Welcome, Guest
Username: Password: Remember me
CYTX Financial performance development
  • Page:
  • 1

TOPIC: Q2 Reported Financials & OA results

Q2 Reported Financials & OA results 04 Aug 2016 15:36 #7532

  • fas
  • fas's Avatar Topic Author
  • Away
  • Moderator
  • Moderator
  • May the fat be with you
  • Posts: 3295
  • Thank you received: 1110

Cytori Reports Second Quarter 2016 Business and Financial Results
Aug 04, 2016
SAN DIEGO--(BUSINESS WIRE)-- Cytori Therapeutics (NASDAQ: CYTX) (“Cytori” or the “Company”) today announced its second quarter financial results and provided updates on its corporate activity and clinical development.
Second quarter 2016 net loss allocable to common stockholders was $6.4 million and $0.43 per share. Cytori continues to tightly manage its operating cash burn, spending approximately $5.7 million in the second quarter 2016. Cytori ended the second quarter of 2016 with $20 million of cash and cash equivalents.
“In the first half of the year, our team has advanced our development pipeline in the U.S. in multiple indications, most notably completing enrollment in our Phase 3 trial in scleroderma. Additionally, investigator-initiated studies are progressing in Europe and Japan, and we have continued to lay a sound foundation for early clinical adoption and profitable revenue growth in Japan and Europe, which can provide near-term revenue and importantly build longer-term strategic value,” said Dr. Marc H. Hedrick, President and Chief Executive Officer for Cytori. “Corporate milestones over the next twelve months include the first readout from our US phase III scleroderma trial in mid-2017, the initiation of an externally funded clinical trial in burn patients later this year, treatment of the first scleroderma patients as part of our compassionate use program, and Japanese revenue growth.”
Select Recent Highlights:
Enrollment completion of US STAR phase III trial for scleroderma hand dysfunction
Report of 48-week US pilot/phase IIb ACT-OA trial preliminary topline data
Limited regulatory approval received by a Cytori customer regarding use of Cytori® Cell Therapy™ for osteoarthritis of the knee at its clinics in Japan
Completion of rights offering for gross proceeds of $17.1 million
Broad orphan drug designation granted by European Commission, and small or medium-size enterprise (SME) status granted by European Medicines Agency
Q2 and Year-to-date 2016 Financial Performance
Q2 2016 and year-to-date operating cash burn of $5.6 million and $10.7 million, compared to $4.8 million and $9.8 million for the same periods in 2015, respectively.
Cash and debt principal balances at June 30, 2016 of approximately $20 million and $17.7 million, respectively.
Q2 2016 and year-to-date total revenues of $2.8 million and $5.7 million, compared to $3.5 million and $5.8 million for the same periods in 2015, respectively.
Q2 2016 net loss allocable to common stockholders of $6.4 million or $0.43 per share, compared to a net income of $4.5 million or $0.45 per share (or a net loss of $8.7 million and $0.94 per share when excluding a non-cash credit charge of $13.1 million related to the change in fair value of warrant liabilities) for the same period in 2015.
Year-to-date net loss allocable to common stockholders of $11.7 million or $0.84 per share, compared to $18.2 million or $2.22 per share (or a net loss of $15.2 million or $1.86 per share, which excludes a non-cash charge of $2.3 million related to the change in fair value of warrant liabilities and a beneficial conversion feature charge for convertible preferred stock of $0.7 million) for the same period in 2015.
“We reduced our net losses by over 25% from Q2’15 to Q2’16, despite substantial development progress that includes completion of enrollment in our U.S. Phase III scleroderma trial,” said Tiago Girao, VP of Finance and CFO of Cytori Therapeutics. “Our current projections indicate that the net proceeds from our Q2 financing activities coupled with ongoing downward pressure on expenses coupled with revenue growth, will provide liquidity for at least the next 12 months of operations.”
Summary of ACT-OA trial and topline 48-week results:
The ACT-OA trial was a randomized double blind phase II trial comparing a single administration of either low or high doses of ECCO-50 autologous cellular therapeutic placed into the intraarticular space of one knee in 94 patients with knee osteoarthritis of moderate severity. This pilot trial was designed to establish safety, feasibility and explore a number of efficacy endpoints for a more definitive trial with appropriate statistical powering. Topline results concluded:
Intraarticular application of a single dose of ECCO-50 is feasible in an outpatient day-surgery setting; no serious adverse events were reported related to the fat harvest, cell injection or to the cell therapy.
Consistent trends observed in most secondary endpoints at 12, 24 and 48 weeks in the target knee of the treated group relative to placebo control group; as reported in Q1, 12 week primary endpoint of single pain on walking question did not achieve statistical significance.
Consistent trends observed in all 6 pre-specified MRI Osteoarthritis Knee Score (MOAKS) classification scores suggesting decrease in target knee joint pathologic features at 48 weeks for the treated group relative to placebo control group.
“The safety and feasibility goal of this first trial in OA was substantially achieved,” said Dr. Mark Marino, Cytori Senior Vice President of Clinical Affairs. “Additionally, even though this first randomized controlled trial was not statistically powered to test for a specific therapeutic hypothesis, it showed evidence of a potential cell effect including in the joint imaging data. Further analysis is ongoing on specific patient subsets and in-depth anatomic assessment of the MRI data.”
Anticipated Forthcoming Milestones:
Clarity for European Union Conditional Market Approval in scleroderma hand dysfunction
File IDE and obtain approval for burn wound therapy trial related to contract with BARDA (anticipated in 2016)
Report of 48-week US pivotal/phase III trial data for scleroderma hand dysfunction
2016 Reiterated Financial Guidance
Operating cash burn within a range of $18 million to $20 million
Total revenues (product and contract) within a range of $12 million to $14 million


