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Metastat Sells 4,800,000 shares of QTMM.
Per Ted's post, on June 30, 2014, Metastat received 4,800,000 shares of QTMM from an investor in lieu of $1,000,000. Per this 8-K filing from Metastat: http://archive.fast-edgar.com//20141030/AFK2K22CK222M2Z3222G2MZZMBBIA2X2Z262/ it looks like Metastat sold all the shares given to them by the unnamed investor and the total value exceeded the $1M he had committed to investing. So, between June 30 and today, Metastat sold out all the shares and got an average price of .267/share.
That might help to explain some of the drop in share price over the last 4 months. I calculate about 38m shares traded. That's 12% of the volume just from Metastat getting out of the shares given to them.
I do not believe Metastat has any interest in QDs.
First Quarter Report (10-Q)
http://xml.10kwizard.com/filing_raw.php?repo=tenk&ipage=8268891
They see some (minimal) income from Laviv.
$16,108 actual Laviv revenue booked in Q1.
$98,542 deferred LaViv revenue booked in Q1.
They performed a total of 189 biopsies in Q1, many of them free.
From 10-Q:
The principal reasons for the relativity small level of revenue and large cost of sales in this quarter are as follows: (1) Timing – costs are incurred starting with receipt of a patient’s biopsy. Revenue is not recognized until at least three months after receipt of the biopsy, when injections are made ready for shipment to the patient’s physician. Injections normally occur four weeks apart so the revenue cycle can be up to six months or more (three injection sessions); (2) Charging for biopsies and injections – we are offering complimentary and reduced price biopsies and injections in our introductory period. Costs are charged to cost of sales immediately as incurred for complimentary biopsies. For reduced price biopsies, the reduced price is booked to work in process.
About 166M shares outstanding with all warrants exercised and series D converted.
See page 50 of http://www.sec.gov/Archives/edgar/data/357097/000095012311084081/w84154b3e424b3.htm
remember that each series D converts to 2000 shares of common stock. Add up all the number on page 50 and you should get 166,255,856.00
Nov 17 Converence Call Notes
Acne Scarring Study
Presented by Dr Girish (Gilly) S. Munavalli
Multi-center, randomized, double-blind, placebo-controlled study. 99 patients received up to three injections with fibroblasts on one cheek and placebo on the other at 14 day intervals. Limited to one vial per side, 9 cm square area. Statistically significant higher percentage of subjects responded to treatment with LAVIV than with placebo, as rated by both the study investigators (58.7% vs. 42.2%; p=0.016) and patients (43.1% vs. 18.3%; p=0.000011) at the final assessment.
Swelling max 3 days, typical 1-2 days.
No serious adverse events reported.
Poor response among patients older than 60. Active acne patients also screened out. Most participants in the 30's-40's.
80% of all treatments in dermatology are off-label. "I would be remiss if I didn't mention this as an option for treatment". "This is such a big problem, acne scarring, that I think there is a favorable attitude towards pursing a formal indication, on both sides".
David Pernock Presentation
In active discussions with FDA and hoping to finalize phase 3 protocol assessment for acne scarring in the near future. At least 3-4 million potential patients in US.
Burn scarring orphan drug status application is in review. Hope to hear within a few weeks. (my note: should be by Dec 1 given a Sept 1 application).
Vocal chord scarring orphan drug status application to be submitted within next few weeks.
Pursuing marketing via bloggers and socialites. Primary markets, NYC, LA and Miami. Getting lots of local press coverage.
Natrillaire skin cream with your own fibroblasts to be launched 1Q2012, available only through physicians.
Will be in December issue of Allure Magazine.
As of Nov 16, 25% derms on west coast, 50% east coast (NY, WDC, Balt, Miami), 19% midwest (Texas, Chicago, Tenessee).
154 doctors completed Fibrocell training.
Expect to be at 270 trained by end of year.
105 biopsies in process.
Burn rate 2 - 2.5M per month.
I believe he said that starting in July 2012, they will be charging doctors $2000-$3000. Prior to that there is a promotional offer in place. So, I deduce, until July, 2012, doctors are getting Fibroblasts for a price of less than $2000.
