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TOPIC: Q3 Results

Q3 Results 09 Nov 2016 15:32 #7973

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It is business as usual I presume..:bye:

Nov 09, 2016
SAN DIEGO--(BUSINESS WIRE)-- Cytori Therapeutics (NASDAQ: CYTX) (“Cytori” or the “Company”) today announced its third quarter financial results and provided updates on its corporate activity and clinical development.
Third quarter 2016 net loss allocable to common stockholders was $5.4 million and $0.26 per share. Operating cash burn was approximately $4.6 million in the third quarter 2016. Cytori ended the third quarter of 2016 with approximately $15 million of cash and cash equivalents.
Selected Recent Highlights:

  • BARDA, a division of the U.S. Department of Health & Human Services, increased its contract funding to Cytori

  • Completed enrollment in its US STAR phase III trial for scleroderma hand dysfunction

  • Reported 48-week follow up data from US pilot/phase II ACT-OA trial

  • Additional limited regulatory approvals received by Cytori customers in Japan for use at their clinics of Cytori® Cell Therapy™ for osteoarthritis of the knee
Q3 and Year-to-date 2016 Financial Performance

Q3 2016 and year-to-date operating cash burn was $4.6 million and $15.4 million, compared to $6.2 million and $15.9 million for the same periods in 2015, respectively
Q3 2016 and year-to-date total revenues were $2.6 million and $8.4 million, compared to $2.5 million and $8.3 million for the same periods in 2015, respectively
Cash and debt principal balances at September 30, 2016 were approximately $15 million and $17.7 million, respectively
Q3 2016 net loss allocable to common stockholders was $5.4 million or $0.26 per share, compared to a net income of $1.5 million or $0.15 per share (or a net loss of $5.8 million and $0.56 per share when excluding a non-cash credit charge of $7.3 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 was $17.1 million or $1.06 per share, compared to $16.6 million or $1.87 per share (or a net loss of $21 million or $2.36 per share, which excludes a non-cash charge of $5.0 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
“In Q3, we continued our focus on operational efficiency and maintaining momentum in our clinical development programs, we reduced our quarterly net losses by 7% and our operating cash burn by 25% from Q3’15 to Q3’16, respectively,” said Tiago Girao, VP of Finance and CFO of Cytori Therapeutics. “Our forecasts indicate that cash on hand coupled with efficient management of expenses, projected revenue growth, and modest influx of capital from a combination of business development activities and potential use of our ATM facility, will fund operations through mid 2017 and to important future milestones.”
Anticipated Forthcoming Milestones:

  • IDE approval for thermal burn trial related to our contract with BARDA

  • Report of 48-week US pivotal/phase III trial data for scleroderma hand dysfunction

  • Complete enrollment on Japanese phase III for urinary incontinence

  • Expansion of the Japanese osteoarthritis treatment centers
Updated 2016 Financial Guidance
The Company expects full year 2016 combined product and contract revenues to be lower than prior expectations based on the Company’s third quarter 2016 revenue results and the Company’s revised forecasts for the Managed Access Program fourth quarter 2016 product revenue.
Combined product and contract revenues anticipated to be within a range of $11 million to $13 million
Operating cash burn anticipated to be within a range of $19 million to $20 million





View source version on businesswire.com: www.businesswire.com/news/home/20161109006259/en/
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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:

Q3 Results 09 Nov 2016 20:48 #7974

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I'm on vacation and only had time to listen to the ATHX call which was terrific. What's up (or down) with IDIS revenues? What excuses were given? Its always something and debt is coming due soon.

WST

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Q3 Results 10 Nov 2016 02:22 #7975

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Sounds like virtually no revenue from IDIS until Q1 2017. I would be more dissapointed if I didn't have this last decade of experience to set my expectations with going into the call. I know its always a safe bet to count on "over-promise, under-deliver" with this company. :yep:

It was reminiscent of an old Calhoun conference call though, with all the vague but promising talk of multiple partners waiting in the wings. The term inflection point was even mentioned by an analyst if my ears heard correctly. Boy oh boy did that talk used get me and others I know to pull out our check books time and time again... A sucker is born every day, wish I hadn't been one of them lol.

All this said I do sincerely hope that Hedrick is able to come through in the 11th hour, and that STAR achieves its endpoint. This therapy deserves to see success and approval, and so many patients can be helped even with just one indication. Wishing the best for all.

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Q3 Results 10 Nov 2016 05:59 #7977

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I am not sure what you mean by "terrific" re the ATHX call?

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Q3 Results 10 Nov 2016 06:12 #7978

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I glanced through the Seeking Alpha transcript just now and picked up a few points of interest-



  • Conditional approval for scleroderma (I presume in Japan) is not possible based on only 12 patients.

  • The MAP program is behind somewhat, first 2 patients anticipated to be treated in Q4 or early 2017

  • Scleradec II is slow (only 10 patients done due to only one site- Marseille), but 3-4 sites will be added and enrollment completion still scheduled for mid 2017

  • Fourth app will be breast reconstruction after all. Seems pretty advanced in Japan already (as usual a typical Cytori surprise, similar to Japan OA approval, of which there surely quite a few more will follow) At least RESTORE I and II will not be totally for the birds after all

  • Long explanation by Hedrick on partner deal situation. Looks like another excellent option year for the boys at Callan Road :evil: :bash:

  • I will listen to the call and correct the Seeking Alpha transcript on the 2 topics- breast and partnering- so that they make sense.

