Last week, with the winter flu season nearly upon us, we checked in on what has been happening in the Avian Flu MegaShift. This week, I continue on a similar track with an update on the big picture for the Biotech MegaShift, because from a seasonal perspective, autumn is typically the best time of year for biotech stocks. But before we dive into this sector, I want to lead off with a potential repurchase in the Content on Demand MegaShift.
BRSTing Apple’s Bubble
No, I’m not talking about the backdated stock option chickens that are about to come home to roost. As you know, the biggest reason that we don’t own Apple is because I think Steve Jobs will be indicted in the Apple and Pixar backdating scandals. This week, Apple lost two rounds. Steve was subpoenaed by the SEC in their civil case against Apple’s former general counsel, Nancy Heinen. It’s a very good idea to tell the truth to the SEC when under oath, as Martha Stewart found out, and in this case, the truth is that Steve knew about the backdating, understood the accounting implications and profited from it. As the only CEO of two companies on the SEC’s bad boys list, it’s hard to believe that he is going to walk, no matter how many strings Senator Feinstein pulls. The second round was the Boston Retirement Board winning some access to Apple board meeting minutes about backdating. They had to sue in California Superior Court to get it — after all, they are only the shareholders who own the company.
However, the judge denied the heart of the retirement board’s suit: Access to documents related to Apple’s internal investigation into the backdating fiasco, led by Al Gore. And any documents that Apple hands over can’t be disclosed to anyone else. The judge’s order will be issued tomorrow.
Apple’s more immediate problem, though, is their lawsuit against Burst.com (BRST on the pink sheets). Burst is now a three-person company after spending 20 years and over $66 million with 100 employees developing and patenting ways to send digital audio and video over networks. They own a moat of patents covering delivery of video over the Internet. Microsoft tried to get around them, but couldn’t, and after numerous nasty tricks that nearly broke the company, Microsoft finally paid BRST $60 million for a license. Apple’s iTunes video downloads violate many of the BRST patents, but they assumed Microsoft would wipe Burst out when they started using the technology. Yet, instead of following Microsoft and settling, Apple sued to have the patents declared invalid. A big mistake, in my opinion, but not in the opinion of The New York Times, which published an article last Thursday that knocked BRST down to $1.40 for a split minute.
We originally bought BRST at $1 on September 7, 2006, and sold it for a 105% gain on June 28, 2007. I really didn’t expect to see it under $1.50 ever again. But the Times story reported on Apple’s lawyers filing a motion to have Burst’s countersuit thrown out and their patents invalidated as not novel, obvious, and having nothing to do with iTunes or QuickTime. The Times slant was this is just another little company trying to hold up a big company for ransom based on flakey patents, and the big company is about to cream them. The reporter included some pretty caustic comments from Apple’s counsel. It read like an Apple public relations release.
That’s just about 100% wrong. Microsoft gives away the technology that they stole from Burst and later licensed it for $60 million. Apple sells it, and Burst calculates their damages, based on over three billion iTunes downloads, at around $500 million. And Burst has been winning the battle with Apple so far. In patent lawsuits, there is a step called the “Markman claims construction ruling” that determines what the actual words in the patent do or don’t mean. Burst won more than 90% of the Markman issues, and the judge who issued that ruling was actually surprised when Apple moved to dismiss the suit, which The New York Times didn’t mention.
I still think that Burst.com is going to win the patent lawsuit with Apple, most likely in a very large out-of-court settlement. The reason I label this a “potential” repurchase is that I only want you to buy BRST if you get another chance under $1.50. My target this time is $3, because I think the settlement will be larger than I previously estimated. If you want to read the original recommendation, it is here.
Biotech MegaShift Update
With the equinox just behind us, this is a timely update because fall is the best time of year for biotech stocks. Over the last 20 years, the AMEX Biotech Index (BTK) has compounded at 16% per year, and 80% of the gains come in the fall. Nineteen out of 20 years, the BTK rose in the last half of the year. The numbers are similar for the NASDAQ Biotech Index (NBI), which was up five of the last six years for the September to November three-month period, averaging a 9% gain. Biotech also did pretty well during the credit-related chaos this summer, which provides a good base for the usual yearend strength.
