Seattle Genetics: Positive Read-Through From Roche's Investor Day [View article]
Ohad,
I'm surprised you place so much faith in SGEN, and none in IMGN. T-DM1 will earn far more for IMGN once it's approved and Roche starts to market it as the replacement for Herceptin because it's simply much better than Herceptin, and their patents will be running out on Herceptin, so it figures. It may take a few years to reach the $6 billion annually that Herceptin sells, but it won't stop their either as other Her2 positive cancers get into the act.
Both companies have substantial pipelines, but I believe IMGN will bring 1 to 2 of it's wholly owned drugs into the clinic annually. I don't believe that SGEN has nearly that many preclinical products to bring forward.
I know you were strong on IMGN a few years ago, while the low royalties with T-DM1 holds down the earnings there, nearly 5% of many billions is still a big number. T-DM1's success has permitted IMGN to gain far better terms in newer partnerships, and post approval they'll get even better.
4 Small Cap Biopharmas With Near-Term Catalysts [View article]
Like many, you stress Perifosine, and ignore a rather broad AEZS pipeline. Let's look at the other near term actions that should boost the stock.
AEZS-108 should initiate its Phase III Trial any day, it's in the Clinical Trials database with a target of March.
AEZS-130 should have it's NDA for detection of HGH deficiency filed this quarter. This may be a niche market, but their is no competition as the existing drug has been taken off the market. By mid year we should also see Phase II results for use of this drug in Cancer Cachexia, if this proves to be effective it could be a real game changer.
AEZS has a number of other drugs in earlier stage trials as well as data from both Perifosine and AEZS-108 in earlier stage trials that show both to be effective in several cancers each. If AEZS had the funding of a major Pharma, both of these drugs would probably be in a few additional Phase III Trials. This could happen with one or both by partnership.
Certainly I'll be interested in the recommendation of the trial managers after the peek in the MM Trial, but believe we'll get nothing stronger than a recommendation to continue. Meaningful data rarely comes out of peeks, even if the clinicians are impressed with results to date. The company may get some indication of the clinicians enthusiasm, but not the actual data.
Look at the whole company, not one drug, and I believe you'll see it ought to be worth far more than it is.
Sentiment Shows Investors Bullish On Aeterna In 2013: Here's Why [View article]
Two minor things you should know. Perifosine is not wholly owned by AEZS, North America and Europe, two of the largest markets as well as others are still available, but some parts of the world do have partners. The second, which actually could be very big, is that AEZS-130 ought to be completing Phase II Trials in Cancer Cachexia. If Phase II data's positive and the drug's approved for HGH deficiency testing, off label use of the drug could be far greater than it's approved use as their is no approved drug for cancer cachexia. Potentially a niche drug could have blockbuster potential. Currently the Phase II Trial is scheduled to conclude mid-year, before approval even if AEZS should get priority review, so any potential partner would know the true potential of the drug before AEZS finalized a partnership.
In time, partnerships should be concluded for all the late stage products. Perhaps when AEZS has a substantial revenue stream they'll consider taking drugs worldwide themselves, but without that, at minimum regional partners will be required for much of the world.
Biotech Portfolio Update: 2012 Summary And 2013 Outlook [View article]
T-DM1's approval may be assumed, but ask yourself what the stock price should be once IMGN's receiving annual royalties in the hundreds of millions. With positive date in gastric cancer, others to follow, I believe T-DM1 could be a $10 billion plus drug in perhaps 5 years netting IMGN nearly half a billion annually. What's a fair price for the stock on that income alone.
The CEO's speaking at the J.P. Morgan conference and the PR put an emphasis on a new drug from IMGN entering the clinic soon, it seems this drug has many targets and may be bigger than anything currently in the clinic, though all have blockbuster potential IMHO. I think reality is he'll talk about the entire pipeline, but this is the first time this drug is being put under the limelight, so it's the one thing that's new.