As usual - I am off to bed and will look at the transcript tomorrow- any comments before that are appreciated. :grin:

Please Log in or Create an account to join the conversation.

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:

Q2 Reported Financials & OA results 04 Aug 2016 15:43 #7533

  • Wall Street Titan
  • Wall Street Titan's Avatar
  • Offline
  • Platinum Boarder
  • Platinum Boarder
  • Posts: 873
  • Thank you received: 148
OA data certainly do not indicate stellar results:

"Consistent trends observed in all 6 pre-specified MRI Osteoarthritis Knee Score (MOAKS) classification scores suggesting decrease in target knee joint pathologic features at 48 weeks for the treated group relative to placebo control group.
“The safety and feasibility goal of this first trial in OA was substantially achieved,” said Dr. Mark Marino, Cytori Senior Vice President of Clinical Affairs. “Additionally, even though this first randomized controlled trial was not statistically powered to test for a specific therapeutic hypothesis, it showed evidence of a potential cell effect including in the joint imaging data. Further analysis is ongoing on specific patient subsets and in-depth anatomic assessment of the MRI data.”"

This was a PHASE II and all they seem to have is trends. Showing Safety and feasibility was expected and a non event for this simple procedure. I said it before... I think they may have dosed too low.

Please Log in or Create an account to join the conversation.

Q2 Reported Financials & OA results 04 Aug 2016 22:19 #7536

  • myownhedgefund
  • myownhedgefund's Avatar
  • Offline
  • Platinum Boarder
  • Platinum Boarder
  • Posts: 2760
  • Thank you received: 199
Call starts right out with Kesten departure 'retiring"
I remember a CEO that "retired"

A unexpected note was filing for FDA orphan drug approval for scleroderma as they expect a multiple treatment system may develop and it would fit a orphan protocol. They expect to hear from the FDA rather soon but no exact time table given.
Sclerodac 2 enrolling more slowly than expected. May effect projected completion timeline but not approval filing as they expect to use USA data as well.

OA
I am going to give a small tip of the hat burying this within the overall conference call rather than making it a separate release where the full focus would be on what I consider sad results.( Mr Kesten ????) Anyway hints, tweaks, data reevaluations blah blah blah.
Two points that I will mention and then readers can add additional comments if they chose.
1. No difference between 20 or 40 million cell doses.
2. It take 48 weeks to show minor hints on MRI....yes nearly a year.
NOT impressive by a long shot imho.
JK tries to save them later in the Q&A part with a what endpoint would they use going forward question.?

UI
Still expect data in 2018
Zzzzzz !!!

BARDA
Looking for late 2016 trial approval from FDA to enroll 45 patients by mid 2017

Financials
A year of cash left
Olympus debt paid off
sales up 200K quarter over quarter

Harris comments
I will give this guy one thing. He is clear, concise, and easy to understand. I still cant get past that his voice sounds like its JK's brother.....LOL
MAP / IDIS applied to all 38 countries and have heard back from 17
Of the 17, 9 have given the green light, 4 want more info, 4 small countries say no basically. Still waiting for the balance to respond.
Can we get the numbers we need?....yet to be seen ! (my comment here obviously)
Japanese asthetics market grew at 160% clip year over year although still small....a nice tidbit but kinda meaningless when we are still talking TOTAL product sales of 1.1 million for the quarter. (also some personal interjection)
China / Lorem...Lorem still in arrears. No real other news here and no real progress reported. They may be able to monetize some of the areas.

