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That's not the trial they'll be filing the first NDA on, it's the trial on Colon Cancer which originally was targeted to end last quarter, but revised to this quarter. The trial's to be ended at the 360th event, as of their last appearance, they've still not been told it's imminent, but they've not yet changed the guidance to 1st or 2nd quarter, but that could happen if by the next time they speak, next week both KERX and AEZS appear at Investor's conferences. If we're told the event's imminent, March will almost certainly be it, top line data in April, and perhaps an NDA before the end of June. That could potentially lead to an approval before the end of the year.
I'm not saying this will happen, but it's a possibility. As for the MM trial, it need not be approved if Colon is to gain substantial orders for MM based on the data to date as a valid off label use of the drug. I say valid as a way of saying that Insurance Companies will either pay, or can be pushed into paying from the data already available. Of course use will expand with approval, but it will be in the game as soon as the first approval comes in, and that should be for Colon Cancer.
Gary
I believe $5 to $10 very possible, higher on approval. Remember, KERX is responsible for the trial and all else in North America, so they'll be the one to file the NDA, but AEZS has been clear about working with them, and filing the same documentation for European Approval with the agreement by European Authorities to accept it without further testing being required.
I believe the question of whether AEZS handles the drug completely themselves in Europe, or partners or contracts for services is still up in the air. The good news is they have more staff in Germany than anywhere else so they could potentially keep Europe to themselves if no offer is deemed worthy. AEZS also apparently has the production capability needed to support at least the initial sales in the U.S. and elsewhere.
IMHO the real value in AEZS will come with both Perifosine and AEZS-108 expanding their labels after approval into many more cancers than they're currently in Phase III trials on, or will be shortly, in the case of AEZS-108. Both these drugs could potentially be blockbusters several times over, but it will be years before their full potential can even be estimated properly.
Even if the outstanding shares in AEZS reaches a couple hundred million, earnings over time could reach billions if their pipeline continues to produce winning products which both Perifosine and AEZS-108 appear to be. The potential of this company if it's not bought out is the sort of number that dreams are made of, but they'll take years to materialize.
Gary
Investors should also be interested in hearing what the company said, and reviewing the slides from this mornings BIO CEO Presentation. Here's a link to the site:
http://www.bio.org/events/conferences/bio-ceo-2012-presenting-companies-0
I frankly think some of the CEO's remarks weren't given that much thought by investors. While he clearly indicated another peek could come mid year, he didn't reiterate what Investors should know, that such a peek could result in a trial halt and early NDA. He allowed for full duration of the trial resulting in an NDA filing next year, and approval next year or early 2014. I believe that's largely what investors heard, rather than recognizing what they should know, peeks are only taken for one purpose at this point, early approval.
Certainly we know that peeks can end trials for futility, but we know that's not the case here because the DMC suggested the peek based on efficacy, clearly the drug was performing well at the last peek, just not quite well enough to terminate the trial. I believe when the company makes it clear that the FDA has signed off on another peek, it will spur the stock. If I remember correctly, they agree in principle to the peeks, but all details haven't been worked out.
Please listen for yourself, I believe if you think about it, it was a very positive presentation. The only weakness I see is something the CEO spun positively, funding. He indicated they're in good shape with 18 months funding on hand, enough to complete the trial and submit a NDA. To me, no company should take funding below a years, and preferably have more than that. I do believe their are many possibilities, not just dilution, but certainly if in the next 6 months a partnership or some other funding event occurs that isn't dilutional, I would expect some sort of offering, perhaps an ATM. The current O/S of this company is really quite low, so I'm certainly not overly concerned about funding, I just think a CEO ought to say it might be necessary, rather than suggest we can go for approval without it. Even if possible, it's the absolutely wrong strategy as big Pharma senses financial weakness and their offers to partner drugs often reflect their sense that a company's in dire straights financially.
It's clear that Celsion at most may look to keep the U.S. and European market to themselves, clearly they're open to partnerships elsewhere and have some partners already. The fact that the European Authorities have agreed to accepting U.S. data, and perhaps even less, is saying the cost of approval in Europe is small, but Celsion still requires manufacturing, distribution and sales support which almost has to come from a partner, or contracts, in most, if not all the world.
Gary
While I find what TA shows useful, I believe companies like AEZS are more events driven. It's difficult to say whether tomorrows presentations by KERX followed by AEZS will become one of those events.
I don't believe that KERX can avoid a statement on the status of the Perifosin Phase III Trial's status. We'll hear if the trial's still running, concluded, or if they've been told the conclusion is imminent.
While I believe the trial's we'll beyond the point where an approval should be the result, you can bet that bashers will suggest that imminent or concluded is bad, perhaps even terrible news. Certainly there are longs among us who also have models suggesting they won't be comfortable until we're into March, perhaps even some that insist it has to go into the next quarter.
I frankly believe how the company modeled the trial where approvable results would have been achieved had the trial concluded on it's original schedule, 4th quarter last year. I know the target was moved when they had sufficient knowledge to know it was running long. I don't believe at this point it's about meeting the minimums, it's about how much better we are than the minimums.
If the control group survival is essentially as planned, even if we took the last day of the quarter as the target for completion, we'd now be nearly 3 months longer than the 2 months required by the SPA. Why? Because only half the patients get the drug, so for the trial to run 15 days long, the half getting the drug need to live 30 days longer to achieve that average. We're near mid February, so 5 months over the control ought to be the worst case based on anticipating 31 December as the target.
Had 31 December been the target date, I frankly believe the company would have earlier said the target was 4th or 1st quarter. I would think they'd have said the same thing for anything in December, or even late November. I believe if they had an actual date in mind it was closer to mid November. If mid November was when a 2 month advantage should be seen, we're now essentially 3 months beyond, that by my logic could give us an 8 months advantage.
I'm not saying it's 8 months, nor am I saying it's 5 months, but I believe that establishes the range we should be at, provided the control group was precisely where the data indicated. Again, if on average they lived 15 days longer, that would add a month to their side. If I'm correct about 5 months being worst case if they were on schedule, they'd have to average living an extra 45 days to bring our advantage down to the 2 months required. Of course, if we looked at the best case, 8 month advantage, they'd need to live 3 months longer than anticipated to bring that advantage down to 2 months.
