Biotech: Get in at the beginning of the next big bubble

By MoneyWeek Editor John Stepek Feb 05, 2010

John Stepek

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John Mauldin, the US investment adviser and pundit, is hardly what you'd call bullish. Like us, Mauldin expects tough times ahead for the global economy, involving a double-dip recession and huge problems dealing with government debt.

But for all the potential bad news ahead, there is one asset class he's very interested in. In fact, last month he announced that he's started buying stocks in this sector and plans to keep adding to his holdings "at least every quarter for several years".

So what's he buying? Some defensive combination of gold majors, tobacconists and tinned goods manufacturers? Far from it. Mauldin is investing in biotech, arguably one of the most speculative investment areas this side of junior mining stocks. And he's buying now because he wants to be well-invested in the sector by the time the bubble he expects to arrive one day has inflated there. "I have lived through a number of bubbles. I have never gotten to invest in one. This time, dear God, just once please let me be at the beginning of a bubble."

What is biotechnology?

The word "biotechnology" encompasses several scientific fields, including agriculture and some forms of alternative energy. But often when people talk about biotech, they're referring to its medical uses. And the medical biotech sector certainly has everything you need to create a bubble. For one thing, few sectors have better fundamentals than the healthcare industry. Everyone gets ill. Everybody wants to live for longer, and to be healthier. And the fact is that only wealthy populations live long enough to die in great numbers from the sorts of diseases and conditions, such as cancer, that only biotech-based medicine holds the promise of cures for.

It's exciting too. It holds the same golden combination of the promise of life-changing potential with a sort of science-fiction wizardry, as the internet did. Who wouldn't want to invest in a firm with a cure for lung cancer or a method of regrowing your heart walls? It's the chance to do some good and to make a lot of money in the process.

Of course, a sexy story and sound long-term fundamentals are one thing. Fulfilling that potential is another. Since the last big biotech boom ended in 2000, alongside the popping of the tech bubble, the sector hasn't realised its potential either in terms of investor returns, or for those hoping for the raft of miracle cures promised at the millennium. And for the really 'blue-sky' treatments that Mauldin is interested in, such as stem-cell therapy, we could be waiting a while before we see widespread commercial applications.

But even if you exclude the potential for bubble-blowing in the sector, there are several good reasons to expect 2010 to be a good year for biotech.

Big pharma's pipeline squeeze

Big pharma companies are running out of drugs – and out of time. The main players face a 'patent cliff' in 2011, says Andy Smith, manager of the Axa Framlington Biotech Fund. AstraZeneca, for example, could see drugs that account for around 38% of sales coming off patent by 2012. When that happens, generic rivals swoop in with their cheap copycat products and sales fall hard. And the trouble is, most big pharma companies don't have the new products to replace these old blockbusters. As Smith puts it, their research pipelines are being "squeezed at both ends".

So where are they going to get their new drugs from? Well, they won't be filling the gaps internally. Again looking at AstraZeneca, at its latest results, the group plans to cut a further 8,000 jobs. About 3,500 of them will be in research and design. Anders Ekblom, executive vice-president of drug development, said the group wants to create "healthy tension" between in-house and external researchers. As Jeanne Whalen and Sten Stovall put it in The Wall Street Journal, "this fits a trend in the industry: growing pressure on internal research and development staff to justify their existence as companies increasingly look to outside biotechnology firms and academic groups for new experimental drugs to buy and develop."

The good news for big pharma is that it might be short of ideas, but it's not short of cash. As James Burns, head of investment trusts at Smith & Williams says, these firms "have very strong balance sheets and huge cash positions with which to make acquisitions… and solve the problems they are facing".

And the companies that are best placed to provide these new products are biotechs. These firms have in some cases been working for up to 30 years to create new treatments. Many are now at the stage where they can provide the pharma sector with the new products it needs. The economic woes of the past 18 months have seen consolidation between the big players in the health sector rather than big spending on small biotechs. But with time against them, the impetus to look at buying in products is greater than ever before.

