why is Byetta is losing ground?
Friday, July 23, 2010
Saturday, September 26, 2009
Thoughts on AMLN, DNDN, ARNA... And a few green shoots..
AMLN.... My problem child, just as the stock showed some life, Eastborn, one of the biggest holder, decided to sell a major chunk. A bit confused why they did that since they made such a big deal of changing the BOD. Fundamentals have not changed (see previous posts), but a couple of interesting developments... Merck's Januvia is finally showing its true colors, cases of pancreatitis. This drug will eventually be pulled out of the market or die from lack of sales because its essentially ineffective and dangerous (pancreatitis is only the tip of the iceberg). FDA delays decision on Ligaritude until Q4. Both development are positive for AMLN, now if we could only fix the management!!!!
DNDN... They continue to roll and make us money. Unless the sky falls, keep holding this stock. I sold the Oct $40 calls on all my holdings when the stock reached $30, 25% out of the money after it had gone up more then 20% on rumors of a deal with a big pharma.. I figured since it already had gone up 20%, chances to get a greater then 40% premium were slim... Couldn't believe I got close to $1 for these calls....The stock is back down to $26, so I am fairly happy with that move.
ARNA... September data looked good... For those that are experienced with the industry and the game the short hedges play, the move back below $5 was expected. Next step is to decide when and whether to jump in with both feet. I will post when I decide what to do.
Green shoots... SGMO, it has major home run potential, a la DNDN, I am studying this stock carefully. JAZZ, might have a blockbuster, filing an NDA in Q4, I also need to study more...
I really need to decide, what to focus on.. My experience is that its ok to follow a few stocks 5 or stocks... But you can only get serious about 2 or 3... The stock you are serious about take a lot of time.. So right now, I am serious about DNDN and AMLN, and would like to get serious with ARNA, ELN, SGMO, and potentially JAZZ... ARNA and ELN are at the right PPS for serious accumulation, SGMO and JAZZ are not, but could be shortly... I guess these are good problems to have.
DNDN... They continue to roll and make us money. Unless the sky falls, keep holding this stock. I sold the Oct $40 calls on all my holdings when the stock reached $30, 25% out of the money after it had gone up more then 20% on rumors of a deal with a big pharma.. I figured since it already had gone up 20%, chances to get a greater then 40% premium were slim... Couldn't believe I got close to $1 for these calls....The stock is back down to $26, so I am fairly happy with that move.
ARNA... September data looked good... For those that are experienced with the industry and the game the short hedges play, the move back below $5 was expected. Next step is to decide when and whether to jump in with both feet. I will post when I decide what to do.
Green shoots... SGMO, it has major home run potential, a la DNDN, I am studying this stock carefully. JAZZ, might have a blockbuster, filing an NDA in Q4, I also need to study more...
I really need to decide, what to focus on.. My experience is that its ok to follow a few stocks 5 or stocks... But you can only get serious about 2 or 3... The stock you are serious about take a lot of time.. So right now, I am serious about DNDN and AMLN, and would like to get serious with ARNA, ELN, SGMO, and potentially JAZZ... ARNA and ELN are at the right PPS for serious accumulation, SGMO and JAZZ are not, but could be shortly... I guess these are good problems to have.
Tuesday, August 18, 2009
AMLN... Still disappointing investors...
I am very disappointed in Amylin's performance. The root cause of the problem is well established. They truly have one of the most inept management team ever assembled. I had high hopes that with the changes in the board of directors would come a change in the executive suite, particularly Dan, who is really in way over his head as a CEO. He has shown very few leadership qualities, he is a terrible communicator, and as far as I can tell, commands little respect form his employees or the street. So far no changes have been made, and Amylin shareholders continue to suffer the consequences. The sad part is that he is probably hard working and was very successful as a middle manager, he just has been promoted beyond his level of competence, a classic case of the Peter principle. To bad that Joe Cook chose him over Alain Baron, probably was the biggest mistake Joe has ever made with AMLN.
Anyway, there are still so many unresolved issue with AMLN, its a wonder the PPS is still around $13... I will list them again although I know I am repeating myself...
- We must hear from the FDA on Monotherapy for Byetta. Its been 18 months now, the decision is a year overdue. An example of AMLN's management inability to close with the FDA.
- Same with Pancreatitis label... That warning by the FDA was a joke, its been proven to be a joke, yet AMLN has yet to close on the issue with the FDA...
- A new Chairman of the board. AMLN does not have a real CEO as it is, and now they don't have a Chairman of the board as well. Its glaringly obvious that the company needs leadership... Right now the employees are doing their job with little fear of being held accountable. Its a recipe for disaster.
