label from children to adults with SR-aGvHD.
• A meeting was announced in early November 2025 with the FDA in early December 2025 to discuss data on opioid reduction and cessation from the rexlemestrocel-L Phase 3 study for chronic low back pain (CLBP).
• Key Opinion Leaders, such as Dr. Joanne Kurtzberg of Duke University Medical Center, presented scientific data on Ryoncil® as a third-line treatment for SR-aGvHD in adolescents and adults.

Finance: draft 13-week cash view by Friday.

Mesoblast Limited (MESO) - Canvas Business Model: Channels

You're looking at how Mesoblast Limited gets Ryoncil® and its corporate updates out to the world, especially now that the product is commercially available in the US. It's a mix of direct selling, third-party logistics, and global partnerships. Here's the breakdown of the channels they use as of late 2025.

Direct US Sales Force and Center Onboarding

For the US launch of Ryoncil® for steroid-refractory acute graft-versus-host disease (SR-aGvHD) in pediatric patients, Mesoblast Limited is using a highly targeted direct sales force. The initial strategy focused on the centers that perform the most transplants, which previously included the Top 15 highest volume centers accounting for roughly 50% of patients. The commercial team build-out is now complete, with the full team of nine key account managers (KAMs) commencing activities in the last week of April 2025.

The channel strategy centers on fully onboarding the 45 priority transplant centers, which collectively account for approximately 80% of U.S. pediatric transplants. You can track the progress of this critical channel activation:

Metric	As of March 31, 2025 (Q3 FY2025)	As of June 30, 2025 (Q4 FY2025)	Target/Goal
Fully Onboarded Priority Transplant Centers	10	More than 25	Complete onboarding across all 45 centers this quarter (post-June 30)
Centers with Enrolled Patients (via MyMesoblast™ hub)	5	Data not specified for this date	N/A
KAMs in Activity	Not fully deployed	Full team of 9 active since late April	Accelerate onboarding of remaining 35 centers

The KAMs are there to drive on-the-ground engagement with both healthcare providers and administrators at these key sites. That's how you ensure the product gets used where it's needed most.

Hospital and Specialty Pharmacy Distribution Network for Ryoncil®

Getting the cryopreserved product to the patient requires a specialized chain. Mesoblast Limited established its distribution network using Cencora, a leader in specialty pharmaceutical services. Cencora handles the logistics, utilizing its cryogenic logistics capabilities and cryogenic storage infrastructure for secure delivery to U.S. treatment centers.

The distribution has two main pathways:

• Direct delivery to U.S. treatment centers.
• Use of a specialty pharmacy option.

This entire logistical chain is supported by the patient access hub, MyMesoblast™, which is also managed by Cencora to handle patient enrollment, shipment, and logistics support for both inpatient and outpatient settings. Coverage is a key part of this channel; as of the quarter ended June 30, 2025, coverage for Ryoncil® expanded to over 250 million US lives insured by commercial and government payers. Mandatory coverage for all 44 million lives in the remaining states was expected to become effective on July 1, 2025.

Licensing and Distribution Agreements Internationally

Mesoblast Limited is not going it alone outside the US. The company has established commercial partnerships covering key territories, specifically in Japan, Europe, and China. These agreements generate revenue through royalties on partner sales.

For instance, in the quarter ended June 30, 2025, Mesoblast reported US$1.6 million in revenue from royalties on sales of TEMCELL® HS Inj. sold in Japan by their licensee. Looking at the first half of fiscal year 2025 (H1 FY2025), total royalty receipts were US$3.2 million, compared to US$3.4 million for the same period in FY2024. The company's overall gross revenue from Ryoncil® sales post-launch through June 30, 2025, was US$13.2 million.

Investor and Analyst Webcasts

To keep investors and analysts informed on corporate and financial progress, Mesoblast Limited uses scheduled webcasts. The company hosted a webcast to discuss operational highlights and financial results for the full year ended June 30, 2025, on Thursday, August 28, 2025 (EDT). You can expect these updates to detail key channel metrics, such as the $11.3 million in net product sales reported through June 30, 2025.

Other key communication touchpoints for this audience include:

• Trading Update at the Annual General Meeting (November 24, 2025).
• Participation at the Piper Sandler Conference (December 4, 2025).
• Quarterly Activities/Appendix 4C Cash Flow Report (October 20, 2025).

These events serve as the primary channel for disseminating performance data, like the US$161.6 million cash balance reported at June 30, 2025. Finance: draft 13-week cash view by Friday.

Mesoblast Limited (MESO) - Canvas Business Model: Customer Segments

You're looking at the specific groups Mesoblast Limited (MESO) targets with its cellular medicine products, which is crucial for understanding their revenue strategy, especially post-Ryoncil® launch in the US.

