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TOPIC: $10 by 2020 stinks

$10 by 2020 stinks 25 Feb 2013 14:04 #197

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CYTX: The Road to Celution – One more CE Mark

Ø Cytori announced this morning that it has received EU approval (a CE Mark) for Intravase, a reagent intended to be used with the Celution System. Today’s news paves the way for physician investigators and academic researchers to safely treat patients with Cytori’s “optimized” adipose-derived stem and regenerative cells (ADRCs) for autologous intravascular delivery.

Ø What is it? Intravase is a sterile, GMP-grade secondary reagent (an enzyme) that is used with the Celution System to prepare the Celution cell output for safe intravascular delivery. We believe the reagent helps the final product avoid any “clumping” (and therefore risks of embolism). Intravase is currently part of the processing systems being used in both the U.S. (ATHENA trial) in patients with refractory heart failure due to chronic myocardial ischemia and in the European (ADVANCE trial)for acute heart attack (STEMI) patients.

Ø It’s not about if or when—it’s about SWOT: Strengths, weaknesses, opportunities, and threats, or the classic pharma analysis on how a new product enters the marketplace. We see Cytori as ideally positioned to be the first company with an approved therapy in cardiology (chronic myocardial ischemia – CMI). We believe this, although it’s not obvious on the surface. Cytori is now in a U.S. Phase II (pilot) CMI study. It is our understanding that the study enrollment is going very well. Cytori could complete enrollment by this summer and have data by year-end 2013. Proof of concept (POC) data in CMI sets the stage for a modest single Phase III study that could result in an approved indication in CMI by 2015/2016, in our opinion. We see the CMI paradigm as a perfect fit for Cytori.

Ø CMI: a blockbuster opportunity. Cytori is competing directly with Baxter (BAX - $67.00 - Not Rated). Baxter is currently in the first of two Phase III studies in CMI; however, we are not hearing positive feedback on the trial. In fact, we believe that Baxter is looking to divest its cell therapy business and the principal investigator may be leaving the company. We also believe that enrollment is slow and that patient compliance has not been perfect. We believe the ease of administration of the cellution system has critical patient convenience advantages, as well as a significant COGS advantage. We estimate the Baxter products will cost upwards of $12,000 per unit, which have to be individually processed (i.e. Provenge) versus Cytori (processed rapidly, on-site, in less than an hour, with a COGS approaching $200 per unit). Unlike Baxter, Cytori is pursuing a PMA pathway (device) and, as such, need only show efficacy (and safety) in one pivotal trial sized for the effect (which we expect will be significant). Hence, we believe Cytori can catch Baxter and not only have a very simple and easy-to-manufacture therapy, but also position itself to be the price leader.

Ø Valuation. Basing the valuation on our assumptions in CMI and STEMI (we see 2020 EPS of $11.19) and discounting back at 30% yields a $10 price target. We note that Cytori is scheduled to report 4Q12 results on March

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$10 by 2020 stinks 25 Feb 2013 14:32 #198

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Roth-

Ø Valuation. Basing the valuation on our assumptions in CMI and STEMI (we see 2020 EPS of $11.19) and discounting back at 30% yields a $10 price target. We note that Cytori is scheduled to report 4Q12 results on March

I will take a small break from spring training baseball (Yanks-O´s)

You definitely require some training in financial analysis- EPS= Earnings per share. For a high flying growing Company folks allow Price/Earnings multiples of 20-50 times -ISRG has 35 at present- this would mean a 2020 valuation of 391,65$, which discounted back to present day value gives you the 10$.

With interest at 2-3% you can understand discounting at 30% takes all risk out of the equation and is the usual analyst cop-out.
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Board moderator and Site-owner. I still regret the day I started analysing the prospects of MacroPore (now Cytori) back in 2004- a left-over from the tech-bubble at that time from the century change in my portfolio- and became addicted to Cytori´s fat cell technology. :cry:

$10 by 2020 stinks 25 Feb 2013 16:33 #201

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roth:
I think the real matter here, assuming all goes well in the trials, is Maxim's timing of events..the approval will be one thing but reimbursement is quite another time consumer then ramping of a market. I simply do not see CYTX hitting these lofty cardiac earnings in the time Maxim suggest.