-Lilly continues to drag its feet with worldwide byetta sales... AMLN management needs to question what it going on, particularly in light of Lilly pushing their own GLP-1 forward.
In addition, the Ligaritude decision is about to come down from the FDA. If its positive it will devastate Byetta scripts.
So you might want to ask, why am I still in this stock. Main reason is that I still have hope that LAR will be a blockbuster drug and that by the time we get the approval, a new management team will be in place to execute the launch of LAR. But that is really it at this point, its AMLN's last chance at success. Some folks are toting AMLN's obesity pipeline, but I have completely discounted any hope of it providing any meaningful contribution to the value in the near or even foreseeable future.
I would not add anymore shares at these levels as the PPS might get much lower with a positive Ligar decision.
Anyway, there are still so many unresolved issue with AMLN, its a wonder the PPS is still around $13... I will list them again although I know I am repeating myself...
- We must hear from the FDA on Monotherapy for Byetta. Its been 18 months now, the decision is a year overdue. An example of AMLN's management inability to close with the FDA.
- Same with Pancreatitis label... That warning by the FDA was a joke, its been proven to be a joke, yet AMLN has yet to close on the issue with the FDA...
- A new Chairman of the board. AMLN does not have a real CEO as it is, and now they don't have a Chairman of the board as well. Its glaringly obvious that the company needs leadership... Right now the employees are doing their job with little fear of being held accountable. Its a recipe for disaster.
-Lilly continues to drag its feet with worldwide byetta sales... AMLN management needs to question what it going on, particularly in light of Lilly pushing their own GLP-1 forward.
In addition, the Ligaritude decision is about to come down from the FDA. If its positive it will devastate Byetta scripts.
So you might want to ask, why am I still in this stock. Main reason is that I still have hope that LAR will be a blockbuster drug and that by the time we get the approval, a new management team will be in place to execute the launch of LAR. But that is really it at this point, its AMLN's last chance at success. Some folks are toting AMLN's obesity pipeline, but I have completely discounted any hope of it providing any meaningful contribution to the value in the near or even foreseeable future.
I would not add anymore shares at these levels as the PPS might get much lower with a positive Ligar decision.
Thursday, July 9, 2009
AMLN and ARNA
AMLN
Ok, so now we've had two positive news releases by AMLN... One indicating that the LAR NDA was accepted by the FDA and the other that they've had some good results out of the Phase II obesity trial. I did not expect much out of the NDA press release as it was expected. The obesity Phase II trial results on the other hand should have yielded a better price movement. The study was sizable (608 patients) and the results were excellent, as a reference point, about twice as good as what ARNA got in their latest Phase III announcement. The result confirmed earlier Phase II trials the results of which can be found in one of my earlier post in a comparison chart with other competitors. What does this mean for my investment in AMLN, literally nothing, I am neither adding nor subtracting shares based on this and this is why.
- The obesity pipeline is still only in Phase II... And AMLN has had multiple phase II obesity trials..
- They have offered no guidance as to what is next
- Their obesity cocktail is an injectable. And AMLN's history with marketing injectables is very suspect
- Other competitors, although plagued by safety concerns, are further ahead and are not injectables.
- Obesity commercialization is far in the future... 2013?
- No partner yet. I don't feel that the obesity pipeline impact on PPS will be reflected until they find a partner. Wall street might then think they are serious and truly have something. AMLN management on its own has close to zero credibility left.
The near term drivers in this stock are still.
- FDA decision on ligaritude
- FDA decision on monotherapy for byetta and the bogus pancreatitis label update.
Obesity is not in play at this time for AMLN
ARNA
The stock to a tumble to $4 over the last couple of days after the announcement of the stock offering. This is fairly typical response whenever their is a dilutive stock offering. In general stock do recover once the shorts have taken their pound of flesh. I expect he same will happen with ARNA.
So in summary, ARNA is in play for obesity, AMLN is not yet in play....
Ok, so now we've had two positive news releases by AMLN... One indicating that the LAR NDA was accepted by the FDA and the other that they've had some good results out of the Phase II obesity trial. I did not expect much out of the NDA press release as it was expected. The obesity Phase II trial results on the other hand should have yielded a better price movement. The study was sizable (608 patients) and the results were excellent, as a reference point, about twice as good as what ARNA got in their latest Phase III announcement. The result confirmed earlier Phase II trials the results of which can be found in one of my earlier post in a comparison chart with other competitors. What does this mean for my investment in AMLN, literally nothing, I am neither adding nor subtracting shares based on this and this is why.
- The obesity pipeline is still only in Phase II... And AMLN has had multiple phase II obesity trials..
- They have offered no guidance as to what is next
- Their obesity cocktail is an injectable. And AMLN's history with marketing injectables is very suspect
- Other competitors, although plagued by safety concerns, are further ahead and are not injectables.
