My Best Stock Picks

Byetta tanking

2010-07-23T14:56:00.000-07:00

why is Byetta is losing ground?

Thoughts on AMLN, DNDN, ARNA... And a few green shoots..

2009-09-26T18:09:00.000-07:00

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.

AMLN... Still disappointing investors...

2009-08-18T19:50:00.001-07:00

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.

AMLN and ARNA

2009-07-09T16:19:00.001-07:00

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....

ELN heating up, AMLN should be heating up, DNDN, ARNA maintaining status quo

2009-07-03T13:04:00.001-07:00

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.

AMLN, ELN, DNDN - Brief updates

2009-06-01T21:42:00.000-07:00

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.

AMLN and the obesity pipeline

2009-05-28T23:16:00.000-07:00

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....

May update - DNDN, AMLN. ELN

2009-05-23T08:16:00.000-07:00

DNDN
Obviously, I am very happy about DNDN as we saw some very positive results from the Provenge trial and the stock went up 500% from where I bought it. I did a few trade to reposition myself in the stock and generate some cash....
Although I am still very bullish on the stock and have a 1-2 years time horizon, I sold roughly 20% of my holdings to take out my initial investment. I also sold some puts from $10-$15 to try to add more shares if the stock fell to that level. Concurrently I sold Jan 2010 $30 puts and got $15. What this means is that if the stock gets to $30 by January I get to keep $15... If the stock stays below $30, I get to buy it for a net of $15. For anyone reading this don't hesitate to call if you have any questions.
My next look at taking more money of the table would come when the stock gets in the $40 range which I expect will happen within the next couple of years and I will continue trading DNDN options to add shares or generate cash over that time period

AMLN
AMLN is the first stock that I held a large position in and one that I am again accumulating because it is very undervalued at these levels ( see earlier posts for valuation discussion). Icahn has done the same thing, so I feel that I am in good company. The main problem with AMLN is its management, they have utterly failed to take advantage of the incredibly life changing two first in class diabetic drug that the company has. It is really a shame both for diabetics and for shareholders. The only hope for AMLN is a change management. Again, I feel very validated in my thinking as Icahn is also seeking a change in management. For the record, I came to that decision before him, lol... See below an email that I sent to the company.
I bought more stock since I last posted my latest buy being at $11, I have also been selling puts along the way. My latest being at $10
Anyway, I am bullish on the stock relatively short term and also longer term. In the short term, I expect byetta monotherapy approval and label clarification. There is significant risk in owning this stock beyond the normal stock risks. Obviously should the mono decision and or the label go against them, then the stock could fall in the $5 range. Also, besides Icahn, there are big institutional holders of this stock, and should any of them get fed up with management and decide to unwind their position, it could be painfull. But I remain bullish in the short term, I think high teen to $20 is achievable in the next few months and in the long term a price above $40, if Icahn doesn't push for a sale before that...

My letter to AMLN
Hi Alice,
I am a small individual Amylin shareholder. For what its worth, this is why I am not voting for Amylin's slate of nominees.
- Amylin's inability to defend byetta in the court of public opinion, in the press and investment community, and even with GP's regarding the pancreatitis issue.
- Overly generous compensation for its executives and BOD, particularly in light of PPS performance and experience level.
- Since Joe departed the CEO post, the board has hired two essentially inexperienced and weak CEO's. This at a time when the company needed a strong hand the most.- Inexcusable delay in applying for Byetta monotherapy. That was a big strategic mistake particularly in light of having received an unexpected gift of an approvable letter from the FDA
- What appears to have been an unchecked hiring binge and increase of non essential expenses, such as the construction of an expensive cafeteria.
- The delay in the LAR filing time line, that completely took the investment community by surprise when initially revealed
- What appears to be an inept PR department, which lays squarely at the feet of the CEO.
- Management was not able to recognize the Januvia threat, incorrectly stating that it was not competition, when it clearly took a big bite out of byetta sales.
- Very, very weak marketing, branding efforts for Symlin and Byetta. Symlin should have much bigger penetration with type I's.
- Although the FDA is an agency that is very difficult to deal with, the inability to clear up the label issue and obtain monotherapy for byetta is a clear indication of an at best ineffective relationship with the FDA.Interestingly, when it came to saving their jobs, Amylin executives have finally shown the fervor, passion and aggressiveness I wish they have had when conducting all other shareholders business. I would appreciate it if you shared this letter with all executives and board members and would be more then happy to discuss it with them in person.
Best,
zino

byetta scripts and the problems with AMLN

2008-10-03T18:11:00.000-07:00

The picture tells the story... Although scripts were flat before, the bogus pancreatitis warning by the FDA had an effect on scripts. Couple this with the LAR bio-equivalence debacle and with the pounding that the whole stock maket took and you have the current AMLN stock price of $7.4... Here is my take on things....
- AMLN management is really really bad. There response to the pancreatitis bogus warning made the situation worse. They have also failed to cultivate proper relationships inside the FDA so that they are always surprised and one step behind the FDA decisions.
- The drugs, Symlin, Byetta are first in class and the pipeline potential of LAR and the obesity drugs make the AMLN potential unrivaled in the industry.
- However, given the ineptness of the management team and the reluctance of the BOD to do anything about the management I am starting to worry that the company will ever capitalize on its potential.
- At this point the stock is more of a value play then a growth story. Th PPS is selling at less then 2x revenues, and it has plenty of cash on hand, essentially if someone was to were to buy at today's prices they will be getting the LAR potential and the obesity pipeline for free.
- As sad as this maybe, I don't expect AMLN to remain an independent company for long. I expect that the stock will recover to around $15 by February, March time frame, then I expect the company to be take out between $25 and $30/share.
- I have been adding between $12.5 and $7

