Go Big or Go Home – Pt.3 – Imetelstat’s Potential Market Size

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Go Big or Go Home – Pt.3 – Imetelstat’s Potential Market Size

Post by kmall » Mon Jun 01, 2020 4:36 am

Go Big or Go Home – Pt.3 – Imetelstat’s Potential Market Size - MDS

The previous 2 posts in this series – well actually 3 – Pt. 2 was split in half, laid out the evidence of a much larger patient population globally for MDS then is now being reported. As a fairly newly recognized Hematologic Disease and the previously discussed short comings with registry, it’s easy to see how a projected $2.5 Billion potential can be greatly adjusted to the upside. Well, just to back track a bit here – the $2.5B is in MDS and MF combined, so in all fairness the argument I presented earlier was solely based on MDS misrepresentations as far as patient populations were concerned. Most of the figures pertaining to Imetelstats revenue stream here will focus primarily on MDS as well. I’ll provide links to all research gathered, and in the end, you can judge for yourself what future revenue potential Imetelstat holds.

For starters, I’m in no way an economist or Wall St. wiz; as I’ve explained from day one. I come here simply as a common investor and former caregiver of a friend who passed away from multiple sarcomas. My background has been a double-edged sword in some ways. The excitement and prospect of Imetelstat being a leader in an Unmet need category has at times blinded my common-sense approach to investing. Clear signs along the way were disregarded during the run up to the J&J CD. It’s easy to play arm chair quarterback now, however, like myself many of my fellow long / investor comrades were also lured into a false sense of security as Imetelstat topped the list of J&J’s future Oncology pipeline; and especially that Janssen job posting for the strategic pricing manager of Imetelstat in Europe, the Middle East, and Africa – posted exactly one month to the day of the J&J meltdown.

J&J 2018 Oncology pipeline - https://jnj-content-lab.brightspotcdn.c ... 2q2018.pdf

Janssen job posting - https://www.fool.com/investing/2018/08/ ... ews-f.aspx

All of this now is deep in the past. My take is that it all boiled down to business. We were lowballed, and Dr. Scarlett knows best what the future financial potential of Imetelstat holds. So does Dr. Rizo, Dr. Gutierrez, Dr. Wan, Sharon McBain, Dawn Bir, Elizabeth O’Farrell, Anil Kapur, Patrick Murphy and all of Geron’s recent hires and newest board members.

Ok, now to focus on the topic of Imetelstats marketplace potential, since that was candidly stressed in Thursdays call in a way that I have not seen since closely watching every public event unfold surrounding Geron for the past 2+ years.

MDS - Myelodysplastic Syndrome Market Size

MDS Drugs Market Size Worth $2.4 Billion by 2022
https://www.grandviewresearch.com/press ... ugs-market

“Emerging markets such as India, China, and South Korea are expected to exhibit lucrative growth during the forecast period due to favorable government policies, rising awareness about hematological malignancies, increased investment, and improved healthcare infrastructure”
“Currently, there are about 45 pipeline drugs in various stages of clinical development. Promising pipeline candidates such as Aranesp, luspatercept, Vyxeos, guadecitabine, and pevonedistat are expected to generate significant revenue upon launch.”

So, notice 2 of the countries mentioned above that I touched on in the previous post – India and China………

Now let’s look at another discrepancy regarding the actual numbers of MDS patients here in the US alone – where registry and diagnosis are most likely more on target – even though we have seen from the previous posts in this series that there is an instance of misrepresentation of up to 40% of the patients diagnosed.

And of even more significance here is the mention of Luspatercept……..we already know how we dominate Luspats efficiency by leaps and bounds. Kind of puts the tick in the tock, eh?

Going back to discrepancies in numbers being registered or misdiagnosed, this 2015 abstract confirms what we know to be the case already.

“MDS prevalence is estimated to be 60,000 and –170,000 in the USA and projected to grow.”

What????.......so we are basing our future financial projections on a patient population here in the US of 60,000?……..here we have definitive proof that, that base number is in fact that. Base. It is most likely 2-3x that. Exactly where we had pinpointed most of these population projections when you start to lay out all of the growing evidence of a booming patient population globally. See why I’m thinking $2.5 Billion in MDS and MF is conservative now? It’s most likely $2.5 Billion just for MDS alone. I wouldn’t be surprised to see the global market size of Imetelstat actually top $5 Billion or more, given all indications applicable and the possible 2 year+ time frame to commercialization if we get a green light through early approvals. Of course, a lot of speculation on my part, but looking at surmounting evidence of escalating patient populations and costs of treatment, it doesn’t seem like that much of a stretch after all.

With the cost of MDS in mind this 2013 abstract goes into financial detail; going as far as breaking down the cost of medicines, outpatient and hospital services. Of key importance with regards towards Imetelstat is:

“ this research on MDS aims to explore the differences in cost and quality in relation to TI and TD status, rather than their absolute values. Table 9 shows that, when passing from the former to the latter, healthcare costs more than double [18], or triple [40], and the costs of drugs go up by two thirds [26]. In particular, resource consumption analysis shows that TD patients are hospitalised more than 3 times as often as TI patients and attend almost twice as many office visits (Table 3). It is also necessary to consider, however, that the greater economic burden of TD patients as compared to TI patients is due not only to the transfusions themselves, but also to the fact that this condition is generally associated with a more severe MDS status and consequently related to a worse prognosis for patients.”

It concludes by stating:

“This literature search demonstrates that the use of new medications able to contain or reduce transfusion dependence could be a rational alternative for healthcare decision-makers at various levels.”