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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:

    Q3 Results 10 Nov 2016 07:15 #7980

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    listened but too tired to post yesterday, been a busy week for me.
    Anyway, I only took a few notes.
    ACT OA continues to hold up as the latest Cytori fiasco for me
    Some post treatment follow up was given.
    Some of the MRI data was basically worthless as either showing little or sample size too small to make any conclusions.
    Post treatment 30% still saw worsening of cartilage left
    Post treatment 70% saw stable cartilage
    Hedrick later stated 10 of 14 saw reduced cartilage loss...which is the 70% just mentioned.
    My take is this...after this treatment one has a 70% chance of ending up right where they started. Reduced cartilage so bad that they went to their doctor to seek treatment. Its good that it stopped loss for 70% but this certainly isn't going to get the word of mouth patients we want. We already knew pain while walking failed the double blind challenge.
    As expected Hedrick noted a potential OA partner was in its very early stages...ya think ? LOL
    Scleroderma
    Well I have suggested for some time this was delayed and its official now. IDIS going slower that expected by a quarter or two. We may see the first couple of patients treated this year or early 2017. To me, hints that pricing in this app may get reduced in the future but that is a bit of tea leaf reading by me. In the EU still just 9 countries approved and of those Cytori will only set up in 4. UK, France Switz. and Spain. Only one center in each country. Demand must be off the charts...LOL My own previous thoughts that at $1000/patient for IDIS didn't leave much room for a motive to push. Greater that 50 doctors have made inquires about the treatment. I really don't know how to judge that for this disease. I wonder if they gave some push back on price. After last call and DOV's latest adjustment to his spreadsheet I did some very rough back of the napkin potential patient estimates on the potential of the IDIS program. Trusting Tiago wasn't a reliable enough for me so I took Okyanos as a example and came up with a wide ranging potential pool of 50-285 patients to be treated by the program through 2018. Assuming current pricing remains I will reduce this estimate to 30-155 patients. I look forward to what DOV will be will to offer and although I often vigorously disagree with his estimates, I do respect he is brave enough to put them out there for all to see. If you do make adjustment DOV, I wonder if now you wont seriously consider lowering OA and burn numbers to more realistic levels. See scleroderma partnership possibilities below.
    Balance sheet:
    They again stated the ATM is a viable source for funds. I still feel same as last Q it is a fore gone conclusion they will need to tap it.
    It seems USA is back in the offing for a worldwide scleroderma partnership. Did I hear that wrong ? They also are looking at throwing in other hand dysfuntions as part of a wide ranging deal. My read is the money, interest or both requires such a move. We certainly know they need big money to end the balance sheet cycle.
    That's enough from me for now.
    Markets turn to comment.

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    Q3 Results 10 Nov 2016 08:16 #7982

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    Yes, I have found Tiago Girao just a foot soldier of Hedrick - useless for "insight" guidance.

    1. Currently the Far East is really the place for major sales and marketing, with South Korea and Vietnam added for the celution system. OA data is useful over there, but not good enough here. As FAS has commented, Hedrick may have other invesitigators initiated pivotal trials coming (on top of the latest one in breast reconstruction). EU is not the main combat zone, so I would not expect too much there.

    2. I think Harris would love to invade into the Lorem licensed territories, since KT Lim's people are virtually useless (they can be foot soldiers to Harris, on Lorem's expenses).

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    Q3 Results 10 Nov 2016 15:20 #7991

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    No response from WST - interesting that he thought the call was terrific and ATHX was still down .06 on heavy volume - hate to see if the call was not good - I am an owner of ATHX and I am very disappointed in the recent price action, but we must try to keep it all honest - also, everyone should try not to bash CYTX once you are apparently out!

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    Q3 Results 10 Nov 2016 17:25 #7992

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    I know that both Rodney Strong and WST folloe ATHX. Personally, I favor CYTX. I think ATHX's focus in stroke and other cardiovascular disorders bear a lot of risks, including cost, duration of trials, acceptable outcomes.... ATHX, just like CYTX, needs money, a lot of money to keep the company running at $ 6 - 7 million cash burn per quarter (currently, they have about $ 19 million in the bank). The main problem with CYTX is the $ 17.7 million debt.

    I think CYTX has 3 geographic areas for business and r/d.

    1. EU - it is really a history of failure and I do not think CYTX has its focus there. However, many investigators sponsored trials would generate leads for further clinical trials (particularly for the US and Japan).

    2. The Far East - Harris' main focus. CYTX has been in Japan for over 10 years and now the regenerative law is clear and pave a clear road map for the 510K sales and marketing (general strategy for the entire Far East). Seeding studies (at no cost to the company, except equipment and reagents) through opinion leaders promotes sales. Conditional approval and final indication approvals will only make sales and marketing more favorable. Clinical data from the US and EU will be very help in all aspects of sales and marketing. Partnerships will only help sales. Japan used to contribute 75% of annual revenue (I think $ 13 million was peak). I think Harris will do a great job there.

    3. US - Scleroderma should be a great catalyst for PPS rise (the study is done and cost from here on for the next few months should be very low). Barda's thermal and radiation trial is the next focus - support by the US government. CYTX should not start another US trial even for a niche indication (no money at the present) Company should keep the expenses low till they can raise more money with PPS rise.

    Just my thoughts.

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    Q3 Results 10 Nov 2016 18:02 #7993

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    Franshei, just to be clear, I also favor CYTX over ATHX and have a much greater position in the former.

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