If anyone can fault my logic, please feel free to do so. If you cannot fault it, don't listen to the bashers who'll try to say it's too early for the 360th event. Any doubts should be ended once Top Line Data is announced, but that can take several weeks, sometimes over a month from the actual event. Bashers will make you thing the news is bad if not released a matter of days after the event itself, they'll build on that with every added day, don't believe them.
Gary
I suspect that someone put in a sell order at that price. If a buyer is foolish enough to put in a market order to buy, the seller gets the price, but with no news it's right back down to $.0001 on the next trade.
We need news and a lot of missing financial filings to really give this company credibility.
I recently skimmed through a magazine on Solar energy that had numerous articles on thin films, I found no references or adds for Cetek in the magazine, but clearly there's all sorts of work being done in this area. I cannot say if CTKH is doing anything that others can't do as well or better, but if they are, we'll not know it until they become a compliant company again.
In the mean time, perhaps we too should put in sell orders, as long as we're dreaming, why not ask $5.00. I don't know if the broker will even take the order, but if they do and someone wants to buy at the market, how many shares do you want.
Gary
I've very positive on AEZS. Both Perifosine and AEZS-108 are potential blockbusters several times over, and they also have niche products like AEZS-130 that could get approval this year, or next which probably will create enough income to offset the cost of other drug development. If I'm right about that, all the earnings from sales, royalties, and milestones from the other products would become pure earnings.
I would expect by the end of this quarter we'll learn of the conclusion of the first of two Phase III's that Perifosine is in. Of course the longer the trial goes, the more likely the data's positive, but we're already one quarter later than the originally forecast date. I'm told the data in the second trial in Melanoma is even more compelling, but that will be next year. I believe we'll gain approval in colon cancer and sales for melanoma and perhaps others will start almost immediately in off label use.
As for AEZS-108, look for a Phase III to start at some time during the first half of the year, with or without partnerships. While I've got to believe both big Pharmas and regional partners have probably spoken with AEZS, they're in the drivers seat for now. If the data they see for Perifosine says approval, they can take AEZS-108 to approval themselves which doesn't mean they'll do it, but if they partner, it will be largely on their terms.
I'm not suggesting that AEZS could take on worldwide approvals, sales and distribution, they will need partners, or contractors to perform these functions. I'm unsure if they already have commercial manufacturing capability for 108, though they do for Perifosine. In short, they are in a very strong position as long as drugs continue performing, and they have a long list of additional drugs in early stage clinical or preclinical development.
Gary
I certainly can't say what will happen, but in another company I invested in, the company changed direction and symbol, and suddenly years of quarterlies and annual reports were filed, all at once. Don't get me wrong, the company isn't a huge success since they became compliant, still selling for under a penny, but clearly they're attempting to build a business publicly.
I've actually hoped FH has done the opposite, built Cetek into a money making proposition, then suddenly will recognize they'd benefit from divulging what they've been doing all these years.
I have no idea if what CTKH is doing has anything to do with displays we see today, or the OLED TV's recently displayed at CES, but that technology appears to be the next generation that actually is far thinner, lighter, and supposed to have a picture that's as good or better than what's on the market now at a fraction of the energy use. While I still believe CNT's are supposed to be even better, that may still be many years away. From what I heard, 55" OLED HDTV's weighed less than 20 pounds. This is a very exciting technology, hopefully CTKH is in some way involved with it.
By the way, I'm considering a 3-D TV for the next TV I buy. I'm tending toward the L-G approach that doesn't have electronic glasses, but have not decided for sure. Anyone have any advise or experience. I've seen demos of both and both were impressive, but I'd like to hear from those who routinely use them.
Gary
This is barely the beginning if the Perifosine data's positive. As I see it, just positive data could be sufficient to produce a multiple of today's prices with approval perhaps making it a ten banger or more from where we are today.
In my view, our timeline is something like this:
1. Thursday we get a PR on AEZS-108 in Prostate Cancer in Phase I Trial. Price may see $2 again.
2. Sometime this quarter we learn of the final event in the Perifosine Phase III Trial. Up but fluctuating as bashers attempt to create doubt on why top line data's not announced. $2 to $3 range.
3. Top line data released together with statement on filing an NDA, about 2 to 6 weeks after final event. If the data's so strong that even bashers cannot find flaws to question approval, the price goes to $4 to $10. If data as expressed clearly exceeds minimum requirements for NDA filing, but investors/bashers still have doubts, $3 to $8. If the data is perceived as just meeting NDA requirements, $2 to $6. On filing NDA the price should rise 10% to 40% from where it was trading prior to the NDA.
4. FDA Approval on schedule. $10 to $20. FDA delay, $3 to $5. FDA denial, $1 to $3.
Other price movers during this time:
1. Filing NDA for AEZS-130.
2. Start of Phase III for AEZS-108.
3. Trial results from earlier stage drugs.
4. Conclusion of MM Phase III with Perifosine.
5. Partnerships.
Depending on how solid the above are, the above prices could be increased by 5% to 50%.
In short there is great potential here, but of course there is risk as well. Any and all drug trials can fail, but I certainly don't expect it. With each additional day and week before the final event in the Phase III Trial the data appears to be getting stronger. If on the last day of February we've still not heard of the final event, or that it's imminent, I believe anticipation should have us flirting with $3. If the same is true the end of March it's hard to say just how high the share price will be, but barring patients not getting Perifosine suddenly living months longer than anticipated, the data should be great.
Gary
I don't know why, but GNVC in spite of positive news just seems unable to sustain a rally. Perhaps the cause is the positive news recently isn't directly tied to dollars, even if dollars were paid, the amount wasn't specified.
While ultimately I believe dollars will be paid and announced, and with only about 15 million shares outstanding the stock price will grow, but I cannot say how long it will be.
I believe our imaginations could develop scenarios in which the hearing and balance drug could be approved in under a year, while others could show it will take a decade or more. Personally I'd put it at 3 to 6 years after the initial clinical trials start if the drug is proven effective in Phase I, without that it will not go further. With so few share outstanding, I believe a positive Phase I finding will result in double digit prices, perhaps in the $20's or higher.