update on AMLN and the pancreatitis BS

2008-08-27T12:38:00.000-07:00

Just in case anyone is following my AMLN recommendation and have seen the price tumble today down to $20. Don't be fooled by the pancreatitis story, it is all smoke and zero substance. The reality is that there are more pancreatitis and deaths for the diabetic population not on byetta then the population that is on byetta. Byetta rate of pancreatitis is the same as the general population. So you could make a better case that taking byetta actually reduces the rate of pancreatitis. Sadly though, the company management has failed to properly communicate these facts and the FDA is just a very inept, and corrupt organization. Another sad fact is that there are now diabetics that could benefit from the drug that will probably stay away from it. This will make one of my PPS drivers even less likely to happen then I originally thought. I expect that when the dust settle the PPS will recover some. The two reasons that I was and still am long AMLN are still intact ( obesity partnership or LLY buyout). The buyout is actually now more likely then ever. The PPS of the buyout unless the price fully recovers to the high 20's low 30's is probably now unfortunately lower. These levels are obviously a better entry point.

Update on AMLN, DNDN, and I am starting to nibble on ELN - August 07 2008

2008-08-07T11:12:00.001-07:00

I know I promised to update this blog but Summer is my favorite time of the year and I try to stay away from the computer as much as possible.. Plus I am the kids chauffeur and they have a lot of activities, lol... But here we go...

AMLN:
A lot of churning since my last post but back to where we were in June... I still like AMLN short to mid term as they are a lot of catalyst for upside price movement. The risks are limited to the stock market vagaries and biotec surprise events like healths scares attributed to the drugs.
The multiple upside catalysts are...
- Byetta up tic in scripts. Amln and LLY have increased the sales force. They are hoping to see results in early September. I am not holding my breath on this catalyst as so far management moves to increase sales have all been a bust. I give this a 10% chance at success.
- Obesity partnership: Speaks for itself, should be an injection of cash plus give further credibility to its pipeline. I look for the stock to eventually move into the 50's on the strength of that move this year and much higher in the future. I expect this to happen this year but strongly depends on the next catalyst.
- LLY acquires AMLN: LLY views AMLN as a captive take over target. Plus a lot of the AMLN executives come from LLY. My guess is that LLY is working on that move right now. They do not want to let AMLN get an obesity partner as it would make their take over of AMLN more expensive and complicated. This is my least favorite catalyst as LLY is cheap and the upside is limited. Even a 50% premium form these levels we are looking at a price in the mid 40's.

So in summary AMLN is an excellent short to mid term investment with limited native downside. Buy the stock or leaps now. 6 month price target mid-40's to high 50's..

DNDN:
As I've said before this is not a stock for the faint of hart, very high risk. I am in it because it has 10 bagger potential. Provenge and Neuvenge could potentially become the standard of care for prostate and breast cancer... Let that sink in for a minute in terms of potential market cap for DNDN... And we should know as early as October or as late as the second half of 2009. Let me expand. In October the FDA has essentially agreed to approve Provenge ( DNDN has an approvable letter) based on the interim result of a large Phase III trials. Now it will be much harder to prove efficacy with the interim results, survival delineation in the trial becomes more obvious the more time goes by. But I give the interim a 30% chance of success. If the interim is not successful, then we have to wait until mid 2009 to get the final results . I give the final results an 80% chance of success.
My strategy:
Although the interim ha a low probability of success, I can't afford to be out of the stock because of its explosive potential. So I have been accumulated enough stock to be very happy if the interim is successful. However, I am also selling long and mid term puts $5 and $2.5 strike price, that I expect will be assigned to me if the interim is not successful. This will essentially allow me to double down if the interim fails.

Near term ( October): interim successful - PPS mid 20's, low 30's; Interim not significant / not positive: PPS ~ $2....

ELN:
Over the past week, I have taken a serious look at ELN. My initial impression is that the short took control of the stock and manipulated the news to drive the stock below what the real news warranted. The price is now at $11. I have started to nibble on the stock by buying calls and selling puts. I will expand more on this stock as I learn more and recommend a strategy with expected price target.

My best stock picks - June 5th 2008

2008-06-05T16:27:00.000-07:00

AMLN:
I have owned AMLN for years. I first accumulated AMLN when the stock was around $8... I sold all my position in 2006 at $43. I started accumulating AMLN again this year. I feel that there are near to mid term catalysts that could double the price per share. The share price today 6/5/08 is $32.5.

DNDN:
I bought DNDN last year at around $5 and saw it catapult to $25 after a couple of months. I did not sell because I felt the stock had a much higher potential. I did not count on the corruption at the FDA to raise its ugly head. The stock went back down to $5. This stock is not for the faint of heart. It has an incredible mid and long term upside but also some mid term risk. I will expand on both at a later time