Bullish on Biotech

By Richard Moroney, editor
Dow Theory Forecasts

By George Wolff

       As the dust settles from the great dot-com and telecom debacle, the bulls and bears are pitted against each other in a battle over biotechnology. After all, who wouldn't be wary about investing in profitless companies after the beating so many investors took by betting on high-flying Internet, telecom and e-commerce companies?
       That may be a sensible concern, but it merits closer examination by investors considering growth opportunities in biotechnology.
       Let's hear from the bears first and get all of the negatives on the table from the outset. It's a plain fact that fewer than 30 biotechnology companies are currently profitable; a strikingly low number in an industry composed of more than 350 publicly traded companies. Even more sobering is the fact that the biotech industry has been around for a quarter of a century, yet it has annual revenues of only $25 billion industry-wide to show for all the time and money invested so far.
       No bear would fail to point out that biotech stocks are intensely volatile. Investors who bought into the industry during peak periods are facing large losses.
       Looking to the fundamentals of biotechnology companies, most of them are involved in drug development, an inherently risky and time-consuming venture. When a biotech company suffers a setback for a product in clinical trials, the effect on share prices can be devastating.
       The degree of risk involved in biotech investing is clearly daunting, but let's not declare the bears "winners" without a good fight. The biotech sector has rebounded time and again from industry-wide market setbacks. The reason is simple. Biotechnology offers extraordinary growth potential.

The Bulls Fight Back

       Nothing illustrates more clearly the potential upside of biotech innovation than the success of Amgen, currently America's premiere biotechnology company. Ten years ago Amgen was a chronically unprofitable firm, just beginning to rise from penny stock status. But in 1999 Amgen's growth curve went exponential, shooting from the $20 range to more than $70 a share. Based largely on the success of two successful drugs, Epogen and Neupogen, Amgen now enjoys revenues in excess of $3.5 billion a year and a market capitalization that usually exceeds $60 billion.
       Spectacular gains in share prices are the norm among biotech companies that have successfully brought important new drugs to market. MedImmune and Idec Pharmaceuticals are two other frequently mentioned companies that have delivered gains greater than 1,000% with successful drug launches. Success on this scale is at the heart of the biotech industry's appeal to investors.

       Currently the biotech industry has more than 350 drugs in development including a remarkable 175 new medicines for cancer. Approximately 100 drugs are in the pivotal third Phase of clinical trials. The revenue potential from this flood of innovation is staggering and the industry's growth phase may well continue throughout the entire 21st century. I have no argument with those who say biotechnology is poised to become the world's largest industry.
       In the past few years the biotech industry entered a phase of hugely accelerated development, an event marked by the mapping of the human genome in a span of time most scientists had believed to be impossible. Supercomputers, laboratory robots, lasers and "microarrays" (or laboratories on a chip) have accelerated the process of developing new drugs to the point where some industry executives complain of being awash in new drug targetsa far cry from the predicament of pharmaceutical companies that fretted about an "innovation deficit" only a few years ago.
       There seems little doubt that a substantial number of biotechnology companies will generate significant new revenue streams in coming years, just as Amgen, IDEC and MedImmune did in the recent past. The investor's challenge is to find the companies most likely to deliver returns in the shortest possible time.