Of course there are other possible catalysts to substantial increases in share price, RSV has tremendous potential, Merial drugs as well, but if the hearing and balance drug's effective and approved, it could lead to the sort of success we were anticipating years ago from TNFerade.
Gary
Just wanted to demonstrate that a company can reestablish itself after years of not filing. Here's a link to a post where it happened:
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=57100026
I honestly lost track of a company with symbol APPI when all filings stopped being made. I suddenly noticed WHEN showing up in my portfolio and found that it was the former APPI and suddenly was compliant and trading again. While it's still only worth a small fraction of what I invested and with billions of shares authorized I'm not holding my breath for its increase to pennies, dimes or more, my point is there is always hope. WHEN is in the business of turning algae into bio-diesel and other products, while APPI was supposed to be about plant based pharmaceuticals.
I recently saw where OLED TV's would be on the market later this year, they're a fraction of an inch thick and have tremendous pictures. I have no idea if FH has anything whatsoever to do with OLED displays, but remember that CNT displays were supposed to be the be all end all in the future, I wonder if FH is still involved with that.
Frankly I suspect that if we could look far enough into the past to find the Ancient Astronaut's, we'd find that some of these technologies existed here before, we didn't find them because they've turned to CNT dust.
Gary
As long as we're wishing I hope he not only issues a PR, I hope we suddenly have the financials issued so we're compliant, and that they show we're very profitable. We can all dream.
Happy New Year's,
Gary
Happy New Year's.
While I won't hold my breath until FH does something, I cannot help but remain invested when I look at what's on the website found when you enter this board.
FH hasn't given a damn when it comes to shareholders, but he keeps building on what comes under the Cetek banner. I don't know if we'll see anything while FH is in charge, but no telling when something may happen.
I had a small investment in a company doing plant based drugs, APPI, I held it as essentially worthless with nothing reported for years. Suddenly WHEN showed up in my portfolio along with years of financial filings, and the company evolved into a method for growing algae and converting it into Bio-Diesel and other bi-products. It's still trading for a fraction of a cent, but it's trading and most recently fell to about $.0006 and came back to $.0025. If someone's actively trading it, the percentage profit potential is great. As for me, I'm just holding and watching what's happening. Perhaps some day it will trade for pennies, then dimes, but it will take dollars to put a new car in the garage, and/or perhaps a new boat in my slip. In the case of CTKH, dimes could do that.
Gary
Ask yourself this, what will happen if the final event in the Phase III Trial is announced along with positive Top Line Data and the intention to file an NDA in the next quarter or so.
I believe if we're at roughly $2 we'll go to over $3, if we're near or over $3, $4 to $5 or more is very possible.
Then ask yourself what if KERX is bought out at say $10 to $15 at roughly that same time. I believe AEZS share price would move to somewhere between 75% and 110% of the buyout price for KERX.
This is biotech, there is no guarantee results will be that great, but I believe the longer the trial lasts, the greater the potential of the data being great. Today we sit at the point where the trial was originally anticipated to be ending, but now they're saying next year, I believe that's good news. If we reach February speculation of really great data ought to push the price up dramatically. Should the trial reach the 2nd quarter I can't imagine the data not being excellent, but we still must see and hear the data.
Let's be clear, it's not a guarantee if the trial goes months longer then anticipated, GNVC's trial did and it was determined the SOC somehow mysteriously started working better in Pancreatic Cancer. It's happened before, but by Phase III the odds are on our side, and I believe with each passing month the odds improve. Today I'd say that the odds are worthy of approval are 75%, I'd say they move up roughly 5% for each added month.
As always this is JMHO, but if I'm right post approval AEZS ought to be at least a ten banger from where it is today.
Gary
It seems to me that if there is no moderator, someone at IH ought to remove the rights of deleting posts to a former moderator.
I don't pay for IH, perhaps someone who does would have a chance of getting them to resolve the problem.
Gary
I see there is no moderator for this board. If that's actually true, who keeps deleting posts.
Gary
Penny,
While I applaud your efforts, the truth seems to be that nothing moves FH unless he determines to move himself. When he sees a benefit to trading again as a reporting company, he'll do it.
Another company I had stock in hadn't reported for years, all of a sudden the name of the company changes, years of financial reports were suddenly filed, and it began trading routinely under a new symbol. It can happen. The stock, unfortunately, is still worth only about a tenth of a cent, but like with CTKH, I'll hold it and watch what happens. I believe if either stock's ever worth $.01 there is no reason it can't go to $.02, or $.10 or more. The point is, many people hold stocks that go down until they're even again, then sell. When a stock has returned to where it was purchased, their is no reason it can't go dramatically above that price.
I'm not holding my breath until FH acts, it's very possible he never will, but perhaps his kids who inherit the company will find it's better to compliant with the SEC again.
Gary
The beauty of AEZS's partnerships is that with the exception of KERX, the partnerships have come late in drug development and bring far better premiums then if AEZS partnered Perifosine worldwide early in its development. KERX has done the heavy lifting and AEZS will be very well paid should KERX be bought out as they hope in the near future.
A partnership for Europe is really of questionable need. AEZS appears to already have the needed production capability, so a European partner would primarily be responsible for approval, distribution and sales. Approval however has already been established to be based on the FDA acceptance, so there is little to do to achieve that. With much of its staff already based in Germany, it's very possible that AEZS will keep this piece of the pie for itself. The added cost of personnel that might be added would easily be handled by royalties from KERX or its buyer until European sales themselves become profitable. In time, I believe they'll be highly profitable.
Good Thanksgiving all,
Gary
I may be wrong, but if AEZS can supply the demand for the drug with currently available production facilities, indicated by the latest partnership, the question of Europe may become, do they go it alone there. Not saying they will, but with European approval tied to the FDA, they will have practically no expense in establishing a market in Europe. While AEZS is headquartered in Canada, it has more employees in Germany than anywhere else.
In short, AEZS may be well positioned to keep the European market for itself, greatly enhancing it's long term earnings. Certainly if it partnered, it could bring in funds more rapidly as both the partnership itself, then European approval should bring in substantial milestone payments, but earnings from sales will certainly be higher if AEZS owns the drug there then if they're getting royalties from a partner.
