Monday, November 28, 2011

Celsion safely past interim look

CLSN released a PR today:

http://www.celsion.com/releasedetail.cfm?ReleaseID=627024

Of which the important parts are shown below:

"Celsion Corporation (NASDAQ: CLSN), a leading oncology drug development company, announced today that the independent Data Monitoring Committee (DMC) for Celsion's Phase III HEAT Study, a multinational, double-blind, placebo-controlled, pivotal study of ThermoDox® in combination with radio frequency ablation (RFA) for hepatocellular carcinoma (HCC) or primary liver cancer, has completed a planned interim analysis for safety, efficacy and futility and unanimously recommended that the study continue to its final analysis as planned. The DMC evaluated data from 613 patients in its review, which was conducted following the realization of 219 progression-free survival (PFS) events within the study population. A total of 380 events of progression are required to reach the planned final analysis of the study.

Celsion also announced today that the DMC, in its review, followed a statistical boundary determined by the Company using the Lan DeMets implementation of the O'Brien-Fleming spending function. This approach allows for the Company to conduct additional interim efficacy analyses prior to final data read-out at 380 PFS events with no increased risk of statistical penalty. The additional analyses may allow for earlier stopping of the study. Additionally, based on its internally modeled estimates of PFS events, Celsion reconfirmed that 380 PFS events are projected to occur in late 2012.

"The DMC's unanimous recommendation is a significant achievement for Celsion based on the most comprehensive review of the HEAT Study to date, including the first-ever review of efficacy results," said Michael H. Tardugno, Celsion's President and Chief Executive Officer. "Critically, we have the potential to realize a successful outcome to the study prior to its planned completion. We are encouraged by what may be sufficient rationale for conducting an additional preplanned efficacy review prior to the 380 events called for in our protocol, and will seek to amend our Special Protocol Assessment Agreement with the FDA accordingly. We thank the DMC for their work and thorough review, and are grateful for the continued support and enthusiasm from the healthcare community, regulators, our investors and our employees."

The HEAT Study is being conducted under a U.S. Food and Drug Administration (FDA) Special Protocol Assessment, has received FDA Fast Track Designation and has been designated as a Priority Trial for liver cancer by the National Institutes of Health. Target enrollment of 600 patients was reached in August 2011, after which the DMC conducted this interim efficacy analysis based on the realization of 219 progression-free survival events. Consistent with the Company's global regulatory strategy, Celsion is continuing to enroll patients in the HEAT Study in order to randomize at least 200 patients in China, a requirement for sFDA (State Food and Drug Administration) registrational filing in that country and to ensure timely readout of final data. In addition to meeting the U.S. FDA enrollment objective, the HEAT Study has also enrolled a sufficient number of patients to support, in Asia, registrational filings in S. Korea and Taiwan, two very important markets for ThermoDox®."

So - my thoughts are as follows:

Disappointed? Yes - I did think we had a great shot at interim. Funny thing is, we just don't know: was P-value there but OS not enough of a trend? ("totality of the data")

So what do we know?

Safety is not an issue.

Enrollment at 613 (mid/late Sept?) This worries me a little bit. If 600 was ~ 8/5 and enrollment was 613 on 9/19ish, enrollment in China is slow. However, I believe that only those treated and at least one follow up might qualify under the 613. In that case, true enrollment might be closer to 625ish... I will have to follow up with the company here.

219 evaluated as "events". Q was asked at cc about the # past 190 and MT said "not substantial." 29 over = ~15% surplus... in my book that is substantial, but whatever.

The biggie in my estimation is that DMC advised them to seek an amendment to the SPA, instead of "simply" reccing a continue to 380. There is NO reason for this unless they were awfully close to being close enough to stop the trial. There is no other reason - period.

We have enough cash for about 8-11 months, depending on how much burn changes from the mrq. HEAT costs are "over the hump" supposedly but then we're still enrolling to 700, plus ABLATE expenses start. I assume ~1.7-2M a month, yielding my 8-11 months. We've demonstrated that we're willing to scrape the barrel... In my opinion it depends 1) on the FDA chat re the SPA and how soon we decide to take another peek and 2) on how licensing talks with big pharma (BP) go. Now that we're "de-risked" past the interim, BP may be more willing to loosen the purse strings. I repeat: with the DMC rec to amend SPA, the cat is out of the bag.