The primary, currently served segment is US pediatric patients (2 months+) with steroid-refractory acute GvHD (SR-aGvHD). This is a niche but high-need population. Annually, approximately 375 pediatric patients in the U.S. are diagnosed with SR-aGvHD. Mesoblast Limited (MESO) made Ryoncil® commercially available for this indication on March 28, 2025. By the end of the first quarter post-launch (quarter ended June 30, 2025), Mesoblast Limited reported US$13.2 million in gross revenue from Ryoncil® sales. For the quarter ending September 30, 2025, net revenue from cell therapy products, primarily Ryoncil®, rose to US$20.6 million.

The next layer of customer segments involves the healthcare providers and institutions that administer the therapy. These are the major US transplant centers and specialized hematology/oncology hospitals. Mesoblast Limited is executing a staged approach, focusing on the highest volume centers first. By the end of the quarter ended March 31, 2025, ten priority transplant centers had been fully onboarded. These priority centers account for approximately 80% of U.S. pediatric transplants. The company expected to complete onboarding across all 45 priority transplant centers by the quarter ending September 30, 2025. Furthermore, Mesoblast Limited has been aggressively expanding payer coverage to ensure these centers can treat patients; coverage expanded to over 250 million US lives by June 30, 2025.

The future customer base for Mesoblast Limited is significantly broader, focusing on large chronic disease markets with its rexlemestrocel-L product candidate. This includes patients with chronic heart failure with reduced ejection fraction (HFrEF) and inflammation, and patients with chronic low back pain (CLBP) due to degenerative disc disease. The Total Addressable Market (TAM) for both of these indications is estimated to be >US$10 Billion each. Specifically for HFrEF, the target market in the U.S. is approximately one million patients with ischemic HFrEF and inflammation.

The final segment involves entities outside of direct US patient care, specifically international licensees seeking cell therapy products for their markets. Mesoblast Limited has established commercial partnerships in Japan, Europe, and China. The Japanese licensee, JCR Pharmaceuticals Co., Ltd., markets TEMCELL® HS Inj. for GvHD. For the quarter ended June 30, 2025, Mesoblast Limited recorded US$1.6 million in revenue from royalties on sales of TEMCELL® HS Inj. in Japan.

Here's a quick look at the scale of the current and near-term target segments as of late 2025:

Customer Segment Detail	Metric	Value/Amount (2025 Data)
US Pediatric SR-aGvHD Patient Pool (Annual)	Diagnosed Patients	Approximately 375
US Transplant Centers Onboarded (Priority)	Centers Onboarded (as of Q1 2025)	10
US Transplant Centers Targeted (Total Priority)	Centers Representing 80% of US Peds Transplants	45
US Payer Coverage (as of June 30, 2025)	Insured Lives	Over 250 million
Future HFrEF U.S. Target Market	Patients with Ischemic HFrEF and Inflammation	Approximately one million
Future HFrEF U.S. TAM	Total Addressable Market	>US$10 B
International Licensee Royalty Revenue (Q ended June 30, 2025)	Royalty Revenue from Japan	US$1.6 million

You can see the immediate revenue base is tied to the limited SR-aGvHD population, but the future opportunity is anchored by the multi-billion dollar TAMs for HFrEF and CLBP. Also, note the growth in Ryoncil® gross sales, which hit US$21.9 million in the quarter ending September 30, 2025.

The key customer groups for Ryoncil® adoption include:

• Pediatric Hematology/Oncology Specialists
• Bone Marrow Transplant (BMT) Physicians
• Hospital Pharmacy and Therapeutics Committees
• Payers/Insurers (for coverage and reimbursement)
• Caregivers of pediatric SR-aGvHD patients

For the future pipeline products, the customer segments shift to:

• Cardiologists treating HFrEF with inflammation
• Pain Management Specialists for CLBP
• Clinical Trial Investigators (for ongoing Phase 3 enrollment)

What this estimate hides, though, is the specific breakdown of revenue contribution from the international licensees versus direct US sales, which is key for forecasting future cash flow. Finance: draft 13-week cash view by Friday.

Mesoblast Limited (MESO) - Canvas Business Model: Cost Structure

You're looking at the core expenditures Mesoblast Limited is making to drive its pipeline and commercialize Ryoncil®. Honestly, for a company at this stage, the cost structure is heavily weighted toward R&D and the new commercial push.

The total Net operating cash spend for FY2025 was US$50.0 million. That figure was a slight 3% increase over the prior year, and it explicitly includes the costs associated with building out the commercial team and launching Ryoncil®. That's the top-line cash burn you need to track.