Gary
While it's very possible a few more percent buy and sell within the quarter, they'll not need to report such manipulation. By the time the company is over $5 you'll see Institutional Ownership grow to 30% or more, by $10 the Institution's could become the majority.
Now if a partner in Perifosine also took say a 15% interest in the company, if they were allied with most of the Institutions, effectively they could have control. The least I think such an interest would get is a seat on the BOD. Many years ago a similar move was made at IMCL for 30% of Erbitux as well as 30% of the company, half the shares were tindered, half were newly issued, all told it was to be a $3 billion dollar deal. I frankly believe that Perifosine could be bigger then Erbitux, but then BMY was stung by IMCL's lies about discussions with the FDA and the shares fell as approval was delayed. This is also the cause of the insider trading that put Waksal and Martha Stewart in jail, but my point is that if properly staged, AEZS could bring some very big numbers either for Perifosine, or for AEZS-108 in the not that distant future.
Gary
The really big Institutional buying won't occur till the Market Cap is dramatically higher, probably at stock prices at $5. Institutions which formally are chartered not to invest in stocks below a certain market cap or stock price frequently do get in, but then they get out before the end of the quarter unless the price goes above their threashold by the end of the quarter. Institutions only report what they hold for over the end of a quarter if it hasn't been held for a full quarter or more. An institution buying in October can sell on December 31st and not report at all, or if they do report I won't show until Mid February. While computers would permit all this to be done instantaneously, the rules permit Institutions not to report until half way through the next quarter. By the time Investors know what's really happened the news could potentially be as much as 4.5 months old if an Institution made it's move on the first day of a quarter.
It's my belief that by the time AEZS is $8 it will probably be 50% of more Institutionally owned. While some of these shares may come from newly authorized share, the overwhelming majority will come from individual investors selling.
I believe those who'll make the most money on this stock are probably not currently invested in its. If Perifosine and AEZS-108 are both successful, don't be satisfied with a 10 banger, in a few years it could be a 100 banger or more.
Gary
Here's an excellent response to AF's article about the Phase II.
http://messages.finance.yahoo.com/Stocks_%28A_to_Z%29/Stocks_K/threadview?m=te&bn=10207&tid=88849&mid=-1&tof=1&rt=1&frt=1&off=1#-1
Gary
I know, but clearly FH has ignored us for years, I don't expect anything until he's willing to reveal all. Sadly in the Pinks this kind of attitude goes without punishment from regulatory authorities. If FH determines he wants CTKH to legitamately trade he can file years of data all at once and all is forgiven.
If you don't believe me, take a look at WHEN. I hadn't even heard of it, had another stock known as APPI that hadn't reported in years, suddenly they took the new name and symbol and filed years of financials all at once. It's not worth much either, but perhaps it's building something worth holding. They are working on biofuels from algae growth, it does work, we'll see if it's more economical then other ways of getting it. Personally I believe it's better then creating it from growing crops, but the price to really beat is doing it for less then petroleum out of the ground.
I cannot see selling either of these companies for the few dollars they'd bring. If something real is happening behind the scenes, at some point we'll learn what it is.
I did get rid of all the CEXI but note it's still trading, and they still believe they have a product worth selling.
Gary
Years ago there was all sorts of discussions about how Carbon Nanotubes were going to dominate the market in all sorts of applications, including virtually all flat panel displays. Since that time LED displays that use less power then LCD and far less then Plasma are dominating the top of the line market.
Is it possible that FH while selling some product is primarily still involved with development of CNT's and when these products are ready for the market he'll finally open up about what the company's been doing.
I'm not saying this is the case, just that if it's possible, one reason for going completely underground on what you're doing could be the secrecy required by the other companies you're working with in doing it.
It's still my belief that CNT's will replace all sorts of things from how processors are made to flat panel displays, perhaps that roll up, to electrical transmission lines that are smaller, stronger, and have far lower line losses. I haven't kept up with developments, but I do pay attention to scientific news in general and advancements in CNT's just seems to have dissappeared.
At this point, regardless of what happens, I cannot see selling at prices under a penny if there is a viable company here, and if it's not, it will never go much higher then the $.0002 we've seen recently.
Gary
Many seem to be blaming the ATM on Yahoo. I have no idea how many shares from the ATM are being sold. It would be my hope that ATM shares would be used largely for institutional sales where the MM's generally would have to accumulate shares to deliver large orders. I would prefer that, and not selling many at these prices at all, but I don't know how the ATM's being handled.
If as some suspect each time the price runs up a bit ATM shares are coming into play, it is thwarting the rallies. This too will pass, and good news eventually should move the stock dramatically.
I originally thought the ATM could be better then a discounted offering, but if it's constantly being used, it's hurting the price worse than a one time offering.
Gary
I certainly agree. Even with millions of shares I can't see selling at any time soon, even at significantly higher prices, if the company doesn't release a full financial disclosure.
I cannot understand what's going on in FH's mind, but at some point I believe we'll find there could be real equity here. Perhaps never a dollar, but a dime would be huge.
Gary
It's my belief that Phase III is being planned, and perhaps it can be without other events occurring, however, in the back of my mind I have to wonder, is the company in the final stages of negotiating a partnership for AEZS-108.
If AEZS is considering a single worldwide partner for AEZS-108, at this point in its development, over $100 million up front could be reasonable. Certainly it's not guaranteed, but less impressive drugs have brought in substantially more.
Of course AEZS may be thinking of taking it well into Phase III, at that point history has shown big Pharma's willing to pay billions, when they also take a position in the company. What's clear is that until something is announced, AEZS has choices.
If AEZS is certain of Perifosine approval next year, one choice could be to wait and try to keep AEZS-108 totally to themselves. This might be possible, but even with Perifosine Approval driving the stock price up substantially, it would still require substantial dilution. Why? Because even if earnings in the first few years reach $100M, the cost of an approved commercial production facility for AEZS-108 as well as the cost of establishing approvals, distribution and sales worldwide could easily go into the hundreds of millions, or even billions. Much of what's needed is already available at most big Pharma's. In many cases even the manufacturing can be an adaptation of an existing facility rather then starting from scratch.
