Well I finally got time to do a summary of the meeting from my notes
Good turnout numbers wise - by 9.15 there were very few chairs left.
Chairman
The meeting started with a video from the Chairman as he was unable to be there. One takeaway from me was that Joseph Swedish knows his stuff pertaining to reimbursement from health insurance companies. His credentials obviously support this notion.
He made reference to how the USA reimbursement organisations were very supportive of new healthcare treatments as they tend to relieve cost burdens for health care. SI expanded on this with an example in his aGVHD presentation - you will have to wait until I get to that section for this... hehe
CEO
I noted in the slides SI was using the header now states:
"Premier Global Cellular Medicines Company"
I like the new terminology and SI basically went through the slide outlining tech, pipeline and commercialisation.
aGVHD
SI ran through what most of us on here know and basically what was on the slides so I won't bore you with further notes except some points I believed he emphasised upon:
Small Sales Force required due to hospital networks already in place. (Suggested 12-15 people)
Impressive growths in royalties from Japan
He did go on to take the Chairman's statement in relation to reimbursement one step further by running through an example.
Stressed the huge burden of costs in the USA.
Reference was made to the hospitalisation period for a patient suffering aGVHD and how it cost approx $10,000 per day.
He then described how our Remestemcel-L treatment could reduce this hospitalisation period by up to 60 days and that a reduction in costs (savings) was enormous.
Commercialisation strategy was ramping up through Lonza and that we only needed about 12-15 people on the ground (Sales Team) due to hospital network created through trials and EAP.
He made reference to Temcell being a guide for the USA and of course the BLA submission.
He expected up to $700m market penetration in the USA for aGVHD.
Product Pipeline
SI basically ran through slide so I won't bore you.
Partnerships
SI basically went through the partnerships listed but made reference to the enormous potential of the USA deals - again something we all knew.
Global IP
Again information we already knew 1000 patents in 68 families, however SI leveraged off the Takeda (TiGenix) deal and used this example of what could eventuate in the future from similar circumstances globally with other pharma companies.
CHF
Interesting comment SI made was:
"CHF is as bad as most cancers" ... I had never really looked at this from this perspective.
SI outlined the resurgence in drugs to treat early stage CHF by companies like AstraZeneca, Lilly and the like. He added that as the disease progresses to more advanced class 3/4 stages these drugs become less effective. I have written that he stated that when used in conjunction with our Revascor product it prolongs life.
He sounded upbeat about the CHF trial and re-iterated that they undertook an efficacy and futility test about about one third of the way through (which we all know about) but I believe he said that it met the primary and secondary endpoints at this stage. I am not sure I have heard this mentioned in previous conference calls ? Someone may be able to say whether I am having a blonde moment with this statement or in fact this is the first time the "endpoints" have specifically been referred to ? SI added that this result has "given ourselves a very strong chance of success".
He also added that MSB was targeting patients that don't have other options.
... and that this was the "biggest trial ever performed in cell therapy"
LVAD
SI went through what we already know. He also went on to say that the MOU has now advanced to an agreement for protocol for the Phase 3 trial.
He made reference that this trial should start in the 'foreseeable future'.
CLBP
Usual information that many of us are already aware.... but one comment certainly grabbed my attention: "50% of opioid prescriptions written are for CLBP" ... I had not seen this reference previously, but again I could be having a blonde moment?
SI then ran through the parameters of the Grun deal, which again many of us know inside and out from reading the ASX announcement pertaining to same. He again made comment that this Grun deal has created tremendous leverage for the USA deal in this sector.
Q & A
Q: CHF results question regarding what would happen with FDA if the results were extraordinary? From our own resident @stanjupiter (I can say that now that she has posted she was there and I had the pleasure of meeting her)
A: SI made reference to mortality benefit and that the FDA has previously approved other indications based on a single trial basis in other areas but it would depend on how well we met our primary and secondary endpoints. He said 'all options were on the table'
Q: From Stuart Burn Aust Shareholders Association - He asked about risk plans, costs, commercialisation and the split between MSB and partners if applicable?
A: SI used aGVHD as the first example and stated that manufacturing of this product will be undertaken by Lonza and would underpin commercial distribution. (I think I missed something in that sentence - my apologies) ... he then went on to say 'of course we have risk strategies in place' ... and added that warehousing in the USA could even be looked at.
Q: From Stuart Burn Aust Shareholders Association - He asked why retail shareholders were not offered any of the recent placement of $70m @ $2 per share ?
A: SI made reference that he always likes to involve shareholders in these types of arrangements, however he pointed to the fact that the share price is currently 10% lower than this price of $2 so we still have the ability to increase our positions as it turns out - signalling we have not been disadvantaged from the CR.
Items of Business
General run down on resolutions were undertaken and displayed on the screen. Stuart from Aust Shareholders Association raised a question about options for Directors and that it diluted current shareholders - this question received some good rebuttal points.
Stuart also raised a questions in relation to 'gender diversity of the Board' and Directors with little or no shareholding.
We were advised that his concerns were noted regarding Director holdings (we hear you re: Directors holdings - I think that is what was stated) and that 'as MSB move forward diversity will be a major factor in Directors Appointments'.
Meeting was then closed and I got to meet some of our fantastic HC MSB members.
I hope this helps those that were unable to attend, but please bear in mind that I have taken notes and quotes to the best of my ability .... if I have made a mistake or if anyone can add bits I would appreciate it as there were other attendees and I am only human after all ... hehe
All in all I came away very happy, one might even say with a 'heightened enthusiasm' and I liked that SI made this comment:
"The next 12 months is going to be very exciting for Mesoblast"
.... and while some naysayers will say yes we have heard that before, take a step back and look at just what is coming up in that time frame - just sayin'
GLTAH
Valid point @stokdog ... I just read your post as it took me ages to do mine ... hehe
I'd go so far as to say he is advising the FDA in the meetings and they may be learning off Mesoblast.
and SI basically went through the slide outlining tech, pipeline and commercialisation.
(20min delay)
