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TOPIC: Q1 Financials Announcement May 11, 2017

Q1 Financials Announcement May 11, 2017 12 May 2017 04:55 #9317

  • fas
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Just for completeness sake- the Announcement from last night..

Cytori Reports First Quarter 2017 Business and Financial Results

May 11, 2017
SAN DIEGO, May 11, 2017 (GLOBE NEWSWIRE) -- Cytori Therapeutics (NASDAQ:CYTX) (“Cytori” or the “Company”) today announced its first quarter 2017 financial results and provided updates on its corporate activity and clinical development.
First quarter 2017 adjusted net loss was $5.9 million, or $0.26 per share, and excludes a $1.7 million non-cash charge for in process research and development expense from the Azaya Therapeutics asset acquisition. Q1 2017 GAAP net loss was $7.5 million, or $0.33 per share. Operating cash burn for the quarter was approximately $4.8 million. Cytori ended the quarter with approximately $6.3 million of cash and cash equivalents, or approximately $15 million pro-forma at March 31, 2017, when considering $8.7 million in net cash proceeds since March 31, 2017 from the issuance of shares under Cytori’s underwritten public offering that closed on April 17, 2017.

Selected Key Recent Highlights:

  • Received U.S. FDA approval for thermal burn IDE pilot trial application related to ongoing BARDA contract.

  • Received U.S. FDA orphan drug designation for cryopreserved or centrally processed HabeoTM for treatment of handmanifestations of systemic scleroderma.

  • Received U.S. Small Business Designation and related fee reductions.

  • Q1 2017 Financial Performance

    Q1 2017 operating cash burn was $4.8 million, compared to $5.1 million for Q1 2016.
    Q1 2017 total revenues were $1.6 million, compared to $2.9 million in Q1 2016.
    Cash and debt principal balances at March 31, 2017 were approximately $6.3 million and $15.9 million, respectively.
    Q1 2017 adjusted net loss was $5.9 million or $0.26 per share, compared to a net loss of $5.3 million or $0.41 per share for Q1 2016.
    Q1 2017 GAAP net loss was $7.5 million or $0.33 per share, compared to a net loss of $5.3 million or $0.41 per share for Q1 2016.
    “Our areas of primary focus is on stockholder value creation through bringing two valuable late stage products to market,” said Dr. Marc Hedrick, President and CEO of Cytori. “Specifically, our U.S. pivotal STAR trial for HabeoTM Cell Therapy for scleroderma will report top line data in Q3. Also, we currently project completing bulk manufacturing of our nanoparticle doxorubicin oncology product for testing and validation purposes by year end. In parallel, our marketing team is preparing for initial commercial launch of our scleroderma and oncologic products with the goal of obtaining regulatory approvals in the late 2018 and 2019, respectively. Until then, we will carefully manage our capital resources as we have in prior quarters.”

    Selected Key Anticipated Milestones:

  • Complete contracting discussions with BARDA regarding their potential funding of our thermal burn trial (Q2)

  • Report of 48-week US pivotal/phase III trial data for scleroderma hand dysfunction and preparation for US PMA filing (Q3)

  • Complete manufacturing activities required for submission of an MAA to the EMA for our recently acquired nanoparticle doxorubicin (Q4)
  • 2017 Financial Guidance - Reiterated
    The Company expects full year 2017 operating cash burn to be higher than 2016, primarily due to the development of assets acquired from Azaya Therapeutics, as well as costs to be incurred in preparation of anticipated HabeoTM launch and the Company’s expansion of its development program for secondary Raynaud’s Phenomenon.
    Operating cash burn forecasted to be within a range of $26 million to $29 million.


    In my view, the product revenue was extremely low for this stage of the game, but Harris said that was due to a few postponed installations in Japan, on which he would elaborate, which in the end he did not elaborate at all.

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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:

    Q1 Financials Announcement May 11, 2017 12 May 2017 05:04 #9318

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    As some commented in the other thread- there was (finally) some flak from somebody who probably "sneaked" into the CC and a lot of time wasted by some blockhead from Riley, who wanted his spreadsheet adjusted in everybody elses time..the idiot.

    From the edited transcript that is now available at Yahoo

    Kenneth Grutman
    I'm just wondering if you guys have quantified the amount of market cap that's been eroded over the past decade in your company. And if you have any -- what your immediate plans are to improve the stock price. Nice thing now that it's again under $1, looks like it's getting set up for a reverse split again potentially and another 50% haircut, if you wouldn't mind. And finally, is anyone going to resign over it?
    Marc Hedrick
    Well, I can answer some of your questions. Thank you. In terms of how do we create shareholder value, I think that's right upfront in our press release and very clear. In the biotech space, the way to create value is clinical data. And so this company is now at a place where it's never been before, where it's been -- it's to a point where we have a fully enrolled potential approval trial in the U.S. for a relatively large unmet medical need in the U.S. And so I think that data comes forward. If it looks good, I think that will be a positive outcome for the company and I think will change the environment and the value for shareholders..

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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:

    Q1 Financials Announcement May 11, 2017 12 May 2017 06:00 #9319

    • myownhedgefund
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    Well I personally was expecting Japan to be light and felt it was set up on the last call. Just my feel at the time. Other than buying a 200K celution system, consumables are cheap so you need to be selling them by the thousands to really move the needle. They did state their biggest customer has 9 of 50 centers set up and so felt there was room for growth there as well as other areas. They did keep year end guidance the same.
    The most positive aspect was Hedrick expressed confidence in the upcoming scleroderma data and spoke briefly that they felt the trial was well powered. Even over powered. This after considering you always add in a few extra participants to allow for drop outs (normal in any trial). I thought this was the most positive aspect in the call.
    As far as the guy who wanted to complain about the stock price. I guess everyone would love to take a shot at that discussion but I felt it was UNPROFESSIONAL !!!!!!! Everyone here knows I have complained for years about "scripted" calls but this was a classic example of why some management teams heavily screen callers and prevent serious investors the opportunity to dig at serious issues in a open forum.
    Fas, I didnt think the Riley guy talking what margins were looking like at this stage was so bad. They seemed to run out of callers anyway.
    I do have one question the board may be able to comment on. Is it me or are they all over the place on projected scleroderma revenues ? I thought they said $600 million market for US and didn't they recently show in a slide $450 million ? They also hinted at biologic pricing levels....so is this a increase or where we have been thinking in the 50K/treatment area ? They did lay out they plan to start at 40 centers but no indication on how quickly that it ramps to that level. EU a $300 million market projected (annually ??) starting in UK.
    If earlier approval comes then a post market study will be done. I felt this was US related, no mention if it would also apply in EU.
    Debt now being reduced by 590K a month now. $15.9 million outstanding. A massive boost when this is gone imho. (Note, I am not saying PPS necessarily but should be helpful )
    I have some other notes but this covers the more pressing stuff to me.

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    Q1 Financials Announcement May 11, 2017 12 May 2017 08:36 #9322

    • franshei
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    FAS

    I personally think it was a good conference call. The company has now two businesses: cell therapy (which will probably remain a small business) and nanotech (which may grow faster -nature of the drug industry). Somewhere in between is Hedrick's nano regenerative medicine.

    CYTX is now a different company and it needs 2 major changes for our limited investment space:

    1. New stock analysts coverage - Maxim and Reilly are not enough; we need real pharma analysts: we are no longer a medical device company; we need people who can see not just the current revenue, but growth potential.

    2. New group of investors - the old ones are passing and replaced by pharma orientated type.

    This is what Joe Rubinfeld and David Fineman would do, based on Amgen internal thinking in its infancy.

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