Was it Rodman & Renshaw that said $6 if a continue? I'm disappointed today, but especially if the overall market rallies, we'll nudge out of the mid $2s soon enough.

-Trond

Thursday, November 10, 2011

Celsion quarterly call

Following are my notes, in very rough form.
I'm very excited still, but very conscious that an investment here assumes that company guidance for 12 month placebo median PFS is correct. More precisely, it appears that anything up to about 17 months placebo PFS would give great odds at interim, which is 40% worse than guidance! So I am comfortable with such risk, but others need to decide for themselves.

26.6M shares OS, $21.4M cash, Q burn was 6.9M (will slow down somewhat - Q3 was high for HEAT milestone payments)

Acknowledged that burn will decrease slightly simce "hump" of HEAT costs are over in Q3.

380 events "possibly as early as q412".

HEAT enrollment extended to 700.

[me - was 640-650 to allow China to be registrational.]

later in QA acknowledged that 700 will get them to 380 events quicker

No OS (overall survival) bar is set at interim - it is "totality of the data".

Cash should last through 2012 [me- although this would reduce us to scraping the barrel again - doubt they'd go past 2q12]

S Korea and Taiwan are registrational in size, China [believe he said Taiwan in the call, but misspoke] is "quickly approaching" 200.

Japan PMDA still reviewing but no action. Yakult in charge of details of new trial and approach.

ABLATE - data should "closely follow" the approval of TDox. [assuming company guidelines]

Gross margins should be 90%+

SPA says if interim hit FDA would need to be consulted. No specific process.

If only a continue, co guidance is that DMC will only relay that fact. NO EXTRA DATA.

Well placed in terms of competition on horizon.

Co. gets "standard set of data" after continue - but pooled, not broken out per arm - it is still blinded!

No saying when DMC meets or when 190 happened [except we know 190 in 3q11 from the 8k filing. my best guess still second week of Aug '11]

Will not disclose p-value needed at interim. Can figure lots of stat data from that - not fair to all shareholders.

Went to 8-10 weeks for processing data... [believe this incorporates taking "extra care" with data into account w/ the increase over prior 6-8 weeks given]

Not substantially more than 190 events, but included a "safety margin".

Licensing talks continue.

Tuesday, November 8, 2011

MarketWatch contest - round 2 article

MarketWatch is running a contest to find its "Next Great Investing Columnist." I've entered, and my first column made it through the initial round, thanks to social media voting placing me in the top 25.

Now it gets interesting - as they are technically running two contests. There is an "Editors' Pick" winner (who actually wins the gig writing a column) and a "Readers' Pick" (based still on social media voting). The editors picked one additional writer to put through, so there are 26 remaining contestants. This round, 6 total writers will make it through - three Readers' Picks and three Editors' Picks.
I'm pretty much in need of being an Editors' Pick this time, as the top three vote getters in the first round all got more than 300 votes ("likes" on Facebook) and mine, while respectable in the field, drew only 148 votes.

I really don't mean to bag on the actual contest, but allowing the social media voting is a bit of a farce. The lead contestant got over 800 votes, more than twice as many as the second place vote... and the article is in broken English and extremely hard to follow. I guess I need more friends on Facebook. *grin*

I am asking the gentle readers here to visit the column, nevertheless. Any "likes" are certainly welcome, but I would actually appreciate comments in this round. I think the editors are more likely to place some credence on comments this time around!

My second article can be read here:
http://blogs.marketwatch.com/great-columnist/2011/11/07/dont-settle-for-average/

My thanks to all!

Regards,
Trond

Wednesday, November 2, 2011

Celsion - buy, sell, or hold?

We should be hearing from the DMC (data monitoring committee) regarding the interim results at nearly any moment.

While I am a raging bull as far as Thermodox goes, this is a clinical trial and "anything" can happen. I feel it a very slim-to-none kind of possibility that the trial be stopped for failure, but one has to keep it in mind. If the loss of your dollars here would cause you to lose sleep at night; then it may be time to sell, today.