Q&A was very short, nothing of merit imho.

My comments:
Execution risk remains high. IDIS really needs to come through and right now things are about a quarter behind from previous management expectations. OA was a mess. They are trying to salvage something from the data....imho it was another poor trial design !
Right now we are a scleroderma company. Branching this into a multi treatment therapeutic could make up for a lot of misteps with big revenue potential. Sadly, we also have to keep in mind this is Cytori and if there is a poop pile to step in, they will find it.
They are calling for late 2018 break even...I think that puts the lid on any chance of 2017 profitability.
I am expecting ATM to come into play in 2017.
I think that is it....fairly tired tonight but I believe I got it all straight.
Look forward to comments from others !
The following user(s) said Thank You: fas, Joncon63, Old Young Fox

Please Log in or Create an account to join the conversation.

Q2 Reported Financials & OA results 05 Aug 2016 06:59 #7537

  • DOV
  • DOV's Avatar
  • Offline
  • Platinum Boarder
  • Platinum Boarder
  • Posts: 347
  • Thank you received: 194
I do remember reading in the 2015 10K that Stephen Kesten's bonus and salary had been reduced by a substantial amount in the 4th quarter as a result of requested personal time off. Frankly, I forgot to inquire further.

Please Log in or Create an account to join the conversation.

Q2 Reported Financials & OA results 05 Aug 2016 08:40 #7538

  • Wall Street Titan
  • Wall Street Titan's Avatar
  • Offline
  • Platinum Boarder
  • Platinum Boarder
  • Posts: 873
  • Thank you received: 148

I do remember reading in the 2015 10K that Stephen Kesten's bonus and salary had been reduced by a substantial amount in the 4th quarter as a result of requested personal time off.


..and I remember a Dr. Dizon was expecting Kesten to show up at a meeting with Philippine authorities to try and get approval to open up a stem cell clinic and he didn't make the meeting because of last minute passport problems according to Dr. Dizon. What an unprofessional disgrace. I don't know the exact details but Marc should not be speaking glowingly about him.

Please Log in or Create an account to join the conversation.

Q2 Reported Financials & OA results 05 Aug 2016 08:44 #7539

  • fas
  • fas's Avatar Topic Author
  • Away
  • Moderator
  • Moderator
  • May the fat be with you
  • Posts: 3295
  • Thank you received: 1110
Thanks Hedge for the trouble. I read the Seeking Alpha transcript this morning, but Had a lot of understanding/comprehension issues, maybe due to the SA texting or the clearness of the presentation. As usual I am very unhappy with the level of detail of the provided information - but that is nothing new.

Its my plan, to listen to the CC for a change, but am afraid that I fall asleep when I start listening to the "inspiring" Marc Hedrick, so I wait for that when I am fit sometime this week-end. As said- there are a few things I do not understand, especially in matters OA. And especially there the level of detail provided was really appalling- all just very general stuff, so that it is assured that we are still as clueless as we were before the call.

Anyway- they put a nice image on the front page today-



On Steven Kesten. He should be 58 right now - you see him on the picture in the back on the right side. You never know with folks- burn-out or severe psychological issues on top of a whole lot of other nasty things, can occur at any age. So maybe he retired or was let go. It doesnt matter, nobody of us had the chance to get to know him, so it is what it is.
Attachments:

Please Log in or Create an account to join the conversation.

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:

Q2 Reported Financials & OA results 05 Aug 2016 09:34 #7540

  • fas
  • fas's Avatar Topic Author
  • Away
  • Moderator
  • Moderator
  • May the fat be with you
  • Posts: 3295
  • Thank you received: 1110
This Mark (again? :whistle: ) Marino has a very very impressive CV. This is a high caliber professional similar- or even exceeding from my perspective- the level of Harris, who I see as a good candidate to succeed Hedrick (hopefully soon)

Details can be read here: LinkedIn Profile Marino




Drug Development professional with experience spanning preclinical research, first in man, experimental medicine, phase 2 and phase 3 studies. Leadership experience includes large international groups as well as being an individual contributor within small biotech organizations.

