Encysive says it will need to raise cash, reports $28.0 million second quarter net loss

By Jennifer Lanning Drey

Eugene, Ore., Aug. 7 - Encysive Pharmaceuticals will need to raise additional cash due to the delayed approval of Thelin (sitaxsentan sodium), said Gordon H. Busenbark, chief financial officer of the Encysive, during a company conference call held Monday.

The company is currently exploring financing options, he said.

Encysive reported $75.4 million in cash, cash equivalents and accrued interest at June 30, compared to $127.9 million at Dec. 31, 2005.

The company said Monday it has not made definitive decisions regarding the amount of cash it will look to raise, the timing of a transaction or the specific financial vehicle it will use.

Encysive received a second approvable letter from the Food and Drug Administration for Thelin on July 24. In the letter the FDA said one of the substantive items raised in a previous approvable letter remains unresolved, according to a company news release.

Encysive had productive discussions with the FDA in the last week, and the company believes it now understands the issue in question, said Bruce D. Given, chief executive officer of Encysive, during Monday's call.

However, the company does not have a clear picture of the timing of further actions on the part of the FDA or know whether additional meetings will be necessary.

"We feel that events are moving rapidly in a direction that can lead to resolution," said Given.

Second quarter loss

Encysive reported a net loss of $28.0 million, or $0.48 per basic and diluted share, compared to a net loss of $19.2 million, or $0.33 per basic and diluted share, for the second quarter of 2005, according to the release.

Revenues for the second quarter were $3.7 million, compared to $3.0 million for the second quarter of 2005.

Encysive reduced cash burn in the second quarter and is looking for additional ways to control spending and reduce its cash utilization while the company works with the FDA to prepare for the commercial launch of Thelin, Busenbark said.

"We will continue to look for ways to control spending and reduce our cash utilization while we work with the FDA to resolve the remaining item in the approvable letter," he said.

The company is also currently working with the European Agency for the Evaluation of Medicinal Products to finalize distribution and risk management programs for Thelin, in anticipation of approval in Europe.

Encysive expects to launch Thelin in the United Kingdom and Germany in the fourth quarter, followed by other major countries in 2007, Given said.

Encysive is a Houston-based biopharmaceutical company.

© 2015 Prospect News.
All content on this website is protected by copyright law in the U.S. and elsewhere. For the use of the person downloading only.
Redistribution and copying are prohibited by law without written permission in advance from Prospect News.
Redistribution or copying includes e-mailing, printing multiple copies or any other form of reproduction.