Subject: Soaring Somatogen Leaves No Room for Investing Error Date: Published: 12/19/91 (115 lines) Source: Wall Street Journal. Copyright Dow Jones & Co. Inc. Heard on the Street: Soaring Somatogen Leaves No Room for Error For Investing Under the Spell of Biotech Fever ---- By Anne Newman Staff Reporter of The Wall Street Journal NEW YORK -- Biotech fever is still widespread among investors even after the group's recent cooling, and nowhere is their enthusiasm more evident than in the case of Somatogen. The stock has more than doubled to 39 3/4 in the four months since the young biotechnology concern went public at 19. The company's market value exceeds $280 million, not bad, considering that Somatogen doesn't expect to have a product on the market at least until 1995. If then. The Boulder, Colo., company is engaged in the noble but daunting task of developing a cheap and pure substitute for oxygen-carrying components of human blood. Several other companies also are vying to be first in what some think could be a $2 billion-a-year market for blood substitutes untainted by the threat of diseases such as AIDS. No matter how good the company's science is, some analysts say, Somatogen stock at these levels holds the potential to disappoint investors because the road to market for a scientific breakthrough is rarely short and straight. What Somatogen has achieved to date is this: It has transplanted the human hemoglobin gene into bacteria, and is producing a genetically engineered human hemoglobin known as rHb1.1, which it hopes can be used for blood transfusions. Now Somatogen faces two high hurdles. It must crack an obstinate scientific mystery by showing that a hemoglobin-based product can be safely used in humans, which has never been done before. The company has just begun low-dose trials on humans to see if it has solved that problem. Then, it must construct one of the largest production plants ever built in the young biotech industry, complete with big fermenting and purification processors that will resemble silos. Bulls say the company's top-notch researchers will solve the safety issue in their first round of human studies. Last month, when federal regulators cleared Somatogen to begin human trials of rHb1.1, the stock hit a high of 42 1/2. The trouble is, hemoglobin-based products have never before been introduced into humans without making blood vessels constrict, causing shortness of breath, high blood pressure and other problems. Hopes have been dashed before when several promising products worked in animals, but failed in humans. "We all thought that hemoglobin would float in the bloodstream without major side effects," says Col. John Hess, chief of blood research at the U. S. Army's Letterman Institute of Research in San Francisco. The Army has been conducting and following research on hemoglobin for 24 years, but Dr. Hess says its effect in the bloodstream may be toxic. "I'm not sure anybody knows whether a human-based hemoglobin can be made safe," says Dr. Hess, who declines to comment on individual companies' research. "There are some very fundamental problems" with hemoglobin still to be solved, agrees Joseph Fratantoni, chief of the U. S. Food and Drug Administration's laboratory of cellular hematology. "We don't know what we're up against yet," he says, adding that the regulators will be closely watching Somatogen's initial tests on healthy volunteers. Chief Financial Officer James C. T. Linfield says Somatogen is "very encouraged" by its animal tests. He concedes, however, that "it's not clear what the mechanism is" that led other products to cause adverse reactions in humans. If early tests show safety isn't a problem, Somatogen must spend at least $100 million on a plant to boost capacity by a factor of 33, using three 50,000-liter facilities to purify the product. The plant is crucial as it must be licensed by the FDA before Somatogen can begin final product tests. Financing must be lined up for the plant, due to be built by early 1994. Meanwhile, development costs are growing. Analyst Robert M. Peterson of Hanifen Imhoff Inc. of Denver estimates losses at about $107 million over the next four years. Somatogen needs to slash output costs, to compete with cheaper, existing sources of blood. "They seem to have the best technology so far," says Tony Sutton, a biotech analyst for Fidelity Investments in Boston, which owns some of the stock. Rivals tackling the problem from different angles include Baxter International; Alliance Pharmaceutical; newly public DNX, which is in an even earlier stage of development; Biopure, in which Upjohn has a major investment; and a number of closely held companies. Mr. Linfield says there are few financing alternatives for companies such as Somatogen that want to retain full marketing rights rather than share potential profits with a big corporate partner. Mr. Peterson estimates sales at $270 million and earnings at $7 a share in the fiscal year through mid-1996. The company's investment banker, Alex. Brown & Sons, has a much higher fiscal 1996 profit estimate, $12.10 a share. Somatogen won't discuss the estimates. Much as Mr. Peterson admires Somatogen's "world-class science," he recommends waiting to buy the stock at lower levels. --- Somatogen Inc. (OTC; Symbol: SMTG) Business: Biotechnology Year ended June 30, 1991: Revenue: $1.7 million Net Loss: $7.1 million; $1.21 a share First quarter, Sept. 30, 1991: Per-share loss: 31 cents vs. 25 cents Average daily trading volume: 100,372 shares Common shares outstanding: 7.1 million [This article is made available here by Dow Jones Co. for the personal and non-commercial use of callers to this bbs, in the hope that it will be of some help to those who are suffering from the disease and others who are seeking to help them.]