Why do biotech stocks go up about now? There are so many annual medical society meetings and biotech brokerage firm conferences between now and January that it sometimes seems like companies time their clinical trials to conclude in time to have data ready for the fourth quarter. We’ll also see FDA filings before yearend, so companies have something to brag about in their shareholder letters. There also used to be a real push by the FDA to get drugs approved by the end of the year, if only to show Congress that they were doing something and deserved a bigger budget. But the jury is still out on whether the FDA is any more effective after the last few years of leaderless paralysis. Last year’s crop of yearend filings is supposed to get reviewed in 10 months, and that’s another reason for the cluster of regulatory decisions that should be coming soon.
But with only a couple of exceptions, we don’t need the FDA to do anything other than keep their special protocol agreements. What we are looking for is clinical trial or marketplace results. Here’s our stock-by-stock outlook for our Biotech and Avian Flu holdings:
Affymetrix (AFFX) has successfully launched the SNP Array 6.0 DNA chip reader, and it is regaining market share from Illumina. I also expect to see a settlement of their patent lawsuit against Illumina by the end of the year, giving Affymetrix 12% to 15% royalties on Illumina’s sales of the infringing technology. I have raised the buy limit on AFFX $1 to $27, while keeping my target at $40 for now. Buy AFFX.
Amgen (AMGN) said this week that they will cut more than 1,000 jobs at their California headquarters and Rhode Island manufacturing plant, starting to fulfill their promise to shareholders to slash costs to offset possible lower sales of Epogen and Aranesp due to the recent reimbursement changes by Medicare. That’s 5% of the company, and they plan to cut another 1,800 jobs over the next year. They’ll also cut capital spending by $1.9 billion, trim R&D projects and close one of the two Rhode Island plants.
Stocks normally go up when companies cut costs, and there is lots of room for Wall Street to turn positive on Amgen based on how management is protecting the bottom line. Right now, though, Wall Street is neutral on the stock, with only one buy recommendation since mid-March. Next February’s day-long meeting in New York to go through the entire clinical pipeline in detail is going to be a seminal event for AMGN, and I expect many analysts to get ahead of it by putting out buy recommendations between now and the end of the year.
The patent trial against Roche is underway, and we should have a decision by the end of the year. This looks like an easy win for Amgen, and it is going to cost Roche a bundle to settle now, compared with what they would have had to pay before the trial began.
Amgen will earn about $4.20 a share this year, and grow that 12% to $4.70 in 2008, even though revenues will flatten for one year to absorb the Medicare changes. As I’ve said before, if Medicare reverses itself before the blood banks run dry, Amgen’s stock will rocket higher. But I am not counting on that to get it to $95 by January 2009 — we just need a number of Amgen’s drugs currently in trials to advance towards approval. Buy the Amgen January 2009 $70 LEAP call (VAMAN) all the way up to $12.50, for a $25 target price when AMGN stock hits $95, on or before the LEAPs expire.
BioCryst (BCRX) is still looking for a bottom after last week’s clinical disappointment, and they may have found it this morning at $7.24. The lack of Phase II statistical significance for the intramuscular injection of peramivir for seasonal flu, which I covered last week, is a setback for that program. They may have a way out if their 40-person test of injections using a longer needle works out, with results due by the end of the year, but my main interest is intravenous (IV) peramivir for patients hospitalized with avian flu. If that Phase II trial works, as I expect, peramivir will go on the government stockpile purchase list right away, and it would be years before peramivir for seasonal flu would get through its Phase III trials. The stock had a dramatic decline even though it was the far-off program that ran into problems, while the IV peramivir program that will pay off near-term is still on course.
Fodosine for T-cell and cutaneous T-cell leukemia, plus BCX-4208 for transplantation and autoimmune diseases, are also worth $5 to $10 a share. So, we are getting peramivir for avian flu free, even if the seasonal flu indication never pans out. I think BioCryst will book $500 million to $700 million in government stockpile sales by 2010. Buy BCRX up to $13 for a $30 target.