My point is that economics probably still says AEZS will partner the drug, if not, they may contract for services. I.E. they won't go it alone. At some point something will happen. The question is, are they trying to make it happen now, where a partner will take charge of Phase III, or do they wait.
There is a huge benefit to doing it now. Trial size. While no doubt both AEZS or a partner can reach an agreement with the FDA on the trial protocol. Lets say for the sake of argument that 500 people are to be enrolled and the trial will be concluded after 350 events. Acting independently AEZS would probably be able to fund sufficient clinical sites to enrol 100 new patients a year. If median survival was in the 18 month range such a trial could take 7 years to run. Big Pharma on the other hand might fund sufficient clinical sites to enroll 500 patients in less than one year, the trial could be run in perhaps 3 years.
It's my belief that even though long term shareholders may earn more without a partner, the benefits of a partnership at this point in the drugs development are tremendous. The biggest benefit is that instead of having to devote most of the companies finances to the development of the drug, they suddenly have substantial funds available for creating other drugs.
Eventually when drugs like Perifosine, AEZS-108, Solorel, etc are bringing in $100's of millions in annual earning, AEZS would have the funds needed to take blockbuster potential drugs to conclusion themselves.
Why not partner Solorel? Because it's a niche drug. With a small manufacturing capability and the assistance of someone like Fed Ex or UPS, AEZS can probably meet worldwide demand for this product themselves. I believe Solorel can bring in $10's of millions in earnings on sales that perhaps go into $100's of millions. That's enough to be worthwhile doing, but not of interest to Big Pharma.
Gary
Forgot the link:
http://ih.advfn.com/p.php?pid=nmona&article=49026129
Gary
You're right, here's a like to the recent and upcoming presentation.
I think $2's easy if the market's stable, but it's hard to rise in a market that's falling and I'm uncertain that won't continue until we have a stronger degree of confidence in the economy recovering. It's unfortunate, but our Politicians are putting Party above Country in not compromising on policies which most American's would say are right for the time.
Personally I'm all for greatly cutting corporate taxes, while greatly increasing revenue from corporations. I know that makes no sense, until you lower the rates dramatically, but remove the loopholes that have many corporations paying nothing. I'm not saying all exemptions should be removed, but lets lower the rate dramatically, strike all the current laws, then revisit those exemptions where a strong enough case is made to do something, but in every case that something should assure some tax is paid.
Some of our biggest corporations with tremendous profits currently pay nothing, or extremely low rates. If I remember correctly GE for example earned $7 billion and paid no taxes. To my way of thinking they shouldn't pay $2+ billion, which they would if they paid at the full corporate tax rate, but a 10% tax rate would cost them $700 million, I believe they'd agree its a fair rate.
There is a risk in simplifying taxes and tax law, we'd be adding to the unemployment picture as so many accountants and tax attorneys wouldn't be needed. Product prices could probably come down as legal and accounting costs would come down and even after paying the taxes, earnings would go up.
Imagine what would happen if we said all the laws past by Congress could be no more than 50 pages double spaced 10 pt. type. I suspect we'd have laws that were easily understood and contained virtually no pork as it couldn't be hidden in thousands of pages. Congressment who wanted billions to build an International Airport somewhere no one flies to, cause it's in his district, would have to write and defend such a bill. I'm not saying the money shouldn't be spent, but instead of that airport, perhaps it ought to be spent building new highways, upgrading our power transmission, sewage systems, fresh water systems, etc. Imagine what would happen if when their is flooding along the Mississippi and a drought in Texas that we could pump some of the excess to where it was needed. While I doubt we could ever pump enough to avoid all floods, we could diminish their impact, especially if we started pumping well before flood stage was actually met.
I know the above won't happen, but there is so much good we could do if we put our mind to it, but what the heck, lets get another International Airport built somewhere in the middle of nowhere, perhaps in time a city will grow around it. It's what our Congressmen do for their district while other Congressmen get their support for building something else equally unneeded in their districts. It's the American Political Way.
Gary
I believe their are milestone payment with royalty increases at pre-established sales levels. What's important to remember is that royalties are normally based on sales, not a percentage of the earnings. It's said that earnings from most drugs sold are in the 20 to 30% range, the remainder going to the cost of production, distribution and sales of the drug. If this is essentially true, the royalty figure AEZS receives should be 50% or more of what KERX should earn at absolutely no expense. When you add milestone payments and the cost of the trials, such an arrangement is fair for both sides.
What's equally important is that AEZS has the rest of the world, and as I understand it, Europe has agreed to accept the data provided to the FDA for European Approval consideration. I'm uncertain that AEZS with a large part of its staff in Germany is considering handling Europe alone, or if they'll either partner or contract for certain services. What's important is that however Europe is handled, AEZS should see considerably higher earnings from European sales then in places where rights were established far earlier in the trial process.
If KERX is sold post approval there is little doubts the buyer might want to either acquire AEZS as well, or partner with them. Personally I much prefer a partnership, even one which the partner takes a major interest. I believe shareholders still have the potential of tremendous future growth even if a partner essentially takes control. A 15% to 30% interest in the company would provide substantial control of the company after drug approval. Why? Because with the higher prices that Approval will bring, AEZS will see Institutional Ownership greatly increased and the Institutions will follow the lead of a Big Pharma that has substantial ownership. While 15% might only assure a seat on the BOD, 30% would effectively give nearly complete control as to the direction the company takes, yet they still would effectively operate separately.
Gary
Joel,
I really didn't mean to ignore you, I've been out at Catalina for over a week and spending little time on the net.
As for the price, I can't say who's trying to keep it down but believe they can only do it so long. If whatever data's revealed and whatever news is forthcoming reinforces the likelihood of approvals from the NDA's which should be filed next year, you'll not see it at these prices ever again.
Of course when you're dealing with the FDA their may be delays, in fact I believe the price could be 5 to 10 times higher prior to an FDA decision and even a delay that experts believed would be under 2 years shouldn't get a retrenchment to these levels. Only an out and out failure in Perifosine could do that, and even then other trials could lead to its approval.
