Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
So, pick your mammal ("you can milk anything, Falker!") and get into the transgenetic game, plenty of "know how" out there. I don't think this dialogue is heading there is it?
Dew, regarding GTC's patent on proteins from milk:
"covering the production of therapeutic proteins in the milk of transgenic mammals. The allowed claims, which are expected to issue in the next several weeks, include all classes of proteins in all mammals"
When we read articles like the one mblimon posted here:
http://www.investorshub.com/boards/read_msg.asp?message_id=16611149 , just how far does GTC's patent go? Is it that we can demand royalties on others' production? If so, how is it determined? Or do we have rights to production? I'm confused on just how broad and/or enforceable this patent is.
Thanks
Uggh, sorry for posting an outdated piece. I'll go back to sleep so I can see better...
I suppose I shouldn't speculate, but that IS what it feels like to me. Some kind of valuation based on average closing share price to facilitate an offering, a partnership, or a deal of some sort. Someone has shares to burn. The story is to good here and the valuation (EV about 60M after all that's gone into this company) too low to warrant this kind of aggressive knock-down day after day.
Anyway, it does seem unlikely and maybe we will see some changes in ownership, short interest or both soon that will give us real insight.
I would guess shares are and have been getting priced here again.
One can't help but wonder at the strange trading here but when it is all said and done, GTCB stock probably has the basic historic charachter as it has had in the past. I take it to be a highly volitile stock with lots of potential; kind of a story stock. When all these shares are absorbed and stuck into the cubbyholes, things will make more sense, trading wise IMO.
I doubt LBF and others get their blood from blood banks; I wonder how they do obtain their blood. Speaking of Count Dracula... :)
They can control costs to a degree.
Thanks again for the links to additional potential for rFVIIa. I wonder how many investors really understand and appreciate just how important, yet unattainable this protein currently is vis. it's outrageous price. This staggering potential should sink in over the next year or two.
Dew, you have an awesome gift of clarity. Thanks for sharing it here and I am looking forward to following this board in 2007. Thanks also to all other contributors here and merry Christmas to all.
It hurts to see the price decline, but down here it is getting to be pretty damn tempting again. My ASP is 1.32 and I wouldn't mind dropping that to around $1.00-$1.10 so I (perhaps a little too glibly) say bring it!
This quote is representative of what I perceive to be a high degree of confidence that GTCB engineers have in their platform. I translate this and other signals along these lines in terms of lower risk. It is a wonderful position for a company to be in when they have the luxury of controlling pricing through low cost production. GTCB is after very expensive, proven drugs that have existing markets and marketing in place but that are too expensive for widespread use. If GTCB can save more lives by making these expensive drugs more accessible, then this is more than just another bio tech looking for a wonder drug.
Amazing what we can take for granted!
>>The first rule in biotech is don't get scammed<<
Look, at $1.04 per share you may want to consider your disparaging remarks very carefully. Do you consider GTCB a sell at this point or not?
The dillution is actualy putting a floor under this stock at this time IMO. Buyers today are getting a significant discount to both W. Harris and LFB. Against all the speculation about market forces etc., is the EV of the entire company sitting at around 50M. Sure, dillution in the future is an issue, but it could just as well be at $5.00 as $.50; we just don't know and its out of our control.
If you are going to talk logic, you have to use logic IMO.
I know GTC will not make public the internal projections for Atryn sales. I know they think the total market is 50M for both US and Europe. Anyone willing to guess at the ramp up of sales in the coming months and years?
Is that "secondary" terminology like "off label" use? Thanks
Knocked 7M off the cap today. EV now abut 51M. Getting cheaper by the day.
Question: If GTCB says it has 2 yrs cash now, doesn't that imply a similar cash burn as at present? Don't they have to ramp up for LFB development or can they do it with current capacity and not a lot of extra money thrown at it?
Do I understand correctly that we start with PIII in the USA for Atryn?
Thanks, I wasn't aware of the PPS driver years ago. Seems longs have a similar, but limited driver today with the hopes of wider use through better pricing.
>>a synthetic coagulation protease that is structurally similar to human-derived plasma FVIIa<<
I don't understand what "structuraly similar" means. I wish I knew more about the structure. In my experience with chemistry, for example, a small structural difference might as well be an ocean of difference as re. the properties of a substance.
>>immense dilution<<
EV is only 60M here - c'mon. So this has gone from a near term bonanza to a near term low risk potential significant gainer. Then, one could hold on for solid appreciation over the years, IMO. This could still be a great stock and probably will. I don't see that much risk. GTCB's disclaimer that these protiens may be difficult to create in quantity seem to me to be in the slim to nothing category (but then I have to wait for my girls to get further in their medical career so they can teach me why).
>>What's the incentive to invest if Atryn approval can't move the stock? Moral satisfaction?<<
Atryn approval did move the stock. The rest is beyond our control.