Here's my notes on the call (new information only, not rehash of investor presentation at Rodham conference). I do wish someone had asked a question about Pernock's expectations for future rounds of financing.
Completed 3 doctors meetings to date, NY,LA, San Diego. 30-40 doctors trained. One a week scheduled around country for the rest of the year. Target at least 200 physicians.
Short term promotional offer to break into market. Price to doctors by July 2012 to be in $2000-3000 range. (implies short term means next 8 months)
Hired 55 people for manufacturing: technicians, quality assurance and quality control
Will not give quarterly procedure goals.
Hoods and incubators used in process can be bought off the shelf.
Any increase in size of current manufacturing facility requires FDA concurrence.
$5-6 million to build another unit the size of the one they have.
Very big volumes increases can be achieved for $10-20 million (presumably 2-4 more units which would give 3-5 X current capacity)
First acne study cost: 10 months $5 million. Enrolled very quickly.
Can segregate sales to do geographical or vertical division based on who they sell to (ie. derms, dentists, who else? etc)
Ideal partnering opportunity is for periodontal or dentistry applications
Defense Medical Research and Development Program mentioned. Not clear if they are working with them or just will work with them post burn scarring approval...
China targeting 2012 start up. No chance for 2011. Modest expectations for 2012 are best. Will build out manufacturing capability as volume increases.
Opportunity to partner separately in Japan.
No celebrity endorsement for 2012. Expect to have more than enough demand. Perhaps down the line.
42 biopsies in process!!!
Looking at page 50 of the registration statement, I calculate about 200M shares outstanding, assuming all warrants are exercised and preferred Ds converted. Add all the numbers on page 50 and then add in the additional 41,409,461 that will need to be issued for the August 3 offering.
Am I double counting some shares, somewhere?
Confusion between warrants and preferred shares seems to exist all over this board. On 6/24, people with D preferreds could convert them (but were in no way required) to common shares. This undoubtedly caused the downward pressure. People could also exercise their warrants, but have no motivation to do so (as noted by another poster).
Conversion of preferreds does not benefit the company in any way. Exercise of warrants does, but no one would exercise their warrants unless they have converted and sold all common shares related to their preferreds and want to take even more profit.
Most likely big investors smell another financing round and are intentionally pushing down share price by selling their common shares (gotten from preferred conversion). They are hoping to then put that money into another round of financing at a lower price than they sold their converted preferreds, get more preferreds and more warrants while keeping the warrants they currently have.
It would be nice if instead of another round of dilutive financing, FCSC worked an agreement with current warrant holders to exercise their warrants in exchange for less dilution. Such a deal would be short term bullish for the stock price.
For the long term investor, this is just noise and doesn't affect the 2 year price of FCSC.
There are 1437 As&Bs unconverted as of June 22. Conversion of these will only add 2,874,000 more shares to the count. If no more warrants are exercised, the share count on Jul 7 will be in the 44 million range.
There are 17,965,825 warrants unexercised related to all financing prior to pref D. There are 16,802,640 warrants unexercised related to pref D. The are 15,558,000 shares for pref D conversion. There are 14,135,000 shares in the employee stock option plan. There are 1,900,000 shares due to the recent financing.
Add all the number here and it adds up to 110 million. Yes, I know Ron said there are 107M fully diluted, so there is a discrepancy somewhere, but it isn't that big, so there may be a miscalculation somewhere but, it really is immaterial. I have contacted Fibrocell about this and am waiting for a response.
Somebody is buying shares. A LOT of shares at BARGAIN prices. My guess is we see some schedule 13Gs in the not too distant future and will find out who it is.
Preferred A &B MUST be converted by July 7. (Total of 1437 preferreds). Preferred Ds (total of 7779) and their associated warrants can be converted when the S-1 that was filed today is accepted by SEC.
Once shares are registered, warrants can be exercised AT ANY TIME.
The company can force investors to exercise warrants if the volume weighted average price, EACH DAY, is $1.25 or greater for 20 consecutive trading days. Then they can issue a warrant call and investors have 30 calendar days to exercise warrants.
