Because Rickey the G-D CEO was in charge of compensation before he became ceo and authorized the over payment of all these overpaid managers. Shores should have been long gone and as revenues fell short due to lack of sales no matter how they spin it the buck should stop somewhere an Shores should be held accountable. Thing is nobody in upper management is held accountable for anything. They get paid big, get big options and continue to fail to deliver. They should all benefit when we do and that is when the G-D PPS rises to respectability.
Well looks like I was righ and with market closing in less then a hour lower then I thought but maybe a bounce before close. Doesn't really matter is this is just the traders having a field day. Cytori has become predictable. It hit $3.25 day before call as I had written back in Feb sold off profit taking by traders. Now sell off by new investors that bought in on the hype. Rinse wash repeat. We go down a few days and hopefully back up above $3 so the traders and shorts win again. Cytori not for the faint of heart and aggavating as hell for us long term Cytori stuckhiolders
Bundle the above is a Maxim report. written by Jasomn Kolbert if you listened to yeserday call you heard him ask a question. On Roth I just listened to the presentation and there was nothing new from yesterday. Unfortunately we were not taken to the breakout room to listen to Q&A. There is a regular poster on the YMB who was at the Roth conference so maybe he will post later.
ATHENA: Designed to optimize the path towards approval. Endpoints that might be possible in a pivotal program could include functional QOL endpoints (versus mortality and rehospitalization trial endpoints). This would translate into faster, smaller trials and a quicker path to market. We believe this is a direct result of the unique device pathway that Cytori is pursuing, which is not an option for competitors in this space.
3. BARDA: Cytori has met its three key milestones and submitted to BARDA. These include the development/validation of a next generation system, demonstrating that exposed patients (burns and radiation) can supply cells (their own cells) and show efficacy in the target indication (burn repair). The next tranche of revenues from BARDA could equal $56M and, as such, would be transformative for the company, but we recognize that much of the funds will go to pay for clinical work.
4. Sports medicine: The RECOVER trial. Cytori is now FDA approved to expand the RECOVER trial to a multi-dose, multi-center, double-blind, placebo-controlled trial. Cytori’s RECOVER trial will evaluate patients with Grade II tears of the hamstring muscle. RECOVER will initially enroll 10 patients in the United States. The first 10 patients will be given one of two doses of cell therapy (open-label), with the first five patients receiving the lower dose and the second five patients receiving the higher dose. Once the safety and feasibility of administering the therapy is confirmed in the first 10 patients (Part A), Cytori has the option to expand RECOVER to include an additional 60 patients in the multi-center, double-blind, placebo-controlled phase of the trial (Part B). The 60 patients would be divided into three groups of 20 patients. Patients in the three groups will receive a lower dose, a higher dose, or the placebo. The study will assess safety and tolerability and evaluate the effect of the cells on how fast the muscle tear heals (ultrasound and MRI), muscle strength, muscle function, and pain. The timeline to complete the first phase of the study will be provided once the trial is initiated and Cytori is able to forecast enrollment.
5. The competitive landscape is actually helping. Only one competitor has begun a phase III trial in the cardiovascular space (but that trial is large and should take some time—two or more years—to enroll), so the gap between PII and PIII has not widened while ATHENA was delayed. Again, the delay may actually be okay, as we believe it is a result of Cytori carefully planning and building the infrastructure to run a larger pivotal program.
6. Japan is coming. Having operated in Japan for a decade, we believe that Cytori has ideal positioning to capture what may be one of the largest opportunities in the cell therapy space as fast-track regulations emerge that may allow therapeutic approval’s based on a single modestly powered trial.
7. China too: Lorem will also be in a position to open up China, Singapore, and Australia.
8. Good data in the cell therapy landscape could trigger a gold rush. A wide range of data results and related clinic events should play out over the coming year. These include: Proof-of-concept studies in stroke and ulcerative colitis are coming up on results from three Phase II trials. Four pivotal trials in GvHD, CHF, DDD, and fusion are set to begin. Other trials in exciting areas such as AMD and spinal paralysis should complete enrollment and may have top-line data in 2014.
We believe the net result will be for investors to begin to ask: If this company has good data, what else exists in the space?
Valuation. Basing the valuation on our assumptions in CMI (we expect 2020 EPS of $11.04) and discounting back at 30% yields a $10 price target.
A Few Key Points that Investors Should Consider:
1. Cytori raised $24 million at $3.00 a share (a significant premium) last year—a good raise that has other benefits. Cytori’s revenue line should build now as a result of the Lorem partnership, and this build should help finance the clinical programs, which we ultimately see as the principal value driver for the company.
2. The timeline for ATHENA is now on track. Based on our discussions with the direct managers responsible for the sites, we believe the company is executing a great phase II trial that can be used to leverage into a pivotal trial. All eight sites are screening patients, and the 23rd patient has now been enrolled (it’s approximately halfway completed). Enrollment could complete by Q2/Q3-2013. Top-line data could arrive in early 2015. ATHENA II has already begun enrolling patients in parallel with ATHENA I, keeping the momentum going and paving the way for a pivotal program for the company.
