Worldwide sales of lead drug Thelin -- a pulmonary arterial hypertension (PAH) treatment -- were $4.0 million in the quarter. Thelin is approved in numerous countries, but not the U.S., and has been on the market in the European Union since late last year.
Encysive had operating expenses of $20.6 million in the third quarter, excluding restructuring charges. It ended the quarter with $54.2 million in cash and equivalents on its balance sheet.
Encysive guided for operating expenses around $21 million in the fourth quarter. This high burn rate for such a small drugmaker is despite a more than 50% year-over-year reduction in its research and development spending and a hefty overhaul of the rest of its operations following receipt of the third approvable letter for Thelin from the FDA.
Europe's fragmented markets are always much slower for any new drug to penetrate than the U.S. This puts Encysive in a tough position without substantial resources on its balance sheet to fall back on until Thelin sales can bring it closer to breakeven.
As a little glimpse of what Encysive is missing by not having U.S. approval for Thelin, consider that Gilead Science's
Just two weeks ago, Encysive presented long-term data indicating that Thelin is an effective drug, but it still needs the additional clinical trial that the FDA requested more than 18 months ago.
Encysive said the needed trial is likely to be a 200-person, 12-week study that will take "a little bit longer" than 14 months to enroll. This would put possible U.S. approval toward the end of my previous forecast of late 2009 or early 2010.
With such limited resources but compounds that may be effective in a range of indications -- including Thelin and Encysive's endothelin antagonist TBC3711 -- the best option for Encysive is to shop itself to a large pharma like Pfizer
Encysive investors would likely only get pennies on the dollar for their shares, but Encysive already painted itself into a corner. The only other alternative is a continual burning up of cash and copious amounts of future share dilution.
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