CombinatoRx (CRXX) will have Phase II results for one drug by the end of the year, and just yesterday they started a Phase II trial for CRx-102 in osteoarthritis of the knee. The company will put three more drugs into Phase II trials in the December quarter. The news releases alone should move the stock up. I really like the broad pipeline and high level of clinical activity in a company that spends only $100 million a year on R&D. I want you to buy CRXX under $7.50 for a $16 target this time next year, when they will have results from several of the new Phase II trials and should be announcing partners for Phase III trials.
Crucell (CRXL) had a bit of a bumpy week, when Merck announced that they were discontinuing their HIV study that is produced by CRXL’s PER.C6 technology. This is silly and I was glad to see the stock bounce back after stating that the discontinuation of the study is not in any way related to the safety or efficacy of their technology. Crucell also reaffirmed their revenue outlook for the year — $310.2 million to $317.3 million. I agree, as CRXL will see rapidly accelerating revenues in the September and December quarter as the flu vaccine season gets underway. CRXL is an excellent buy at these levels and up to $28 for my $50 target.
Dendreon (DNDN) could announce a European partnership any time, or they might wait until after the interim peek at the data next year. They will do one or two data presentations between now and then, but I expect the stock to be quiet until a partnership or the peek results are announced. Buy DNDN under $8 for my $40 target after Provenge is approved.
eResearch (ERES) should beat $25 million in sales in the September quarter and then guide for around $28 million in the December period, as revenues finally start accelerating to match the growth in the backlog of cardiac study contracts. I would like to see more than $30 million in orders for the September quarter. The stock has built a steady up-and-to-the-right chart since last November’s plunge under $6, and nearly doubled since then. But there is still a long, long way to go with the dominant company in outsourced cardiac safety testing for FDA clinical trials. ERES is a Top Buy up to $16 for a $30 target.
Geron (GERN) has been in a $6 to $9 range for a year, perhaps showing the impact of Federal policy on embryonic stem cell research. However, no matter which party wins the 2008 election, the bans are likely to be loosened or eliminated. Companies like Geron need independent validation of their work by academics, who in turn are funded by National Institutes of Health grants. Today, these academics write grant applications for non-embryonic stem cell research, even though many of them don’t believe their research will be useful. As Tom Okarma, CEO of Geron, says: “An enormous amount of scientific damage has been done. I assume whoever is elected will change the policy.”
I don’t assume anything, since President Clinton signed this ban into law. But I expect that the candidates will have to take a stand, and if it is Giuliani against Clinton, both will tend to lean towards reviewing or changing the policy.
In the meantime, Geron is spending millions of its own money on stem cell research, and announced in August that animal studies showed transplanted human embryonic stem cells improved heart function after a heart attack. Their showcase program is an embryonic stem cell drug to repair spinal cord damage for the 11,000 people a year that suffer these injuries — the same one that killed Superman. They need FDA approval to start a Phase I trial. GERN is a buy up to $9 for a run to my $18 target after the next major news story.
Isolagen (ILE) will have clinical trial results by the end of the year for the wrinkles and creases study. Most of Wall Street doesn’t expect successful results from the trial, but I think that they are underestimating what the company’s new management team is capable of doing. And any positive news from the trial will push the shares higher. Buy ILE under $4.50 for a $9 first target.
Millennium Pharmaceuticals (MLNM) will present efficacy data from their Phase III study of Velcade as front-line therapy for multiple myeloma at the American Society of Hematology meeting in December. If you recall, this 682-patient study was stopped early because the drug worked so well. If the numbers look better than Celgene’s Revlimid, MLNM will shoot up. In any case, Millennium will file for the label expansion in the first quarter of 2008. The company is now a prime takeover candidate for any one of several big pharmas. Buy MLNM while it is under $12 for my $23 target.
QLT (QLTI) should see some presentations of doctor-sponsored trial results of using Visudyne in combination with Lucentis or other new macular degeneration drugs before the end of the year. I still believe combination therapy is the answer to this crippling disease. Buy QLTI on any dips under $8 for my $16 target.
Rochester Medical (ROCM) could settle with Covidien any day, which will send the stock soaring. I also think that the September quarter will be pretty good, beating the lone estimate out there for seven cents a share. ROCM is a Top Buy based on the possibility of a potential settlement with COV. The buy limit is all the way up at $23 for my $40 target.