As long as you can live with that chance, the remaining choices are a recommendation for continuing to the final look or a recommendation for filing for early approval, based on overwhelming statistically significant advantage.

Message boards have been frothy with the odds of success as high as 60% or more. And I have to say, there appears to be some good data backing up such assertations. Nevertheless, the most likely possibility, in my opinion, is simply a continue. So what does that spell, in terms of CLSN's price?

I believe this depends solely (short term) on what data is released with such a recommendation. It is important to note that the DMC does not have to release anything extra. That said, if there is a definite trend, regardless of meeting the higher bar at interim, it is conventionally believed that the committee will say something about the data.

A drop, short term, could easily happen, especially if there is not extra data released. Many stat experts have been saying, contrary to company assertations, that the final look at 380 PFS events will not occur until mid 2013 (company has been guiding for about Q3 2012). With such an extra amount of time in between interim and final, I think the price would drop again to the $2s.

However, with the release of some data, speaking to the improvement seen to date or at least the placebo arm's performance, would go a long way to being able to peg the actual performance of Thermodox. If we can see that at the final, it looks to be a success, we could even see some price appreciation.

A buy here would simply be a lottery ticket for interim success; with normal volatility I'd say a hold here is prudent, again as long as you can stand the possibility of a near 100% loss on an admittedly low chance of trial failure.

Regards,
Trond

Monday, October 24, 2011

HARPing on refi reform

President Obama is stumping for changes to the HARP program -- and while I try to stay politically neutral here, I reserve the right to call out idiocy anywhere I see it. (and yes, idiocy may be a stronger word than is called for - but wasting political capital slightly modifying a program that is very weak and doesn't address some fundamental issues, is not exactly smart)

http://www.marketwatch.com/story/mortgage-refi-plan-targets-hard-hit-borrowers-2011-10-24?siteid=nwhpf

"To spark interest in HARP, the program will lower fees, eliminate the current 125% loan-to-value ceiling, waive lender warranties and eliminate the need for property appraisals. "

Gee, make it easier for bad credit risks to refinance? Here's my take.

Yes, something needs to be done. But allowing people who fundamentally are screwed *anyway* to get out of their loans (which includes forgiveness of some principal) shifts the burden unfairly to the bank-stock shareholders. If you are underwater on a mortgage, it is not necessarily an emergency. Absent plans to move, all it takes is some time to change the situation. The wholesale granting of "liar's loans" a few years ago was obviously a stupid things for banks to do; I am NOT excusing them. But folks who enter a mortgage need to realize that a secured loan is exactly that - and the house IS the security. You pledge to pay $250,000, and fail to pay it back - you don't get to keep the house. No one questions the repossession of a car after failing to pay a $20,000 car loan!

So it is all well and good to question this kind of program - but what do I propose instead?

First, only allowing a program that is guaranteed by FreddieMac or FannieMae does not help the 70% of homeowners who have a mortgage through another institution. Secondly, principal should not be forgiven. Third, credit issues still need to be resolved. Here's my proposal.

Allow a two-year period where refinances can be done with the following waivers:

* Any amount can be refinanced, up to the current loan amount.
This only makes sense. If the bank is on the hook for $400,000, then they by definition cannot be hurt by allowing a refinance of $400,000. By allowing the refi, they increase their chances of getting repaid AND make more in interest charges the next few years!

* Modify the appraisal process.
This is basically a correlary of the above point. We don't care about what the home is worth; we just want to make sure it is structurally sound.

* Credit still needs to be checked. Income verification needs to be revamped.
We do want to make sure that the loans made can still be repaid. If a household is bringing in $5,000 a month, is there any doubt that a $2,000 payment - 40% of their income!! - might be a stretch, still? If their P&I payment was $2,800 a month but an extra member of the household used to be working, their situation has changed enough that perhaps they shouldn't be owning a house anymore.

I guess I am angry that only a small percentage of homeowners may qualify under HARP and that the fix hurts shareholders who have already been nailed by the last few years of bank stocks' crumbling share prices.