Because I am a new investor here, I first look at the tech (over my head but it seems solid), then I look at the 200M and climbing capital investment here and think, hey, I own a company that has a market cap (soon to be) 116M, cash of (soon to be) 54M, an approved drug, partners, and more, all for an enterprise value of about 50M bucks! Crazy cool (or am I crazy?)
Dewophile, is there a safety advantage in GI delivery? Convienence?
Oops, last paragraph of prior post snuck in - omit.
Risks per GTCB (partial)
http://yahoo.brand.edgar-online.com/fetchFilingFrameset.aspx?dcn=0001193125-06-054015&Type=HTML
"Developing products based on transgenic technology is subject to significant development risks. Each DNA construct is unique and it is possible that it might not be expressed in the transgenic animal’s milk at a level that is commercially viable. Purifying the recombinant protein out of the milk to use as a biotherapeutic may be too difficult to be commercially feasible. In addition, production of the recombinant protein may have negative effects on the health of either the mammary gland or more systematically on the animal as a whole. This would compromise the ability of the animal to produce the recombinant protein. Directing the mammary gland to produce additional proteins in the milk could negatively affect lactation, thereby shutting down milk production. The mammary gland may also modify a protein in such a manner that it is non-functional or harmful to human subjects. It is also possible that there may be disease agents present in goats or cows that would prevent the use of products derived from these animals. If an as yet unknown disease was identified that could not be effectively mitigated, government agencies may confiscate or destroy the animals, or prevent the utilization of their milk. Any of these governmental actions would prevent the use of the recombinant proteins.
To our knowledge, Pharming B.V. is the only other entity to have completed human clinical trials of a transgenically produced product, although Pharming has not filed for marketing authorization in the United States or Europe for any therapeutic protein produced in the milk of transgenic animals. Until we have completed our current pivotal trial and submitted a Biologics License Application, or BLA, to the FDA for ATryn ® , or our MAA for ATryn ® is approved upon successful re-examination in Europe, we will not have confirmation that our ATryn ® trials are sufficient for approval in the United States or Europe. If we are unable to complete all clinical trials that may be required by the FDA or EMEA, or if any of our other transgenically produced proteins in development are not proved to be safe or effective to the satisfaction of regulatory authorities, it would have a material adverse effect on our business and operations. In addition, it is possible that research and discoveries by others could render our transgenic technology obsolete or noncompetitive as a method of production for protein-based therapeutic products."
Advantages per GTCB:
http://yahoo.brand.edgar-online.com/fetchFilingFrameset.aspx?dcn=0001193125-06-054015&Type=HTML
Advantages of Transgenic Technology
We believe that our current and future partners will elect to employ transgenic technology for the production of recombinant proteins in cases where transgenic technology either uniquely enables development of proteins that are hard to express with traditional methods or offers economic and technological advantages over other production systems. These advantages, any one of which may be critical to the decision to proceed with a particular development project, include:
• Technological Enablement. Transgenic technology offers the ability to produce certain biotherapeutics that cannot be made in a commercially feasible manner in any other system. Transgenic production systems have the capability to produce therapeutic proteins for large volume indications. In addition, we have achieved consistent expression rates with complex molecules, which may not be producible at commercial scale in cell culture systems. This accomplishment means that transgenics may be a viable production system for some complex proteins regardless of the volume required.
• Lower Capital Investment. Developing a herd and providing appropriate production facilities can be accomplished with substantially lower investment than building a cell culture bioreactor facility.
• Lower Cost of Goods. Economic factors unique to transgenic production may lower the ultimate cost of goods in most cases. The lower amortization of the initial capital investment, the lower cost of consumable materials and the high productivity of operations result in the cost of transgenically produced products, in most cases, being substantially lower than that of a cell culture derived product.
7
--------------------------------------------------------------------------------
Table of Contents
• Flexible Production. Transgenic production offers the ability to match production capacity to the market demand, once the first appropriate animal is identified. If the product’s market is larger than originally planned, the incremental investment to breed additional animals and expand capacity is relatively small. In contrast, traditional bioreactor methods are hard assets with a generally fixed capacity. If a bioreactor product’s market will support sales significantly higher than the installed capacity can achieve, more bioreactor space needs to be built or acquired at unit costs similar to the original capital investment, with construction times of generally three to five years.
• Patent Protection. Extended patent protection on the method of manufacture in the U.S.
I don't know enough about it except to say it "sounds" like another rung in the ladder towards a lower risk bio tech company.
Jesse, I think the other side of it is the R&D and engineering. It is impossible for me to quantify, but I have sensed that GTCB engineers have a greater control over the process. Given an objective within the scope of the platform, they seem to have a high degree of confidence that they can produce the required drug per specifications. Perhaps this is not that unique. Maybe the state of genetically engineered drugs is such that all or most of the producers have a high degree of confidence that they can produce what is required.