The current S1 gives the following information:
Since May 20,
5,285,727 warrants have been exercised (people bought that many shares of common stock from FCSC for 0.50 each, giving the co an additional $2,642,863.5 of income since May 20.)
2075 Preferreds have been converted to 4,150,000 shares of common stock (no $ to FCSC, each investor paid $1000 for 1 share of preferred which converts to 2000 common).
This totals to 9,435,727 shares of stock have been added to the shares outstanding since May 20.
More importantly, there are still a total of 34,768,465 warrants that can be exercised, at the investors choice. For each warrant, the investor gives FCSC $0.50 and they get 1 share of common stock. In addition, there are still 9216 preferred shares that have not yet been converted. They convert to 18,432,000 shares of common.
Thus, there are still 53,200,465 shares of common stock that will be added to the total shares outstanding. The people who hold the warrants or preferred shares have a cost basis of $0.50.
The S1 is a refiling to register the 31,116,000 shares of common stock related to the last round of financing (Jan -Mar 2011, preferred D share s). The 31m is included in the 53M figure above. These shares are not convertable or warrants exercisable under the SEC accepts the registration. (SO, yes, I contradict myself. in fact not all the 34m warrants are immediately exercisable nor are all the 9216 preferred immediately convertable, but it will happen soon.
I suspect this is the reason for the lack of upward movement in FCSC. Too many shares out there have a cost basis of $0.50. However, at some point the sellers will dry up and the stock will start moving.
I am way long FCSC.
http://sec.gov/Archives/edgar/data/357097/000119380511000180/e607979_sc13ga-fibrocell.htm see page 8 for a summary of shares owned.
http://sec.gov/Archives/edgar/data/357097/000119380511001105/e608564_sc13ga-fibrocell.htm see page 8 for a summary of shares owned.
Per their Feb 3 filing, as of Dec 31,2010, they had the 4.9M shares.
Per their filing today, as of June 6, 2011, they had 0 shares.
Be careful reading this. At first I thought it meant they had over 14 M shares. This is wrong. There is a bunch of shared ownership. The number next to James Flynn of 4.9 M is the TOTAL number of shares Deerfield had control over, combining preferreds and warrants. They converted all their preferred, exercised all their warrants and then sold all their shares.
Per today's SEC filing, Deerfield Capital sold 4,900,717 FCSC shares in the last 5 months. Most of them probably in the last 6 weeks. As of June 6, they no longer owned any shares. This helps to explain the tremendous downward pressure on the stock.
Let's hope we see some buying pressure in the next few days
PDUFA Date information
PDUFA dates are set to be 6 months from the date a NDA (New Drug Application) is accepted. There is an equal chance for PDUFA date to be set to any day of the week. Since the FDA does not work on Sat & Sun and they typically announce by the PDUFA date, this means statistically speaking, Friday announcements are expected to occur 3/7 of the time.
The FDA sometimes makes an announcement after the PDUFA date. If anyone remembers the label expansion for Ranexa with CV Theraputics, it came at least 2-3 weeks after PDUFA. The FDA sometimes announces before the PDUFA date (Intermune). For Spectrum they waited until 9PM friday evening to make their announcement. They are the federal government, they can (unfortunately) do whatever they want.
Typically, the stock will be halted for at least an hour for news to be disseminated.
I am way long FCSC and expect approval
Series D Preferred - Forcible conversion CORRECTION
From the registration:
Commencing six months from the date of the acquisition of the Series D Preferred, if the volume weighted average price for each of any 20 consecutive trading days exceeds 200% of the then effective Conversion Price and various other equity conditions are satisfied (including that the resale of the shares underlying the Series D Preferred has been registered under the Securities Act), upon 30 days notice, the Series D Preferred plus all accrued and unpaid dividends will automatically convert into shares of Common Stock.
So, there are dates from Jan - Mar of this year for preferred D sales. Fibrocell cannot issue a conversion notice until 6 months and 20 trading days after the acquisition date. However, since preferred Ds are now registered, people can convert voluntarily and/or exercise warrants at any time. This creates the potential for 32 million common shares to be added to the base of shares outstanding.
