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It's very likely FCSC per question 7:
7) For past job references, we not a contract manufacturer. We can provide a summary of clinical trial campaigns and FDA approval/inspections as evidence of continued performance. Please let me know if this would be acceptable.
FCSC is the only company with an FDA approved procedure to manufacture fibroblasts for autologous reintroduction and they were "not a contract manufacturer"!
Too many wannabe conspiracy theories. The company is now:
1. Clear of all debts, ie, no concern of bankruptcy for the foreseeable future.
2. Clear of all preferred shares, ie, no more dividend payments.
3. Having sufficient money to build out manufacturing.
4. Acne patients already use laViv on an off-label basis.
5. Already having enough demands for laViv to overfill current manufacturing capacity.
The worst are now behind them. They still need to execute to succeed but they have clear path ahead to generate revenue, develop new indications for laViv, and pursue work on stem cells. That's why the stock is holding up ok.
http://totaldermatology.com/blog/2012/08/special-notice-about-laviv/
Old news but maybe some are not aware of the above.
Most biotech partnerships are for drugs+indications not yet approved. So, acne and burn are good for that. Of course, non-US is wide open for anything. The sticky issue with acne and burn is likely how to control for off-label usage so that the partner won't lose money when doctors go to FCSC directly. Burn is easier to control but less money. Acne has a bigger market but is also more susceptible to off-label usage.
1. Wrinkle is not a serious disease so that a superiority trial is needed for compassionate reason. Also, designing a non-inferiority trial is nontrivial and it can be expensive. For example, testing against a good hyaluronic acid at 6 months would be foolish and at 1 year or longer would be expensive and could be complicated by patients on the control arm doing some other secondary treatments.
2. A decade and a half ago, growing cells was complicated. Today, not so much. Cell-growing media can be bought off the shelf for cheap and lab equipment have dropped in price by an order of magnitude. The cost to manufacture laViv today is far cheaper than when Isolagen started. I've posted some cost estimate before.
Harping on trial design and costs based on decade old info shows dated diligence. The stock price today is a result of bad financial engineering, not because of how laViv perform or how it is being accepted by the public. The former can be fixed. Whether or not the CFO can pull that off is the question.
Generally agree with what you said about laViv. However, we should acknowledge that the CFO of this company did not perform. He should have done a financing before the BLA was approved to get sufficient money to build out manufacturing. He badly mishandled the recent 10-K and investor relations. Some sort of a PR to explain what was going on in terms of marketing laViv along with the filing would have done right by investors. It was good that investor Ken dressed them down at the end of the last CC. Let's hope they have learned their lesson.
Moving on, below are the yearly numbers of procedures of Sculptra since its introduction in 2004:
2004 2005 2006 2007 2008 2009 2010 2011
872 46,732 54,912 75,511 79,653 85,883 120,194 143,777
The growth curve for Sculptra has been great, especially considered the deep economic debacle in 2008 and 2009. That was helped in part by an increasing number of men choosing the procedure (15% in 2010). This point is interesting because men tend not to do things that drastically change their appearance, instead opting for some gradual solution and Sculptra fits this need.
Now, think of laViv as a far better solution than Sculptra, much safer (some doctors avoided Sculptra for its side effects) and lasting much longer (up to 5-10 years instead of 2). There is no inherent reason that laViv should not have the same or better growth curve as Sculptra.
The main thing keeping them back is the lack of manufacturing to meet demand. This brings us back to the performance of the CFO. Nonetheless, if he can help bring about a good financing, then we'll be off to the race. That's the next binary event.
Sorry Kipper. Dew is always in touch. You just never know if what he touched was a part of the known universe. Talking about headwinds from problems that have not happened for 15 years is a sign of a good conservative investor as Dew is!
Now, what was that about those Botox adverse effects that made the FDA slap a black box label on the drug? How long did it take for those to show up? Hmm... Do you think laViv can compete with that speed of adversity?
Let me start counting until this post is gone, one, two, three... LOL.
LOL. That's hilarious.
The first patient treated with laViv was more than 15 years ago. So up to about 15 years, no known long term problem. But, yeah, we are long term investors so let's worry about the next 15 years, hell, 30 years. So, maybe 45 years from now, somebody will report a problem that put laViv to rest.
Now, lemme see. 45 years from now, I'll be way over that threshold of being 80 so, according to Dew the great: "paradoxically, from a safety standpoint being older may be better", I'll be able to use laViv and look younger anyway. Well,I'll take that. Thank you, mam.
Rickk, just curious. Is that just a rhetorical question on an off day? Or, are you communicating something obliquely?
Yes, they could do a better job with informing investors. It looks like some guy named Ken taught them that lesson well. If they keep their promise for monthly CC, then we'll know that the lesson sticks. Hopefully, they'll have their financing in place by the next CC. They did say that a non-dilutive approach is being considered.
