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TOPIC: Maxim ON Today's EU News

Maxim ON Today's EU News 07 Apr 2015 09:51 #4097

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Maxim Group
EQUITY RESEARCH
COMPANY UPDATE
.
Cytori Therapeutics Inc (CYTX - NASDAQ - $1.32 )
Buy
Target Price: $7.00
Cytori Gets the Go Ahead for China & Gets Orphan Status
Summary:
Cytori announced today that the European Commission, acting on the positive recommendation from the European Medicines Agency Committee for Orphan Medicinal Products, has designated Cytori’s ECCS-50 cellular therapeutic as an orphan medicinal product for the treatment of scleroderma. This designation marks the first autologous adipose derived cell therapy for scleroderma granted orphan status in the European Union (EU).
Cytori announced yesterday that its exclusive licensee, Lorem Vascular, has been granted regulatory clearance for the Cytori Celution System by the State Food and Drug Administration of the People’s Republic of China (CFDA). This regulatory clearance officially makes Cytori’s Celution System available in the largest healthcare market in the world and triggers a substantial 2015 product purchase order for Cytori from Lorem Vascular.
In the U.S., Cytori is about to begin a phase 3 clinical trial with the same product (ECCS-50 therapeutic in 80 patients with scleroderma) associated hand dysfunction. This clinical trial is currently planned to begin enrolling this year with up to 20 sites enrolling patients. This clinical data could also be useful to support regulatory approvals and reimbursement in the EU as well as other global markets.
Details:
What is scleroderma? Scleroderma is an autoimmune disorder that causes skin fibrosis and destructive changes in blood vessels. Scleroderma is a systemic disease that affects the major organs but most commonly causes changes in the skin and hands, often resulting in disability, diminished mobility, and pain. Care is largely palliative and is based on treatment standards for Raynaud’s phenomenon. There are 75,000 scleroderma patients in the U.S. alone, and most have hand manifestations of the disease.

As a reminder, in late 2013 Cytori entered a partnership with Lorem Vascular subsequent to commercialize cell therapy in China, Hong Kong, Malaysia, Singapore, and Australia. Under the agreement, Cytori and Lorem Vascular entered into a long-term supply agreement for a 30-year exclusive license to Cytori's cell therapy for cardiovascular disease, renal failure, diabetes, and all other indications, except alopecia and aesthetics, in the licensed territories. Pursuant to this agreement, Lorem Vascular will pay up to $500 million in commercial milestones and will initially commit to order $7 million in Celution devices and consumables. Lorem Vascular will now place a second "$5 million order" as China approval marks that milestone..

Valuation. We assume Cytori will be successful in scleroderma and multiple other indications utilizing ADRCs (thermal burns, stress urinary incontinence, and osteoarthritis). We apply a 25% risk cut to our therapeutic model and a 30% discount to financial models for FCFF, discounted-EPS, and SOP to arrive at our $7.00 price target.
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Maxim ON Today's EU News 07 Apr 2015 10:03 #4100

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Fas, remember our talk yesterday... it says it is $ amount not number of celutions for China... Interesting, but I am not sure I can trust the numbers.

What do you think?

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Maxim ON Today's EU News 07 Apr 2015 11:35 #4102

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Fas, remember our talk yesterday... it says it is $ amount not number of celutions for China... Interesting, but I am not sure I can trust the numbers.

What do you think?


Analysts cannot work with system units if their spreadsheet is not accommodating to that- so translate to $$$$.

In my mind the key point is- these triggering of contractual orders are meaningless, if it means that Lorem has to store them somewhere in their backyard and there are no customers for them. Important is only when the "pipeline" of units and consumables is flowing due to market demand and not being "clogged" by contractual orders.
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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:

Maxim ON Today's EU News 07 Apr 2015 15:12 #4106

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Fas...you dont think that there will be some study work done in the Lorem areas ?
I understand what you are saying but until approvals and reimbursement its going to continue to be slow going....I am viewing the Lorem order as cash towards the Scleroderma and OA trials....so a small but positive event.

BTW...what ever happened to our clinic in the Philippines ? A big Grand opening then silence !!!

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