Smitty, notice the language says "each of any 20 consecutive". So any day where the VWAP is below the threshold resets the count of consecutive days back to 0.
Preferred Shares and Warrants Remaining
If you read Fibrocell's S-1, filed May 27 to register the series D preferred, you can find the following information:
As of May 20, 4378 preferred shares were converted (to 8,756,000 common), 11291 preferred shares remain, 3512 of which are being forcibly converted by July 7 (to 7,024,000 common) after which 7779 Preferred Ds remain . No revenue to company for any preferred share conversion.
A total of 4,373,541 warrants have been exercised (giving the company $2,186,770.5). A total of 40,054,192 warrants remain UNEXERCISED. Fibrocell can force conversion of these warrants 30 calendar days after 20 consecutive trading days of the volume weighted average share price being $1.25 or above. (Thus getting another $20,027,096). Yesterday reset the clock on the 20 consecutive days. They cannot force warrant conversion until end of July at the earliest.
Almost all warrants issued were in conjunction with preferred shares. The bulk of any selling to date has been from shares gotten by converting preferreds, NOT exercising warrants.
Investors with preferreds and warrants can cover their initial investment by selling half their converted shares and hold the warrants for profit post approval.
Now that the common shares for the series D have been registered, people can start converting preferred Ds. It would make sense that Fibrocell would issue a conversion notice for the Ds 20 trading days after their registration (assuming share price remains above $1.00)
oops. preferred D's, closed in March 2011
They will issue a warrant call as soon as they can, given that they would like the additional $$. People can exercise the warrants at anytime they want, but the soonest the company can issue a warrant call is June 20. Investors have 30 calendar days after the warrant call in which to exercise the warrants. SO, this means by July 20 (at the earliest).
Someone asked about preferred share conversion: each preferred shares automatically converts to 2000 common shares. There is no buying or selling involved. Investors paid $1000 per preferred share. Thus, when they are forced to convert, they are given 2000 shares, which have a cost basis of 0.50. This conversion takes less than 1 business day and the company issues x shares of FCSC common stock to the investors brockerage account (via DWAC).
They only are forcing conversion of Preferred A &B shares. Too lazy to check for sure, but I think that they cannot force conversion of preferred Ds until 6 months after the closing date (ie. 6 months after sometime in March 2010). The same may hold true for the warrants associated with the preferred Ds.
Exact number of O/S shares is difficult to get. From their 10-Q "As of May 9, 2011, issuer had 30,911,561 shares issued and outstanding ".
By my calculation, a total of 2311 series A &B preferreds had converted as of March 30. This represents 4,622,000 shares of common stock that were added to the outstanding shares pool - and the price has still risen.
This number pales in comparison with the number of shares the forced conversion puts into the market place (11,158,000). However, people who have not converted have done so because they DO NOT WANT to sell (and want the 6% dividend). Once they convert, they can just as easily hold onto common shares as preferred shares.
Note that they cannot force conversion of the series D preferred shares. There are 6,134 series D preferred, representing 12,268,000 shares of common.
The rules (slightly simplified) for forced conversion of preferred are 20 consecutive trading days with price over $1.00. They can notify preferred holders of forced conversion. The forced conversion date is the 30th TRADING day after the notice is given (which turns out to be July 7).
The rules (slightly simplified) for call notice of WARRANTS are 20 consecutive trading days with price over $1.25. They can notify warrant holders of of warrant call. The call date is the 30th CALENDAR day after the notice is given. As stated in my previous post, a complete warrant call would cause as additional 43,474,167 shares to be outstanding.
Note that any investor should be valuing the company based on all preferred shares and warrants being converted. This implies somewhere in the range of 100m shares outstanding (105M according to Rodham & Crenshaw).
This dilution has already occurred. Preferred share holders have already converted and done some selling of shares to reduce their risk. This will continue to limit the pre-approval up-side.
Forced Conversion of Preferred shares, not warrants!