Regards,
Trond Hildahl

Wednesday, October 19, 2011

Next Great Investing Column contest

Well, I appear to be in full solicitation mode this morning. Facebook, Twitter, Google+, and now my blog...

I'm in a contest to become an investment column writer for MarketWatch. The first stage's winners (25 of them) are determined solely by social media voting. If you've enjoyed my blog posts over the years, please help me out and vote for me here: http://blogs.marketwatch.com/great-columnist/2011/10/19/dont-be-an-english-lord/.

And THANKS!
Regards,
Trond Hildahl

Tuesday, October 18, 2011

Marketocracy results

Well, I am a big fan of full disclosure, but this is a hard post to write. The Marketocracy website allows anyone to participate in managing a mutual fund - fake of course. Nevertheless, you are bound by some rules; you can't bet it all on one stock, as no one stock can be more than a certain percent of the total. You can't be on margin, and you must be at least 65% invested. If you want to be a sector based fund, then a certain percentage of the holdings must be in that sector. They do all the calculations across months, quarters, and years to figure your returns and most importantly, compare those returns against the other marketocracy funds.

The best of the best are called the M100 - the 100 best performers, long term; culled from the 85,000+ managers and the 100,000+ funds being managed. Those 100 actually make a little money, too - the company uses the best managers' ideas to run an actual mutual fund and those managers are compensated. It is no secret that I firmly intend to be one of those manangers one day.

And that is why I am writing so sheepishly today. They update the quarterly returns quite late - Q2 was just posted about a month ago. And in my Heartstone Health fund (http://www.marketocracy.com/cgi-bin/WebObjects/Portfolio.woa/ps/FundPublicPage/source=CmOhHbFfEfOmLoNbMaKiAbDf), I was the 7th best fund (yes, 7th, not top 7%!!!) for the three month period. For the 3 year returns, for as long as I've HAD the fund for more than 3 years, I've been in the top 89%, and this quarter I came in at #67 overall.

I was ecstatic, of course, but now for the disclosure. Since they posted the results in September, I knew already that my 3rd quarter results were going to equal my second quarter results to the downside. Yes, I fear that I may well be the 7th WORST fund across the universe this coming quarter. Celsion dipped about 40%; VirnetX went from the $30s to about $20; and Dendreon crashed from the $30s to about $10! To be frank, I am not sure if any holding had a positive return in this quarter.

Since I am a sector fund (biotech/healthcare) my beta is quite a bit higher than the S&P 500. Beta is a measure of how volatile I am versus the market-as-a-whole. It is the long term that matters, of course, and I'm fully confident that I will come back and with a vengeance. Bring on the fourth quarter!

Regards,
Trond

Sunday, October 16, 2011

Celsion info re: Mangrove

Hello all,

It has been quite awhile since I have updated the blog. I've been a busy beaver on multiple fronts, but I still have great expectation for Celsion. Below, please follow the link to a great interview with Nate August, whose Mangrove Partners, LLP recently took an 8% stake in Celsion, expecting a great result at the interim look of the HEAT trial.

http://celsion.blogspot.com/2011/10/exclusive-interview-with-mangrove.html

Regards,
Trond

Thursday, September 22, 2011

Barry Ritholtz's blog

Occasionally there is something blogged that compresses exactly what I'd like to say in such a simple way that I just can't improve it. Barry Ritholtz (The Big Picture) is such a writer most days, and I highly recommend a daily stop there.

Check out his post today (and his linked article about black swan events is a must-read as well).

http://www.ritholtz.com/blog/2011/09/what-should-investors-do-now/

People almost always need to do "something", however. If you can't just sit on your hands, I'd suggest reviewing your allocations, now that stocks have taken a pounding.
-Is it time to rebalance so that you buy into stocks again now, when they are "on sale"?
-Have you contributed fully to your IRA for the year? Get it in now and buy low.

Yes, the markets could certainly sink somewhat lower. Is it the end of the world yet? Probably not! While I think we could see a recession again in the next quarter, the stock market has been diverging from the economy quite a bit in the last three years - Sept/Oct, when going down, is historically a pretty good time to be buying stocks.

