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TOPIC: Q2 15 Financials

Q2 15 Financials 06 Aug 2015 15:18 #4947

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SAN DIEGO--(BUSINESS WIRE)-- Cytori Therapeutics (NASDAQ: CYTX) today announced its second quarter financial results and provided updates on its corporate activity and clinical development.

Cytori continued to reduce its operating cash burn, spending approximately $4.8 million in the second quarter 2015, compared to $9.2 million in Q2 2014. Second quarter 2015 net income allocable to common stockholders was $4.5 million (or a net loss of $8.7 million and $0.06 per share when excluding a non-cash charge of $13.1 million related to the change in fair value of warrant liabilities) compared to $11.8 million (or $0.15 per share) for the same period in 2014. Cytori ended the second quarter of 2015 with $23.8 million of cash and cash equivalents.

Selected Q2 Highlights:

Cytori and Lorem Vascular were granted regulatory clearance for Cytori Celution® System by the State Food and Drug Administration of the People’s Republic of China – April 2015
Cytori received initial purchase order of Celution devices and 1,100 consumable sets from Lorem Vascular, our Chinese Licensee – April 2015
Cytori was granted orphan drug status for treatment of scleroderma in European Union – April 2015
Cytori reported positive top line 12 month follow-up data on SCLERADEC-I Trial – April 2015
Cytori presented preclinical and mechanistic data supporting use of Cytori Cell Therapy™ in wounds combining thermal burn and radiation exposure - April 2015
Cytori published Preclinical Data for Treatment of Thermal Injury in the Journal Burns - June 2015
Cytori completed enrollment of US Phase IIb Osteoarthritis Trial - June 2015
Cytori reported its Licensee, Kerastem Technologies, received conditional approval from FDA for a Phase II Alopecia Trial - July 2015
Cytori announced Japanese approval trial for Stress Urinary Incontinence using Cytori Cell Therapy - July 2015
Cytori began enrollment of US phase III/pivotal scleroderma STAR trial – August 2015
“2015 corporate performance has thus far met or exceeded management expectations and we will endeavor to keep that momentum going through the remainder of the year,” said Dr. Marc H. Hedrick, President and CEO of Cytori Therapeutics. “My confidence grows daily that we can continue to manage cash burn down, enroll our US trials, expand our clinical pipeline while maintaining a relentless drive to obtain FDA approval for our technology and bring it to market as rapidly as possible.”

Q2 and Year-To-Date Financial Performance

Cash and debt principal balances at June 30, 2015 of approximately $23.8 million and $17.7 million, respectively.
Q2 and year-to-date operating cash burn of $4.8 million and $9.8 million, compared to $9.2 million and $18.1 million for the same periods in 2014, respectively.
Q2 and year-to-date product revenues of $1.6 million and $2.5 million, compared to $0.9 million and $2.0 million for the same periods in 2014, respectively.
Q2 and year-to-date contribution (profit/loss) from our sales and marketing organization, excluding share based compensation, of a loss of $0.3 million and $0.8 million, compared to a loss of $1.6 million and $2.8 million for the same periods in 2014, respectively.
Q2 and year-to-date contract revenue of $1.8 million and $3.3 million, compared to $0.4 million and $0.8 million for the same periods in 2014, respectively.
Q2 and year-to-date net loss/income allocable to common stockholders was a net income of $4.5 million (or $0.03 per share, or a net loss of $8.7 million and $0.06 per share when excluding a non-cash charge of $13.1 million related to the change in fair value of warrant liabilities) and a net loss of $18.1 million (or $0.15 per share, or $15.8 million and $0.13 per share when excluding a non-cash charge of $2.3 million related to the change in fair value of warrant liabilities), compared to a net loss of $11.8 million (or $0.15 per share) and $22.2 million (or $0.29 per share) for the same periods in 2014, respectively.
“The reduced operating cash burn, restructured debt and Olympus liabilities, and the proceeds from our Q2 financing activities, significantly strengthened our balance sheet, and based on current projections, provide liquidity for over 12 months of operations without further capital infusions,” said Tiago Girao, VP of Finance and CFO of Cytori Therapeutics. “Operationally, we are laser-focused on the execution of our key clinical objectives with continued emphasis on the phase III scleroderma and phase IIb osteoarthritis U.S. trials.”