Picking the Winners

       Before getting down to specific criteria for stock picking, it's important to learn about the tools of the trade. First, if I may say so, I suggest you do some background reading, checking out excellent books like "From Alchemy to IPO" by Cynthia Robbins-Roth.
       Most biotech investment strategies begin by assigning companies of interest to three tiers according to their market capitalization only.
       In my book, "The Biotech Investor's Bible," I have chosen to break the industry down into four tiers, giving unique status to profitable biotech firms. These Tier One companies are much easier to judge by conventional stock-picking techniques because they exhibit all of the familiar metrics such as P/E ratios. Unprofitable firms require more specialized criteria.
       The lower three tiers are made up of biotech companies that have yet to turn a profit and are broken down largely by market cap. Those with a market capitalization of a billion dollars or more are generally among the most promising contenders.
       These Tier Two firms are typically characterized by large research staffs, significant pipelines of drugs in development and alliances with major pharmaceutical companies worth hundreds of millions of dollars each. Major names in this tier include Millennium Pharmaceuticals (MLNM), Human Genome Sciences (HGSI), Protein Design Labs (PDLI) Abgenix (ABGX), Affymetrix (AFFX) and Vertex Pharmaceuticals (VRTX).
       Tier Three biotech companies are valued between $500 million and $1 billion. Usually these companies have at least one major drug approaching FDA (U.S. Food and Drug Administration) approval. They are very risky because they have typically been overvalued in anticipation of FDA approval. Imclone (IMCL) appears to be the most recent victim of over enthusiasm about unapproved drugs.
       Companies in Tier Four may have interesting products in their pipelines but they tend to be in earlier stages of product development, hence their lower market capitalization (usually well below $500 million). There is a considerable risk of loss in this group, but, as a precaution, investments in this inherently exciting arena should be kept very small.
       The time required to bring a product to market is crucial in assessing biotech firms. The three phases of clinical trials generally consume six or more years and product failure is possible at any stage. Even a drug that has made it through clinical trials to a company's own satisfaction stands a chance of being rejected by the FDA.
       The pharmaceutical industry says that only one drug in five entering trials will make it to market, therefore it stands to reason that a drug which is in the pivotal Phase III testing is a better bet than a drug in Phase I. That's the first key test of a biotech company's viability.
       Equally important is the breadth of a company's product pipeline. Clearly a company with only one product in the testing pipeline is a risky investment. In the past year several biotech firms suffered 70% losses in their stock values when a single drug failed during trials. A broad product pipeline increases the chances of product approval and lessens the financial impact on the investor if one product does fail.
       Alliances are another key test of a biotech firm's viability. All of the companies I named earlier in Tier 2 rose sharply in value when they struck deals with major pharmaceutical firms. The top company in the tier, Millennium Pharmaceuticals boasts of drug discovery alliances with Lilly, American Home Products, Pfizer, and Monsanto. Although Millennium has a somewhat smaller pipeline than its competitors, its alliance profile indicates strong validation by leading pharmaceutical scientists, backed up by hard cash commitments from its partners. The company's alliances also have the potential to produce large revenue streams well beyond Millennium's own pipeline through royalties from successful products produced for its partners. Millennium is also actively acquiring other biotech firms to build the size of its pipeline.
       Investors receiving news of exciting scientific developments may also be blinded to risk by the potential of a major discovery. Always keep in mind when reading of scientific breakthroughs that many years will pass before a fundamental discovery can be transformed into a marketable product. The industry abounds with scientific achievement but products and profits are still scarce. Invest accordingly.
       Finally, a few words about Tier One biotech firms, the names we are all familiar with such as Amgen (AMGN), Biogen (BGEN) and Genentech (DNA): an investor who checks the P/E ratios on such firms will often discover that they are quite high by normal standards, even in a down market. That's because investors are paying a premium for the profit potential of drugs still in development.
       Biotech P/E ratios have been the focus of much debate but, in the wake of the tech-wreck, this perspective is changing.

High PE? No PE?

       Certainly in the wake of the dotcom disaster investors and investment advisors at every level profess an aversion to unprofitable companies. Many of my clients in the financial planning industry now openly scoff at the notion of investing in emerging companies that have yet to turn a profit.
       Typically, most investment gurus still recommend widely known corporations, basing their judgments of a company's future potential on ephemeral variables including vague predictions about the state of the economy, interest rate forecasts and changes in levels of consumer confidence.
       This sort of speculation still plays well in the financial media, appearing to be prudent and conservative prognostication. But, permit me to ask the question, how "conservative" are today's mainstream stock plays, compared to biotechnology.
       In search of perspective, I reviewed the metrics of the top twenty stocks that are listed as "Favorite Stocks" by the New York Times and the Associated Press.
       Surprise! There among the top twenty companies were seven major firms sporting the dreaded N/A symbol in their Price-to-Earnings ratios. Seven of the top twenty companies are hemorrhaging money, but still they retain remarkably high market capitalizations.
       I compared these seven unprofitable majors to seven top quality (unprofitable) biotechs. The two tables below tell the story (See Table 1 and Table 2).

Table 1: Favorite Stocks: New York Times & AP
Company P/E Market
Cap (Billions)
Income/
Loss
Cash 52-week
change in
share price
Cisco Systems N/A $120 -$2,290,000,000 $7,500,000 -16%
AOL-Time Warner N/A $109 -$4,920,000,000 $719,000,000 -33%
AT&T Corporation N/A 56 -$4,860,000,000 $11,300,000 -27%
EMC Corporation N/A $25 -$507,000,000 $2,500,000 -68%
 AT&T Wireless N/A $23 -$91,000,000 $0 -51%
Lucent Technologies N/A $16 -$13,000,000,000 $3,000,000 -56%
Avaya Inc. N/A $1.8 -$415,000,000 $252,000,000 -44%
March 17, 2002 Data from Yahoo Finance, Multex, S&P, New York Times, AP

Table 2: Leading (Unprofitable) Biotech Companies
Company P/E Market
Cap
(Billions)
Income Cash 52-week
change in
share price
Millennium
Pharmaceuticals
N/A $6.7 -$192,000,000 $1,470,000,000 -3.8%
Human Genome Sciences N/A $2.9 -$117,000,000 $1,690,000,000 -46%
Vertex
Pharmaceuticals
N/A $2.1 -$68,000,000 $0 -7.3%
Abgenix, Inc. N/A $1.7 -$60,000,000 $557,000,000 +11.7%
Affymetrix, Inc. N/A $1.6 -$34,000,000 $368,000,000 +4.5%
Medarex N/A $1.3 -$2,690,000 $491,000,000 +25%%
Ligand
Pharmaceuticals
N/A $1.2 -$43,000,000 $37,000,000 +87%
March 17, 2002 Data from Yahoo Finance, Multex, S&P, New York Times, AP

