PART 2 - OUR OWN PROJECTION...
In Part 1 you guys got a soap box speech from me...what are just some of the things needed to be researched...what will make OUR investment STAND out from the pack....what are the ingredients needed to remain competitive and WHY will we be successful? Part 2 is the more exciting stuff..it's that top gravy on the meat...the meat base was always tender and yum...the gravy makes it...and it adds to the practicality of what we hold.
We have heard just recently some really good possible projections comparing us to CSL...yes yes all good and it's lovely to read this, inspiring as well...but let's do a little of the analysis OURSELVES...in-house style...SO tonight let me present a possible scenario.
Now remember, this is all highly speculative in nature and it depends on oh-so many factors...yes all the stars kinda have to line up and hey, it does happen some time. As per usual, do enjoy!
Lining up those stars...get them all in a row..a and watch the eventual fun play out.
Let's consider three possible paths and you know what the most exciting part of this is? Not one of the below am I factoring in, has anything to do with OA revenue in USA and Europe....Amazing
CONSERVATIVE SCENARIO 1
Ok in this path way let's imagine November 2020 rolls around and PAR duly gives us an update on the TGA Provisional, they say that they are close to submitting the required docs, they are just waiting on the final toxicology study and for the P3 to begin.....so in other words they will be submitting mid way through Q1....*more waiting*...ok well better late than never right?
Now according to the TGA website, the median provisional green tick of approval takes about 208 working days (median according to TGA website). If I whip out my calc, and a calendar - That takes us to October 2021...I'm going to add 2 months to this for provisions for slight delays and by the time they are ready to roll...that's December next year...
MPS....well again, highly speculative but let's say the IND happens November 2020....actually, let me add one more month in case..December...by then the FDA and EMA get back to us (they have 30 days before we can start officially) it will be end Jan....ok so the trial begins then? How long will it go for...I'm saying conservatively it goes for a full year!...So Jan 2022 is read out....we then prob need another few months to get organised, labelling and marketing finalisation.
MORE REALISTIC SCENARIO 2
Same as above but let's shave a fraction off....SO TGA provisional approval program is started at the same time as scenario 1 above...but instead of taking 208 working days...let's dial it down to 180....why? Well there are actually a number of cases that have been approved in a shorter period of time (quickest was around 160)...we can still add maybe a 1 month buffer on to the end so this now puts us at late September 2021...that's looking better...MPS program? Not sure how much we can shave off...prob only a month or so if we are being realistic...maybe Dec 2021 read out.
OPTIMISTIC SCENARIO 3
Ok let's go wild, loosen up that hair (mine is short at the moment, thought I'd go a # 2 during lockdown number 2 In Vic in case the barbers are all closed...)Let's pretend PAR announce in November that TGA submission is closer than we think,.....maybe mid Dec? 180 days from then is Aug 2021 ...MPS? Again not a lot of room to play here but perhaps the one full year isn't required...maybe the results after just 6 months are compelling...it still means that it will be a little longer than 6 months at a min as we are in multi sites, the two agencies wouldn't just rely on one site's data and certainly one batch's data no matter how good the results are and how much the patients jump for joy.
So we have to say at least 8 months...and then still another 2 for prep work before roll out. Don't forget as others have stated, the time taken after a read out and to the actual first day of sales can be longer than just 1 or 2 months. This puts us roughly at September? Maybe October 2021. You also gotta understand that the chance of a Big Bro Pharma deal increases markedly as the data comes back... Very exciting.
WHAT NEXT?
Ok Mozza, well and good...as we wait for us to leg up to the next level in terms of share movement...how about this for a scenario...let me have my fun, take this with the due cautions, DYOR, Do NOT rely on this speculative info.
No matter what plays out above, have a read of this:
ONE day we will get TGA approvalONE day we will get MPS GO(my views)...this is how it really could play out:
In my mind we will probably get TGA approval first before MPS. So...It has been said by others a whole lot more professional than me, better equipped in terms of software and connections than my team....(yes my staff is just ONE...I firmly believe there is a MOZZ in TEAM) and have been in the industry longer than I have or ever will be.....that in the first full year of TGA approval, we may treat upwards of 10,000 Aussies...
Now each of these guys are going to be paying around $2500 AUD for the course of 12 injections and they will pay it out of their own pocket, this is why the numbers are a little on the conservative side...if it was Govt backed/Insurance covered and PBS ticked, it would be well north of this 10,000 number even in just 1 year....
10,000 x $2,500 = $25 Million
Now that's good revenue for a starting company in their first year of revenue.....Guys, the excitement is still to come.....listen to this one:
MPS - So by estimates, and they are a little hard to glean, my guess is there are approx 700 or so MPS patients in Australia. How did I come up with that number? See Appendix A.Word of a joint pain reduction solution without side effects will travel fast in the MPS community. It's a tight knit connected group.
Well connected community...word of a FIRST TIME EVER genuine joint pain relief will spread, and quickly.
Not only that but if we piggy back on a big bro pharma then our sales will ramp. For now, let's take just a 10% penetration in the first 12 months. That's 70 patients.
C'mon Mozz, 70 patients is a blimp in the ocean.Not true, read on.
70 x $75,000 = $5,250,000
(Yes $75K, that's what we may be able to charge). A respectable $5.25 Million in one year, add this to the above...we get $30 Million.