Solarel (AEZS-130) is currently viewed as a Niche product which certainly can help the price, but at least today it's not looked upon as a tremendous profit center. It's use could change that if a greater percentage of the general population was found to be HGH deficient. This should be the first time in history where the determination of HGH deficiency can be simply and accurately determined. If it's determined that more then expected have the problem, it's use could greatly expand and suddenly a Niche product could approach Blockbuster potential. I'm not suggesting this will happen, it will take years post approval to determine if more people are affected then currently thought, but if that's the case, it could become part of our physicals once, or perhaps a few times in our lives. I don't know what AEZS will make for each use of the drug, but if they earned just a dime and the drug was administered once a decade to everyone on the planet, we'd be wealthy beyond our wildest expectations from this drug alone. Please note, I didn't say they sold it for a dime, I said they earned a dime, clear profit after all costs were paid out including the salaries and bonuses of all at the company. I don't know if that means selling it for a dollar, or ten dollars, my point is, if the volume were that great, it doesn't need to be a treatment that costs thousands or more. How'd you like to get just a dime for every dog that gets a rabies shot.
Gary
NP,
Personally I look at all these drugs as tools an Oncologist ought to be allowed to use. The fact that some other drug achieved a higher percentage is meaningless if that drug won't help a particular patient the Oncologist is working with, and AEZS-108 or some other drug which had lower percentages would help.
I'm of the belief that any drug benefitting perhaps as low as 10% of the population where other drugs don't appear to work could prove itself worthy of FDA approval. More importantly, I believe Oncologists will find combinations of this and other drugs never in trials together which will prove far more effective then any of them used alone, or used in specifically approved FDA protocols.
Of course with my attitude the FDA ought to approve more drugs, perhaps some day they will. I think the best test for whether a drug should be approved or not would come from people asking if they'd want access to it if they were stricken with the cancer, and if all other approved drugs failed. Only 20+% recieving benefit may sound low to you, but it wouldn't if you were somewhere in that 20%.
Gart
I'm not suggesting that all the technical theories are bunk, but the period after the 4th of July and Labor Day is often referred to as the Summer Doldrum's when it comes to Biotech's, largely because of a general lack of news during this period. This year's probably far worse then the average because of so much negative economic information bringing down markets everywhere in the world.
It's not that AEZS has had no news, the conclusion of the Solorel trial, anticipation of the Phase III of Perifosine trial ending, top line data for both, and finally anticipated NDA filings are all newsworthy, but it's all news that's completely been expected. Much the same is true with most other biotechs, but DNDN's announcement of less then anticipated sales tanked both them, but to a greater degree the entire industry.
I don't know what it will take to straighten out the economic mess all over the world, or even here for that matter. I believe we'd make a big step forward if Politicians put Country ahead of Party and spoke with one another, rather then through one another. The next election will probably be one of the nastiest ever as the Democrats wage class warfare and the Republicans scream cut taxes. The truth I believe is, we need a little compromise.
It's true that cutting taxes on Corporations could create jobs, if they were paying taxes. To me it's logical to lower Corporate tax rates, but eliminate regulations that permit them to operate offshore, or hide all they're earning in loopholes we've provided them. 60 Minutes had several CEO's defending their actions as what's best for the shareholders, wish I could disagree, but it's our laws that permitted the likes of GE to earn something like $7 billion and pay zero taxes. I believe we'd take in far more money if the Corporate rate were lowered to perhaps 15%, but most, if not all the loopholes and subsidies they get were removed and companies doing business here paid taxes here.
On the other hand the Republican's insistance on maintaining all the benefits for the wealthiest of us, while others suffer with less all the time cannot fly with voters. Cutbacks by States, Cities, etc because of lower tax revenue effect all our lives with lessened services. Our wealthiest may not notice the decay as much, flying around in their jets or traveling in limos, but the rest of us feel the potholes, and we'll feel the pinch if Social Security or Medicare is cut dramatically, at least when we're at that age, which I am. One solution to extending the benefits would be to take the level where you continue to contribute to the fund dramatically higher, yes, you can call it a tax on the wealthy, but it's the same percentage the rest of us pay on all we earn.
If I had a choice, I'd vote for a Moderate Party that promised to put Country above Party and would kick all the current politicians out. While I'm a Democrat by affiliation, I'm sickened by both Parties actions and would openly support a Moderate party that's somewhere in the middle, but not the fringe parties attempted by the likes of Perot and others.
AEZS and other biotechs will eventually soar, or fail, based on news that's specific to the company, not the economy, or other biotechs. Right now the big news people want to hear is Top Line Data for Perifosine, which should come a month or so after they announce the completion of the trial, perhaps by years end, or early next year. We've been told that Top Line Data for Solorel should come this month, while hopefully it's good, they've said they'd file a NDA early next year, that's a hint, but understand, this is a drug which should earn them some money, but not a fortune. The real news is about Perifosine, about AEZS-108 after that, both these have blockbuster potential, as do other drugs that are years further out in development.
The Dow's down over 100, AEZS is down pennies again, when it was down 50 we were slightly up. The point is barring other news we are influenced greatly by the market. When good, or bad news comes in, it's not that the market has no influence, but the influence is diminished. I'd much rather see great news on an up market day, but regardless, the news will ultimately lead to approvals and approvals will lead to earnings, it's those earnings that eventually will dictate stock value, though it's always influenced by what's happen in and around it. Under the right conditions a company like AEZS with earnings could be valued at 30 to 50 times earning under the right conditions, however under other conditions it might be judged worth 10 times or less. The earnings multiple is dramatically effected by other influences, if optimism pervades, the higher figures certainly come into play, but if pessimism is seen in the market or company, the multiplier will clearly be lower. In the time I've been writing this paragraph the Dow's improved to down 80, and AEZS is down just a penny. Things just happen this way.
Gary
Joel,
At this point much depends on what the data tells Analysts and Investors. We may only get Top Line data from the trials prior to NDA filings, but if that Top Line information is extremely positive suggesting almost certain approval, the stock price could rise dramatically on that. On the other hand, if the Top Line info is solid, supporting the NDA filing, but if there still are questions in the minds of the experts as to whether approval is a sure thing, then the price gain may not be nearly as great, but I'd still expect a rise as the PFUDA date approaches.