IMGN has a very strong pipeline, though trials advance slowly. If you ignore the entire pipeline, but see T-DM1 replace and expand on Herceptin, as I expect it will, I think you'll see the company should see near triple digits on that alone. It's all about earnings once T-DM1 is approved, while many products failed to live up to expectations, I believe T-DM1 will exceed expectations. As I understand it, IMGN will be paid royalties based on quarterly sales, if correct, it shouldn't take long to see if sales growth isn't impressive. I believe Roche is positioned to market and sell product almost immediately upon notification of approval, we may see royalties announced after the end of the 1st quarter. If they increase dramatically each quarter, what should the stock price be by the end of the year. My estimate is approaching $30.
Can AEterna Turn A New Leaf In 2013? [View article]
While I believe you're correct in all you're saying, you're ignoring the potential for tremendous upside growth in many other ways for the company in 2013.
Partnerships are certainly possibilities for almost instantaneous growth as right now both AEZS-108 and 130 are wholly owned, and much of the world, including North America, is available for Perifosine.
Another joker in the deck would be the Cancer Cachexia trial with AEZS-130. This drug is only a niche drug when considered for diagnosing HGH deficiency. The drug may have blockbuster potential if the current Phase I/II Trial in Cancer Cachexia produces positive results. Today their is no drug approved for this uncontrolled weight loss which often leads to death well before the cancer would take the patient. It's very possible that for at least some patients the cancer may be put into remission, but the patient passes because of the weakness of other organs caused by tremendous weight loss.
My point is, you're right, but their are many other catalysts that could take the stock far higher this year.
Cel-Sci: Immunotherapy Opens New Door To Investors [View article]
I've followed CVM for over a decade heard many claims made for Multikine being the answer to all sorts of diseases, including things like avian flu. While I hope you're right and this cure finally found it's disease, I still have my doubts.
I have no doubt that the company will finance through further dilution on any positive news, it's how they stay in business.
Aeterna Zentaris (AEZS) -12% to $0.61 after saying that it's consolidating its shares on a 6-1 basis as part of an attempt to regain compliance with Nasdaq's minimum bid-price requirement. Aeterna Zentaris expects that the post-consolidation stock will begin trading on Friday. The move will cut the number of outstanding common shares to 18.7M from 112.4M. (PR) [View news story]
I wish I could agree, but reverse splits rarely work and the company could certainly have waited to execute this one until they were actually threatened with the Nasdaq delisting. I grant you, that was in November if they didn't ask for it to be delayed 6 months. Had they asked, I believe the odds were about 99% in their favor of it being granted as they have sufficient funds, and a sufficient market cap for it being granted.
I'll be very pleasantly surprised if by this time next year the share count hasn't grown to at least 25 millions, that may not sound like many shares, but it would represent about 25% dilution. If a few years from now the O/S isn't over 40 million I'll be surprised, that would be over 100% dilution from where we'll be on Friday.
I hope the company proves me wrong, but frankly believe it's the biggest benefit they'll see from the R/S. The good news is the potential of the drugs they've created hasn't changed, but if the dilution is what I expect, we'll see less in all that growth as we'll own a much smaller share of the company.
I believe your royalty levels are low. Cramer openly spoke of 6% when Junius appeared on his show. If you can find the original partnership, you'll see there are several sales milestones where the royalty rate grows, of course the numbers are completely blacked out, but I believe by the time sales exceed those of Herceptin, the royalties will be much higher single digit numbers.
With T-DM1 going into testing in other cancers, growth to $10 billion or more is very possible. If I'm correct, and at those numbers IMGN earns 7 to 9%, IMGN would be closing in on a billion a year in earnings. Remember, IMGN did get an earnings boost when they assisted Genentech with production. I believe that probably took an inititial 5% royalty to 6%, and perhaps the top percentage as high as 9%.
People seem to discount the fact that Roche does have other products licensed with IMGN, because to date nothing entering the clinic has been announced. Remember, they took nearly a decade to bring T-DM1 to the clinic. IMGN may be shooting itself in the foot by announcing newer linkers and effector molecules that partners may try. In that it costs hundreds of millions once you're in the clinic to go to approval, but far less to preclinically test a new drug, I believe many companies nearly ready to enter the clinic may want to run test with the brand new technology before committing to the older technology they're working with. If the new technology proves substantially more effective, further delay results as all the preclinical work must be redone. The positive side of all this is that better drugs should result, but the timing may suffer dramatically.
