Last Chance for a Tax Loss (CVTX)

At the end of every year, like many investors, I like to look through my portfolio to see if there are any losing positions that I want to sell in order to book a loss for tax reasons.

This year, unfortunately, fate has conspired against me to some degree -- I certainly have some losers in the portfolio, but they're generally in the wrong accounts or they're stocks I don't want to get rid of.

Almost all of my losing positions are in tax-advantaged accounts of one kind or another (401K or IRA), and while some of those may deserve to be sold there's no particular reason to sell them at the end of the calendar year. I have six stocks in the portfolio that are down more than 5% or so, including all three of my most speculative positions -- the bulletin board companies Cryo-Cell (CCEL), SpaceDev (SPDV), and MMC Energy (MMCN) -- as well as Chico's (CHS) and Imax (IMAX). Those five are all in IRAs.

But I do have one holding that I could sell for a tax loss this week -- CV Therapeutics (CVTX) is held in a taxable account, and it is certainly down (my position is in the red to the tune of about 34%). So should I sell it?

I haven't written much about CVTX lately, but I bought the shares on the promise of Ranexa (Ranolazine) as a potential new front-line angina treatment to compete with the sometimes ineffective beta blockers and such that have been in use for decades.

And here's where it gets interesting -- CVTX is down dramatically because they have not yet gotten approval for Ranexa as a front line treatment, and because sales of Ranexa for patients who have already tried other treatments started extremely slowly this year when the drug was approved for that much smaller market.

So that slow takeoff might mean that cardiologists just don't like the drug -- in which case, CVTX has a long slog ahead even if they do get an expanded label for the drug. Or it might mean that the doctors are waiting for the completion of CVTX's expanded MERLIN trial, which has been delayed a bit already, before they start prescribing Ranexa.

The MERLIN trial is underway now to examine the potential for Ranexa as a front-line treatment, and to use as an argument for the FDA for an expanded label to dramatically expand the sales potential for the drug. Essentially, an investment in CV Therapeutics is a bet that the MERLIN trial will back up CVTX's safety claims and give them a huge market to sell Ranexa into, because they don't have much in the way of other promising drugs intheir pipeline.

So I'm thinking that this one probably makes sense as a tax-loss sale, even though I do think Ranexa has some great potential (and is moving forward a little faster in Europe, which is promising). Why? Because it's going to be months before we hear important news from the MERLIN trial, so I have plenty of time to sell now and buy back after 30 days if I still have that inclination, with certainly no catalysts expected in the next month or so.

Of course, I could always be surprised -- news could leak, either good or bad, from the MERLIN trial, or a new drug could be discovered to have great potential in their very thin pipeline, or cardiologists could suddenly fall in love with Ranexa and spike prescriptions higher in the short term. Or someone big could buy the company. While those are certainly possibilities, I consider them all remote -- and especially remote in the next month, so I'll be taking a tax loss in CVTX and reconsidering at the end of January whether I want to re-open a position.

full disclosure: I sold my shares of CVTX at $14.01 this morning. As of this writing, I still hold all the other stocks mentioned here.

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CVTX Still Falling, PDLI Still Cheap

Interesting day for Biotech investing -- two of my companies released earnings, neither of which could really be called great, and one stayed even while the other continued its flushing spiral.

PDL Biopharma (PDLI), formerly Protein Design Labs, was the mildly positive one -- this company is pretty far along as far as small biotechs go, with several marketed (if small time) products and a deep royalty stream and solid pipeline. They released earnings that show they're continuing to be cash flow positive, if not yet with positive real earnings -- that's a significant step, but not a surprise.

The bad news for PDLI was that one of their minor clinical trials failed. One of the drugs they acquired with their takeover of ESP Pharma last year, a takeover that also brought in all of PDLI's current marketed drugs and helped to bring them to the verge of profitability, failed in a phase three trial.

I was hoping that this failure, in which terlipressin did not meet its primary endpoints but did show some potential good effect, would bring PDLI's share price down even further -- I had a buy order in at $16 in the hope that investors would overreact to this failure and dump the stock on the "failure" headlines without reading further.

No such luck, though it did shoot down for a while in after hours trading. PDLI also released earnings yesterday, which included higher than expected costs but still reflected a reasonable financial position and some very good royalty streams, and the shares are relatively unchanged, though they're only a dollar above their 52-week low.