       In terms of market performance (through the worst year in recent market history) the biotechs have held up remarkably well. The biotech firms compared to the "most popular" stocks show better metrics in almost every other respect as well. Looking at their losses compared to cash reserves, the biotechs generally have a much better cash position to sustain their burn rates.
       One obvious difference is the past performance of the so-called favorite stocks. Many of these once high-flying tech stocks were profitable for a time and their continued popularity can only be explained by a belief that an eventual return to profitability will also restore their shares' once stellar prices.
       Perhaps, but most financial professionals I have interviewed say privately that they do not expect the tech companies in Chart #1 to return to their previous highs. Never.
       Perhaps that is a bit extreme, but keep in mind that at the height of the high-tech speculation binge, companies like Cisco and Intel were briefly valued on a par with General Electric. Clearly it is not rational to expect these companies to regain such exaggerated values in the foreseeable future. Many must show share price gains well in excess of 100% to recover their former values
       What about the biotechs? Do they have exponential growth potential? Clearly I believe they do. But, biotechnology companies that are engaged in drug discovery may not have steady growth curves like those of conventional companies
       Sudden rises in the values of profitable biotechs like Amgen, Medimmune and IDEC are driven by the approval of major drugs after long and costly periods of research and trials. Hundreds of companies worldwide are currently engaged in promising research and there is every reason to expect that a number of them will enjoy sudden gains in share value as this research eventually brings products to market.
       Critics of investment in profitable biotechs often cite the high P/E ratios of Tier One companies. (I myself have indicated a preference for investment in companies with greater growth potential in my book: "The Biotech Investor's Bible.") Now, under current market conditions, biotech P/E ratios are starting to look like a bargain.
       Here's a comparison. The first table shows four tech stocks that do have positive earnings from the same New York Times/AP list of 20 "Favorite Stocks" They are compared to profitable biotechs. Many "favorite" companies display remarkably high P/E's. (See Table 3)

Table 3: Favorite Stocks, Profitable Tech Companies
Company P/E
(Billions)
Market Cap
(Billions)
Income 52-week
stock
performance
Microsoft Corporation 56 $332 $6 +13%
Intel Corporation 167 $210 $1.3 +9.5%
Verizon Communications 224 $127 $.59 +2
Oracle Corporation 31 $72 $2.4 -15%
March 17, 2002 Data from Yahoo Finance, Multex, S&P, New York Times, AP

       Compare those metrics to five profitable biotechs. (See Table 4)

Table 4: Profitable Biotech Comparison
Company P/E
(Billions)
Market Cap
(Billions)
Income 52-week
stock
performance
Amgen Corporation 60 $64 $1.1 +10%
Genentech 184 $28 $.155 +13%
Medimmune 63 $10.7 $.149 +27%
IDEC Pharmaceuticals 116 $10.6 $.101 +74%
Biogen 28 $7.4 $.272 -19%
March 17, 2002 Data from Yahoo Finance, Multex, S&P, New York Times, AP

       The high P/E ratios of profitable biotechs seem far less daunting when compared to the so-called favorite stocks. And, in general, the biotechs have also shown superior 52-week stock performance.
       What are the high P/E ratios of the large cap tech stocks based on? Largely on faith that a recovering economy will boost profits so dramatically that these companies will regain their former valuesno matter how exaggerated they may have been at their peaks.
       What are the high P/E ratios of biotech stocks built on? Something much different. They are based on the belief that sharp increases in come can still be realized by these companies as their proven research teams develop new blockbuster drugs and bring them to market.

Conclusion:
Biotech's Future

       There is no shortage of naysayers and prophets of doom among commentators on biotech investments. Certainly this is a volatile and speculative sector but it is nothing like the dot coms and telecoms of the so-called "new economy." In the last two years, while the new economy became old news, the biotech industry raised an unprecedented $48 billion in capital and forged more than 400 corporate alliances. The majority of biotech companies have enough cash in reserve to carry on for several years, a period long enough to bring some extraordinary new products to market. (Obviously investors should check corporate balance sheets to make sure that a company isn't burning cash too quickly to bring its products through the lengthy clinical testing and approvals phase.)
       Nevertheless, the fact that the biotech industry has survived twenty-five years of financial hardship remains a testament to its durability and to the widespread belief in the industry's long-term profit potential. As hundreds of new drugs from biotechnology begin saving lives and earning revenues, investors will witness, and hopefully participate in the emergence of many new "Amgens" and "Biogens."
       We are now in the emergent phase of a major industrial sector. In the coming century, biotechnology's achievements will go well beyond the development of new drugs. The industry is inventing entirely new technologies that will likely affect every industry that has a role in the management of living things. And that, if you take a moment to consider the implications, is an industrial revolution in the making. Good reason to be bullish.
       Editor's Note: George Wolff is an award-winning international journalist and currently a professional speaker and business consultant to several firms in the investment industry. He has addressed and reported on more than 200 biotechnology companies, issuing a number of valuable white papers charting the emergence of biotechnology. Strategies to choose the quality companies and techniques to assess them are set out in detail in George Wolff's book, The Biotech Investor's Bible, $29.95, published by John Wiley & Sons available at all major book stores June 22nd. Visit his web site at www.biowolff.com.

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