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New Blog post- Another Backdoor Slider 15 Jul 2013 07:52 #641

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My Computer blew up or better "down" last night, since all power was suddenly lost and whilst I was watching my A´s.

At that time I just had posted the article, which really is the result of 4 weeks research. I HAD TO KNOW- since obviously Cytori is NOT educating their shareholders. Hopefully my PC will be repaired soon, while I do not like the other equipment I have here.

Anyway-

This is a really important article- if you grasp everything in there- you will understand how important CYTX is and what a HUGE Company it will become.

And a lot faster than most people think. Another Backdoor Slider

By the way- the picture is Jarrod Parker throwing another backdoor slider :cool: :grin:
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New Blog post- Another Backdoor Slider 15 Jul 2013 11:47 #644

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Thats a lot of info Fas and I freely admit I had to re-read some sections to make sure I understood what you were trying to communicate...LOL

Of course, for me the reimbursement part has always been the biggie...so I look forward to the next segment. :cool:

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New Blog post- Another Backdoor Slider 15 Jul 2013 12:36 #645

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In general-

the rule of thumb is that it takes three years from market authorization i.e. therapeutic claims on Celution to getting the coding for the DRG lists.
However in between reimbursement is possible too through special programs - the surgeon has to initiate that.

Anyway- my sophisticated guess is that after "certain" partner deals, marketing will start and Cytori will publish some of the to date "undisclosed" data around the achievement of the 6 odd marketing authorizations which are already in the bag.

Your estimates on the time when revenues start building are (for me) totally wrong- the US is kids play and far off - yes- Europe and Japan are just around the corner- say one to two years for significant growth. :nice:
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New Blog post- Another Backdoor Slider 15 Jul 2013 13:05 #646

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***Your estimates on the time when revenues start building are (for me) totally wrong***

Which time and revenues do you mean...perhaps I can clarify or perhaps I must remain totally wrong.

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New Blog post- Another Backdoor Slider 15 Jul 2013 15:33 #647

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LOL - I know you never have been very specific, but have indicated I believe that a lot more money is needed for things to start rolling.

I sniff the inflection point somehere late 2014 or early 2015- meaning 10+mio revenue from that point growing fast.

Time will tell, :bye:

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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:

New Blog post- Another Backdoor Slider 15 Jul 2013 15:48 #648

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Sorry Fas...but 10+ million revenue ?
Arent we looking for 12 million in sales revenue for 2013 ?

However, just going from the dates... yes a serious sales ramp starting in early 2015 would be ahead of what I currently expect.
Japan can be a game changer depending on the number of reimbursed indications by that time and maybe EU follows after that but I will remain conservative for now. Let me see what a partnership can do for us. Let me read what you can tell me about the EU reimbursement process. Excited about the Astellas slide you dug up on regen. medicine with cells but translating that into how steep the ramp will be is a unknown to us all. Let me say I am rooting for your version !!!

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New Blog post- Another Backdoor Slider 15 Jul 2013 15:56 #649

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To be perfectly clear...by serious ramp I am meaning sales make the company self sustaining and earning begin to show on the bottom line.
Stopping CC from burning cash !!!! LOL

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New Blog post- Another Backdoor Slider 15 Jul 2013 18:29 #650

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Very interesting article. Hopefully your views on the Japanese and European timelines are proven true. The potential partnership agreements are also a game changer with regard to market perception, and stock price.

Unfortunately US investors are very insular and seem to think that only developments in their own country are of any value. :KO:
To that extent the ATHENA trial data will be very important in establishing the company's bona fides in the USA. If the data is positive then the fact that approval would only require a rlatively small pivotal device trial will begin to loom large in the investing public's consciousness. That is when they will begin to understand the significance, and similarity of the european device approval process with that of the USA. It will be at that time when they start to see the tsunami of indications being treated in europe that they will start to extrapolate into the US market. :woohoo:

Fas, do you think that there is any chance of the european authorities accepting ATHENA trial data as supporting a CE approval for chronic heart failure indication? A larger trial in five different hospitals will certainly be serious confirmation, pressuming data is similar to that of PRECISE.