It was the royalty streams for Genentech's blockbuster drugs that first got me interested in PDLI -- they own the patent on the humanized monoclonal antibodies that enable Herceptin, Avastin and others, so I think that stream of income should only grow in the coming few years.

But the argument for PDLI growing significantly beyond what these royalty streams can do is that they have three solid compounds in clinical trials -- not including terlipressin, which was a bit of a long shot for what seems to be a nearly untreatable disease, and is really being developed by Orphan Therapeutics (PDLI just has US rights if the drug pans out). Terlipressin was the most advanced drug in the pipeline, but the more promising Nuvion and Ularitide are also well advanced in Phase II, and there are three other lower profile drugs in Phase II trials as well (Full clinical pipeline is here). The next year or two should show some really significant clinical results for PDLI, whether good or bad, and as we wait for those results we see them maintaining a solid revenue stream (over $100 million in sales this quarter, up 20%) that's growing quite well and helping to pay for these expensive clinical trials.

PDLI, EXEL and ISRG remain my favorite investments in health care right now, and I think PDLI is criminally cheap at the moment -- perhaps the kneejerk downgrade from First Albany will help to bring the price down a bit, I never thought I'd see 16 again and if I do I will be hard pressed to resist adding to my stake.

CV Therapeutics (CVTX), on the other hand, is just plain depressing. This is largely a one-trick-pony (OK, two tricks -- but neither one is really up to Cirque du Soleil standards). Their two lead drugs on the market are Ranexa and Aceon, and they have some other pipeline drugs that don't have anyone excited, along with Regadenoson, a promising new cardiac imaging agent.

But CVTX shares right now are really just an option on Ranexa, and the news has not yet been nearly as good as investors hoped. Shares dipped by about 10% this morning on dramatically higher costs, largely, I think, because those costs -- without enough offsetting sales increases -- clarify what is already known, that Aceon is not exactly flying out the door, and that CV's new sales force is having a really hard time selling much Ranexa so far.

Ranexa right now is approved on a pretty limited label, as more or less a last resort drug for angina. If you think that's as far as Ranexa will go, you've got no business buying CVTX.

But if you believe, as CV does, that they can get an expanded label for Ranexa and make this into one of the core drugs for chronic angina (which hasn't seen a new treatment in decades, and counts millions of sufferers anxious for relief), then the shares are dirt cheap right here.

So we wait for the FDA.

Ranexa is now in a follow up phase III clinical trial called MERLIN, which is aimed at proving safety and getting the FDA to expand the label. There has been no bad news out of the trial yet, and they recently got permission to move forward with continuing the trial (which means, at least, that the drug is not proving to be dramatically dangerous), but it's going to be the end of the year before we really know anything substantive. With the cautious FDA and a condition that isn't necessarily life threatening or untreatable, the bar is likely pretty high for CVTX to prove that Ranexa is safe.

I have no idea what will happen, and I remain conflicted on this holding -- whenever I think of the millions of people clamoring for new angina drugs to provide an option beyond beta blockers and the like, I get optimistic and think CV has a real chance and a big market opening up to them. Whenever I see the FDA being extra cautious, and the examples of that are legion but include Encysive's recent woes with Thelin, I think CV is going to run through hundreds of millions of dollars to get a "thumbs down" from the FDA, and investors will be left with a portfolio of small time drugs and no real hope of future profitability.

At this point, my shares have fallen so far on what was initially just a small position that it's not worth it to me to sell -- I'll take a chance and hold on to see what the future holds for Ranexa. But until there is news from MERLIN and the FDA, I'm resolved to not buy any more, no matter how cheap it looks.

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Buy on the dip -- PDL Biopharma (PDLI)

I haven't quite caught up on the busy goings-on in earnings land for all my companies over the past week of my absence (huge move up by ISRG, down by Chico's ... I'm getting a little seasick), but I did take a moment this morning to make a small purchase.

After seeing the PDL BioPharma (PDLI) earnings release, and noticing the dramatic decline in the stock price -- around 20% -- I couldn't resist adding on to my position.