We remain focused on ATHENA as the principal driver. Recall that ATHENA I is an N=45 PII study at eight centers, most of which are now up and running. ATHENA II has also begun to enroll an additional 45 patients (high dose) at 10 centers. ATHENA I is expected to complete enrollment by this summer. Critical for investors to understand is that Cytori still has certain strategic advantages in the race (based on the regulatory pathway and what will be determined as the acceptable endpoints for the trial) to be the first approved cell therapy for cardiovascular disease, although the window is closing. We are excited to watch the progress.
ATHENA: Designed to optimize the path towards approval. Endpoints that might be possible in a pivotal program could include functional QOL endpoints (versus mortality and rehospitalization trial endpoints). T
Cytori Quarterly Update and 2014 Outlook
Ø Cytori reported total revenues for the full year of $12.2 million. For 4Q, product revenues were below our expectations at $2.7M (we had expected a year-end ramp of $7M); however, we note that product revenues excluded $3.6 million in shipments to customers in 2013, which are expected to be recognized as revenue in 2014. Cytori ended the year with $15.5 million of cash and cash equivalents and $4.2 million in accounts receivable. In January 2014, Cytori received an additional $9 million upon completion of the second closing of the previously announced Lorem Vascular stock purchase agreement. With a potential BARDA award pending and clinical trials now enrolling, we believe 2014 could be a major year of transition for the company. Please see our comments on the next page.
2013 and Year-To-Date Highlights: (from Cytori):
o Activated enrollment in all eight ATHENA sites and first ATHENA II site
o Achieved all three planned contract milestones related to BARDA contract
o Achieved FDA Investigational Device Exemption (IDE) approval for a hamstring injury clinical trial
o Received Intravase CE Mark approval to enable vascular use in the EU
o Received marketing approvals for the Celution System in Australia, Serbia, and Singapore
o Divested non-core Puregraft product for $5 million upfront and up to $10 million in future royalties
o Formed commercialization partnership with Lorem Vascular
o Refinanced term loan to extend maturity to 2017
2014 Operating Goals: (from Cytori):
o Complete ATHENA enrollment and make substantial enrollment progress in ATHENA II (both trials have begun)
o Publish long-term outcomes from European PRECISE trial
o Advance BARDA contract into the next phases, including a U.S. feasibility trial and expanded research and development
o Achieve approval for the Celution System in China
o Grow research product sales in existing and new markets through new partnership
i am in. not buying hold re:evaluate May my expectation would be at least date announced for Barda review assuming positive review this month by FDA. I want to see some credibility on timeline outlined in call. i would like to know what is going on with publication of precise data it is late based on mgt. timeline which has moved out no mention of partnership but not an issue with 56 million pay out over say 2-3 years
Do we close with a 2 or 3 tomorrow as we hurry up and wait. as i said revenue pushed to 1st qtr to make up for shortfall. fda meet this month which is sooner then I thought by a month. Barada is the deal breaker so the bet is on do they get the 56mil or not. Short position will tell , mgnt seems positive but scared this is make or break regardless of all else on the table. this will be soonest catalyst and not getting this funding causes all sorts of problems and would be a major set back. I think they get it so holding but have too much skinn in the game to increase my bet. decrease on a decent bump perhaps on some cheaper shares. i thinks tomorrow you see $2.90 . hope i am wrong will relisten to call. no need to thumb down please just offer your opinion and why
March 09-12, 2014, Dana Point, California
ROTH OC Growth Conference
The above was cut and pasted from Cytori site so it means you did not look in the right place.
it can't be. if you go back to same time last year they missed the number. it was explained away that as revenue was generated in japan. japan accounting applied so revenue would roll it q1. based on guidence from CC they should make the number without this and this will be accounted for in Q1 or whenever shipment and payment occurs. Using it to make up for a shortfall would be a disappointment.
thumb me down but don't shoot the messanger. i don't like it either but is is what it is and sometimes the truth hurts. deal with it.
I expect them to make the number and also give good guidance. Perhaps I am giving CC too much credit but.. Earnings call purposely scheduled day before roth conference. Good call with a surprise, perhaps barda scheduled meeting and comment on fda guidance. This allows them to say at Roth conference follow up on how this announcement will propel them to success. all the new opportunities. No way they would be answering questions in a breakout at Roth, they want to be speaking positive. For the traders I think you easily have .50 before the 11th.
thubs down on my post from the village idiot chuckles but it's friday and look what happened just as I said. Same next Friday as well. Traders are the winners here. New investors buying in and learning what its like to be Cytori shareholder. Next week another bonaza for the traders followed by March 6 conference call offering nothing new. look out for the roll back in PPS.