Tuesday, July 29, 2008

Elan stumbles

Hi all,

Where to begin tonight? I have to admit I am a little glum, just from the share price point of view. Elan presented the detailed results from their Phase II trial tonight at ICAD – the International Conference on Alzheimer’s Disease – this is one of the two largest AD symposiums in the world (other one is the AAN). In June they had released summary results and by all indications it was a total success.
The trial was for their drug AAB-001 and involved 240 patients. 4 different doses were given, and half got the drug and half got placebo. So really, 30 people got the drug at each dose. Overall, they missed statistical significance on both the cognitive and functional endpoints for the study.
So why do I say it was a success?

First, Phase II trials are still mostly concerned with safety and determining dosing strength, and secondarily with efficacy. After looking through the results, they discovered that the non-carriers of a certain gene (APOe4) got statistically significant cognitive AND functional results from the drug, and even the carriers “trended” towards significance. Carriers of that gene, by the way, have already been proven to be a higher risk to develop AD, so it is not just out of left field to latch on to that subgroup.
How about safety? The largest problem for the carrier group at the highest dose was vascular edema (VE), which is a temporary swelling of the brain. None of the 12 affected patients were harmed and all recovered AND continued in the trial at a lower dose. However, because they “switched” mid-trial, their results were not counted, which hurt the overall trial – 12 extra patients in the denominator but not counted in the numerator! Add to that, the lowest dose was also found in the Phase 1 results to not have much if any impact, but they stayed with that dose in the Phase II trial to confirm – another 30 patients who really did not count except to hurt the overall study.
Yet even with those hiccups, they STILL found significant improvement over placebo in the non-carrier group.

Elan started a Phase III trial last December – 4000 patients worldwide; 2000 in the US and 2000 in Europe. Each of these have 1000 carriers and 1000 non-carriers, so even with the carrier reactions, they still saw enough significance to have them be half of the participants! This is an 18 months trial, again with both cognitive (measurement of mental decline) and functional (how do they actually function in the real world) endpoints.

So – tonight.
They gave all this and the actual numbers and P-values (basically the probability that the result achieved was real and not just a fluke) and some extra safety info. 3 patients given the drug died. Sounds bad, but the trial doctors were all unanimous in that the drug had no affect on those deaths – if they were mugged, they’d still be reported as having died during the trial. Yet the very first headline I saw from Reuters was that “Patients died in Elan’s Alzheimer’s trial”.
The share price was around $34 and sank during after-hours trading down to $23.

The CEO will be speaking right after market open tomorrow on CNBC, and I hope to hear something about pricing and when they might potentially file for an early FDA approval. If not, we may see low $20s for awhile.

All that said, I am still a staunch supporter. I think the drug works, (and with a medium strength dose even for the carriers) and in the worst case there is only 20 or so months for the trial to end. Even if only the non-carriers get approved, that is still tens of billions of profit, which would make it the best selling drug ever, by multiples.

Even without AAB-001, they have Tysabri and their nanotechnology drug delivery unit, which combined would value the company at around $35 per share. They still have a world class pipeline with other drugs for AD, Parkinson’s disease, and diabetes.

I think this is a world-class buying opportunity.

Regards,
Trond

Sunday, July 27, 2008

Port 24 Update - July expiration

Well, I am super busy at work right now and will be through mid August. So this will be a quickie post.

I was exercised on the Cardiome calls and kept my SuperGen and NVidia stock. I sold SuperGen on 7/25 at a loss -- the Dacogen trial was bad and I just don't see enough in the pipeline to keep the stock here. NVidia I will definely keep, although I am selling calls way below where I bought. Also sold calls (on 7/25/08) on Arena, Syneron, Taser, and calls on half my Neurocrine and Sangamo holdings.