PDLI I first bought about a year ago after noticing them named as back-end participants in what I thought would be a boom market for Genentech's Avastin and reading up on several good Motley Fool articles on the company. I wrote about my earlier purchases here and my feelings about the company remain the same. Their earnings weren't as strong as I or the market might have liked, and their increased R&D costs going forward (and the resultant short-term hit to earnings) are clearly what moved the stock down ... but their lead drug candidates are still doing well and they still have royalty claims on a host of exciting drugs including Avastin, Tysabri, and many more. The last big dip I caught was when the Tysabri problems hit, and that was clearly an overreaction since Tysabri will never be a huge part of PDLI's business. I'm hoping that this large dip is going to turn out to have been an overreaction as well.

In the long term, PDLI has a varied pipeline, a lot of royalties coming in, and, at least for now, a reduction in partnership research money that has the market concerned. Since that doesn't impact their sales of their current drugs, or the potential of their pipeline, I'm not all that concerned this year about whether PDLI is making a few cents a share or losing a bit ... it was nice that they broke even on a non-GAAP basis, but this is still an early stage biotech story that I plan to follow for a long time.

Today's purchase at $21 even moves my cost basis up a hair to $19.17 ... I wouldn't be surprised to see it dip further to the high teens, but I like this price.

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Biotech Bloodletting (VRTX, CVTX)

It's very odd to see the market react so angrily to earnings reports from two companies that we have always known are a long way from having actual positive earnings. With early stage biotechs like many of those in my portfolio, we're buying the hope of future drug performance or approvals .. not the current earnings.

CV Therapeutics (CVTX) and Vertex Pharmaceuticals are getting absolutely pummeled today after releasing their earnings updates last night. Since there was no significant news on either company's pipeline with those earnings releases, it's hard to see good reasons for these drops in share price ... but these are also two very different cases.

In the case of Vertex (VRTX), the company has been trading on the possible approval of it's Hepatitis C drug VX-950, which is still uncertain and is several years away. The market probably overreacted to the potential of this drug when the early clinical results were so spectacular last year, and I'm not surprised to see it dip 10% today ... with so many investors jumping on the momentum train and expecting miraculous announcements every time the company opens the PR gates, there was bound to be some disappointment as soon as it became clear to momentum investors that patience is necessary even with potential blockbuster drugs.

As I wrote a couple months ago when I lightened up my VRTX position, I was worried that the market had bit up the shares to a valuation level that really assumed we would see both of their most promising drugs become blockbusters in the next few years. I still think that's a possible outcome and am holding the majority of my shares, but it's far from certain. I'm not buying any more even though we're seeing some significant drops here, but I've seen no bad news on their pipeline and still expect this one to do very well in the long term.

CV Therapeutics is a very different story, one that's playing out painfully and slowly. Their valuation should be based on their lead drug Ranexa, which is the first new treatment in decades for angina, a huge market. They're also dropping nearly 10% today, and the shares have been weak for months.

It seems that investors are having trouble assessing the performance of Ranexa and Aceon, the drug that CVTX is copromiting with Solvay. We have to wait for results of the Merlin trial for label expansion for Ranexa -- expected at the end of the year (with possible preliminary results earlier) -- to see if the hope for Ranexa becoming a blockbuster-size drug will come through. So all that we have to work with now is the very slow rampup of Ranexa and Aceon sales ... I'm willing to be quite patient with this one, since I am not surprised to see that these two drugs that are new to US cardiologists are taking some time to get traction. I do see a significant amount of risk if the Merlin trial is not enough to convince the FDA that an expansion to treat first-line angina sufferers is in order, but given the lack of other alternative treatments and the lack of efficacy of some treatments for a large number of angina sufferers I'm fairly optimistic.

Ranexa is by no means the kind of blockbuster candidate that VX-950 is for Vertex -- the good performance relative to existing treatments is clear and the drug definitely has a place, but so far we've not seen that it's shockingly good or dramatically better than existing treatments.

So I'm still thinking of taking another nibble at CVTX if the market continues to beat up the shares and build in pessimism about Ranexa's performance ... as I wrote about three weeks ago when most of my biotechs were taking a beating, this might be a solid buying opportunity ... though I've never been able to pluck a falling knife at just the right point.