Here We Go Again With AEterna Zentaris... Again [View article]
Steve,
Much of what you said makes sense, but what you didn't say is more important IMHO.
Take AEZS-130, it could go from a Niche product to a blockbuster should the Cancer Cachexia Trial go well.
Look at the Phase II Trials for Perifosine and AEZS-108, both have had some excellent data in numerous cancers. Certainly, Perifosine failed in Stage 4 Colon Cancer, but the majority of the Phase II data was Stage 3, and it shined there. If Perifosine is approved in other indications, Colon most certainly will be revisited.
The key is approvals building revenue that spurs further trials, of course partnerships with big Pharma can provide those trials even without approvals if they so choose, but even big Pharm likes revenue flow from approval to fund additional trials.
I think you should rethink T-DM1's potential long term. I believe that the drug will replace and substantially build on Herceptin's sales over time, perhaps to over $10 B annually. This produces substantial revenue even if only at 5%, but a recent review of the partnership shows several milestone payments and royalty adjustments. While all numbers are redacted, I believe the final milestone will produce royalties much closer to 10% than 5%. I also believe Cramer indicating 6% after speaking with Junius last year may have been a slip by Junius in private conversations, but the true starting point after factoring in the increase for the assistance they provided in developing production of the product.
I understand they're forecasting two other drugs going Pivotal next year, so future advancement is looking better as well. If you only look at T-DM1 alone over a long enough term, I believe you can make a solid case for triple digit share prices.
Is Keryx Pharmaceuticals Heading For The Dollar Mark? [View article]
To date KERX has not stopped the MM Trial for Perifosine, they indicated it was being considered, but it hasn't happened. If they were to maintain that trial, announcing that after review they still believe in the probability of success being good, I think it could restore some of the losses sustained by both KERX and AEZS.
I'm invested in AEZS, not KERX, but regardless, there are several Perifosine trials still ongoing both from KERX and others. Until it's determined that there is a fundamental flaw in the drug or how they're using it, other results say it works in many other cancers.
FDA Approval Practically A Done Deal For Keryx And AEterna Zentaris [View article]
I don't blame Jeremy for being so confident, I said months ago that the only way the trial could fail was if people lived much longer than historical data supported. Unfortunately, that's what happened.
I doubt we'll ever know and understand why, but I also don't understand why so many believe the same flaw must exist in the MM Trial.
If after examining the failed trial, I believe both KERX and AEZS must examine the MM trial and independently determine whether it's flawed in the same way or not. If KERX determines they'll not further fund it, but AEZS doesn't see the one trial affecting the other, I believe they should take over the trial.
AEZS might not only take it over, they may also be able to gain support from those partnered in other countries. Not saying this would happen, but it may be worth asking.
While I'm reasonable certain AEZS will be working with KERX in determining what happened, it's very possible they don't see eye to ey on where to go from here. If KERX returns the drug it could prove to be the best thing that ever happened to AEZS if they went on to make it a success.
Keryx: A Biotech For Aggressive Investors [View article]
Mel,
I'm surprised you're not also commenting on AEZS, the company that developed Perifosine and has partnered is in some of the rest of the world, but not yet Europe, South America, etc. At $2 I believe the upside potential for AEZS is even greater, as is the width and breadth of their pipeline, which also included another oncology product, AEZS-108 which is wholly owned and about to enter Phase III Trials.
KERX has expressed a desire to be bought out, AEZS has not, so such action may produce a bigger pop for KERX, but in the long run I believe the AEZS pipeline will take them to values that are large multiples of the KERX buyout price should it occur.
The Other Side Of Keryx And AEterna [View article]
I believe you can learn a lot from what others say, however I agree it's what a company says, or fails to say, that trumps all.
One big problem is that companies frequently cannot say what they'd like to say because agencies like the FDA and SEC create so much fear that it's not permitted, and then their are the agreements between companies with confidentiality agreements that prevent it. It's rather like the drug commercials that spend far more time in discussing the negative side effects then the benefits from the drugs.