- Obesity commercialization is far in the future... 2013?
- No partner yet. I don't feel that the obesity pipeline impact on PPS will be reflected until they find a partner. Wall street might then think they are serious and truly have something. AMLN management on its own has close to zero credibility left.
The near term drivers in this stock are still.
- FDA decision on ligaritude
- FDA decision on monotherapy for byetta and the bogus pancreatitis label update.
Obesity is not in play at this time for AMLN
ARNA
The stock to a tumble to $4 over the last couple of days after the announcement of the stock offering. This is fairly typical response whenever their is a dilutive stock offering. In general stock do recover once the shorts have taken their pound of flesh. I expect he same will happen with ARNA.
So in summary, ARNA is in play for obesity, AMLN is not yet in play....
Friday, July 3, 2009
ELN heating up, AMLN should be heating up, DNDN, ARNA maintaining status quo
ELN
With the latest J&J cash infusion and partnership, ELN now has all the tools to succeed, money & strong pharma support / validation of its pipeline... Two clouds remain, the PML issue, although with no real news or development, continue to be used relentlessly by the short cabal to drive the PPS down every time a case is reported... I don't know how long this will be allowed to go on, as the FDA allows for 1/1000 case to occur and with all the reported case we are well below that rate. The second cloud is the management strength, let's hope they don't waste the new opportunity they've been given. The current stock price does not reflect the new found strength, as a lot of the risk has been removed from stock. I am looking for the low teens in the near future and selling puts to accumulate.
AMLN
What a disappointment this stock has been this second time around! Never, has a management team done so little with so much. They have money, an incredible pipeline, two first and best in class drugs and yet they don't succeed. The root of the problem is the management team and culture that has permeated this company since the beginning. They were essentially a good development team, then after their drugs got approved, essentially did not and still have not changed their mode of operation. They have not been able to successfully switch from being a development biotech to a pharma with products to sell. They have hired poorly and their current CEO is a big part of the problem.. He appears to be a hard worker, but exudes little confidence and is a horrible communicator... Anyway, enough ramblings... What to do?
I am staying put with my holdings, the upside is still great, but I probably will exit in the mid 20's if the pps gets there. The catalyst for a move up in the short terms are..
- A rejection of ligaritude ( a byetta competing drug ) by the FDA.. The FDA should reject or at minimum give them an approvable letter, but you will never know with the FDA as they are for the most part a captured and political agency. Note that Ligar has just been approved in Europe.
- Monotherapy for byetta. Its a decision that's more then 6 months behind schedule. I do not understand why the FDA has not responded yet, scratch that, I do understand, see above comments.
- Clarification of the Byetta label and the removal of the pancreatitis cloud from Byetta. Again, the FDA botched that one. They issued a safety warning for byetta for pancreatitis when the rate of occurrence is at worse equal to the diabetic population. The reality is even more perplexing, since byetta is prescribed to obese patient because of its weight loss proprety, the byetta population is even more prone to pancreatitis. So, the data seems to indicate that Byetta actually decreases the rate of pancreatitis... But go figure our FDA, they issue a warning, what a bunch of boobs!!!
But ultimately, its the role of management to play whatever game the FDA needs them to play to get these things done... And this management team just does not know how to play the game. The recent Icahn and eastbourne BOD wins, have yet to translate to any material changes .
A note of caution. A ligaritude approval could eviscerate the byetta scrips and send the PPS back to the single digits.
With the latest J&J cash infusion and partnership, ELN now has all the tools to succeed, money & strong pharma support / validation of its pipeline... Two clouds remain, the PML issue, although with no real news or development, continue to be used relentlessly by the short cabal to drive the PPS down every time a case is reported... I don't know how long this will be allowed to go on, as the FDA allows for 1/1000 case to occur and with all the reported case we are well below that rate. The second cloud is the management strength, let's hope they don't waste the new opportunity they've been given. The current stock price does not reflect the new found strength, as a lot of the risk has been removed from stock. I am looking for the low teens in the near future and selling puts to accumulate.
AMLN
What a disappointment this stock has been this second time around! Never, has a management team done so little with so much. They have money, an incredible pipeline, two first and best in class drugs and yet they don't succeed. The root of the problem is the management team and culture that has permeated this company since the beginning. They were essentially a good development team, then after their drugs got approved, essentially did not and still have not changed their mode of operation. They have not been able to successfully switch from being a development biotech to a pharma with products to sell. They have hired poorly and their current CEO is a big part of the problem.. He appears to be a hard worker, but exudes little confidence and is a horrible communicator... Anyway, enough ramblings... What to do?