I'm happy to see that CV has ramped up Aceon to the level that they're finally getting royalty payments, which is a positive sign for the salesforce's presence in cardiologists' offices, and I think the shipments of Ranexa in the second quarter should show some significant improvement as the sales team continues to get some traction -- especially if preliminary results on Merlin continue to trickle in with positive news. Hopefully, the market's pessimism will really set in on Ranexa and bargains will appear ... we're getting close now, but I haven't yet bought more.

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Biotech opportunity?

If you're interested in picking up shares in any small biotech companies, today looks like a great day to get started. Most of them in my portfolio are dropping like stones, perhaps on overall market sentiment or perhaps as a reaction to the Merck verdict, or perhaps for other reasons that are less clear ... I obviously don't know, but there has been no truly substantive news out of these companies today to justify their decline.

All of my small biotechs -- Myriad Genetics (MYGN), Exelixis (EXEL), CV Therapeutics (CVTX), Vertex (VRTX) and PDL Biopharma (PDLI) -- are down at the moment.

The highflier is hardest hit, as VRTX is down more than 7% and may be worth buying again if it continues dropping (I sold a bit back at $38 because I was worried it was ahead of itself, but I still love the long term potential).

Exelixis and PDL remain my favorites in this bunch, and the ones least likely to give me angina -- PDLI has the most reliable foundation and the most compelling combination of pipeline and existing licenses, and EXEL the biggest upside as their early stage drugs worth their way through ... both are falling at about the same rate today and might be worth a few more dollars.

But speaking of angina, one company may both give it to me and treat it. CV Therapeutics is the one that I'm watching most closely today. It's the only one that I'm actually underwater right now, by just a percent or so, and it's also the one that is most dependent on a single drug. Ranexa is going to make or break this stock in the next year or so as it tries to build a position in the treament catalog for angina, and if you believe that the MERLIN trial will allow for an expanded label and that the CVTX salesforce will be able to drive some prescriptions for Ranexa (their performance with Aceon is not very compelling yet, but it's only been six months or so), then CVTX may be a bargain here. That's the feeling I'm tending toward, I'll be watching as the price continues to fall and reading up some more on Ranexa uptake as I try to make a decision in the near future.

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A few week-ending thoughts

It has been a pretty interesting week for me in the market. A couple things I'm thinking about:

As I wrote last night, Jack Byrne potentially leaving as chairman of Overstock (OSTK) worries me. I'd like to see more than just this Wall Street Journal article that quotes him as saying he'll "think about it", however ... will see if I can hold on for long enough to get a more definitive answer, or if I decide that it's just not worth it to watch OSTK decline.

I'm thinking about giving Irobot (IRBT) a chance. I've been critical of them and their products since their IPO, don't remember if that criticism was in this space or not, but now I'm thinking that perhaps they have something worth investigating. I think the Scooba is doomed to failure as a floor cleaning robot, and I still am very skeptical of the Roomba even though it certainly has a huge cohort of fans, but maybe I'm thinking of this the wrong way. I listened to the CEO on the radio and found his arguments fairly compelling -- the company is focused on practicality and cost effectiveness in robotics, which certainly makes sense. After all, the stuff on the Jetsons is almost all available to us right now ... if we're billionaires. It's IRBT who has brought the first significant robotic tool for a humdrum daily task into our homes at a reasonable price, so perhaps I shouuld look into it with a less jaundiced eye. I also am convinced that their military robots might show some real promise. Hopefully I'll have a chance to read up on the company in the near future.

CV Therapeutics (CVTX) has had a rough week after earnings -- their lost a little more than expected, which is not a huge cause for concern since they're transitioning to building a sales force, but analysts are sounding warning bells that Ranexa's uptake in the market may be slower than folks are expecting. If it's just "slow", then I might see an opportunity to add to my shares this year before Merlin results hopefully allow for an expanded label ... if it's "slow" because there are actual concerns about the drug in the marketplace among cardiologists that could be a cause for actual concern. We'll see.

And I'm wondering why Formfactor (FORM), a company that has had a huge run, is filing for a secondary share offering that could pull in about $200 million at today's share price. They've got about $5 a share in cash already as far as I can tell and no debt, and they've already completed a large new facility ... I'd hate to see them diluting our shares just because they know they can get a good price for them today, but if they have plans in mind for expansion or acquisitions I'd be interested to hear them.