Regards,
Trond

Thursday, September 8, 2011

More thoughts on Celsion's 190th event

So it looks like the company has probably hit the 190th event... recent PRs talk about "confirming" rather than "achieving" the 190th event.

A reputable poster (biopharmpr) on Yahoo, who also tweets a bit under Magicsia and has a blog with some great info about Celsion, says he spoke with IR and the company is now backing off saying they will PR when the 190 happens.

Supposedly, they are concerned about having more than 190 events by the time they confirm 190 for sure, and then having to explain THAT makes them not want to do so at all. So - it is getting more likely that the next PR about the HEAT trial will end up being the actual interim results!!

I don't like this for several reasons, and I will probably call Jeff Church tomorrow when I can get my thoughts down cogently. But the important things for CLSN investors today are:

Per the last filng, they expect the 190th event in the 3rd Q and results in the 4th Q.
Previous guidance is for 6-8 weeks between the two.

Absolute best case is results by 9/17 -- meaning the 190th occured quite a while ago, has already been confirmed, and the DMC is currently doing the scutwork of visiting sites and checking paperwork ad nauseam... leading to a postulation of the interim results at 8 weeks by 10/1, but being done in only 6 weeks: 9/17/11. I find this extremely unlikely and think Q4 means exactly that.

Worst case would be the end of December. This could happen if radiologic reviews truly take 2-4 months to accomplish, meaning the event probably happened already, the confirms are pending, and might still take a couple months from now. Adding in the 6-8 weeks to compile/check the trial site info, we could be looking at December before knowing results.

I am mostly in shares, but did dabble in Oct and Jan calls. I think Jan are definitely the safest but there could easily be an "October Surprise" by the third Friday of October. I still expect a runup through September to the $5-7 range. As Mr. Market gets wind of the potential of Thermodox (and who doesn't like a binary event thrown in?) there will be some speculators also riding this up.

Regards,
Trond

Wednesday, September 7, 2011

Dendreon - time to cut bait

I am selling all remaining shares of Dendreon in the Port24 - today's current price is $11.58. This is at a steep loss to the buy in price, but I simply have no patience for mgmt anymore.

I certainly hope I'll be buying in again at some point, but what with mgmt indications from the last call that they will be letting folks go and the unwillingness to throw out any kind of revenue estimates, I cannot urge a position here at the present time.

Regards,
Trond

Tuesday, September 6, 2011

Celsion - To PR (190) or not to PR

An online friend contacted CLSN's IR today regarding the 190th even in the HEAT trial. Instead of regurgitating the content, I am just going to direct you there.

I will note, however, that I am putting less credence on having results by the options expiration in October. I still firmly believe we'll see quite a runup through Sept and October, but anyone betting on the Oct strike timeframe will probably not see the actual results by then.


http://celsion.blogspot.com/2011/09/dont-bank-on-190-pfs-event-press.html

regards,
Trond

Saturday, August 13, 2011

Building a business


As announced previously, I am going through a number of steps to hang out a shingle on my own. I'll be doing financial planning and investment management; combining what I love to do, I love to talk about, and what I can see myself doing for a long time without burning out.

In the next few weeks, I'll post somewhat frequently about the steps in setting up such a business. While a sole proprietorship in some industries can be started by simply taking on work, this type of business is quite convoluted in some ways.

For liability reasons, I have decided that I need to either incorporate or form an LLC. And as a financial planner, I will need to pass the NASD Series 65 test to become a Registered Investment Adviser (RIA).

Those two steps, and the associated compliance, will take a couple months as well as about $7K to get the ball rolling. Then there are the practicalities to think about:
An office, a home-office, or a "virtual" office?
Equipment? Laptops, smart phones...
Business name, fictitious business name, trade/service marks, logo design...
Domain names, building a website...
Accounting! Taxes!
CRM (client relationship mgmt) software, electronic signature vendor...
Marketing! Advertising! Networking (I don't know any millionaires, personally), what is my niche? What are my bragging points?
What services exactly will I offer? Pricing?