Sequenom (SQNM) is our second investment in gene chips, behind Affymetrix. The stock has run up since I recommended it — we currently have a 52% gain. Yesterday, they announced a new assay design and validation service, and they have more new services and modules to announce over the next few months. The news popped the stock almost a buck today, or 15%. It probably would take a couple of scary days in the market to break it back down. I am raising the buy limit to $5 just in case you missed getting in the first time around — it closed at $6.89 today — but I’m keeping the target price at $8 for now.
SXC Health Solutions (SXCI) is extremely cheap, considering that they are one of the key players in keeping down healthcare costs through efficient pharmacy benefit management. I expect major new contract announcements before the end of the year. Buy SXCI under $23 for a move up to $30 by the end of 2007 and my target of $46 by the end of 2008.
ViroPharma (VPHM) is down due to their problems with transient liver side effects in their HCV-796 hepatitis C study partnered with Wyeth. But we own this stock for the management team, which has an opportunity to take the cash flow from Vancocin and buy or in-license another major drug. That announcement could come any day. I want you to buy VPHM on dips under $12 for my $25 target.
China MegaShift
All right, someone has to say it: China is in a bubble stock market similar to the Internet bubble, and it is going to end the same way. I really don’t know if this is equivalent to the beginning of 1999, which means Chinese stocks can go from overpriced to ridiculous, or the end of 1999, which means we are already at ridiculous. Yes, I know they are growing GDP 10% a year, and the government will pull out all the stops to make the 2008 Beijing Olympics a flawless coming-out party. I know that they have more cell phone users than the U.S., more Internet users than the U.S., and a middle class developing like the U.S. in the 1920s and 1930s. But you may remember that there was a little decline in our stock market at the end of the 1920s, and I fear the same is coming in China.
Here’s the problem: Since the beginning of 2006, the Shanghai index is up 400%. This summer, when the U.S. market crumbled, Shanghai went up. This was widely regarded as a good thing and a sign of incredible strength. But the buyers are first-time investors who have never seen a bear market, and they really don’t have a concept of stocks going down and staying down. They have absolutely no experience with that. They don’t sell short, and they don’t buy puts for protection. They never heard of a crash that lasts more than a day. They think that stocks only go up, and one is stupid not to open a brokerage account and buy stocks. And until August 20, it was illegal for them to invest outside of China.
On August 20, the Chinese government started trying to relieve the pressure of money flowing into the Shanghai Stock Exchange by letting mainland investors buy Hong Kong listed stocks, which sell for about a third of the P/E ratio. Bulls on China think that means you just have to buy Hong Kong and wait for the tide of money to lift all the boats. But the Hong Kong Hang Seng index was up 30% in the month after the announcement. It’s already been discounted.
Unfortunately, it is the institutions that are running Hong Kong up, planning to dump their stock on the mainland newcomers. At this week’s Interest Rate Observer Conference, a speaker from Shanghai Shenyin Wanguo Research and Consulting, an institutional research firm, said that Chinese stocks are not in a bubble because they are only trading at 35X next year’s estimated earnings (43X current year estimates). He thought that was cheap for 10% to 15% revenue growth and 15% to 22% earnings growth.
So, there is an obvious risk that Shanghai stocks will start declining as money switches to Hong Kong, institutional traders sell and individual investors learn to their sorrow that some stocks go down and never come back. This week, China Construction Bank went public on the Shanghai Stock Exchange. The stock went up more than 30% the first day. Investors were so disappointed that it didn’t pop at least 50% that they knocked down the Hong Kong-listed shares 7%.
There are honest companies in China, but most of the state-owned enterprises and virtually all of the banks are not among them. Their accounting standards are not up to Western standards, and I am sure that a lot of the numbers being reported are fraudulent. Every bank is bankrupt under Western loan loss reserve standards, and the coming financial crisis will make the U.S. savings and loan mess look like kid stuff. For some reason that I will never understand, many of the big Wall Street China funds invest heavily in these state-owned enterprises. They are going to get clobbered in the downturn. Remember that about a third of the prices in China are still set by the Communist party, so “capitalism” always needs to be in quotes. This system probably won’t blow apart next week, and maybe they can keep it glued together through the Olympics, but some bad stuff is coming.