And finally, it looks like I jumped too soon in taking a flier on my Intel options ... I was guessing that the bad news was out and it wasn't likely to get much worse for this gigantic workhorse trading at a bargain valuation ... but now they've warned that revenues will likely be lighter than estimates and the shares are falling again. I'm still holding a small position in January LEAPs at $20 at a fair loss right now, but on the whole I still think Intel has a good chance to recover in the next several months as folks gear up for the replacement cycle with Vista. So far, Intel's warnings haven't impacted anyone else, and my other semi companies -- WFR and FORM -- have not caught the cold that semi companies typically catch when Intel sneezes, which is good news.

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Annual Checkup -- CVTX

I haven't written much about CV Therapeutics (CVTX -- free RT quote), largely because I bought it on a newsletter recommendation and haven't become much of an expert on the science of this biotech company. The argument for CVTX that I found compelling was that they had a truly new treatment for chronic angina, an ailment that affects millions and that is currently treated with a cocktail of generic drugs that don't always work well for everyone. Their lead drug in that area, Ranexa, has completed phase III trials now and seems very likely to be approved -- and if current treatments continue to be lacking for many patients, they will find a good market, with possibilities for expanding into a blockbuster market in the future. I wrote a couple months ago that bad news for Beta Blockers might be good news for Ranexa, but that's just a wild guess. At the same time, CV's sales force has been built up over the last half of this year as they gear up to sell Aceon, which they licensed in from Solvay Pharmaceuticals, in the hypertension market. With several other late-stage compounds in development that seem to show real promise for other cardiovascular diseases, CVTX seems like a solid bet to have several important products on the market within the next few years. I expect there will be news probably early this year on approval for an expanded label for Ranexa, and approval for the new cardiac imaging agent Regadenoson, and their three other compounds in the clinic may supply some fodder for the news mill as well. If you're interested in more detail, Zacks recently published a long (pdf) analysis with their assessment of the potential of all the clinical compounds. I have a full position in CVTX that I acquired at an average cost of just about $21, so it has been a fine performer even if not as quick a mover as PDLI or VRTX ... but I expect good things over the next couple of years. I will hold on to see if Ranexa, in particular, can catch on quickly with cardiologists. I'll also try to monitor how Aceon is doing, because that will be the acid test for this new sales force before they bring their own compounds out of the clinic.

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Biotech earnings updates -- ISRG, MYGN, VRTX, CVTX

Lots of releases on my biotech companies yesterday and today, some great, some a little bit bad, most just the kind of non-news one often expects from an earnings release from a early stage biotech.

First, Intuitive Surgical -- some might not call this biotech as it's in the medical devices area, but I think of the whole next generation of health care companies as biotech so mabye I'm a bit broader than most. ISRG (get free real time quote from ADVFN) absolutely blew away estimates, again, and took off by 25%, again. In retrospect, of course, I wish I had bought some more yesterday while I was thinking about it ... but I still think my ideas had merit. It's true that their earnings are likely to be lumpy as long as sales of new robots is the major part of their earnings, but it so happened that these last two quarter have been really, really big lumps. My loss, I'll have to think about whether I'm willing to add to my position now at $90 -- this is really a bit of a crap shoot, long term I expect a lot of great growth so I should probably just buy, but short term I can't believe that this won't pull back at some point and give me a better price. We'll see which angel of my nature I follow this time.

Next, Myriad Genetics. They beat the analyst estimates by a bit, which isn't quite as dramatic for them as it is for ISRG since their earnings growth isn't necessarily what everyone's looking for just now -- and it didn't move the share price at all. MYGN's (get free real time quote from ADVFN) earnings from testing services did grow substantially more than predicted, which is great, and I think this part of their business is perhaps a little bit underestimated. But what we're all waiting for are their drugs -- and not even necessarily their top-line drug, the Flurizan for alzheimer's that is their farthest along. The news from that particular drug has been particularly so-so all along, as it is for most Alzheimer's compounds, so it seems likely that actual approval or solid sales would be a good lift for the company. But what we're really waiting on are their early stage drugs -- they show promise, but no news of significance just now so we'll just sit and wait and watch the testing business grow to soak up those drug development costs.