Given that the output of Celution is considered to not be a drug and we go down the device pathway an important issue that may/will crop up is that of partnership exclusivity for an indication. EG. assuming we partner with a company that produces a scaffold for wound healing (Olympus/Terumo) what is there to prevent another company using an alternative already approved scaffold along with the Celution device? Will not the "practice of medicine principal" provide cover for interlopers? :winky:

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New Blog post- Another Backdoor Slider 15 Jul 2013 21:04 #651

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Great post. And you said you weren't sharing everything you learned. I would have to say you have learned quite a bit! Again, thanks for sharing.

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New Blog post- Another Backdoor Slider 16 Jul 2013 02:51 #652

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Hedge- sorry I was not clear- I always think in terms of quarters i.e. when will be the inflection point (quarterwise) when gross margin will exceed GASE & interest. Q4 2014 is a likely choice also in view of the "thinking" by Cytori on the loan conditions.

There they negotiated an extension of the interest free period when revenues beat 27 mio from the 2014 mid point looking backwards for a year. On avarage that would be 7.5 Mio and surely they also see a curve by quarter which will go up sharply..... :yep:

With 70-75% margin they would require roughly 13-15 Mio sales for the inflection point therefore. (by quarter)

Lets make it official- my pick is Q4 2014. :vegas:

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New Blog post- Another Backdoor Slider 16 Jul 2013 03:04 #653

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John-

On EU chronic Ischemia- in my mind we have CONFLICTING statements from Cytori here-

I am 100% sure in a call it was stated by Hedrick (I believe) -yes we need more ATHENA data for the market authorization.
Tom however denied that - in an answer to our raccoon lodge questions on the same topic.

Personally I believe it should work- Dendreon´s Provenge was approved on US data, but with additional data mining on sub populations of patients treated. I strongly believe that is the way it should be.

All that duplication that the FDA often wants is simply outrageous and stupid.

Humans are humans regardless of their passport, although its true that certain population groups react differently on medicine.

The whole thing is- there are Brits and Germans and US citizens nowadays of African, Asian and European decent. :bash:

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New Blog post- Another Backdoor Slider 16 Jul 2013 03:14 #654

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John and to all-

THE KEY LEARNING OF THE ARTICLE SHOULD BE TH KNOWLEDGE THAT THE CELLS ARE NOT - I REPEAT - NOT REGULATED: CELUTION IS REGULATED SO THE THE MARKET AUTHORIZATION WILL BE FOR AN APPLICATION - ON CELUTION: All competitors have to start from scratch for each app and CELUTION is IP protected all over the globe.


What more do you want? Is it not nice to play the game of MONOPOLY all by yourself??? :grin: :vegas: :woohoo:
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New Blog post- Another Backdoor Slider 16 Jul 2013 10:40 #655

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Thanks for the clarification Fas...after I posted that I thought maybe he meant Quarterly sales...anyway, now I know.

Taking your sales revenue we are talking 3700 patients treated in a 90 day period for Q4 2014...give or take depending on the product mix. That is steeper than I see for the end of next year as we gear up country by country. Of course I am using treated patient numbers only. Which wont be completely correct.... If we are still selling celution versions at 250K a pop the number of patients needed can be much lower.

Curious what your thoughts are for puregraft sales for the long term once the celution system starts rolling full steam.

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New Blog post- Another Backdoor Slider 16 Jul 2013 12:19 #656

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Fas, point taken. The output is not patentable, but the process is. The patent estate is extensive and will be a huge impediment to competition. As you say, if someone comes up with a better mousetrap they will still have to go through the trial process for each indication/application. :grin:

One issue that has always troubled me is what exactly does the partner recieve .......? Given that the output of Celution is not a drug and is not patentable, an important issue that may/will crop up is that of partnership exclusivity for an indication. EG. assuming we partner with a company that produces a scaffold for wound healing (Olympus/Terumo) what is there to prevent another company using an alternative, already approved scaffold along with the Celution device? Will not the "practice of medicine principal" provide cover for interlopers? :really:

Of course this creates an issue in partnership negotiations, but conceivably validates your monopoly hypothesis. Everyone has to come to CYTX .......... or spend a lot of time and money to circumvent us !!!!!!!! :woohoo: :vegas:

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New Blog post- Another Backdoor Slider 16 Jul 2013 15:01 #657