In the case of AEZS, they're heavily restricted by KERX having the lead in the Perifosine trials. It's true they may work closely together, but AEZS won't reveal anything that hasn't been agreed to by KERX, or previously disclosed by them.
I believe the fact that a trial announced to anticipate completion in one quarter was moved to the next quarter, and near the end of it at that, is certainly saying people are living longer than originally anticipated. Neither company can say something they cannot prove and only the data will prove what they may believe. The question is, do they tell us when the actual 360th event occurs when it happens, do they wait until the first scheduled event and say it's already happened, or do they wait for top line data and not say anything until they can announce top line data. In that they stated previously that it wasn't imminent, then they reaffirmed it was anticipated in March, I suspect they'll say when it's happened within a few days of it happening.
Within days of saying the 360th event's occurred bashers will attempt to create doubts by saying if results were good, they'd already be publishing top line data. Bashers live to create doubt where their should be none. It does take time to assemble the data, it might be two weeks, it might be six, the time it takes doesn't reflect on how great it is, or isn't. Don't believe anyone who says otherwise.
Seattle Genetics: Positive Read-Through From Roche's Investor Day [View article]
I'm surprised you place so much faith in SGEN, and none in IMGN. T-DM1 will earn far more for IMGN once it's approved and Roche starts to market it as the replacement for Herceptin because it's simply much better than Herceptin, and their patents will be running out on Herceptin, so it figures. It may take a few years to reach the $6 billion annually that Herceptin sells, but it won't stop their either as other Her2 positive cancers get into the act.
Both companies have substantial pipelines, but I believe IMGN will bring 1 to 2 of it's wholly owned drugs into the clinic annually. I don't believe that SGEN has nearly that many preclinical products to bring forward.
I know you were strong on IMGN a few years ago, while the low royalties with T-DM1 holds down the earnings there, nearly 5% of many billions is still a big number. T-DM1's success has permitted IMGN to gain far better terms in newer partnerships, and post approval they'll get even better.
Gary
4 Small Cap Biopharmas With Near-Term Catalysts [View article]
AEZS-108 should initiate its Phase III Trial any day, it's in the Clinical Trials database with a target of March.
AEZS-130 should have it's NDA for detection of HGH deficiency filed this quarter. This may be a niche market, but their is no competition as the existing drug has been taken off the market. By mid year we should also see Phase II results for use of this drug in Cancer Cachexia, if this proves to be effective it could be a real game changer.
AEZS has a number of other drugs in earlier stage trials as well as data from both Perifosine and AEZS-108 in earlier stage trials that show both to be effective in several cancers each. If AEZS had the funding of a major Pharma, both of these drugs would probably be in a few additional Phase III Trials. This could happen with one or both by partnership.
Certainly I'll be interested in the recommendation of the trial managers after the peek in the MM Trial, but believe we'll get nothing stronger than a recommendation to continue. Meaningful data rarely comes out of peeks, even if the clinicians are impressed with results to date. The company may get some indication of the clinicians enthusiasm, but not the actual data.
Look at the whole company, not one drug, and I believe you'll see it ought to be worth far more than it is.
Gary
Sentiment Shows Investors Bullish On Aeterna In 2013: Here's Why [View article]
In time, partnerships should be concluded for all the late stage products. Perhaps when AEZS has a substantial revenue stream they'll consider taking drugs worldwide themselves, but without that, at minimum regional partners will be required for much of the world.
Gary
Biotech Portfolio Update: 2012 Summary And 2013 Outlook [View article]
The CEO's speaking at the J.P. Morgan conference and the PR put an emphasis on a new drug from IMGN entering the clinic soon, it seems this drug has many targets and may be bigger than anything currently in the clinic, though all have blockbuster potential IMHO. I think reality is he'll talk about the entire pipeline, but this is the first time this drug is being put under the limelight, so it's the one thing that's new.