My Elan holdings have no calls against them and I fully expect to sell some calls next Wednesday or so for either the $40s or $45s -- they release their detailed Alzheimer's Phase II results on 7/29 and I truly expect it to knock the socks off of Wall Street.
Dendreon announced last week that the interim results for the Provenge IMPACT trial will be available in October. Thus, my five August $7.50 calls will *probably* expire -- I am hoping for total success in the trial and so my five November calls at $12.50 may well be called away.
Taser had bad earnings, but selling calls at $5 to make some money -- same with Neurocrine but I have a bad feeling I will regret selling the 5s.

My current holdings are listed below: their value as-of 7/25 is $96,312 which along with recent cash update at $11,006 puts me at $107,270. That is a 7.27% return so far through 2.5 months -- annualized at about 35%.

Regards,
Trond

Holdings:
2000 NBIX (-10), 1000 ELN, 2000 DNDN (-10), 1200 TASR (-12), 2000 ARNA (-20), 1000 SGMO (-5), 400 NVDA (-4), 400 ELOS (-4)

Tuesday, July 15, 2008

Early IRA withdrawals - 72(t) Distributions

Well, I am not in a place where I'm able to take early distributions yet, but I came across a nifty way to take distributions without the 10% penalty before age 59 1/2 if you are so inclined.

Note: PLEASE do not do this simply to get at some money early!! But, if you are in a sweet spot and have a couple million in an IRA and still have a few years until 59.5, read on!

72(t) Distributions

First, please note that you still get taxed at your marginal rate on the amount of the distribution. You are only saving yourself the 10% early withdrawal penalty!
Second, you have three methods of determining how much you withdraw -- you cannot just take any old amount.
Third, once you start taking these withdrawals, you have to continue for either five years or until you reach age 59 1/2 -- whichever in LONGER.

The three methods are:
1) Balance divided by your life expectancy.
2) Balance divided by an annuity factor.
3) Balance amortized across your life expectancy with an pre-specified growth rate.

Method 1 results in the smallest annual payment. 2 and 3 seem to usually come pretty close to the same amount, and they can be more than half again the amount from #1.

As always, consult a tax adviser and consider reading the tax code yourself (you were trying to go to sleep,right?). There is a calculator here (http://www.dinkytown.net/java/Retire72T.html) that allows you to see how much you could take now. Have fun!

Regards,
Trond

Port 24

Quickie post -- used up the rest of my cash this morning with 400 more Elan at $33.54. That puts me at $95.92 in cash and the following positions:
2000 SUPG (-20), 2000 NBIX, 1000 ELN, 2000 DNDN (-10), 1200 TASR, 2000 ARNA, 1000 SGMO, 500 CRME (-5), 400 NVDA (-4), 400 ELOS.

Cardiome should be exercised Friday, and SuperGen will be freed up. Elan should be pushing $40 or so by the first of August and I will either sell some shares outright or sell $40/$45 calls for August or Sept.

Regards,
Trond

Friday, July 11, 2008

I can't resist -- one more DeepCapture story about JP Morgan and Bear Stearns...

Totally plagarized...
--------------------
Get 'em fellas!!