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One issue that has always troubled me is what exactly does the partner recieve .......? Given that the output of Celution is not a drug and is not patentable, an important issue that may/will crop up is that of partnership exclusivity for an indication. EG. assuming we partner with a company that produces a scaffold for wound healing (Olympus/Terumo) what is there to prevent another company using an alternative, already approved scaffold along with the Celution device? Will not the "practice of medicine principal" provide cover for interlopers


That is a complex question, which I am not sure that I answer with sufficient authority. But I will try

First- "practice of medicine" allows a lot except for the US (as far as I know)- for instance you can do the wound healing procedure in Germany now at a certified clinic, but you cannot advertise it and of course- it is private pleasure. (and from what I have seen, you cannot guarantee it to work and you will not be able to obtain malpractice insurance as a MD)- this would apply to Celution+Terudermis as well as other mousetrap+other scaffold

For your example- I think the same situation would exist- in DRG lists at least what I have seen) the health insurers describe the procedures in detail by stages and name the materials used, which would allow reimbursement depending on some factors- complexity etc. I think the approved materials need to be used in order to get reimbursement.

Interesting question would be- if Olympus names the scaffold the device and use the Celution etc they could get (after going thru clinics) to the same end result.

Since that does not make sense- they better get together and do some serious marketing in the near future I would think. LOL.

Mind you thats what I have been expecting for years- and maybe the money from the secondary will speed up things- although you never know- a rejected "suitor" Terumo and a white knight Sony surely has created headaches for Mr.Sasa. :evil:

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New Blog post- Another Backdoor Slider 16 Jul 2013 15:06 #658

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Hedge- I never followed Puregraft- I believe Celution is an overkill for plastic surgery procedures and cost prohibitive.

I do recall CC saying that at year end they will put a device on the market for larger volume fat grafts, which should have much greater market appeal.

But like Puregraft , I will ignore that device too. :woohoo:

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New Blog post- Another Backdoor Slider 17 Jul 2013 13:57 #659

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fas

Interesting and very pleased you feel SUI will become that kind of a market. My father passed away 10 years ago from prostate cancer, and the last 5 years of his life, the humiliation of having to wear a diaper was almost too much. He never went anywhere after that. Of course the prostate cancer exacerbated his urinary condition, others will benefit greatly from the cure ADRC's will provide. Thanks for the super blog post! :vegas:

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New Blog post- Another Backdoor Slider 21 Jul 2013 10:16 #673

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Fas and Hedge,

I agree we are coming close to being able to forecast quarterly revenues. 2013 guidance suggests we will see a $5+ million product sales 4th quarter. In addition, a good portion of the 1st phase of the BARDA contract should flow into revenues making the 4th quarter total revenues north of $6 million. That, by itself, should indicate a healthy revenue ramp going forward.

Going on the assumption that Cytori will achieve phase II of the BARDA contract, a straight line flow of $56 million over 8 quarters is $7 million in quarterly revenue. It won't work out that way quarterly, but will be more accurate on a yearly basis. These funds go into an escrow account are are dispersed as expenses are incurred. Chris Calhoun is confident phase II will be awarded in the first quarter of 2014. :really:

It is reasonable to conclude that 2014 product revenue will maintain the 2013 exiting run rate and reach $20 to $25 million. The BARDA contract could very well provide roughly $20 million in contract revenue for 2014. Together, we are looking at between $40 and $45 million in revenues for 2014.

Fas, your "official" prediction of positive cash flow in the 4th quarter of 2014 is supported by the numbers available to us at this time. In other words, I agree with you.

The Japanese fast track vote could be a huge event for 2015.
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New Blog post- Another Backdoor Slider 21 Jul 2013 10:23 #674

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click.icptrack.com/icp/relay.php?r=42980109&msgid=191240&act=IT3L&c=1197914&destination=http%3A%2F%2Fjournals.lww.com%2Fplasreconsurg%2FFulltext%2F2013%2F04000%2FComparison_of_Three_Different_Fat_Graft.40.aspx%23

Fas,

I would not ignore Pure Graft. It is a small dollar item, but it also is growing rapidly as the best-in-class product. In the right circles it has value and it is the only USA based source of revenue.

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New Blog post- Another Backdoor Slider 21 Jul 2013 10:45 #675

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Perhaps we could sell PureGraft to a company with the resources to focus on it.

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