I am staying put with my holdings, the upside is still great, but I probably will exit in the mid 20's if the pps gets there. The catalyst for a move up in the short terms are..
- A rejection of ligaritude ( a byetta competing drug ) by the FDA.. The FDA should reject or at minimum give them an approvable letter, but you will never know with the FDA as they are for the most part a captured and political agency. Note that Ligar has just been approved in Europe.
- Monotherapy for byetta. Its a decision that's more then 6 months behind schedule. I do not understand why the FDA has not responded yet, scratch that, I do understand, see above comments.
- Clarification of the Byetta label and the removal of the pancreatitis cloud from Byetta. Again, the FDA botched that one. They issued a safety warning for byetta for pancreatitis when the rate of occurrence is at worse equal to the diabetic population. The reality is even more perplexing, since byetta is prescribed to obese patient because of its weight loss proprety, the byetta population is even more prone to pancreatitis. So, the data seems to indicate that Byetta actually decreases the rate of pancreatitis... But go figure our FDA, they issue a warning, what a bunch of boobs!!!
But ultimately, its the role of management to play whatever game the FDA needs them to play to get these things done... And this management team just does not know how to play the game. The recent Icahn and eastbourne BOD wins, have yet to translate to any material changes .
A note of caution. A ligaritude approval could eviscerate the byetta scrips and send the PPS back to the single digits.
Monday, June 1, 2009
AMLN, ELN, DNDN - Brief updates
AMLN
Essentially, I am staying put and really not adding anymore shares. Right now, I am not giving much "weight" pun intended to the obesity pipeline. My reasoning is that Amylin with current management and its approach to marketing and sales, have not demonstrated that they can have a blockbuster injectable when going against inferior oral drugs... I will turn on a dime if they start doing better... Maybe the new VP can turn it around... But certainly based on side effect and efficacy, Amylin obesity drugs should dominate... But then again so should symlin and byetta... So until management can show me what they can do in sales with Byetta and LAR, I am ignoring the obesity potential.
DNDN
Nothing new to report. Same strategy as previously posted.
ELN
I have increased my activities in ELN, sold more puts with the intent to add to my initial shares... The more I learn about Tysabri and the positive impact it has on MS patients (see link: http://www.youtube.com/watch?v=1JXDLHcWyws ), the more I think this stock is very undervalued and certainly could do a 4-5x from here. The problem is that I never buy all the shares I want to own in a company all at once... I build the investment in stages, as I learn about the company and get more comfortable with the various forces that affect the share price. Typically I build the position in 4 or 5 stages. I have done stage I with ELN, but this time, I might not have time to add more... The stock jumped a bit today on news that Bristol-Myer, might be interested in buying a piece of ELN. So I probably wont be adding shares by selling puts, I had the June $6... I will have to decide if I should just buy stage II in the open market.
Essentially, I am staying put and really not adding anymore shares. Right now, I am not giving much "weight" pun intended to the obesity pipeline. My reasoning is that Amylin with current management and its approach to marketing and sales, have not demonstrated that they can have a blockbuster injectable when going against inferior oral drugs... I will turn on a dime if they start doing better... Maybe the new VP can turn it around... But certainly based on side effect and efficacy, Amylin obesity drugs should dominate... But then again so should symlin and byetta... So until management can show me what they can do in sales with Byetta and LAR, I am ignoring the obesity potential.
DNDN
Nothing new to report. Same strategy as previously posted.
ELN
I have increased my activities in ELN, sold more puts with the intent to add to my initial shares... The more I learn about Tysabri and the positive impact it has on MS patients (see link: http://www.youtube.com/watch?v=1JXDLHcWyws ), the more I think this stock is very undervalued and certainly could do a 4-5x from here. The problem is that I never buy all the shares I want to own in a company all at once... I build the investment in stages, as I learn about the company and get more comfortable with the various forces that affect the share price. Typically I build the position in 4 or 5 stages. I have done stage I with ELN, but this time, I might not have time to add more... The stock jumped a bit today on news that Bristol-Myer, might be interested in buying a piece of ELN. So I probably wont be adding shares by selling puts, I had the June $6... I will have to decide if I should just buy stage II in the open market.
Thursday, May 28, 2009
AMLN and the obesity pipeline
I can't remember where I got this chart, its a few years old... But its a good summary chart of the competing obesity drugs currently under development by different companies... I will discuss more later.
I am still fuming at the early results of the AMLN board election. Something is very wrong with US companies companies right now. Boards are completely captured by the executive of the companies, so much so that they no longer exercise true oversight of the management... I really wanted Joe Cook out, he was a tremendous leader in the earlier stages of the company, but he has hired to very green CEO's that have both been a complete disaster and definitely not CEO material....
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