Average cost of MDS treatment per patient / year ($US) – $65,000*
https://ashpublications.org/blood/artic ... dysplastic

*This abstract is one of the most recent and also conservative. The numbers seem to be all over the place in various studies as it pertains to both LR-MDS and HR-MDS. Some studies put an average number of about $56,000 (US) / year just for medications……..which is what category Imetelstat would fall under. It’s difficult to surmise how much Imetelsat would eventually cost per patient annually, but I would assume it would be about half of what is the given average for medication. Now, you have to equate how many patients in the MDS categories would benefit and that would be your ballpark figure. For the US alone I’m guessing well above $1 Billion. Globally we could most likely see another $1.5 - $2B or more, given what we actually know to be a misrepresented patient population in MDS.

Let's continue on with AML and MF in our next post........

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Re: Go Big or Go Home – Pt.3 – Imetelstat’s Potential Market Size

Post by Austin417 » Mon Jun 01, 2020 5:38 pm

"All of this now is deep in the past. My take is that it all boiled down to business. We were lowballed, and Dr. Scarlett knows best what the future financial potential of Imetelstat holds." During a completely random encounter last summer at a college football game, I met a lady who worked on Imetelstat with Dr. Rizo prior to the JnJ discontinuation decision. I only had time to ask her one question, which was: "Is it true that the discontinuation decision was a portfolio/business-based decision?" Her answer: "Absolutely, yes, it had nothing to do with the drug... the drug works." This settled that "controversy" for me, and what we've seen in the last year has only proven it beyond any doubt.

Thank you bp and kmall for all you do. Godspeed!

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Re: Go Big or Go Home – Pt.3 – Imetelstat’s Potential Market Size

Post by kmall » Tue Jun 02, 2020 2:19 am

Austin, thank you for sharing your story with the board. It just goes to validate what I've suspected since first hearing about the discontinuation between the two companies. A FIC drug such as Imet and all of the platforms / indications it may be applicable towards would very well be a "game changer" once efficiency is proven. It's my belief that J&J knew all along about -

"the data which had a cut-off date of October 26, 2018 for the target patient population (n=38) in the Phase 2 portion of IMerge, and included 13 patients from the initial cohort and 25 patients from the expansion cohort. That initial cohort had a median follow up time of 29 months, and the expansion cohort had a median follow up of almost nine months. As of the data cut-off date, median duration of RBC TI had not been reached for the target patient population"

That was taken from a Geron PR - 12-3-2018:
https://ir.geron.com/investors/press-re ... fault.aspx

Many feel that J&J were "played" to a certain extent and had no idea how strong the data was. They were totally "blind-sided" - for lack of a better term - by the data that they had been compiling for 2+ years over the course of the P2 IMerge trial. I say baloney. They knew exactly what Imet was capable of, but underestimated Dr. Scarlett as far as the business side was concerned. Dr. Scarlett wanted a better deal. He knew from the Janssen team he was in contact with that "Imetelstat would be approved" - those are his words from the 2019 Needham Conference. Point blank. That CC was the strongest I've heard him yet and to be able to poach the Strategy and Compound Development Lead, Clinical Oncology R&D - Dr. Aleksandra Rizo - speaks volumes. She worked at J&J (Janssen) for 9 years. When you actually look over her resume, she leaves Janssen in March of 2018 and goes directly to Celgene.....hmmmmm.....(that's a whole nother connect the dots twist)

Guess what else happened in March 2018.........Dr. Scarlett raised additional funding to prepare for the inevitable J&J meltdown. Hmmm?? Coincidental?? Without that round of funding we would have been vaporized. I was planning on doing an entire chain of event / who done it Pharma Biotech "summer thriller" read called "The Scarlett / Rizo Connection" on the YMB for any of us GERON-imos interested in twists and turns with plenty of suspense thrown in....it would be more or less, my take on it, based on facts gathered. But for any of us following this story and how it’s played out, I think it would raise a lot of questions - heavy on speculation, but the more you think about it......anyway, I'm kind of busy in real life so for now it's merely an outline. Well thanks for the feedback and so happy for you to tell us about a real-life encounter with someone on the front lines. All the best. -Kmall

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Re: Go Big or Go Home – Pt.3 – Imetelstat’s Potential Market Size

Post by biopearl123 » Tue Jun 02, 2020 2:29 am

Austin, first off, Semper Fi and thanks for sharing your story. I recall your posting that on SA several months ago. To kmall's timeline. I always wondered if Dr. Rizzo has a non compete clause that prevented immediate employment by Geron so some employment time was spent elsewhere while waiting. Its clear she has wasted no time after coming to Geron. bp

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Re: Go Big or Go Home – Pt.3 – Imetelstat’s Potential Market Size

Post by kmall » Tue Jun 02, 2020 2:48 am

Andrew, or perhaps she was directed to Celgene to take a look under the hood of Luspat? You know how Dr. Scarlett has a car thing going on.....

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Re: Go Big or Go Home – Pt.3 – Imetelstat’s Potential Market Size

Post by bucbeard » Tue Jun 02, 2020 2:34 pm

Applying that same logic, JnJ then legitimately remains a player for partnership or acquisition of Geron and Imetelstat in the future.

Personally, I have felt this since the day of discontinuation. This is about "we have other fires to fight at the moment. here are our resources; prove it to us, and we will return to move forward under different terms."

They aren't walking away from this, not after the PCYC Pharmacyclics embarrassment.

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Re: Go Big or Go Home – Pt.3 – Imetelstat’s Potential Market Size

Post by Austin417 » Tue Jun 02, 2020 5:58 pm

You bet, kmall. The lady's daughter and my girlfriend's daughter were roommates, so IMO that further legitimizes what she shared. For her protection I'll stop there.

bp - Semper Fi!

buc - YES, I'd recently asked myself the same question: did JnJ steer their talent to Geron in order to guarantee success so they could capitalize later? Interesting theory...

Gotta go, more later.

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