Neurocrine reports $27.4 million net loss for second quarter

By Jennifer Lanning Drey

Eugene, Ore., July 17 - Neurocrine Biosciences, Inc. reported a net loss of $27.4 million, or $0.73 per share, on revenue of $9.2 million for the second quarter, according to a company news release.

Those were all weaker than the net loss of $5.6 million, or $0.15 per share, on revenues of $33.2 million the company reported for the same period last year, according to the release.

Neurocrine said the decrease in revenue is primarily due to lower revenue recognized under collaborative agreements.

During the second quarter, Neurocrine and Pfizer Inc. announced they had terminated their collaboration agreement to develop and co-promote indiplon, after the company received a Not Approvable Letter for the drug.

Neurocrine said it is in the process of preparing for meetings with the Food and Drug Administration to finalize development plans for the resubmissions of New Drug Applications for both indiplon capsules (IR) and tablets (MR) for insomnia.

The FDA has agreed to review indiplon IR, and the company is planning to meet with the agency in August. Neurocrine also applied this week for a type-A meeting with the FDA to discuss indiplon MR, according to Paul Hawran, chief financial officer of the company, during a company conference call held Monday.

The agency's responses will dictate the way Neurocrine moves ahead with funding indiplon, he said.

"To advance indiplon's commercialization, we will need additional financing. How we proceed on financing will be determined largely based on our meetings with the FDA," Hawran said.

The company's options include staggering indiplon's launch, finding a partnership for it or holding an equity offering, he said.

The company is also assessing whether it will be able to keep its 200-person sales force in place until indiplon is launched and expects to make a decision by the end of the month, he said.

"Our goal is to subsidize the cost of that sales force, keep them focused on the appropriate audience and keep them in place to be there for the indiplon launch. Should that not be possible, we will know this by the end of the month, and we'll unfortunately be in a position where we would have to let that sales force go in full or in part and recreate that organization later to preserve cash and make sure the money's going into indiplon development and registration as well as other product areas," Hawran said.

Neurocrine expects to end 2006 with approximately $180 million in cash, compared to $273 million at the end of 2005, Hawran said.

Expects $100 million cash burn

The company has revised its financial guidance for 2006 to reflect an expected cash burn of approximately $100 million for the year, according to the news release.

"Our plan beyond 2006 is to ensure that we have two years' of cash running forward. That would mean that we bring our annual cash expenditures down to approximately $80 million, not including investment into launching indiplon activities," Hawran said.

The company will also look for opportunities for collaborations involving its other drugs in development.

"We do have the potential to add to our revenues base through additional collaborations, and we believe our strong pipeline contains a number of strong partnering opportunities," Hawran said.

Neurocrine's most expansive pipeline program after indiplon is its GnRH antagonists for endometriosis. The company expects to report results from a three-month safety follow-up with GnRH antagonist NBI-56418 in September, according to Wendell Wierenga, executive vice president of research and development.

The company also plans to start a six-month phase 2b trial of NBI-56418 for endometriosis late in the third or early in the fourth quarter of the year, he said.

In addition, Neurocrine has pipeline drugs being developed for heart failure, anxiety and depression, diabetes and insomnia.

Neurocrine is a San Diego-based product-based biopharmaceutical company focused on neurological and endocrine diseases and disorders.

© 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.