You forgot to mention: demand is increasing, doctors are clamoring to sign up for training (far beyond the original projection), cost to build out manufacturing is getting much cheaper, and the few million dollars debt is trivial. They will get funded, just a question of how. At this time, even a 50% dilution will still make the future of the company attractive. Why?
Consider that an inferior product like Sculptra did about 90,000 procedures in 2009 at an average cost about 2100$. Sculptra is the best of the fillers with effect lasting close to two years and it is also slow to take effect like laViv (although a little faster if you take out the 3 months manufacturing). But, for some patients, it has severe side effects that cannot be corrected. Some doctors have stopped using it because of that possibility.
At the very least, laViv can displace Sculptra because laViv has no known important side effects beside some swelling for a few days and, anecdotally, it works for several years. Plus, with laViv patients will have the option to treat at a very cheap price other areas like fine wrinkles, all face, etc. with the same cells manufactured from the biopsy.
Then, wait for when the words are out about laViv as a natural and gradual treatment. The men market will ramp up quickly to rival the women market. This has nothing to do with vanity. A naturally youthful look is an important component for success in the workplace. The high number of men doing Sculptra (13,500 in 2009) is a good indication of that.
The future for laViv is bright. FCSC will get funding one way or the other. As they say, everything is possible but some are less probable than others. Bankruptcy is possible but with very low probability. JMO.
"What difference does it make if the 1Q12 sales are $20K or $200K."
The difference is a factor of 10. But that's irrelevant. The question is how they will get funding to build out to meet the demand that is clearly there. Note how, not if.
In 2009, about 72,500 women and 13,500 men did Sculptra. LaViv would be a far better solution for these people and their time with the Sculptra effect is now up. Will there be a market for laViv and a future for FCSC?
There's just too much wannabe or just plain nasty fake diligence here instead of any real due diligence. Btw, thanks to Monday, the average per share of our group is now far under 0.40. As I said elsewhere, by year end, we'll know the right picture. Still think FCSC will file bankruptcy?
You probably missed the smiley. It is boring.
Nah. Pretty exciting. Longs are not willing to sell because they are afraid to miss the upside and shorts are too chicken to do anything. The sentiments are pointing in the right direction. :).
Thanks. I missed it somehow. Chart 24 shows that the total number of doctors to be trained on injection technique will be at least 1000 soon.
OneMed Forum presentation. Good reading.
http://www.fibrocellscience.com/wp-content/uploads/2011/11/OneMedForum-January-11-2012-FINAL.pdf
Tenergel will compete directly with the dermal fillers, not so much with laViv which has a completely different MOA.
Besides, whenever you inject an inert material that requires shaping into a soft tissue matrix like the skin, you run the risk that the shape will not hold long term. The material may migrate in unpredictable way and cause skin deformity or, worse, injuries to nearby organs (facial usage could lead to problems with eyes, nose, inner mouth linings, etc.) and other health issues.
None of those problems are of concern with laViv because it's just your own cells. But you already know that. Right?
Cosmetic Surgery Sees Increase in 2011, While Botox and Other Minimally Invasive Procedures Fall.
Noninvasive procedures such as injectables do have a role, but individuals are looking for more durable results, says Kenkel.
...One of the reasons that the numbers are creeping up is that people need to stay in the work force longer, which means that they must compete with their younger counterparts for the same jobs...
http://www.webmd.com/healthy-beauty/news/20120319/most-common-cosmetic-surgery-2011?src=RSS_PUBLIC
What that says is that treating an aging appearance is not just for look but seen as a necessity. The mature patients will not buy on impulse but will study and look for appropriate treatments. laViv will fit those patients better than Botox and artificial fillers because of its gradual correction effect, long lasting results and a great safety profile.
They just finished a training session tonight and will hold one more on Sunday. This should bump up the number of doctors qualified to prescribe laViv substantially.
I believe Botox and other comparable fillers fall into the "perish" category, while LaViv will continue to forge ahead and grow with the personalized medicine field.
http://www.in-pharmatechnologist.com/Processing-QC/Sanyo-adds-cost-effective-GMP-cell-processing-unit
Agree. Meanwhile, the cost for cell processing is coming down rapidly. Just as an example, last year Sanyo introduced a new standalone workstation for cell processing that can operate at about 2/3 the yearly cost of a clean room. This workstation is about the size of a small car and can be set in a class 100,000 clean room. So if FCSC chooses to go this way, manufacturing could be scaled up quickly with fast FDA approval.
Sculptra does not require a harvesting step, and hence it is much more convenient for the patient than Laviv.