MPS might be a touch behind the TGA program...but there could be some timing overlap.The next bit is the best:
If I now simply use this same penetration % and proportion it out to the USA I get the following:70 patients out of 700 in Aus in the first year equates to some1300 in the USA...that my friends works out to be an astonishing $97.5 Million but you forget one thing...Europe....
Europe has about the same number of patients...that's another $97.5 Million...and they are Euros and USD...but let's forget about that in this calc...that brings us to a whopping $225 Million WITHIN 12 MONTHS of beginning these programs? Add this to the 30 Million from above and we are looking like QUARTER OF A BILLION of revenue in the first 12 month!?
Initial % penetration is quite small...but the numbers still add up....and guess what, not a single Global OA revenue $ here!
Paradigmers, just tell me what will year 2 bring? You can easily bump the penetration rate to 15 or 20%...maybe more...word will get out that this stuff really does alleviate your joint pain....at just 15% penetration we are now at $300 Million and how many OA Aus patients in the second year? It could be double the 10 K...20 K would give us some 50 Million...so year 2 might be $350 Million revenue...Our own penetration rates in Aus should be north of the 10 or 15% I'm using, specially after 1 or 2 full years AND given that we will be the ONLY provider of a safe and effective joint pain relief in the world.
A potential deal could happen very quickly in this area specially after the MPS IND. Why? Because whoever partners up with us will have the exclusive rights...they will effectively overnight get a solution that tackles pain along with their own ERT solution in terms of MPS. It will be an exclusive for them and a real advantage over the competition. For us? Mate for us it will be an overnight vast distribution channel....as an example, Biomarin with their Vimizim drug (See also Appendix B below) are present in some 50 countries and in 2019 became the ONLY licensed provider of an ERT in all of China3. According to the same % numbers China may have some 33,000 MPS sufferers! Not saying all of them will necessarily opt for the solution but 3% in the first year is plausible and equates to a massive 1000 patients! I aint factoring in one $ for them either in these calcs and forecasts.
Now all these massive figures aren't a once off...our iPPS solution for MPS is not a one hit wonder...it's ongoing...annual treatment. These figures will be an accumulation as more patients join up every year.All of this without a cent from the Global (ex Aus) OA Program which if all goes well will start in Year 3....Just tell me what Year 4's revenue is going to be and by that time we should have OA global revenue beginning?
Bah...I'm going to call Michael Goldberg, I want to discuss what our SP will be when that EPS hits $25 in 10 years.... Outstanding.
DISCLAIMERS
Disclaimers are always boring...we know we need to be cautious...we know there are risks...we know there can be unforeseen delays, problems and hurdles. I just want you to be aware that there are small chances (my views) that something may fail, there could be a problem, definitely there can be delays...consider it and consider the case where we are not successful though it's so hard to fathom...what if it all comes crashing down....do not find yourself with nothing....alway diversify...come up with other ideas...I would happily give you some but I gotta know your situation and I'm not licensed anyway....and the mods will delete my posts in an instance under the cross post law. DYOR applies.
APPENDIX A
MPS Rough Calc in AusMPS and it's strains occur in some 1 in 25,000 births1. We know the Aussie Birth rate is approx 1.27% 2, this gives us some 318,000 births in Aus....So based on this we can assume there are around 12 that are born with MPS per year...if this is a stable stat then assuming life expectancy of around 50 years, there should be around 50 times this number out in the population, some 636, It might be a fraction conservative as I know the estimated number of MPS sufferers in the USA is around 13,000 that would put our fig around 928...so I'm happy to take a conservative rounded up figure of 700.
APPENDIX B
I don't just pluck figures out of thin air...I want to know the realistic facts and then I dial everything down...I want to use conservative calcs so that when the real data comes through...when the real revenue makes it our way...when we declare profits, well we are pleasantly surprised to the upside.
In this post I have started with just 10% penetration rates and have speculated we may get to 15% in year two...but what is this based on?Vimizim is a treatment by Biomarin, we may partner with them one day but that's a separate topic. They target the ultra rare disease of Morquio A Syndrome. There are just an estimated 1300 of these patients that Vimizim is used for... Don't forget that Vimizim isn't the only Enzyme replacement therapy, Genzyme and Takeda are at least two others that I know that operate in this space. The penetration of Biomarin specifically for Morquio is some 1300 out of a total of 3000 patients...43%....I'm using just 10%. In actual fact once we establish a good partnership with whoever is lucky to be our partner, we will no doubt boost their market share as they will obtain another big plus point from us.
It has been 6 full years since Vimizim got FDA approval...our MPS Joint pain solution may be approved in 1 or max 2 years from now...thus after 7 or 8 years of their product for example, they can add the world's first of joint pain relief to the advantages over their competition of their drug suite. Who will get this first right of refusal? How much will it be worth?
Hundreds of millions of annualised global revenue. All of this without a single consideration of Global OA sales. Compelling? I think so.
REFERENCES1] https://www.mpssociety.org.au/about-the-mps-and-related-diseases/mps-i/#:~:text=It%20has%20been%20estimated%20that,are%20affected%20by%20MPS%20I.
2] https://www.macrotrends.net/countries/AUS/australia/birth-rate
3] https://investors.biomarin.com/2019-06-04-BioMarin-Announces-Approval-of-Vimizim-R-elosulfase-alfa-in-China-for-Treatment-of-Morquio-A-Syndrome