Here's a breakdown of the major cost buckets for the full year ended June 30, 2025:

Cost Category	FY2025 Amount (US$)	Notes
Net Operating Cash Spend	US$50.0 million	Total cash used in operations for the year
Research & Development (R&D) Expenses	US$34.8 million	A 12% reduction from US$39.7 million in FY2024
Selling, General & Admin (SG&A) Expenses	US$39.3 million	Includes a $14.3 million increase over FY2024 for commercial build-out
Cost of Revenues (Product Sales)	US$1.2 million	Represents 10% of net product sales
Non-Cash Amortization (Asset)	US$3.9 million	Expense related to the prior MSC asset acquisition

Significant R&D and clinical trial expenses are a given for Mesoblast Limited as they push their pipeline forward. For the full fiscal year 2025, Research & Development expenses were US$34.8m. This is actually a 12% reduction compared to the US$39.7m spent in FY2024, showing some cost discipline even while advancing key programs like rexlemestrocel-L for chronic low back pain and end-stage heart failure.

Manufacturing and supply chain costs are tied directly to the commercial product, Ryoncil®. The Cost of Revenues related to product sales was US$1.2m for FY2025, which works out to be 10% of the net product sales. This cost covers the industrial-scale, cryopreserved, off-the-shelf cell production.

The commercial build-out and launch of Ryoncil® are clearly reflected in the SG&A line. The company reported Selling, General & Admin expenses were US$39.3m for FY2025. This was a significant jump, specifically an increase of $14.3m on FY2024, which the company attributes to the commercial team build and product launch activities.

You can see the key drivers of cash usage here:

• R&D spend for pipeline advancement: US$34.8 million in expenses.
• Commercialization costs embedded in SG&A: US$39.3 million for FY2025.
• Cash burn rate: US$50.0 million net operating cash used for the year.
• Manufacturing overhead: US$1.2 million in Cost of Revenues.

Finance: draft 13-week cash view by Friday.

Mesoblast Limited (MESO) - Canvas Business Model: Revenue Streams

You're looking at the revenue streams for Mesoblast Limited (MESO) as of late 2025, focusing on the hard numbers from the most recent full fiscal year data available, which is FY2025 ending June 30, 2025.

The revenue generation is currently anchored by the recent commercial success of Ryoncil® in the US, supplemented by established royalty income from international licensees. Here's a breakdown of the confirmed financial streams:

Product Sales of Ryoncil® in the US Market

• Net sales for Ryoncil® in the US market for the full fiscal year 2025 reached US$11.3 million.
• This net sales figure followed gross sales of US$13.2 million, representing a gross-to-net adjustment of 14.6% for the period ending June 30, 2025.

Royalties from Licensed Product Sales

• Royalties received from sales of cell therapies by Mesoblast Limited's licensees totaled US$5.9 million for FY2025.
• This royalty income was consistent with the prior fiscal year (FY2024).
• For the quarter ended September 30, 2025 (Q1 FY2026), royalty revenue was reported as US$1.6 million from TEMCELL® HS Inj. sales in Japan by its licensee.

You can see the key revenue components for the period ended June 30, 2025, right here:

Revenue Component	Fiscal Year 2025 Amount (USD)	Notes
Ryoncil® Net Sales (US)	US$11.3 million	From launch (March 28, 2025) through June 30, 2025.
Licensed Product Royalties (Total)	US$5.9 million	Includes TEMCELL® in Japan and Alofisel® royalties.
Total Cell Therapy Product Revenue	US$17.2 million	Sum of net product sales and royalties for FY2025.

Future Revenue Potential

Beyond the established streams, Mesoblast Limited is actively pursuing revenue expansion through label extensions and pipeline advancement. This represents the next layer of potential financial upside, though these are not yet realized revenue amounts for FY2025.

• Expanded Ryoncil® label for adult steroid-refractory acute graft-versus-host disease (SR-aGvHD).
• Advancement of Rexlemestrocel-L, a next-generation platform technology, targeting blockbuster indications.
• Rexlemestrocel-L has received RMAT designation from the FDA for chronic low back pain (CLBP) due to degenerative disc disease, a condition accounting for a significant portion of US prescription opioid usage.
• Pilot study data suggests Ryoncil® effectiveness in treating medically-refractory Inflammatory Bowel Disease (IBD) patients.

Potential Milestone Payments from Commercial Partnerships

The business model anticipates further non-sales revenue from its existing and future commercial partnerships. These payments are contingent events, so you won't see them as recurring figures yet, but they are a key part of the financial structure.

• Potential for milestone payments tied to achieving specific clinical, regulatory, or commercial goals with licensees globally.

Finance: draft 13-week cash view by Friday.