In the initial case where approval is practically sure, the price prior to approval may not rise dramatically after approval as it's largely built into the price. On the other hand if approval is questionable, then when it occurs the price rises dramatically.
Of course approval is never really sure, and failure of a drug anticipating approval often provides tremendous opportunity when instead of approval you get delay. Look at companies like DCTH or DNDN, both have had delays in the approval process. DCTH will eventually probably get approved, DNDN obviously did, but the sales data recently disappointed and the stock's back to numbers not seen for months before approval. It's important to properly value what's being approved.
Solorel is a niche drug. The niche may grow if more people are found to have HGH problems then currently are anticipated. The company may make millions, or even tens of millions from the drug, but barring a miracle it's not a drug that will dramatically increase the share price.
Perifosine has tremendous potential IMHO. If over time several cancers gain approval for treatment with Perifosine, it could be a blockbuster drug many times over. If AEZS only had it in partnerships world wide, and if those partnerships royalties were just 10%, it could earn them hundreds of millions annually. Even if the O/S eventually exceed 100 million shares we're still speaking of dollars per share in earnings annually. If drugs like Solorel make enough money to offset other corporate expenses in developing other drugs, then the royalty and milestone earnings from a blockbuster can essentially be pure annualized earnings. With other drugs approaching approval I believe a company like AEZS warrants a P/E of 30, but much depends on market conditions. I like $$$'s in earnings with P/E's close to 30. Of course this all starts with approvals, note the plural, for real success a drug like Perifosine needs many of them, the first may be the most important, its earnings will fund many other trials and while not every trial it funds will be successful, each successful trial will dramatically add to those earnings.
It should be noted that only the first approval is needed for drug sales in any capacity. Once approved, drugs can be used off label for other applications, but if you want insurance to pay, their has to be some history of success. If Perifosine is approved say in Colon Cancer, if promising data is seen in say a Phase II in Prostate Cancer, a case can be made for its use and Insurance companies may pay. On the other hand if no data's been established for Prostate and either an Oncologist or patient was convinced it might help, it could be tried as long as someone was willing to pay for it. If successful it could add anecdotal information which can under the right circumstances gain approval or greatly speed the process.
Many investors get in before Pivotal Trials and out just before or after approval. Growth during this period can be tremendous, however, if a company has a large pipeline, and if the drugs approved have tremendous sales growth potential, the company may undergo tremendous growth for many years. I failed to buy AMGN in 1990 when it was about $15. When it split a couple years later I thought it had its run. It went on to split 3 other times that decade, a total of 48 to 1. Since that decade it's largely been dead money, but what a decade. I'm not saying that AEZS could have that big a decade, but looking at it's pipeline, with success in several bigger drugs, it could write the same sort of story if it's not bought out.
Gary
Joel,
While it's possible that Perifosine will end the trial this year, and the end of the trial for AEZS-130 has occured, don't rush the approval process. It takes substantial time post trial to fully understand the data and properly present an NDA, AEZS has clearly stated it will be early next year before their submission on Solorel (AEZS-130) much the same should be expected of KERX on completion of the Perifosine Phase III, so conclusion this year may still take well into next year for NDA submission.
Small biotechs generally partner drugs because they simply don't have the funding required to do everything properly themselves when it comes to testing, manufacture, distribution and sales of what they've developed. Right now it's questionable in my mind whether KERX can do it alone in North America, or whether and even bigger partnership may be established where a big Pharma either partners with them, or even with all currently involved with the company for worldwide rights. Likewise, AEZS with most its personnel in Germany may have thoughts of handling European needs themselves, or again another major regional partnership may be in the works.
As small biotechs mature, they may emerge as major Biotechs if they're not bought out themselves. If for instance Perifosine were approved prior to a partnership for AEZS-108, AEZS could consider if they'd like to consider keeping AEZS-108 completely in house, or only contracting out that portion of the effort it couldn't possibly support. The difference between partnering and contracting is a tremendous amount of money. In a partnership they'd receive a tremendous amount of money up front, and the partner would typically pick up all expenses, then on approval they'd see nice royalties on sales, not earnings, of the drug. The partner might sell $1B a year, but earn $100M, while with a 10% royalty AEZS would also earn $100M for doing absolutely nothing. If on the other hand they keep the drug in house, they'll have to pay substantial money either for a manufacturing facility, or to contract for it. Then they must pay to build a distribution and sales staff, or again, contract for it. This is all in addition to the cost of gaining approvals which grows dramatically in Phase III.
Look at DNDN, many were sure they'd go to triple digits either on sales or once they partnered Provenge. I cannot say if they turned down partnership offers because in their mind they were simply not enough, or if no such offers were made as major Pharma wasn't interested in the logistics involve in individualized drugs. Regardless, much of the shine has come off the company with weak sales.
Personally I hate seeing big Pharma swoop in and buy promising drugs for what seems like a song, but I recognize it's often the best thing a company can do. Had DNDN gotten a partner on Provenge, I don't doubt that sales would have been greater as big Pharma has the wherewithall to build sales in a manner that DNDN didn't. Single digit or low double digit royalties may seem wrong when you've done all the heavy lifting, but with big Pharma pushing a drug it might be a blockbuster many times over, while a company like DNDN is actually losing money on its sales.
While I'd love to see AEZS grow into a major Biotech capable of fully supporting full development, manufacturing, distribution and sales of their own drugs worldwide, it's a huge effort for drugs with blockbuster sales. That's not true of Solorel. It's a niche drug, major Pharma's not that interested and as of it's approval there will be no competition with other products. Because the demand for it is anticipated to be small, the manufacturing capability may already exist, at least for its launch. In short, AEZS may keep this drug completely and while it won't earn billions, it can produce tens to hundreds of millions in sales, and at least tens of millions eventually in earnings.