IMGN has a very strong pipeline, though trials advance slowly. If you ignore the entire pipeline, but see T-DM1 replace and expand on Herceptin, as I expect it will, I think you'll see the company should see near triple digits on that alone. It's all about earnings once T-DM1 is approved, while many products failed to live up to expectations, I believe T-DM1 will exceed expectations. As I understand it, IMGN will be paid royalties based on quarterly sales, if correct, it shouldn't take long to see if sales growth isn't impressive. I believe Roche is positioned to market and sell product almost immediately upon notification of approval, we may see royalties announced after the end of the 1st quarter. If they increase dramatically each quarter, what should the stock price be by the end of the year. My estimate is approaching $30.
Gary
Can AEterna Turn A New Leaf In 2013? [View article]
Partnerships are certainly possibilities for almost instantaneous growth as right now both AEZS-108 and 130 are wholly owned, and much of the world, including North America, is available for Perifosine.
Another joker in the deck would be the Cancer Cachexia trial with AEZS-130. This drug is only a niche drug when considered for diagnosing HGH deficiency. The drug may have blockbuster potential if the current Phase I/II Trial in Cancer Cachexia produces positive results. Today their is no drug approved for this uncontrolled weight loss which often leads to death well before the cancer would take the patient. It's very possible that for at least some patients the cancer may be put into remission, but the patient passes because of the weakness of other organs caused by tremendous weight loss.
My point is, you're right, but their are many other catalysts that could take the stock far higher this year.
Gary
Biotech Portfolio Update: 2012 Summary And 2013 Outlook [View article]
Have a Happy New Year's all,
Gary
Cel-Sci: Immunotherapy Opens New Door To Investors [View article]
I have no doubt that the company will finance through further dilution on any positive news, it's how they stay in business.
Gary
Aeterna Zentaris (AEZS) -12% to $0.61 after saying that it's consolidating its shares on a 6-1 basis as part of an attempt to regain compliance with Nasdaq's minimum bid-price requirement. Aeterna Zentaris expects that the post-consolidation stock will begin trading on Friday. The move will cut the number of outstanding common shares to 18.7M from 112.4M. (PR) [View news story]
I'll be very pleasantly surprised if by this time next year the share count hasn't grown to at least 25 millions, that may not sound like many shares, but it would represent about 25% dilution. If a few years from now the O/S isn't over 40 million I'll be surprised, that would be over 100% dilution from where we'll be on Friday.
I hope the company proves me wrong, but frankly believe it's the biggest benefit they'll see from the R/S. The good news is the potential of the drugs they've created hasn't changed, but if the dilution is what I expect, we'll see less in all that growth as we'll own a much smaller share of the company.
Gary
Is ImmunoGen More Than T-DM1? [View article]
With T-DM1 going into testing in other cancers, growth to $10 billion or more is very possible. If I'm correct, and at those numbers IMGN earns 7 to 9%, IMGN would be closing in on a billion a year in earnings. Remember, IMGN did get an earnings boost when they assisted Genentech with production. I believe that probably took an inititial 5% royalty to 6%, and perhaps the top percentage as high as 9%.
People seem to discount the fact that Roche does have other products licensed with IMGN, because to date nothing entering the clinic has been announced. Remember, they took nearly a decade to bring T-DM1 to the clinic. IMGN may be shooting itself in the foot by announcing newer linkers and effector molecules that partners may try. In that it costs hundreds of millions once you're in the clinic to go to approval, but far less to preclinically test a new drug, I believe many companies nearly ready to enter the clinic may want to run test with the brand new technology before committing to the older technology they're working with. If the new technology proves substantially more effective, further delay results as all the preclinical work must be redone. The positive side of all this is that better drugs should result, but the timing may suffer dramatically.
Gary
Here We Go Again With AEterna Zentaris... Again [View article]
Much of what you said makes sense, but what you didn't say is more important IMHO.
Take AEZS-130, it could go from a Niche product to a blockbuster should the Cancer Cachexia Trial go well.
Look at the Phase II Trials for Perifosine and AEZS-108, both have had some excellent data in numerous cancers. Certainly, Perifosine failed in Stage 4 Colon Cancer, but the majority of the Phase II data was Stage 3, and it shined there. If Perifosine is approved in other indications, Colon most certainly will be revisited.