Associate Professor in Internal Medicine at large teaching hospital and medical university (USUHS)
Head, Pharmacology Laboratory at Walter Red Army Institute of Research (WRAIR)
Head of Clinical Pharmacology at Eisai and Roche
Head of Research and Early Development at Mannkind
VP Clinical Development at Daiichi-Sankyo

Attachments:

Please Log in or Create an account to join the conversation.

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:

Q2 Reported Financials & OA results 05 Aug 2016 09:58 #7541

  • myownhedgefund
  • myownhedgefund's Avatar
  • Offline
  • Platinum Boarder
  • Platinum Boarder
  • Posts: 2760
  • Thank you received: 199
***VP Clinical Development at Daiichi-Sankyo***

Hmmmm.

Please Log in or Create an account to join the conversation.

Q2 Reported Financials & OA results 05 Aug 2016 10:50 #7543

  • franshei
  • franshei's Avatar
  • Offline
  • Platinum Boarder
  • Platinum Boarder
  • Posts: 788
  • Thank you received: 102
FAS,

I visited Sankyo's NYC office several times - very low key, most decisions are made in Japan. (However, I had good memories of the site president, who took me to Waldorf at times.) Sankyo had a collaboration with the duPont Company many years ago, when I was there for 5 years. I had a daily working relationship with Sankyo during that time.

I think Marino's move to CYTORI is a good one. He will do a better job than Kesten, as Marino's background and experiences fit much better.

Walter Reed had a discovery and clinical development program for radioactive protection and treatment for years. They may also have a burn treatment center, as in Brook Military Base in Texas. Mario may have some hand on experiences pertinent to the CYTORI BARDA contract, as a well as any wound healing indication. I think CYTORI will expand the clinical r/d pipeline in the US, beyond scleroderma and thermal burn treatment. Mario is basically a clinical pharmacologist and phase 1-2 trials are really his expertise, while Kesten is more in general medical affairs. Of course, Mario is more than a phase 1-2 doctor, Sankyo is more in phase 3-4 (NDAs and post NDA).

Talking about lack of details in Hedrick's talk - believe me, most MDs talk this way, while many discovery and preclinical scientists are not.

Please Log in or Create an account to join the conversation.

Q2 Reported Financials & OA results 05 Aug 2016 12:38 #7544

  • fas
  • fas's Avatar Topic Author
  • Away
  • Moderator
  • Moderator
  • May the fat be with you
  • Posts: 3295
  • Thank you received: 1110

franshei wrote: FAS,

I visited Sankyo's NYC several times - very low key, most decisions are made in Japan. Sankyo had a collaboration with the duPont Company many years ago, when I was there for 5 years. I had a daily working relationship with Sankyo during that time.

I think Marino's move to CYTORI is a good one. He will do a better job than Kesten, as Marino's background and experiences fit much better.


Franshei-

We have the somewhat awkward situation that investors have zilch confidence in Cytori- evidenced by the 40 Mio market cap. But that pretty high level executives sitting just one or two steps below CEO level at MUCH higher valued companies decide to go to Cytori with the chance that it might not look good on their CV at a later point in time?

Or could it be just the other way round? :whistle:

Please Log in or Create an account to join the conversation.

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:

Q2 Reported Financials & OA results 05 Aug 2016 12:52 #7545

  • blackisle
  • blackisle's Avatar
  • Offline
  • Fresh Boarder
  • Fresh Boarder
  • Posts: 7
  • Thank you received: 0
Maybe they offered him enough money to make it worth the risk.

Please Log in or Create an account to join the conversation.

Q2 Reported Financials & OA results 05 Aug 2016 13:18 #7546

  • fas
  • fas's Avatar Topic Author
  • Away
  • Moderator
  • Moderator
  • May the fat be with you
  • Posts: 3295
  • Thank you received: 1110

blackisle wrote: Maybe they offered him enough money to make it worth the risk.


Corporate salaries for the top brass are generally reported and known. We will know Marino`s compensation package also when the form 14`s are filed. I assure you as a former corporate person, you do not go for the salary to a Mini-mini-mini-cap.

But for the prospects and the options.

Please Log in or Create an account to join the conversation.

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:

Q2 Reported Financials & OA results 05 Aug 2016 15:43 #7548

  • Wall Street Titan
  • Wall Street Titan's Avatar
  • Offline
  • Platinum Boarder
  • Platinum Boarder
  • Posts: 873
  • Thank you received: 148
The big question for shareholders is why they didn't get better results on the OA Knee trial. A few thoughts:

1) Dosing too low.
2) Need some kind of cellular matrix/ gel to hold cells in place.
3) Variability of stem cell quality by patient? Are some patients ADRCs better than others? Is age a factor?
4) Is much of knee pain psychological in nature. See John Sarno , a genius imho. ...and I know this first hand with my wife's experience and my own to a lesser extent.