At any rate, I am interested in trying to get a handle on the risks associated with this company vis. other bio techs.
We should try to quantify the leverage we have with our efficient production platform. I love the fact that we can find drug X out there that is super expensive and already approved and in use but with patent rights set to expire within a window. Sorry if I missed it but is there a list of candidates that fit this profile posted somewhere?
Risk is key in the market. If we do have a robust target list and if our researchers and engineers do have a high level of control in producing known proteins, then I think the market will come to appreciate this combination in time.
I am contemplating the term "bleeding edge" vis. GTCB. I know we are pioneers, but I don't think the term is quite justified here.
GTCB advantages as I see them:
1) Profit margins should be better once a given drug is approved and sold
2) As with LFB, cheaper production means perhaps wider usage. When you can enter markets in which you can control price via lowered production costs you have increased control and lowered risk.
3) GTCB can attempt to produce drugs which have lower risk profiles for them because they have greater control.
4) The goal of GTCB researchers is not primarily searching for novel drugs like so many bio techs. It is primarily to match up opportunities with known capabilities.
Greater control equals lower risk is how I would sum it up in layman's terms.
Thanks. NovoSeven then has no exclusivity for rhFVIIa or it must be a class of drug. This begs the following questions from my lay-person's point of view:
1) Does the fact that rhFVIIa is currently in use mitigate some of the risk of taking a new drug to trials and final acceptance?
2) In general, does GTCB's obvious tact of seeking development and approval of drugs that are both expensive to produce traditionally and have been previously approved in another form or at least have been validated prior mitigate some of the risk vis. another typical bio-tech that is seeking some entirely new treatment?
3) Do you think that GTCB is relatively confident that it can produce the rhFVIIa from its technology? I mean, they seem to have a high level of confidence that they can produce a given protein from milk.
Thanks
>>Background on rhFVIIa
The total worldwide sales of the current recombinant factor VIIa product in all indications were reported to be $845 million (US) in 2005. An independent market research report estimates the worldwide sales of rhFVIIa will reach $2 billion (US) by 2012. Both plasma-derived and recombinant products are used in treating hemophilia caused by genetic conditions in which patients' failure to express enough coagulation factors on their own may lead to excessive bleeding. The application of transgenic technology may enable the production and pricing of rhFVIIa at appropriate levels for broader utilization of rhFVIIa, as well as expanding its use to the treatment of the unmet needs of patients in developing countries and to the treatment of other acquired bleeding conditions.
RhFVIIa will be developed from the milk of transgenic rabbits. Rabbits are anticipated to be capable of supplying the projected needs of the marketplace.<<
I would appreciate an in depth discussion on rhFVIIa. The language of the above paragraph is just enough to raise a ton of questions, for me anyway. What is the "current recombinant factor VIIa product" and who makes it? How do we just step in and "enable the production and pricing of rhFVIIa at appropriate levels for broader utilization"? What does that mean?
Question: what is the latest stage of drug development that a company could commit to using GTCB's platform without jeapordizing work at an earlier stage or jeapordizing the approval process?
GTBC has a vastly superior platform for producing production quantities of a given protein, once it is approved. How competitive is their platform when producing trial quantities?
Conjecture: If it is very expensive to produce trial quantities with GTCB (up front investment in getting the right genes into the goats and developing a process for extracting the protein), potential partners may feel that they will use the cheaper lab for the trial, even knowing they forfeit production efficiency if their drug is eventually approved.
Since GTCB competes with potential partners, they may feel it is too risky to allow GTCB to do the trials.
Conjecture: GTCB is trying to have their cake and eat it; they want to leverage their platform but want to own some proteins too (or 50% of it as in the LFB case). This competitive stance may limit their ability to partner up with other protein producers solely to leverage their superior production platform. Others may feel this gives GTCB too much access to their IP. I have no problem with this if true, I am just trying to understand how this all fits.
>>wanting a partnership<<
OK, if you insist on seeing it that way. I don't think you have any evidence on which to base that. I hope you are right. It looks to me like they wanted GTCB to co-develop this drug but would have been perfectly fine with GTCB coughing up their own 25M in cash to do it. There is something troubling about a business deal where a company has to liquidate 30% of its assets before it can participate. It's not that it isn't done, just that it isn't a position of strength.
>>the company is more likley to buy more shares <<
Sadly, yes. Look at where this 25M is headed; right back into the LFB project. I hope not, but they could end up shoving more dollars through GTCB into this project before it is over, I have no idea how much it will take. I hope the 25M is enough to fund GTCB's portion to completion though, I really do. In fact, I would be thrilled if they only need half of it and the rest was GTCB's to invest in their other programs.