The key is approvals building revenue that spurs further trials, of course partnerships with big Pharma can provide those trials even without approvals if they so choose, but even big Pharm likes revenue flow from approval to fund additional trials.
Gary
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Drugs To Watch At ASCO 2012 [View article]
I think you should rethink T-DM1's potential long term. I believe that the drug will replace and substantially build on Herceptin's sales over time, perhaps to over $10 B annually. This produces substantial revenue even if only at 5%, but a recent review of the partnership shows several milestone payments and royalty adjustments. While all numbers are redacted, I believe the final milestone will produce royalties much closer to 10% than 5%. I also believe Cramer indicating 6% after speaking with Junius last year may have been a slip by Junius in private conversations, but the true starting point after factoring in the increase for the assistance they provided in developing production of the product.
I understand they're forecasting two other drugs going Pivotal next year, so future advancement is looking better as well. If you only look at T-DM1 alone over a long enough term, I believe you can make a solid case for triple digit share prices.
Gary
Is Keryx Pharmaceuticals Heading For The Dollar Mark? [View article]
I'm invested in AEZS, not KERX, but regardless, there are several Perifosine trials still ongoing both from KERX and others. Until it's determined that there is a fundamental flaw in the drug or how they're using it, other results say it works in many other cancers.
Gary
FDA Approval Practically A Done Deal For Keryx And AEterna Zentaris [View article]
I doubt we'll ever know and understand why, but I also don't understand why so many believe the same flaw must exist in the MM Trial.
If after examining the failed trial, I believe both KERX and AEZS must examine the MM trial and independently determine whether it's flawed in the same way or not. If KERX determines they'll not further fund it, but AEZS doesn't see the one trial affecting the other, I believe they should take over the trial.
AEZS might not only take it over, they may also be able to gain support from those partnered in other countries. Not saying this would happen, but it may be worth asking.
While I'm reasonable certain AEZS will be working with KERX in determining what happened, it's very possible they don't see eye to ey on where to go from here. If KERX returns the drug it could prove to be the best thing that ever happened to AEZS if they went on to make it a success.
Gary
Keryx: A Biotech For Aggressive Investors [View article]
I'm surprised you're not also commenting on AEZS, the company that developed Perifosine and has partnered is in some of the rest of the world, but not yet Europe, South America, etc. At $2 I believe the upside potential for AEZS is even greater, as is the width and breadth of their pipeline, which also included another oncology product, AEZS-108 which is wholly owned and about to enter Phase III Trials.
KERX has expressed a desire to be bought out, AEZS has not, so such action may produce a bigger pop for KERX, but in the long run I believe the AEZS pipeline will take them to values that are large multiples of the KERX buyout price should it occur.
Gary
The Other Side Of Keryx And AEterna [View article]
One big problem is that companies frequently cannot say what they'd like to say because agencies like the FDA and SEC create so much fear that it's not permitted, and then their are the agreements between companies with confidentiality agreements that prevent it. It's rather like the drug commercials that spend far more time in discussing the negative side effects then the benefits from the drugs.
In the case of AEZS, they're heavily restricted by KERX having the lead in the Perifosine trials. It's true they may work closely together, but AEZS won't reveal anything that hasn't been agreed to by KERX, or previously disclosed by them.
I believe the fact that a trial announced to anticipate completion in one quarter was moved to the next quarter, and near the end of it at that, is certainly saying people are living longer than originally anticipated. Neither company can say something they cannot prove and only the data will prove what they may believe. The question is, do they tell us when the actual 360th event occurs when it happens, do they wait until the first scheduled event and say it's already happened, or do they wait for top line data and not say anything until they can announce top line data. In that they stated previously that it wasn't imminent, then they reaffirmed it was anticipated in March, I suspect they'll say when it's happened within a few days of it happening.
Within days of saying the 360th event's occurred bashers will attempt to create doubts by saying if results were good, they'd already be publishing top line data. Bashers live to create doubt where their should be none. It does take time to assemble the data, it might be two weeks, it might be six, the time it takes doesn't reflect on how great it is, or isn't. Don't believe anyone who says otherwise.
Gary