I wish I could say what will be the next major event for AEZS, but in reality it has many opportunities and you never know what may interest a major Pharma. If they're more excited about something that's not yet in the clinic, they could partner that before a drug such as AEZS-108 is partnered. Clearly the earlier stage a drug is in its development the less that can be demanded for it, but if Company X really wants drug Y which is preclinical, they may pay more for it than drug Z which is in Pivotal trials, but they're not interested in it. Big Pharma clearly wants Blockbuster drugs, drugs which they feel certain will sell in the billions annually. If they see a drug as promising, but with a limited market, like Solorel, the fact that it should be easily approved means little, they're not interested.
I liked AEZS because of the breadth and depth of their pipeline. Once sales are established for bigger drugs like Perifosine, if AEZS isn't bought out, it truly could become a Biotech Giant, like Amgen. At one time I could have said like Genentech as well, but it's been bought out, spun off, and bought out again by Roche and I have a feeling they may spin off a percentage of it again.
My biggest investment mistake came in roughly 1990 when AMGN was suggested to me at about $15 a share and I didn't buy. If you look at AMGN in the last decade it did essentially nothing, but if you look at it between 1990 and 2000 it rose to perhaps $80 at the end of the decade, no big deal, but it split a total of 48 to 1 during that decade, Big Deal. In short it grew so fast that by 2000 it could no longer support the growth rate, and while a giant Biotech, like Giant Pharmas new blockbuster drugs just sustain it, while blockbuster drugs can explode the price of a tiny biotech, like AEZS.
Gary
Phase IV is a post approval trial which the FDA can require, but certainly not a part of every approval.
I for one would much prefer faster approvals for Phase II or III trials which always were followed with required reporting of the outcome of all use of the drug, call it Phase IV, or something else.
AEZS's drugs are currently in, or have completed, trials which can result in Approval. The company stated that AEZS-130 will be discussed with the FDA in a pre NDA filing meeting followed by a NDA early next year. Sure, it's possible they could have rushed the NDA and filed it this year, but IMHO it's better to take your time and get it right, or at least as right as possible. The FDA asks questions all the time of drugs you know will be approved, delaying approval with each question by at least 6 months, and in some cases for years. No matter how reasonable the question is, they can ask it, and you must answer if you want a chance at approval. When a question is fully and completely answered, the FDA still has the right to ask another question which is totally unrelated to the initial question. I.E. if the FDA wishes, they can delay drug approval as long as they wish. If you look at their history, they seem to have a heavy bias toward approving the drugs from big Pharma, and delaying the drugs from tiny Biotechs, often until they're sold out of frustration to big Pharma.
When the company spoke, they did indicate at least a possibility of expedited approval for AEZS-130, previously they sounded as if they weren't even going to attempt to get it. With expedited approval the FDA has 6 months to act, without it, they have a year.
Perifosine could have it's Phase III end this year, and an NDA filed by the first half of next year. If that's the case, expedited approval is almost certain and should get a decision next year.
As I said, I'd like to see shorter approvals, but all drugs should have outcomes reported, and no outcomes could be hidden by manufacturers willing to pay someone off to withhold negative results. Problems with drugs like Vioxx or FenFen would never have reached the levels they did if negative side effects were reported from the beginning, instead of payoffs to victims or families of victims of these drugs. Has the negative effects of Vioxx been reported initially, it probably would be on the market today, but usages would be restricted to short periods, i.e. sales would have been much smaller, but they'd have been sustained.
Other AEZS drugs should go into Phase III in the not too distant future, but depending on the Phase III Trial design, approval could take several years.
Gary
Thanks Bigcue,
Now if we could learn more about what's behind the payments, we might learn that their is a business there. Of course I've believe there's a business there for some time, FH simply refuses to tell us about it.
Gary
The release gave people a half hour to review the release before the webcast, while this is common, it's normally released by most companies before or after the market day.
I'm still listening to the Webcast, but I believe it's very positive as so much seems to be happening on virtually all the drugs they've developed. By the end of the month we should see top line data on the AEZS-130 Trial which they no doubt intend to develop an NDA for this year. It is possible that they will market this niche product worldwide themselves.
I believe the company's being very open and honest about their plans, but do maintain certain information they can't discuss rightfully. It's unusual to have quarterly webcasts last an hour, this one is almost there.
Gary
Remember, this is a niche drug, it's approval will help, but it won't make you wealthy unless its application expands and/or there are theraputic uses found, not just HGH deficiency detection.
That said, the company has options on how it may handle the completion of the trial. They could announce top line data once they've received it, they could wait for a quarterly to announce it, they might present data at an appropriate technical conference, then discuss it in greater detail with investors, or they might say nothing and just proceed with NDA development and let us know when the NDA's been submitted to the FDA.
I suspect we'll either get top line data from a PR, or they discuss it at the next quarterly, probably early next month. As for NDA development, I believe we'll see it sometime later this year, but probably not until late this year.
As for the expansion of the drugs use in HGH deficience, if after use it's found that a far greater percentage of the population have this problem, use of the drug could expand dramatically. It won't happen quickly, but if a decade from now the SOC said test all patients beginning at age 50 and do so every 5 years, similar to the guidelines with colonoscopies, this could be huge.
For now, if approved late next year it will have little impact before 2013, and even then be quite small. If partnered the impact of a partnership might be greater then the drugs approval, but don't expect tens or hundreds of millions up front from such a partnership, this simply isn't that big a drug, at least not for now.
Gary
Here's a related article which shows the potential of Perifosine to go well into the billions of dollars.
http://www.cantechletter.com/2011/07/aeterna-zentaris-european-patent-perifosin/
We'll know a lot more once the top line data is revealed but once the approvals start, AEZS will either grow tremendously, or be bought out. Personally I'd rather see it grow for the next several years.
Gary
You're giving a good assessment of AEZS for Perifosine, however it's their pipeline that could really move the stock even more dramatically in the future. By the time Perifosine is approved it may be clear that AEZS-108 is close, and could be bigger than Perifosine. It's also very possible that Solarel (AEZS-130) could be on the verge of approval or approved for diagnosing HGH deficiencies, and perhaps showing benefits in other theraputic uses.
I'm not suggesting that AEZS will be bigger than DNDN on Perifosine, but when you add the others it might be the one that others site, instead of DNDN, but it will take at least a couple years.
Gary