Right now there is quite the focus on ARDS and Covid on the forum due to how the covid pandemic has influenced all of our lives, but it's worth having a look at the real "dark horse" that mesoblast has in it's stable, the results so far and potential treatment group that completely dwarfs Covid-19 ARDS.
According to the
CDC there are over 6 Million people in USA now suffering from Heart failure. Over half will die within the next 5 years, and every year another 500,000 are diagnosed with heart failure. It is the
Most Common Diagnosis in patients over 65 of all diagnosis. The yearly death rate was recently 287,000 deaths a year.
The median costs for Heart failure over the lifetime of the patients ( which is typically under 5 years ) varies but figures ranging from
80,000 USD to over 110,000 have been studied. These are Median costs, meaning of the 500,000 yearly patients, 250,000 have payed more, and 250,000 have payed less. It's important to consider how much people are actually currently paying for treatment, to have an idea weather MSB will be affordable to the masses. The data indicates 50% of the entire diagnosed population are currently paying close to 100,000 USD.
How much will Mesoblasts' Generation 2 product be sold for? I have not been able to find any information anywhere giving away even a smidgen of an idea in this area, apart from the basic understanding that Revascor appears to be an MPC cell product, meaning it is less differentiated than an MSC. From the literature I have read, it appears that a lot of the " stem cell" communities have still not agreed on what is an MSC, what is a stem cell and what exactly they all do. Again my understanding here is the less differentiated they are, then the more manufacturing expansions they are capable of.
What did Mesoblasts Phase 3 CHF trial achieve - It was the largest ever recorded double blind clinical trial for Heat Failure and was done in the largest heart center in the USA ( Texas Heart Institute ), who have been studying all kinds of stem cell therapies from mesoblast and all their potential competitors over the last decade or two. As we all know from what Dr Perrin announced, he thinks now what he has seen looks finally like a chance for approval after what he saw demonstrated by the therapy in around 500 patients for over 5 years.
The Revascore treated class 2 heart failure patients demonstrated a 60% reduction in mortality compared with controls over 5 years, which appears to have halted the disease from progressing into class 3 and 4 from class 2.
and
Significant reduction in the incidence of non-fatal ischemic major adverse cardiac events (MACE) due to a heart attack (myocardial infarction, MI) or stroke (cerebrovascular accident, CVA)
by 60% relative to controls in the total population of 537 patients (p=0.002);
Great but what does all this mean for a potential MSB patient. You walk into hospital and get diagnosed currently with CHF, and you have more than a 50% chance of not living past 5 years and it's going to cost you nearly 100,000 USD for soc. Based on MSB results so far, if you elect to receive their one off treatment and you are are a class 2 patient, then the 5 year mortality drops closer to 20% instead of 50%, and for all treatment groups expect a 60% reduction in Heart attacks and strokes along the way.
I don't know about you, but I don't think I know any real people who would accept 50% mortality over MSB's treatment, particularly if they end up being cheaper than the median cost for treatment and offer superior results.
For argument sake, lets say the bottom half could not afford the treatment if it were priced at $80,000, and 50% of the top half who could decide they would rather accept their fate - leaving only 25% of patients treated or 125,000 people.
At a price point of $80,000 MSB would be looking at Yearly revenue of 10 Billion USD, or about the same as CSL.
You can see here the potential upside is absolutely enormous.... perhaps far greater than Covid ARDS and with a disease altering effect observed.
The next questions are when?.... Is the current data enough? ....will EUA be given soon ?. The company has already hinted they believe the results might be good enough for EUA.
If it is given, I think the ability to treat large quantities per year ( over 100,000 ) could definitely be achievable within a decade, considering the COVID 2D ramp up was 10,000 doses within 6 months. I mean they could 2D build 100,000 doses per year if they had to.
I think we are all now eagerly awaiting the NEJM article, the FDA judgement, and if the news comes back good for this one indication with 500,000 potential patients per year. The company is set for life. In my opinion a rise well over double digits will be swift based on what the company could be doing within 5 - 10 years - which in turn would support triple digits easily.
The above contains some facts with some opinions, more than welcome fr anyone to present any sides of the argument here on why it might not grow that fast or in fact debate any of the assumptions or even likelyhood of approval in the first place.
(20min delay)