Fortunately I do not see myself hiring employees for a long time yet... reading up on all the hoops that an employer must go through gave me a headache.

One thing I know for certain, is that I will be using the Spoke Fund concept (see www.SpokeFund.com) for how I handle investing money. Starting a mutual fund would cost about $400K, and while a hedge fund is much cheaper, you can only advertise to "high net worth individuals"... or basically millionaires. With a Spoke Fund, the investor's money remains in his or her own name, with a discount brokerage custodian I select, but invested according to a model of stocks I control. Importantly, my own account is the "hub" - where I am invested in the model myself with all the risks and rewards - and the "spokes" connecting my account and my clients' accounts are simply the model's percentages of the various investments.

As to financial planning, I intend on being a fee-only planner, taking no commissions, kickbacks, or other incentives for the products I may recommend.

So please, gentle reader, lay it on me! Ideas this post may have raised? Questions on the whys or hows? Advice from experience? I thank you and look forward to any comments!

Regards,
Trond

Wednesday, August 10, 2011

401(k) asset allocation

Just a very quick note.

With the market plunge this week, it may be a good time to review your 401(k) existing balances. The percentage you want in stocks may have dipped, and it would be a good time to transfer some dollars from cash or bond into the stock funds.

Rebalancing is touted as a good way to enforce moving money from hotter sectors into weaker sectors - before the hot grows cold and prior to the cold warming up! But those who rebalance only on an annual basis will miss out of this kind of volatility that allows mid-year corrections.

Regards,
Trond

Tuesday, August 9, 2011

Celsion Q2 conference call


I'm most disappointed that they again missed their guidance on the interim calc - most recently in July, they said they'd have results from the interim by the end of Sept. According to the 10Q (pg 20), they now expect the 190th event "in Q3" and the interim results "in Q4". With 6-8 weeks necessary for that calc, that means the results could be anywhere from 10/1 to 11/25. I thus sold my Oct calls today, perhaps a bit hasty but Jan is now the safest. Still expect a runup, just pushed back again by a month or so.

Everything else looked okay, CRLM trial being initiated, EMA guidance for trial approval by eoy, Japan will start a separate trial from HEAT so as to take different standard of care issues into account - Yakult still responsible for 100% of that new trial costs. RCW Phase 2 trial (Dignity study) will be extended to other indications than just RCW cancer in order to speed enrollment, but that kills the registrational ability.

Please note that pushing out the 190 event was blamed on the slower than expected enrollment, but there is some reason for optimism about how well Thermodox is doing. The trial was based on assuming the placebo (RFA only) would lead to a median PFS of about 12 months and Tdox extending that by 33%. It appears to me that both arms are doing better than assumed, but Tdox by at least the same proportion. I still intend on selling 1/2 to 2/3 on the runup, but I'm getting a bit more excited about interim success.

Regards,
Trond

Sunday, August 7, 2011

S&P downgrades US debt

The "unthinkable" happened Friday night when US debt was downgraded from AAA to AA+.

While horrifying to me, simply because it was avoidable, I have some hopes this will be considered a tempest in a teapot within a few weeks. I certainly expect tomorrow's stock market open to be down, but there are some mitigating factors at work.

First, the S&P ratings agency is one of the crooks who gave low risk / reasonable quality credit ratings to all those CDOs that were the culprit of the financial crisis. That fact is pretty widely known - and it is like home inspector who gives you a great report, leaves you with a house that has holes in the roof, and has his brother (coincidentally a roof-repair contractor) come for a visit next time it rains.

Second, Europe (the G-7) was hard at work over the weekend soothing fears over the pond about their own credit woes.

Third, this market has been dominated by momentum traders for the last year - meeting all dips with buying fervor. A lot of cash left the market over the last two days, and will be looking for a home.

Fourth, such a downgrade is bad, but Moody's (the other major credit rating agency) did NOT lower their rating.

Finally, when risk goes up, prices tend to fall. In the bond market, you can look at this thusly: if you think a bond is riskier, that means you think that you have a lower chance of being repaid. For existing bonds being traded tomorrow, that lowers the price you can sell them for. People selling those bonds will be looking for better returns and some may end up looking at the stock market (I would propose dividend-paying large cap stocks or ETFs).