This will force all series A &B preferred shareholders to convert to common stock. Per their 10-Q, there are a total of 2886 series A and 2693 series B preferred shares outstanding. Each share converts to 2000 shares of common stock. Thus by July 7, there will be about 11.158 million additional shares outstanding.
There are 43,474,167 outstanding warrants to purchase common stock (@0.50/share). Note that the warrant holders are the same people that have preferred shares. They have no reason to execute warrants unless they want to sell the stock and have converted all their preferred shares and sold them already. (Why would they want to do that??)
There are also 6,134 series D preferred shares outstanding, representing an additional 12.268 million common shares. (The company is not forcing conversion of these, at this time, probably because the associated common shares are not yet registered)
Fibrocell pays a 6% dividend on the preferred shares, so I suspect that is why they are forcing conversion.
I am way long FCSC.
FDA does not care where your stock trades, or its market cap.
A little History
Isolagen developed this therapy in the 2006-2009 time frame. They went before an FDA advisory panel Oct 9 2009. The FDA advisory panel voted 11 to 3 that Laviv was effective and 6 to 8 that the submitted data demonstrated it was safe.
At the same time, Isolagen had run out of money and went bankrupt. A refinancing was done, debt reduced, a new board of directors and a new company: Fibrocell was created.
The FDA sent Fibrocell a complete response letter on the Dec 2009 PDUFA date. The letter required a histopathological study of biopsied tissue from 25 patients following Laviv injection as well as some more detail on manufacturing process.
Fibrocell spent late 2009 and early 2010 reorganizing and getting financing. Around Aug 2010, they started the study with 29 people. The study was completed Dec 2010 and data submitted to FDA. They got a PDUFA date of June 22, 2011.
So, to sum it all up, the FDA did not in any way question the efficacy of Laviv. There was some concern about safety. Fibrocell did a safety study, (presumably after confering with the FDA on what they wanted to see) and submitted data to the FDA.
We are now anxiously awaiting the FDA's decision.
No financing prior to PDUFA. Cash on hand about 3M, current burn rate between 1.0 - 1.3M per month. Wouldn't make any sense to do a financing. They can easily wait until after PDUFA, when, hopefully, the stock is much higher. At that point, if they call the warrants, they get another 15-20M. Another financing might happen, but it would be much less dilutive than the previous ones.
Current trend down is due to preferred shareholders converting to common stock (their cost was 0.50/share) and then selling.
The 105M is in the Rodman report. Remember, it is just an estimate.
The current 10-Q shows there are outstanding warrants for 43,474,167 shares and there are 30,911,561 shares outstanding. This alone gives you 74.35 M shares outstanding, not counting all the preferred shares that have not yet been converted. Each preferred share represents 2000 common stock shares.
By the way, if Fibrocell forces warrants execution (after meeting conditions from my previous post) this will bring another 21.7 M to the company.
Fibrocell raised 4.6 million in July of last year and 8 million in Feb this year. Both times, they issued preferred shares and warrants to the investors. For each $1000 invested, people got 1 preferred share and warrants to buy 2000 shares @ 0.50. The preferred shares could be converted, on demand, to 2000 shares of common stock.
So, for each $1000 raised, the Fibrocell had to register 4000 shares of stock. (Registered is not the same as outstanding.) For the approximately 12.6 million that they raised, they had to register an additional 50.4 million shares of common stock (actually, a bit more).
Investors are slowly converting preferred shares to common shares so that they can take some profit. Converting preferred shares which increases the number of shares outstanding does not raise any additional capital for FCSC.
To execute warrants, investors have to pay 0.50/share to fibrocell. This does in fact raise some cash for them. IF FCSC trades at a volume weighted average share price of over $1.25 for 20 consecutive trading days, FCSC can force warrant holders to execute all their warrants with 30 calendar days notice. This will raise additional capital for FCSC.
When all preferred shares are converted, warrants executed, etc, etc, there will be about 105 million shares of FCSC outstanding. This is the number that Rodman and Crenshaw based their $3.00 target price on.
GLTA. I am very long FCSC.