Obama's healthcare reforms

This isn't the only reason to expect more mergers and acquisitions activity in the sector. The healthcare sector in general was overshadowed by one thing in 2009: the threat of serious reform to the US healthcare system. When first proposed, says Smith, it looked like the new rules could cost around $1trn across the entire sector. A year later, and for better or for worse (we're not going to delve into that particular can of worms here), those reforms have been seriously damaged by Obama's 'shock' loss of Massachusetts to the Republicans. As Smith puts it, "reform is not dead, but it's on life support. Whatever's going to be taken out of the sector, it will be less than $1trn."

In any case, healthcare reform was always more of an issue for big pharma than for the biotech industry. But that hasn't stopped it from hanging over share prices. Uncertainty has a habit of paralysing activity. If big pharma is scared of higher costs or new regulations dictating the types of drugs it can make, that's one reason not to go on an acquisition spree. It also makes it harder to work out what value to put on a company, says Smith. With this uncertainty lifting, the path should be clearer for increased activity in the sector.

New life at the FDA

Another boost for the healthcare sector in general this year could be a recruitment drive at the US health regulator, the Food and Drug Administration (FDA). Of all the world's health regulators, the FDA is the most important – it holds all the key hoops that any new drug or treatment has to jump through. But as well as becoming more demanding In recent years (not necessarily a bad thing), the FDA has also "historically been chronically understaffed", says Burns, which has slowed up the approval process.

But with the appointment of a new FDA commissioner, Margaret Hamburg, this could change. For one thing, she is expected to be more keen to drive through new drugs. It will also be easier for her politically, because she's been picked by the Democrats. Moreover, the FDA is also likely to get a big budget increase for next year.

As the Los Angeles Times puts it, the agency is "a screaming exception to the Obama administration's freeze on discretionary spending in the 2011 budget. Overall, the FDA budget could grow by as much as 23% to just over $4bn from the current $3.3bn". The budget has already grown by 78% since 2008. "The increased spending would allow the FDA to add 1,200 jobs, expanding its workforce by 10%." Part of the reason for the big hike is precisely so the FDA can keep up. "Today, the FDA is relying on 20th-century regulatory science to evaluate 21st-century medical products," warns the regulator.

Biotech is historically cheap

As Burns says, "the major, profitable biotech companies are now trading at historically low valuations, and are as cheap as they have been since 1991". The p/e of the sector recently fell below that of the S&P 500 as a whole for the first time ever, reports The Wall Street Journal. Moreover, most big investors are ignoring the sector. "Virtually all generalist investors are underweight the sector, so any change in sentiment could have a dramatic impact."

Of course, just because a sector is cheap doesn't mean it can't get cheaper. However, as noted above, valuations in the biotech sector are underpinned by the potential for mergers and acquisitions. After all, if stocks are cheap it's all the more reason for desperate big pharmas to try to pick them up at inexpensive levels before investors get interested in the sector again. That in turn could be a catalyst for the stocks to be rated higher by investors.

So what should you be buying now? We take a look at the stocks and funds that are set to profit from both big pharmas' pipeline problems and from growing interest in the biotech sector below.

The best bets in biotech

So what stocks should you buy to profit from big pharma's woes? The problem with trying to predict which stocks are mergers and acquisitions targets is that you're as likely to get it wrong as you are to get it right. So you are better not to buy stocks simply on the basis that they may be taken over at some point. In terms of getting broad exposure to rising investor interest in the biotech sector, you'd be better off buying an investment trust, or even an exchange-traded fund, in the sector. James Burns of Smith & Williams likes the Biotech Growth Trust (LSE: BIOG). Biotech Growth trades at a discount to its net asset value of 8%. Given the board has a target of trying to ensure the discount doesn't widen beyond 6%, as Burns says, now "would seem an attractive entry level for new investors". The portfolio is currently split between 40% in major biotech stocks and 60% in smaller ones.

Another safer bet than individual biotech stocks is to look for the 'picks-and-shovels' companies that will help biotechs and big pharma firms to get products past the FDA (the US regulator) and thus replenish their pipelines more rapidly. Pharmaceutical Product Development (NASDAQ: PPDI) is a good example. The company is a clinical research organisation. It specialises in helping drug companies – from giants like Pfizer to small biotechs – to get over the various hurdles involved in bringing a product to market, including the various phases of clinical studies undertaken and the regulatory approval process.