A final note is that it will be very interesting seeing the results of the next treasury auction. For bonds to-be-issued, you would demand a higher interest rate to compensate you for the higher default risk mentioned above. Having higher interest rates will cause more issues down the road - paying just the interest on our national debt is doable at the moment because of the historically low interest rates. If you think the bickering over the debt ceiling was acrimonious and protracted - wait until higher interest rates cause us to make really hard choices between cutting expenses and raising taxes.

I am absolutely incensed that ALL of our Congresspeople have forsaken their duties to We-The-People and brought this on. Both Democrats and Republican share the blame here, and the black eye the S&P ratings agency gave us is most definitely their fault alone. We need them to rise above partisan lines and fix these issues: it will take raising some taxes, lowering or erasing some deductible categories, massive cuts in some agencies and freezing the budgets of others, and meaningful discussions about SSI and Medicare.

I am not selling anything Monday morning, and will be looking to buy certain companies at fire-sale prices. As Warren Buffet famously said, "be fearful when others are greedy and greedy when others are fearful."

Regards,
Trond

Wednesday, August 3, 2011

The RollerCoaster named Dendreon

Long time readers and friends know, I love me some Dendreon.

I started reading up on Provenge back in 2006, was just about "all-in" in 2007 during the FDA's Advisory Committee meeting that okayed it, and watched in horror as the FDA then gave the company a Complete Response Letter (CRL) a month later.
I sold some over the next couple years, but was again an active investor in 2010 when they finally got approval. I sold some in the $50s, more in the $40s, and finally sold the very last amount (save one single Jan 2012 call option) around $35, last November. I stay on top of the company news, however, and consider myself a Dendreonaire.

It is with awe and a sickening feeling, then, to see the after hours cratering of the stock price, following the Q2 earnings call. A transcript of that call can be found here: http://seekingalpha.com/article/284445-dendreon-corp-s-ceo-discusses-q2-2011-results-earnings-call-transcript

Let me sum up the entire issue in one paragraph, if I may. Provenge costs $93,000 for a one month round of therapy (3 infusions). Prescribing doctors make about $6K for themselves, but have to "eat" the entire $93K on a credit line or their own resources until they get reimbursed by insurance/Medicare. Up until extremely late June, there was a question of whether Medicare would cover Provenge (and while it did get a determination for coverage, that fact isn't even posted on the proper website yet!). Thus, for cash flow purposes, few urology or oncology practices could prescribe more than 1 patient at a time. Moreover, due to manufacturing limitations and the scale/cost of the one approved plant through most of this period, the company was unwilling to push large scale scripts yet.

All of the preceding hopefully explains the carnage in the stock price. At the end of after hours trading, it was around $13.70 - down from a regular session closing price of $35!

So the proper question now is, what to do: buy, sell, or hold?

The price tomorrow? It could well be $10, or it could be $17.
I would suggest that if one has no position, and a holding period of a half year or more, this is an excellent time to buy, if within the range above.
If you own shares currently, I'd hold on, all else being equal.

I feel, given the facts known now, that the company will recover from this, and end the year 2011 over $20. It may be 2013 before we see the $40s again, but for an extremely long term p-o-v, I believe this is a solid company that should be a core position.

Regards,
Trond

Sunday, July 31, 2011

Celsion upgrade and expectations

JPMorgan Chase & Co. raised their target price on Celsion on Thursday, to $8.50.

http://www.americanbankingnews.com/2011/07/29/jpmorgan-chase-co-jpm-analysts-raise-price-target-on-celsion-co-clsn-to-8-50/

While typically I would hesitate to even point this out, since Needham is the only analyst thus far to cover the company, I view the addition of JPM to the coverage "stable" as a good thing. With enrollment in the HEAT trial expected to be completed at 600 either this coming week or next, and the 190th Progression Free Survival (PFS) event expected in a similar timeframe, the more eyeballs the better.