The harvesting step takes a few minutes. The injections of laViv can be much faster and the management of after effects are much simpler than Sculptra -- no need to keep massaging your face to distribute the molecules.
Although Sculptra can generate adverse effects in some patients, as you noted in your post, most of these effects are mild and transient.
http://www.californiacosmeticsurgeryblog.com/dr_bocks_blogrestoring_th/2008/01/sculptra-the-fi.html
"We have seen Sculptra nodules develop 18 months after the injection and nodules starting as late as three years after injection have been reported. Needless to say, the patients in whom this occurs are not happy. Because of this, we have almost completely stopped using Sculptra."
As a biologically inert product, Sculptra has a very low likelihood of triggering an endogenous mechanism that causes some kind of problem other than the known effects discussed above.
More than 7000 thousands patients have been treated with laViv over more than a decade. No serious safety issues have been seen unlike what we are seeing now with Sculptra.
Sculptra generally costs less than Laviv, even for patients who receive multiple treatments.
It's true that a typical Sculptra treatment course is cheaper than a typical treatment course of laViv. But the safety issue can be tremendous as noted above. One of the attraction of Sculptra is its gradual results as seen in the survey by Sculptra's maker shown below. laViv will fill that niche without the potential safety issues of Sculptra and it lasts far longer. Who do you think will take that market?
http://www.sculptraaesthetic.com/faq/sculptra-cost.aspx
The FDA does not approve w/o a label.
That's correct. The label was part of the approval. Kipper probably meant the Physician Manual used in training. That was not approved until much later because some items in there deviated from the label.
"like you, i am tried of one particular poster throwing out comments without supporting them with facts. i too challenged this poster to support comments back in july/august, not going to happen imo"
Some people do confuse the hot air that they and the cows contribute to global warming as wisdom. But the emperor has no suit.
What we need to do on this board is to continue talking about the facts concerning the business of marketing laViv. As long as I participate here, any bloated egotistical bloviations will be repudiated with more facts.
The bottom line is this: The incessant negative posts stating opinions as if they are facts but empty of any supporting evidence is a smokescreen to divert investors from truthfully sharing the facts concerning progress in moving forward the sales and marketing of laViv. And what are these facts?
They are these: (1) The more than 300 doctors already trained and the several hundreds more soon to be trained would not waste their time on an activity that would not generate them income and (2) If they can get significant income from prescribing laViv then laViv will be generating significant income for FCSC.
The referenced FDA document dated before approval clearly stated "a sponsor-directed training program that is mandatory". Subsequent to approval, FCSC initiated a training program. That is all that is needed to see that the FDA required doctors to be trained and/or certified to be familiar with the proper injection technique.
Even if a large number of patients wanted laViv, they could not be served until a sufficient number of doctors could be trained and certified. In the months to come we will have actual data proving or not that large interest exists. Future information needs time to come.
Now, compare that with this utter BS from post #5946 said without any supporting evidence despite numerous requests: "I could name half a dozen medical companies who tried to wow investors with stats on the number of trained docs rather than actual revenue. All of them eventually went out of business via either bankruptcy or takeout at a firesale price."
It's clear what is "patently false" and where the truth lies.
Also do you understand that laViv is patients' own cells that live only in certain parts of the body so proper injection is an important part of the treatment?
Doctors can use laViv off-label for acne and burn scars or any other indication that they deem right for a patient. The FDA does not regulate that. But proper administration of a treatment is something that they can get involved in and do on occasions.
I am astonished that a supposedly expert biotech investor does not know that.
http://www.fda.gov/downloads/BiologicsBloodVaccines/CellularGeneTherapyProducts/ApprovedProducts/UCM262523.pdf
Consult: Jane Liedtka, MD, Medical Officer, CDER/ODEIII/DDDP
Executive Summary: The sponsor has submitted a manual to be used as part of a sponsor-directed training program that is mandatory for all health professionals who will administer Laviv, an autologous fibroblast product intended for improvement in the appearance of nasolabial fold wrinkles. The sponsor’s BLA resubmission and the proposed package insert (PI) are currently under review. At the time of this review, FDA and the sponsor have reached agreement on nearly all of the contents of the package insert. Reference to the package insert appears throughout this review of the Training Manual.
Now how about "real information" about those 'half dozen medical companies" that you mentioned in #5946? What BS will you pull up next?
1. The FDA requires doctors to be trained before they can prescribe.
2. It takes time to get training materials approved by the FDA.
3. It takes time to set up training sessions in convenient locations.
What is so hard to understand that sale would lag training?
Now how about "real information" about those 'dozen medical companies" that you mentioned in #5946? If you don't have it, then please say so. Your credibility is on the line.