And finally, Vertex and CV Therapeutics.

CV Therapeutics had some surprisingly bad news yesterday in that they need to pull back one of their new drug candidates in Europe for additional research. That definitely hurt the shares, much more than any news about marginally bad losses in the balance sheet. No particular news on ACEON yet, which is what I was hoping to see, just that in their brief selling window before the end of the quarter they didnt' reach the milestones that require royalty payments yet. The real bad news was on ronalizine (Ranexa), which was rejected by European regulators and which will require another trial and resubmission. This sends a message that perhaps this flagship drug will have some trouble and require additional trials in the US as well given the current FDA climate ... so the stock tumbled a bit. CVTX needs Ranexa, but there is no reason that I've seen to suggest that it might not be approved -- hopefully it will just take a little longer, I'll definitely be keeping an eye on this one. According to an AP story, "CV said it plans to conduct one or more additional trials in order to satisfy regulators, but said it does not expect a large or lengthy trial to be necessary."

And Vertex is plugging right along -- they had a big charge this quarter which may have spooked a few folks, but that should have been expected from the retirement of convertible debt. The big news for VRTX (get free real time quote from ADVFN) will be the progress of their clinical trials, and on that front they appear to be on track. The CEO reiterated that they remain on schedule, and that phase 1b for VX-950 is underway and phase II shoudl begin in the fourth quarter, and phase II for VX-702 is fully enrolled. Those are the two real flagships of the pipeline, so good news that there are no announced hiccups just yet. New is going to come hot and heavy from Vertex over the coming year, so I expect lots of volatility -- hopefully much of the news will be good from their trials and reinforce everyone's hopes that VX-950, at least, might reach blockbuster status and be the first actual cure for HCV. After many years of disappointment Vertex really seems to have a few possibly hits on their hands -- let's hope it remains that way.

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Ranexa's competition weakened? (CVTX)

There was a bit of news out yesterday from a JAMA-published study that leads me to think the road to riches for CV Therapeutics may have been slightly smoothed.

CV Therapeutics has a drug called Ranexa that's in the midst of phase 3 trials for chronic angina, and CVTX is hoping for label expansion to treat other kinds of heart disease. One of the major treatments for these heart problems today is a class of drug called Beta Blockers, which are widely available in many generic forms.

Now, word comes that Beta Blockers may be dangerous for some people with specific genetic makeups -- and not just a small number, but a large class of people -- possibly up to a million people a year who are hospitalized for minor heart attacks.

Here's a quote from one of the doctors involved in the study, by way of a Bloomberg article: ``Some people are genetically predisposed to benefit from beta-blocker therapy, and others are unlikely to receive benefit and might even be harmed by these commonly used drugs,'' said Howard McLeod, a professor of medicine at Washington University School of Medicine in St. Louis who was involved in the study, in a telephone interview today.

That adds to the need to approve and get to market an alternative treatment for those people, of which Ranexa may be one, so it possibly means approval might be easier to come by since there is a weakness in the currently available treatment, and it also increases the market for such a drug (not that there was a need to increase the market for chronic angina drugs for this to succeed, demographics are doing that for us).

Now, this may not make a real difference, but I haven't seen other folks mention it's possible significance for CVTX so I thought I'd put it out there. If I'm misinterpreting, I hope someone will correct me.

And as an aside, the other finding from this study is that genetic testing can be of significant therapeutic benefit in determining which treatment(s) will be effective for some diseases for particular individuals, or may even be lifesaving on an everyday treatment basis. Because there are genetic markers that determine whether or not beta blockers will help or hurt a patient, it's quite likely that testing for those markers could become a signficant business. Who might make those tests? Way too early to tell, or at least I haven't heard an answer, but why not Myriad Genetics (MYGN), another of my portfolio companies and the market leader in lots of different genetic tests. Something to think about.

Not sure if this news warrants considering an additional purchase of CV Therapeutics once I've got the funding available ... but maybe. I was already pleased with the potential for Ranexa to make significant inroads as a new treatment option for various heart ailments in the years to come, and the fact that new weaknesses have been identified in some of the existing treatments might tip the scale a little more in their favor. As always, take my opinion with a grain of salt, I have no more capacity to comprehend medical or genetic testing than the next guy.

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