Biopharmaceutical companies with no marketed drugs or history of drug approvals can be very difficult to evaluate. With a development-stage biopharma, undoubtedly the most important asset in determining its future success is its management team. And unless they have strong academic or management pedigrees in past jobs, this is also the hardest area of a drug developer to evaluate.
With its third quarter just finished, ZymoGenetics' (NASDAQ:ZGEN) executive team proved itself just as capable at successfully running drugs through the clinic as its members' backgrounds suggest they should be. The company announced strong positive phase 3 trial results for the company's lead drug candidate, rhThrombin, a month ago.
ZymoGenetics' management's trial by fire is not over yet, as it still has to get rhThrombin approved for marketing. An application for approval of the drug is expected be filed with the FDA by the end of the year, meaning a possible regulatory thumbs-up (or thumbs-down) would come no later than the third quarter next year.
ZymoGenetics is not just about rhThrombin, and the company expects to have its two cancer compounds in phase 2 trials by the end of the year. With trials about to begin, cash burn will begin to ramp up again in 2007, compared to the $20 million used this quarter and $110 million to $120 million expected to be spent this year.
With $290 million in the bank, though, ZymoGenetics has plenty of cash to bring rhThrombin to the market and survive -- without the need for any more dilutive financings -- until revenues from the drug start coming in. If its management continues to prove itself like it has this quarter, it'll be hard to have doubts about the success of the commercialization of rhThrombin and the future of shares of ZymoGenetics.
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Fool contributor Brian Lawler does not own shares of any company mentioned in this article. The Fool has a disclosure policy .