Fas:
If Maxim is correct about intravase in "avoiding clumping" of cells, it sounds as if it has a effect that a anticoagulant would have....so it gets me to thinking what is to stop the ADRC's from flowing right past the point of injury we want them to repair ? Now, I am sure this has been tested in the pre-clinic but I am simply trying to get a better understanding here. As board "chief science officer" can you help a poster out here ?
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$10 by 2020 stinks 25 Feb 2013 17:03 #203

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Hedge-

No no- that is not what it is for- blood thinner I mean. I am speaking with authority here, since Calhoun explained that all in detail. It does not have a therapeutic or any impact in the patient. It is getting the cells ready BEFORE putting them into the patient, so that they do not stick together or clump.
CC mentioned RNL Bio took their clinics to China and there have been a few fatal cases as a result thereof. At the same time it also tells you how dangerous it is for patients getting treated in the US with them Adistem kits for disorders treated with IV injection. OK does not go directly into the heart, but nonetheless. Risky stuff.

Intravase is highly secret stuff- remember Forgot found the reagent Celase described in a patent application? For this reason Forgot will not find Intravase described in something similar. :cool:

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Board moderator and Site-owner. I still regret the day I started analysing the prospects of MacroPore (now Cytori) back in 2004- a left-over from the tech-bubble at that time from the century change in my portfolio- and became addicted to Cytori´s fat cell technology. :cry:

$10 by 2020 stinks 25 Feb 2013 17:31 #204

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Thanks for the reply Fas...I understand that it isnt a blood thinner...which a anticoagulant is...what I was trying to ask is...
You know what...maybe it is easier if I take intravase out of the equation.

I guess maybe I am confusing myself here...

I do not see it as a issue with direct ADRC injection into a tissue.

My query was in the case of a more general IV administration...it would seem that the "anti clumpimg" aspect would interfer with the homing to the site of a injury. Again, I know this would have been tested but trying to more fully understand it.

Perhaps I am answering my own question with the administration type.

Sorry, if I am not being more clear here again :(

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$10 by 2020 stinks 26 Feb 2013 02:23 #205

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Hedge-
Try it this way (the understanding part I mean)

You have to take the proposition that cells are smart things- they naturally are attracted by sites of injury and willingness to repair tissue, just like iron particles are attracted by a magnet. (called- homing ability)
Now- assume those regenerative cells are trapped in a clot of blood cells which "feel happy" where they are and do not want to go anywhere, so those healing cells are trapped and cannot go to their target to which they magically are attracted (magnet example) - that would reduce the healing i.e. efficacy impact.

Right? :KO:
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Board moderator and Site-owner. I still regret the day I started analysing the prospects of MacroPore (now Cytori) back in 2004- a left-over from the tech-bubble at that time from the century change in my portfolio- and became addicted to Cytori´s fat cell technology. :cry:

$10 by 2020 stinks 26 Feb 2013 06:17 #206

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Thanks again Fas.
Had alot going on yesterday....but finally had more time to think about it over night and your extra help this morning has set me straight.

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$10 by 2020 stinks 26 Feb 2013 10:13 #208

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Fas, I appreciate the finanacial explanation. Technical analysis has proven irrevelevant when it comes to Cytori. Cytori has been nothing but a disappointment and the only thing that will help this compnay is execution and it's ability to deliver on promises, which it has not. JK wanting to protect his a$$ with his disounting methodology is simply more slight of hand. That is all we have at Cytori is slight. of hand no results. As a layman Asendiant's target undiscounted of $3.65 in 12 monthas speaks volumes. it speaks to another year of watsed time and non execution. Based on current rate of failure a $10 target in 7 years seems quite realistic. certainly not 10 times my wildesst dreams.Actuallt Cytori has been my worst nightmare. I leave the techical anaysis to those that enjoy the mental masturbation. While I have the utmost respect for many I have been in contact with and have been in contact with CC, they continue to be Calhouned. mangement sits quiet changing directions again and again with no explanation to shareholders. What do we really expect to hear during march conference call reporting results from the 4th quarter. we already know what happened in the 4th quarter nothing. So we will be subjected to listes to more bable that has become all too repatative. Many may even be waiting to actually make a decisaion on what to do with this investment based on what they hear from this call. Why? what will we hear ? Can we actually put any credibility in anything that we hear. Who in this company actually has any credibility left? I guess we are just left with the fact that the mm's and financial analysts will tou with the dumb reatil investor, manipulatiing pps until like magic it is time for cytori to have it's day. I call bull shit.

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