Will U.S.-listed Chinese companies with American auditors weather this storm? Yes, the companies will. And their stocks should do relatively well, falling maybe 30% while the averages fall 50% to 70% and the real junk goes down 90% to 100%. But you can’t eat relative performance, so we are going to stay out of this MegaShift for now, except for holding UTStarcom (UTSI) for as long as the bubble keeps inflating. We’ll let that market tell us when the game is over, and then we’ll exit UTSI.
Content on Demand MegaShift
Akamai Technologies (AKAM) has been under a bit of pressure since another newsletter recommended selling the stock due to the “pricing war” in content delivery. Prices per byte are coming down, but volume is exploding as video takes over Internet sales and marketing. I think the price declines are already factored in the stock, but the volume explosion is not. This sell-off gives you one last chance to grab AKAM under $30 for my $60 target — don’t miss this gift!
Motorola (MOT) has a new hit phone at last, the Razr2. Retailer polls already show strong sales of the phone, which was released in July, and the current $249 to $299 price will be cut to $199 for the holidays. MOT should ship well over two million phones in the December quarter. Buy the Motorola January 2009 $17.50 LEAP calls (VMAAW) while they are under $4 for a $10.50 target ($28 minus $17.50) in January 2009.
Market Outlook
Yesterday’s Associated Press headline said it all about this market: “Durable Goods Orders Plummet.” According to the first paragraph, durable goods orders fell 4.9% in August, the biggest drop since January. It was not until the 10th paragraph that I found the number I was looking for: Durable goods orders ex-transportation. That was down only 1.8%. You see, the extremely volatile transportation component is dominated by orders for Boeing jets, which dropped 41% in the month. Unless you own Boeing, the transportation component just doesn’t matter. But the mood out there is to provide the glass-half-empty perspective on every number that comes along, and try to scare you about a coming recession. Even before getting to the ex-transportation number, paragraph eight said: “Some put the chance of a recession as high as 50-50.”
Well, I think “some” have put the chances of a recession at 50-50 every month for the last two years. I’m not sure what that comment adds to our store of knowledge, but it’s an irresistible sound bite. When it comes to recessions, there are two really good predictors: The S&P 500 and the Economic Cycle Research Institute (ECRI). The S&P is within 2% of its all-time high. The Weekly Leading Index (WLI) growth rate from ECRI shows a soft patch for growth, but no recession. It fell from over 6% growth in June to under 1% in early September, but stabilized as it became obvious that the Fed would act. The ECRI said: “Following a plunge in August, WLI growth stabilized in early September, even before this week’s rate cuts. Thus, a slowdown in economic growth is clearly in sight, but not a recession.”
Also, one of the best concurrent indicators of real global economic activity is the Baltic Dry Index, which is the price paid to move freight on ships. It is skyrocketing to all-time highs, showing the intense demand for space to move goods.
But over 67% of Americans think that we are on the verge of or in a recession, according to a new Wall Street Journal/NBC News poll. Combine that with the scare stories about October crashes that are all around, and one wonders how the S&P can be so high.
And that is the point.
If the market is doing this well when fear is abundant, what happens when the fears go away? The S&P has been consolidating just under the 1528 to 1534 breakdown range for a few days. The most likely course over the next few weeks is a drifty consolidation between 1500 and the 1555 high, as we work our way through earnings reporting season. Then the Fed meets again on October 30 and 31, and either it’s clear that the credit markets have unlocked, so they declare victory, or they cut rates another half point (50 basis points) to set the economy up for a strong holiday season. Either way, the S&P should move up 100 to 250 points by yearend, followed by another 100 to 250 points in the March quarter. That’s a bull market, and we are well positioned for it.
Dollar Death Watch
This morning, the dollar reached yet another low against the euro, after six straight trading days of looking for a new bottom. I suspect it will stabilize for a few weeks around $1.40 to $1.42, and then plunge again as the October 31 Fed rate cut announcement approaches. Remember that a falling dollar is good for U.S. stocks, so this should be another force igniting the next upleg. Also remember to get out of bonds and keep your cash in yen or euros at EverBank, or hedge yourself with the new Philadelphia Stock Exchange World Currency Options.