Why don't you just go ahead and name those companies along with "factual verifiable data" and reasons why their situations are like FCSC situation? Then we can have a real discussion. Your posting of empty words just for argument sake is getting stale.
I've posted on Yahoo some estimates based on 5000 because that was what FCSC said they expected to do by end of 2012 in the July Investor Presentation. But the July 2011 presentation also had a low estimate of number of doctors and areas around the country that would have laViv available. My guess is that the interest from doctors far exceeds expectation. That will translate to patients' interest. So 5000 should be the lower bound for the year. They may do twice that with most growth in the second half of the year, IMO.
Ron: "The company plans on using clinical investigators and about 30+ doctors in key areas such as California, Texas, Florida and New York. Doctors will want to offer this procedure to their patients because it adds value to their practice. The company expects a lot of publicity from news stations, cosmetic magazines and their own advertising company which I believe is the same one Dendreon uses. The company expects 5000-6000 patients within the first year."
It's clear that doctors are signing up faster than expected all over the country -- close to 300 at year end and will soon be around 600. If these doctors start prescribing immediately after training, FCSC can report a significant number of patients treated by the time they hold the CC. Fast business expansion would also make it easier to get financing, partnership funding or loan, to expand operations including manufacturing. Given the high number of hiring, something is cooking.
This is some back of envelope cost analysis for laViv posted on Yahoo, cut and pasted here so that people can try to shred it.
An initial nasolabial treatment requires 6 vials of fibroblasts done over three sets of injections. For potency, each vial must have between 10 to 20 millions cells. So, let's say that the total number of cells needed is around 100 millions.
To grow that number of cells with a commercial growth media, the final incubation step would need about 2 liters of the material. Let's say that another liter is needed for other preparation steps for a total of 3 liters of media.
http://www.cellapplications.com/product_desc.php?id=352
Per the above, the retail cost for each 0.5 liter is 92$. So the retail cost for media is about 552$. Since FCSC buys materials in bulk, let's say they have a 20% discount. Then, the cost is about 440$. On top of that is the costs for labor, other testing materials, facilities, etc. My guess is that 1000$ would be a good upper bound for the cost of manufacturing 6 vials.
The company probably makes double the number of cells to store for future use. In that case, about another 500$ should be added to the initial manufacturing cost for a total about 1500$.
Here's my opinion. The stock has been fluctuating at this level for months while the short interest remains very small in terms of money value. What this says is that there is relatively little trading with most investors holding long or just watching waiting for news. The recent large daily volumes with steady or up price indicates accumulation which means somebody is expecting good news. Hopefully, that will be confirmed. If good news is released, the up turn will be quick. We'll see.
Small volume is normal for this stock. Last Friday was an anomaly and not a bad one at that.
dewdiligence: "It's been more than three and a half years since her last injections and she's still seeing improvement... Paradoxically, this could be part of the problem with this product."
ROTFLMAO. Very funny. Yes, we know. People should be careful with a product that works long term and has no known safety issue. They should use something like Botox that only paralyzes your face for a few months... except when it spreads and kills as the FDA warns below:
http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/DrugSafetyInformationforHeathcareProfessionals/ucm174949.htm
The video shows the nurse wiping the patient's eyes near the end. Maybe she was being treated for frown lines and crow feet lines also. This may be evidence of off-label use of laViv.
About the delayed CC, my guess for the reason is that negotiation is going on for a financing deal and they want to avoid the inevitable questions in a CC until the deal details are finished. There will also be a huge number of doctors trained between now and April, more than doubling the currently listed number on mylaviv.com. Hopefully, the acceleration of laViV marketing will help with the terms of the financing.
Agree. We need to hear about funding and how manufacturing will be scaled up. Sale must be matched by manufacturing. The current manufacturing capacity is not adequate if sale ramps up with the number of doctors that they plan to train.
Thanks for the slides, Rick. It looks like they aim for >1000 doctors trained by year end.
dewdiligence: "People with jobs tend to get more cosmetic procedures than people without them because looking good is a competitive advnatge in the workplace."
Good job. That's thinking. But did you forget to say why this would be detrimental to laViv sales or did you see that laViv may actually sell well to working people who do not want whispers about a sudden change in their appearance?
"He indicates a price range of $4-6K"
The cost for growing fibroblasts has come down a lot since the early 2000's when Isolagen started. There are commercial labs to do the cell cleaning, growing and preservation for $1000-1500 per sample. FCSC is doing this in their own lab so the cost will be far cheaper than that.
Dr Chernoff's estimate of the cost to patients between $4000-6000 includes injection cost and doctor's profit. But, even if the company can clear just a low $2000-2500 for the initial sample, they will be profitable. Future injections would be dirt cheap to produce. There is plenty of money to be made here for FCSC once a sufficient number of doctors are trained.