JP Morgan CEO is Crazy, Too. Time to Subpoena CNBC

July 9th, 2008 by Mark Mitchell
Certain journalists and convicted criminals with ties to hedge funds have suggested that we at Deep Capture are crazy because we believe some short-sellers deliberately destroy public companies for profit.
Last night, JP Morgan CEO Jamie Dimon was interviewed by Charlie Rose.
Rose said, “[Bear Stearns CEO] Alan Schwartz is quoted as saying.. that he thought [the demise of Bear Stearns] was premeditated [by short-sellers].
Dimon responded: “I would say where there is smoke, there’s fire. If someone knowingly starts a rumor or passes on a rumor, they should go to jail…This is even worse than insider trading. This is deliberate and malicious destruction of value and people’s lives. They shouldn’t go to jail for a short period of time. So if I was the SEC I’d find out who made the money and I’d investigate–emails, phone records, you name it–and I’d find out….There’s enough smoke around that I think there should be a full investigation…”
So now the CEO of JP Morgan is crazy, too. So is former Bear Stearns CEO Alan Schwartz. Lehman Brothers CEO Richard Fuld said something similar, so he must be a crackpot. The SEC itself claims to have begun an investigation. They’re all nuts.
Anyway, permit us to suggest an easy way to get this investigation moving: Send a subpoena to CNBC reporter Mark Faber.
On March 13 and March 14, Faber told CNBC viewers that a hedge fund manager – “a friend” whom he “trusts” – told him that Goldman Sachs had refused to accept Bear Stearn’s credit. This information was false. It was a deliberate, malicious rumor delivered to a friendly journalist in order to destroy Bear Stearns.
Find out who Faber’s hedge fund friend is. Case solved.
This would not be the first time that Faber reported misinformation in service to a hedge fund friend. He used to do it for Jim Cramer, back before Cramer became CNBC’s leading “journalist” – back when Cramer was running his own hedge fund. A former employee of Cramer’s hedge fund has written a book, “Trading with the Enemy,” in which he describes Cramer feeding Faber tips and illegally trading ahead of Faber’s reports on CNBC.
It is no small coincidence that a clique of journalists connected to Cramer regularly write false or misleading hatchet jobs on companies targeted by short-sellers connected to Cramer. And it is no coincidence that these same hedge funds have deliberately and maliciously sought to destroy dozens of public companies and people’s lives by circulating rumors, issuing bogus “independent financial research,” clogging Internet message boards with false information, filing bogus class-action lawsuits, getting the SEC and other government agencies to conduct dead-end investigations, and hiring convicted felons to harass CEOs. (And that’s not all; see “The Story of Deep Capture” for the gory details.)
It is also worth noting that in almost all of the companies targeted by these people, somebody has sold massive amounts of phantom stock to further drive down prices. Two companies targeted by these people are Lehman Brothers and Bear Stearns. Both have been victimized by phantom stock sellers.
We’d say somebody should investigate this. But that would be crazy.


http://www.deepcapture.com/

Finally - Port24 Update

Let's see where we're at, about two months into the Portfolio.

On 7/3/08 I had bought 400 Syneron for 15.04 and 400 more Elan for 33.70. So, I now have the following stocks (number in parentheses are the number of calls sold against them)

2000 SUPG (-20), 2000 NBIX, 600 ELN, 2000 DNDN (-10), 1200 TASR, 2000 ARNA, 1000 SGMO, 500 CRME (-5), 400 NVDA (-4), 400 ELOS
Cash balance is at $13,518.90, and the total market value is $100,875.92. That is a .87% return so far, which is obviously below my target. In my defense, I still have a number of July calls to sell -- which I hope to do today (time permitting at lunch!).

Supergen, Nvidia, and Taser are my biggest disappointments so far; Supergen missed on a clinical trial for Dacogen, Nvidia had a horrible quarter, and Taser lost the first lawsuit (out of 71 verdicts so far). Honestly, I will probably buy back the Supergen calls at a profit, and sell Supergen and Taser at a loss. I will make a final determination next week...

Elan is the biggest winner so far, having bought two sets of Elan that I've kept at $27.30 and $33.70, and the price now being $36.82. I am looking to crest $40 at the end of the month and depending on a spike, if any, following the ICAD results I will probably sell more calls on these shares at the next-higher $5 exercise price.

Regards,
Trond

Monday, July 7, 2008

Various tidbits...

Well, okay so blog writing has to take a backseat to family, holidays, and work. I'll be better this coming week.

I wrote down two trades last Thursday but haven't had a chance to update my spreadsheet yet. I bought Elan (ELN) around $33.80 and Syneron Medical (ELOS) around $15ish. I will update early this week!

I also have some IRA info about taking penalty-free withdrawals BEFORE age 59 1/2 that may interest some people.

Hope everyone had a wonderful July Fourth!

Regards,
Trond