Sorry really short on time so format will be poor and not in logical orderMany trapped holders dreaming of ever getting to preconsolidation prices IMO. Many USA posters still trapped from last 3 months .
Level it gets will revolve around a couple of major holders and if they can get it running and if not if they have balls to wait for numbers and get a lift on NAS listing if there are sales numbers worth announcing.
Creating ADR OTC demand and a pump from holders of large overhang no idea if there will be follow through and real numbers early are likely to disappoint but may look OK if stocking orders. Key is ongoing repeat sales and actual demand with limited approval only for adults and only economical in certain circumstances. Key is if it is used in other cosmetic treatments off label and since other countries have resisted and not aware the current management has links in that sector not sure it will be a boon but may add to numbers. the. They keep promoting a low level ( not full) Nas listing but they don't qualify and a whole other lot of reasons. It's slow to introduce a new device , they only have short patent left ( lost recent patent challenge) and 6 year FDA to make $. Patent is on device not on chemicals so IMO after 6 years from last DEC they will have generic competition and in other countries probably earlier . Has been used in korea and india for years and never taken off even for cosmetics . At 1200 in AU they made stuff all sales in Aus and now priced at 5k headline 7500 in USD for USA it will be interesting . That's the rack rate and initial stocking - after that with training and discounting etc who know as it is all about rebates. Recent issue is because they have so many costs in getting initial sales .
Good points - if they can manage a production area they have some extra margin . Previous contract manufacturer sold em the whole kit and kaboodle for stuff all as they didn't want a separate facility for 1 product and wasn't economical and they had waited years to get volume and it never came. Still it is very hard to keep certified and hold all the professionals you need on small volume and keep facility compliant. Big risk and expensive.
Historically and currently management have a large no risk income and no doubt will try and get mega pay for approval and any listing and we have all seen the snouts in before so if it isn't spinning off $ it will suck dry consolidate and raise in US quickly . What comes first , sales or snouts its a hard gamble as management want rewards in front of shareholders and before real size of market and acceptance clinically is resolved IMO.
Current orders and approved trained users are same that were already approved for FDA compassionate use prior to full FDA approval. Now since approval was only for over 18 compassionate will continue for younger and those outside specs. Still not authorised for all parts of body so hands are out. Hospital cycle in accounts will be anywhere from 2 -6 months to approve a new product depending on when internal committees etc meet and many only introduce into budget at set quarter timeframes etc.
Barda- agreement to purchase stockpile . may have changed in number or timeframe due to only being approved for 18+ but will give them a guaranteed reason to run production facility at a economic capacity
20 strong very experienced sales force and several account supports travel, marketing training etc will be sucking lots of cash and only initially 67 America Burns Ass certified centers to target and then others at a lower certification. Target the best highest standard of care facilities first and get best outcomes. Burns are just skin as most patient issues are also complicated by other medical issues , infection, respiratory , blood , etc etc so best patient result are from best highest supported care facilities with integrated physio, etc etc
Dave if you know the original inventor have a chat and see if it is a real business with legs. I know it is a real product that works in teh right circumstances but it has not been used in eastern Australia for example on mass and you would have expected with FDA approval if that was the block that they would have announced that x number of centers had now ordered in Aus etc. Odd I have seen no public or personal comments from the inventor and seemingly no intent on using her for promotion.
This business under a big pharma banner with all the compliance efficiencies , management efficiencies, distribution efficiencies is a totally different beast with different margins and low risk and that may be what key holders are hoping for but big skin pharma know numbers inside out and also know other products with other technologies in the pipeline so anyones guess if they will ever pull trigger and I thought they may try early while it was on its knees as so much margin is in initial launch and could have paid out retired current management with offer equal to snouts in trough but without risk to them.
At pips it was easy but at .5 not sure with so many out there on issue and some loose if it will run. The key holders are active managers when they get the opportunity so if volume happens they will find it hard to just sit as they possibly take some cream and fall back on next issue for the next leg
There IMO will be more issues as it is a expensive business and i don't think they will get volume, big snout costs and if opportunity arises to get another key stakeholder and spread required they will IMO