Upcoming Near Term Catalysts:

Publication of long-term follow up data (12 months) of scleroderma SCLERADEC-I trial, currently in press
Complete enrollment of US phase III/pivotal scleroderma STAR trial
Complete enrollment of French SCLERADEC-II follow-on phase II/pivotal trial
Begin enrollment of MHLW funded Japanese stress urinary incontinence trial
Evaluate and release 24-week data from 94 patient US phase IIb ACT-OA trial
Complete core research and development activities for the next generation Celution System and file for IDE in the U.S. for a BARDA funded burn trial
Management Conference Call Webcast

Cytori will host a management conference call at 5:30 p.m. Eastern Time today to further discuss the Company's progress. The webcast will be available live and by replay two hours after the call and may be accessed under "Webcasts" in the Investor Relations section of Cytori's website. If you are unable to access the webcast, you may dial in to the call at +1.877.402.3914, Conference ID: 95062889.


Living a healthy life nowadays, I am turning myself in, in about 30 minutes.

Comments are welcome as usual, also on CC :cool: :yep:
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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:

Q2 15 Financials 06 Aug 2015 15:26 #4948

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This FASB ruling on Change in fair value of warrant liabilities is totally lunatic for companies like Cytori-

although having no value for the investor it gives Cytori a quarterly profit... :bang:

Berserk- plain berserk :evil: .

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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:

Q2 15 Financials 06 Aug 2015 19:13 #4950

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I think this is a good quarter and the CC is also good.

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Q2 15 Financials 06 Aug 2015 20:59 #4951

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A fair amount of info given in the call....of coursed that is measured against the usual nada or unreliable info but I continue to believe Hedrick is at least trying to improve communication.
SCLERODERMA:
The biggest news to me was we shouldn't expect approval before mid 2018 as they wont even file until they have the 12 month data and expect a 1 year timeframe until approval. Once the EU trial is complete they expect a 1-2 year timeframe to approval. Ugg !
Still in the EU...seeking a partner for this app.
....control will have cells frozen for cross over should the participants desire
....1st patient enrolled by October 2015
....Possible revenue in app from "named trial route" Self pay, 3 treated so far this way. Varies per country on rules.

OA
Strong demand from Doctors and Patients
Should have a draft for a phase 3 trial by the time we get data in 2016...mid 2016 phase 3 possible
Partnership or possibility of "other ways" of funding
expect a phase 3 to look like a 400 patient trial, a year to enroll, cost $20 million

SUI
45 men to be enrolled with a expected Sept 2015 start and a year or more to enroll
little else offered here

BARDA
Possible burn trial in 2016 (mid ?) so I think that is likely when the CTX2 will be ready give or take
Work still ongoing on 3 fronts from pre-clinical...I forget the other 2
not much new here ....approval some time away(my comment)...stilled mentioned possibility of a BARDA procurement before all work complete

CHINA and LOREM
Several hospitals being looked at in China to set up for work.
Heart, OA, and Diabetes mentioned I believe
Lorem was mentioned briefly and the last question on the call was about Lorem...basically expect slow movement beyond the contractual sales for some time.

FINANCIALS
2015 burn lowered to 24 million
revenues reaffirmed....5-8 million in product sales and 6-8 million in contract revenues
Expect 12+ months of cash left with current 23.9 million...so I assume they are thinking warrant revs and or second close cash also helps ???
Q2 saw 1.6 million in product revenues YUK YUK and double YUK...a portion was from Lorem but not broken out on the call....I hope to read the filing this weekend. Self pay market still proves to be minimal.
Several hints at possible sources of revenue beyond a partnership or partnership for specific applications of geographic areas. Japan wasn't hinted at imho. Hedrick at one point read off a list of approx. a dozen possible applications where this tech could serve a useful purpose and parties/clinics interested but no money to pursue....a bit demoralizing of a statement.

Overall a "B minus" grade imho
Communication improvement attempts
Still a long way from prime time
Unclear where further cash comes from but they seemed comfortable that there are, at least at the moment, avenues worth going after beyond the recent horrible secondaries. I will still model the additional floating of shares but don't forget will still have our ATM.
2020 revenues/earnings need to be reduced from our spreadsheet IMHO but I will see what DOV has to offer on this front for discussion.

I think that about covers it...corrections or comments always welcome !!!
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Q2 15 Financials 07 Aug 2015 00:47 #4952

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Thanks so much Hedge. :yep:

I will be away for the week-end and will listen to the CC or read the transcript on Monday.

I hope I will see a lot of comments here- to me the timelines sound very conservative, but maybe realistic in view of past performance??? :whistle:

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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:

Q2 15 Financials 07 Aug 2015 08:22 #4953

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Mr Hedge, excellent summery.

1. Time is always an enemy, particularly when dealing with many investors who want to be rich overnight.

2. Funding is also an enemy for an industry which is not in the limelight.

3. Hedrick and new team are working very hard to build a real company, in the face of many hurdles.

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