They raised another $18M in cash two weeks ago, appearing flush with cash for the first time in years, while maintaining an outstanding share count somewhere around 23M. While they typically have their Q2 earnings call in the first week or so of August, it would not surprise me in the least to see them await these two events before hosting that call - I'm sure the management has no desire to hear all the questions about the trial that they would simply need to be answering within another week!

I still expect a decent runup into August and September; with the price at a post-offering price of $3.83 I'd like to see it hit between $5 and $7 in the next 2-8 weeks. The interim calculation results, still explicitly guided for by the end of September, are expected to take 6-8 weeks after the 600 & 190 events. I'd hazard that the later of those two events will happen by August 12.

I know several readers have advised me they have purchased Celsion shares or options; I still think shares are "safer" but acknowledge the leverage options allow. For me, as a new trade and looking at the October or January calls, I would pay the little extra premium the January strikes demand, for the security of the extra three months.

I hold a pretty large position of CLSN and will be lightening the load in Aug and Sep prior to the interim results.

Regards,
Trond

Monday, July 25, 2011

Today's trades and new Port24 additions

I have two trades for covered call fanatics, today. PIP and VHC both have very good arguments for a trade which yield 14 and 8%, respectively.

PIP is trading at $2.74, with the Aug11 $2.50s selling for $0.65. You'll end up losing 24 cents on the shares, if exercised, but gain the 65 cents on the option, netting 41 cents profit per $2.74 share - over 14% for a month. On the downside (especially important to note if they lose their lawsuit) you are "protected" down to $2.09.

VHC is trading at $34.55 with the Aug11 $35s selling for $2.80. That is an 8% dividend while you wait, with an extra 1% of capital gains if exercised.

I think both of these will end where they are, or higher, on 8/19/11.

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On the Port24 front, I miss having NBIX already, but will not buy in again here.
I bought 2500 CORT at $3.82, 6000 PPHM at $1.78, and 1800 ZIOP at $5.87. I am trying to buy lots of stock that end up somewhere around $10K at a whack.

I sold 20 Jan12 $2.50 calls against 2000 of the 6000 PPHM (Peregrine Pharma) for $25/contract. This is about a 14% return for the 6 month period, with an additional 40% return if exercised. I LOVE this risk/reward ratio, especially since I've only sold options on a third of the position. If the price rises into the $2s again, I will sell more, at much higher premiums.

I also sold 18 Aug11 $6 calls against the ZIOP (Ziopharm) for $25/contract. While "only" a 4% return for the month, I am more than willing to either lose the stock if over $6, or rinse and repeat under $6.

CORT (Corcept) is a stock I will hang onto for a couple months, assuming there will be a runup into the $5s or more as the FDA PDUFA date approaches. I'll sell calls at that point.

Port24:
19.8% annualized return (since 5/14/2008)
$5,468.80 in cash
1500 ARQL (0)
1200 BTX (0)
2600 CLDX (0)
9000 CLSN (0)
1600 DCTH (0)
300 DNDN (0)
1100 EXEL (0)
2000 MITI (0)
7000 NNVC (0)
2500 PIP (0)
1600 SGMO (0)
2500 CORT (0)
6000 PPHM (20)
1800 ZIOP (18)

Saturday, July 23, 2011

July options

Oops, neglected to update the options expiration on the Port24 last weekend!

I had four stocks with calls sold against them - DNDN, EXEL, NBIX, and PIP. Dendreon and Exelixis expired under the strike price, so I retain the shares. NBIX and PIP were called away (although I retain some extra PIP, as I did not sell calls against the entire position).

The Port positions are shown below; I have $35,397.31 in cash with a 20.5% annualized return as of 7/22/11.

I do expect Celsion to continue its run; HEAT enrollment and the 190th PFS event should occur within 3 weeks now. I intend (in the Port24) to start taking some profits around the $5 mark - I'd bought lots around $2.64 and $2.31.

Regards,
Trond

# / Ticker / (calls sold)
1500 ARQL (0)
1200 BTX (0)
2600 CLDX (0)
9000 CLSN (0)
1600 DCTH (0)
300 DNDN (0)
1100 EXEL (0)
2000 MITI (0)
7000 NNVC (0)
2500 PIP (0)
1600 SGMO (0)