Ann: Ryoncil Commercial Launch Update and Product Pipeline, page-124

Hi @vorzaw,

we're looking at the same thing, but IMO seeing different aspects.

The contractual licensing (&sub-licensing) structure I'm describing in the post you linked is, IMO, the most commercially sound mechanism for Mesoblast to use for the rapid, low-capex, cash-flow positive development of product markets. As I see it, it should work brilliantly, if the critical elements can be maintained by MSB management.

The geopolitical or channel distributorship limitation per license is what enables franchising to 'work' (e.g. without marketing rights overlaps that degenerate into legal brawls or worse). The model lends itself in particular to existing i.e. developed products, where access to key information (e.g. regulatory data filings) can be shared across licensed franchises. Critical to the model is the retention of ownership of intellectual property in the franchisor - you can see that this retention is an essential pre-requisite to reliability of the licensing structure (& the commercial exploitation opportunity it represents). This retention of control commands the respect that enables multi-territory franchising to function smoothly, despite territorial ambitions.

Also, not only is this franchising model readily replicable (e.g. in new territories or for new indications), but also it can fit comfortably with head franchisor (i.e. Mesoblast) operation of its own corporate (i.e. MSB-owned) franchises in particualr territories (e.g. the USA) or for particular indications (e.g. those which MSB does not wish to train marketing/ product education personnel on) - in other words, it can allow the corporation to grow fast, but within it's ability to manage necessary resources.

Naturally, IME, operations personnel involved will over time tend to fall into one of 3 organisational Divisions i.e. franchise territory/ indication licensing personnel (the franchising front-end), franchise support personnel (e.g. franchised territory/ indication product education) & last, for those corporately-operated territories/ indications, operations personnel. RYONCIL for SR-aGVHD in the USA fits in this last category, IMO, but CEO Itescu has indicated that Mesoblast intends to take on others " on its own " - great, from my POV, as it deleverages the Novartises of this world that, in their arrogance, believe they will be able to turn what starts out as a license into a tail-wags-the-dog situation.

You @vorzaw seem, IMO, to be looking at the same exploitation opportunites for MSB, but with a focus on the therapeutic licensing & clinical demonstrations required for that purpose. The label extension of RYONCIL to other indications (e.g. adult usage) might not require a franchising structure for its proper commercial exploitation - we should recall the importance that MSB management placed in 2024 on the BMT CTN/ CIBMTR's willingness to fund the required Ph III/ IV clinical trial based almost entirely in return for data sharing by Mesoblast. If the compensation for BMT CTN (& CIBMTR) can be suitably addressed in terms of data sharing &/or a trailing royalty structure, it may not be necessary for MSB to look at arms length licensing i.e. a franchise to exploit those indications.

But I share your view that focussed future clinical trials across other indications - including the blockbuster chronic REVASCOR and rexlemestrocel-l indications - will not (& IMO should not) fall into this kind of model automatically. And it is no surprise that CEO itescu is saying that the Board's intention is exactly along these lines i.e. only to bite off for itself what MSB can reasonably chew. So, if MSB doesn't seek to operate these emerging product lines itself, a timely collaborative license would be the way to go, IMO.

However, I am concerned to see that MSB explores the efficacy of these 'cells across a host of indications' solely by itself, in the first instance, and then franchises the application of the cells. Because if Mesoblast ever waters down its 100% IP protection with a research "partnership", say, well in my experience that only ever leads to problems - sometimes fatal ones.

I'm not seeing that atm. The corporation's pursuit of sole IP owner patent protections in key markets, and demonstrated willingness to prosecute claims is one of the primary protections which I see as underpinning an investment in MSB (at least, in my case). The other primary protection is rapid, first-mover commercial advantage. We'll see how these 2 things play out over the next 12 months.

Cheers
Hope this assists.
GLTALTH