I've been saying for some time that stem cell clinics could remain viable based on the placebo effect along with savvy marketing and that seems to be the case at this point.

Any other thoughts?

Please Log in or Create an account to join the conversation.

Q2 Reported Financials & OA results 05 Aug 2016 15:52 #7549

  • fas
  • fas's Avatar Topic Author
  • Away
  • Moderator
  • Moderator
  • May the fat be with you
  • Posts: 3295
  • Thank you received: 1110

fas wrote:

blackisle wrote: Maybe they offered him enough money to make it worth the risk.


Corporate salaries for the top brass are generally reported and known. We will know Marino`s compensation package also when the form 14`s are filed. I assure you as a former corporate person, you do not go for the salary to a Mini-mini-mini-cap.

But for the prospects and the options.


See to nights 8K-

Cytori Therapeutics Announced Inducement Grant for New Employee
Aug 05, 2016
SAN DIEGO--(BUSINESS WIRE)-- Cytori Therapeutics, Inc. (NASDAQ:CYTX), a late stage cell therapy company developing autologous cell therapies from adipose tissue to treat a variety of medical conditions, announced today that the Compensation Committee of the Company's Board of Directors granted to Mark Marino, M.D., Senior Vice President of Clinical Affairs, a non-qualified stock option to purchase an aggregate of 33,333 shares of the Company's common stock (the “Option Shares”) with a per share exercise price of $2.18, the closing price of Cytori’s common stock on August 4th, 2016, the date of the grant. The stock option has a ten-year term and vests over a period of four years, with one quarter of the Option Shares scheduled to vest on May 23, 2017 (the first anniversary of Dr. Marino’s employment commencement date with Cytori), and the remainder of the Option Shares vesting over the ensuing three years in thirty-six (36) equal, consecutive, monthly installments, in each case subject to Dr. Marino’s continued employment with Cytori as of the respective vesting dates. The stock option is subject to the terms and conditions of Cytori's 2015 New Employee Incentive Plan and the stock option agreement pursuant to which the stock option is granted.
The stock option was granted as an inducement material to Dr. Marino’s entering into employment with Cytori in accordance with NASDAQ Listing Rule 5635(c)(4).

Please Log in or Create an account to join the conversation.

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:

Q2 Reported Financials & OA results 05 Aug 2016 16:01 #7550

  • fas
  • fas's Avatar Topic Author
  • Away
  • Moderator
  • Moderator
  • May the fat be with you
  • Posts: 3295
  • Thank you received: 1110

Wall Street Titan wrote: The big question for shareholders is why they didn't get better results on the OA Knee trial. A few thoughts:

1) Dosing too low.
2) Need some kind of cellular matrix/ gel to hold cells in place.
3) Variability of stem cell quality by patient? Are some patients ADRCs better than others? Is age a factor?
4) Is much of knee pain psychological in nature. See John Sarno , a genius imho. ...and I know this first hand with my wife's experience and my own to a lesser extent.

I've been saying for some time that stem cell clinics could remain viable based on the placebo effect along with savvy marketing and that seems to be the case at this point.

Any other thoughts?


As a nightcap before turning myself in so to speak:

1. very unlikely- depends on endogeneous receptors. 20Mio for the average patient should be ok.
2. yeah- could very well be - some kind of cartilage "conductive" matrix.
3. no- dont think so- the cells in subcutaneous tissue are nicely protected until released. Hardly age.
4. The power of the mind should not be under-estimated. Very important healing aspect.

I will think about the rest tomorrow- Good night. :bye:

Please Log in or Create an account to join the conversation.

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:

Q2 Reported Financials & OA results 07 Aug 2016 12:49 #7556

  • DOV
  • DOV's Avatar
  • Offline
  • Platinum Boarder
  • Platinum Boarder
  • Posts: 347
  • Thank you received: 194

Please Log in or Create an account to join the conversation.

  • Page:
  • 1
Time to create page: 1.295 seconds

Copyright Information

Copyright Fas Kuiters © 2016 young-foxes.com. All Rights Reserved.
This page is made with Joomla CMS and its various templates designed by Fas Kuiters with the excellent Themler tool.

 

 

Shared Spreadsheet Links

DOV´s Revised Projections for the Periods 2017 until 2020

Shareble link : HERE

Fas Kuiters Websites