Ann: Ryoncil Pricing Set and Available This Quarter, page-512

Great questions mate, I was wondering some of those questions too, I have been asking Grok and Chatgpt to provide with answers here are outcome:

From Grok:

• Research suggests Mesoblast has provided some clarity on manufacturing costs, but future costs remain uncertain due to scaling challenges. (only the total cost, not per unit cost)
• It seems likely that insurance coverage for Mesoblast's treatment is being negotiated, with no confirmed providers yet.
• The evidence leans toward Mesoblast not having treated patients with the approved product yet, but they are preparing to start soon.
• Mesoblast has not provided firm revenue or sales guidance as of February 2025.
• Cheaper alternatives for SR-aGVHD treatment are available, such as immunosuppressive drugs.
• Insurance claim rejections are a known issue, and Mesoblast is assisting with coverage, but challenges may persist.
• The research on Mesoblast's product is primarily company-funded, though vetted by the FDA and peer-reviewed.

From Chatgpt:
1, Lack of Disclosed COGS per unit suggests the company carried roughly US$23–31 million worth of Ryoncil inventory into launch (valued at production cost).
2, No major insurer has publicly “confirmed” coverage yet. insurers are expected to cover Ryoncil for its indicated use, but coverage comes with prior authorization and strict criteria. As of now, coverage is on a policy-by-policy basis (e.g. internal criteria from BCBS, Centene, etc.) rather than broad publicly announced agreements. Private payer and Medicaid negotiations are in progress, backed by Mesoblast’s outreach and support programs to facilitate reimbursement.
3. No Official Launch Patients Yet: As of early March 2025, Mesoblast has not announced any “first commercial patient” treatment.
4. No Official Revenue Guidance: Mesoblast has not provided formal revenue guidance for the next fiscal year in its public releases.
5. Ruxolitinib (Jakafi) is the main existing competitor for treating SR-aGVHD (especially in adults/teens) For pediatric patients, Ryoncil is entering an unmet market with no approved rivals. Future competition may come from other cell therapies like Cynata’s CYP-001 or novel biologics, but those are still in trials Overall, Ryoncil’s unique MSC mechanism and pediatric label give it a strong head start, with few near-term direct competitors in its niche.
6. In summary, the key insurance issues are prior authorization, potential step therapy (especially requiring steroid failure and possibly a trial of ruxolitinib in older kids), and the sheer cost prompting thorough reviews.
7. In summary, independent research on Mesoblast’s financials is available from multiple sources: sell-side equity research (Piper Sandler, Bell Potter, etc.), third-party research firms (Edison, previously), and investor commentary (Seeking Alpha, etc.).