The stock trades on a forward p/e of 18, and has a dividend yield of 2.6%. It's not a huge yield, but as Matt Koppenheffer points out on Motley Fool, it has room to grow. "To date, the company's payout ratio has been kept relatively low, at 35%, which provides security and gives the company extra room to raise the dividend in the future. Meanwhile, the company's balance sheet is a thing of beauty, with nearly $600m in cash and no debt."

Within the sector, Forest Labs (NYSE: FRX) is "a great core holding with lots of upside", reckons Jon Stephenson, research analyst for Summer Street Research. Forest is a big pharma group. But unlike most of its peers, Forest is already focused on using external researchers to do the hard work of drug discovery for it, says Jay Palmer in Barron's. "Forest doesn't employ thousands of in-house research scientists... instead [it] lets smaller biotech and medical-research firms come up with the drug and do the initial testing; it then swoops in with an offer to buy, or more often license, the promising ones."

Like most big drug groups, the group has problems with patent expiry. Its best-selling drug, anti-depressant Lexapro, loses protection in 2012. However, it also has a decent pipeline, says Palmer. Seven drugs are in Phase III (late-stage) clinical trials, including a powerful antibiotic and treatments for schizophrenia and diabetes. And as Palmer puts it, "the stock is strikingly cheap". It's on a p/e of 8.7, a big discount to the rest of the sector, and it also has an extensive cash war chest with which to buy or license more new drugs. Stephenson has a price target of $43 a share on the stock. Then there's the market for 'biosimilars'. These are basically the equivalent of 'generic' drugs for biopharmaceuticals – in other words, they are copycat treatments that can be made once existing ones fall out of patent. But there are some key differences. For one thing, biosimilars are harder and more costly to manufacture, simply because biopharmaceuticals themselves are more complicated drugs. But more importantly, says Joseph Kreuger on SeekingAlpha.com, is that they "fall under new patent protection, effectively extending the exclusivity of the old drug it is replacing".

In other words, when companies are facing patent expiries on biopharmaceuticals, one good option would be to manufacture a biosimilar drug to allow them to maintain their hold on the market. One stock to buy to take advantage of this, suggests Kreuger, is PROLOR Biotech (OTC: PBTH). The company uses its patented technology to create longer-lasting and more effective versions of existing biopharmaceuticals. Given that its technology could potentially be used to extend the life of products with a current market value of around $5bn, Kreuger reckons the stock is a very obvious takeover target. Be aware that the company is traded over-the-counter in America, so you'll need a broker who can trade these stocks – TD Waterhouse is one that does.

This article was originally published in MoneyWeek magazine issue number 472 on 05 February 2010, and was available exclusively to magazine subscribers. To read more articles like this, ensure you don't miss a thing, and get instant access to all our premium content, subscribe to MoneyWeek magazine now and get your first three issues free.

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  • 1. Paul

    (05 March 2010, 12:39PM)  Complain about this comment

    The main reason why innovation comes from (small) biotech is not that large pharmaceutical companies are less able. They simply cannot justify spending substantial amounts of their own money into the development of compounds with a 1/100 chance of making it. Small biotechs can do that with "other people's money", as longs as there are investors who like to gamble. But 99 out of 100 such companies will fail and it is therefore hard to see how investing into e.g. an index basket makes sense. Large pharmaceutical companies pick and pay the price for the few winners.
    Recommending a company like PROLOR is a bold call. There are dozens if not hundreds of competing technologies to enhance the properties of existing drugs. And the most expensive part of developing such an "improved version" costs almost as much as for a completely new drug: The "no-efficacy risk" is much lower, but clinical trials still have to be as large and extensive as for new drugs to demonstrate safety.

  • 2. Avmelissa

    (11 March 2010, 08:19PM)  Complain about this comment

    Most of the smaller Biotech companies do the research and are then promptly swallowed up by Big Pharma. Most smaller Biotech companies cannot afford to pay the huge amounts of money to further their research of the biomolecules and wait to be bought out by bigger firms.

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