Welcome!

News Feed Item

Neurocrine Biosciences Reports Second Quarter 2014 Results

SUCCESSFUL END-OF-PHASE II MEETING FOR NBI-98854 IN TARDIVE DYSKINESIA

SAN DIEGO, Aug. 6, 2014 /PRNewswire/ -- Neurocrine Biosciences, Inc. (NASDAQ:NBIX) today announced its financial results for the quarter ended June 30, 2014.  For the second quarter of 2014, the Company reported a net loss of $13.4 million, or $0.18 loss per share, compared to a net loss of $12.2 million, or $0.18 loss per share, for the same period in 2013.  For the six months ended June 30, 2014, the Company reported a net loss of $25.2 million, or $0.35 loss per share, as compared to net loss of $24.3 million, or $0.36 loss per share, for the first half of last year.

The Company's balance sheet at June 30, 2014 reflected total assets of $269.5 million, including cash, cash equivalents, investments and receivables of $261.5 million

"We are very pleased with our recent interactions with the FDA concerning our VMAT2 inhibitor NBI-98854 and the path forward to an NDA filing in tardive dyskinesia," said Kevin Gorman, Ph.D., President and Chief Executive Officer of Neurocrine Biosciences.  "Based on the results of the End-of-Phase II meeting, we will conduct a single placebo-controlled Phase III trial (Kinect 3). We look forward to initiating the Kinect 3 pivotal trial later this year."

Research and development expenses were $10.2 million during the second quarter of 2014 compared to $10.5 million for the same period in 2013.  For the six months ended June 30, 2014, research and development expenses were $18.7 million, compared to $20.8 million for the same period last year.  This decrease was due to lower external clinical development expense related to the Company's VMAT2 inhibitor, NBI-98854, which substantially completed Phase II development in late 2013 and is currently in preparation for Phase III development.  This decrease was offset by higher research and development personnel costs primarily related to higher share-based compensation expense.

General and administrative expenses increased from $3.4 million for the second quarter of 2013 to $4.2 million for the second quarter of 2014.  For the six months ended June 30, 2014 general and administrative expenses were $8.4 million, compared to $6.8 million for the first half of 2013.  The increase in general and administrative expense is primarily due to higher share-based compensation expense.

Pipeline Highlights

VMAT2 Update

The Company recently held an End-of-Phase II meeting with the FDA for its VMAT2 inhibitor, NBI-98854.  The FDA reviewed the current data package and clinical development plan for NBI-98854 and commented on the overall proposal for Phase III development to support the registration of NBI-98854 in the United States as a treatment for tardive dyskinesia.  Based on the results of this meeting and the related minutes, the Company will conduct a single placebo-controlled Phase III study of NBI-98854, the Kinect 3 study. The Kinect 3 study, along with the previous efficacy studies of NBI-98854, will complete the placebo-controlled clinical efficacy evaluation of NBI-98854 in tardive dyskinesia. The primary endpoint in the Kinect 3 study will be the mean change from baseline in the Abnormal Involuntary Movement Scale (AIMS) as assessed by blinded central raters.  The Kinect 3 study will include approximately 240 subjects randomized to either placebo, once daily 40mg of NBI-98854 or once daily 80mg of NBI-98854 for 6 weeks of placebo-controlled dosing followed by an extension of active dosing through Week 48.  The Company also intends to conduct a separate one-year open-label safety study of NBI-98854 to support the anticipated 2016 filing of a New Drug Application in tardive dyskinesia.

The Company is also expecting to submit an Investigational New Drug application for NBI-98854 in Tourette syndrome later this month and plans to commence the clinical program in Tourette syndrome patients this year.

Elagolix Update

AbbVie is currently conducting the Violet Petal Study, a Phase III study of elagolix for endometriosis.  The study is a 24-week, multinational, randomized, double-blind, placebo-controlled study designed to evaluate the safety and efficacy of elagolix in 875 women, age 18 to 49, with moderate to severe endometriosis-associated pain.  Approximately 160 sites in the United States, Puerto Rico and Canada are conducting this study which completed patient recruitment and randomization during the second quarter.

AbbVie is also conducting the second Phase III study of elagolix for endometriosis, the Solstice Study.  This study is similar in design to the Violet Petal Study and will assess 788 women, age 18 to 49, with moderate to severe endometriosis-associated pain at more than 200 sites globally.

Elagolix is also being studied for utilization in uterine fibroids.  AbbVie is conducting a Phase IIb clinical trial evaluating the change in uterine blood loss of 520 women, age 18-51, with heavy uterine bleeding due to uterine fibroids.

Conference Call and Webcast Tomorrow at 8:00AM Eastern Time
Neurocrine will hold a live conference call and webcast tomorrow at 8:00 a.m. Eastern Time (5:00 a.m. Pacific Time).  Participants can access the live conference call by dialing 866-952-1907 (US) or 785-424-1826 (International) using the conference ID: NBIX.  The call can also be accessed via the webcast through the Company's website at http://www.neurocrine.com.

If you are unable to attend the webcast and would like further information on this announcement please contact the Investor Relations Department at Neurocrine Biosciences at [email protected].  A replay of the conference call will be available approximately one hour after the conclusion of the call by dialing 800-839-2459 (US) or 402-220-7218 (International) using the conference ID: NBIX.  The call will be archived for one month.

Neurocrine Biosciences, Inc. discovers and develops innovative and life-changing pharmaceuticals, in diseases with high unmet medical needs, through its novel R&D platform, focused on neurological and endocrine based diseases and disorders.  The Company's two lead late-stage clinical programs are elagolix, a gonadotropin-releasing hormone antagonist for women's health that is partnered with AbbVie Inc., and a wholly owned vesicular monoamine transporter 2 inhibitor for the treatment of movement disorders.  Neurocrine intends to maintain certain commercial rights to its VMAT2 inhibitor for evolution into a fully-integrated pharmaceutical company.

Neurocrine Biosciences, Inc. news releases are available through the Company's website via the internet at http://www.neurocrine.com.

In addition to historical facts, this press release may contain forward-looking statements that involve a number of risks and uncertainties.  Among the factors that could cause actual results to differ materially from those indicated in the forward-looking statements are risks and uncertainties associated with Neurocrine's R&D pipeline as well as its business overall.  Specifically, the risks and uncertainties the Company faces with respect to its lead program, elagolix, include the risk that the elagolix endometriosis Phase III clinical trials will fail to demonstrate that elagolix is safe and effective; the risk that elagolix Phase III clinical trials will be delayed for regulatory or other reasons; the risk that the elagolix uterine fibroids clinical program will not proceed to later stage clinical trials; and the risks associated with the Company's dependence on AbbVie for elagolix Phase III development, commercial manufacturing and marketing and sales activities.  In addition, the Company faces risks and uncertainties with respect to the rest of the Company's R & D pipeline including; risk that the Company's VMAT2 Phase III program will be delayed for regulatory or other reasons; risk that the VMAT2 Phase III clinical program will fail to demonstrate that NBI-98854 is safe and effective; risk that the guidance provided by the FDA in the End-of-Phase II meeting may be modified or may not lead to regulatory approval; risk that the Company will be unable to file an IND for Tourette syndrome or initiate clinical trials for regulatory or other reasons; risk that the Company's research programs will not identify pre-clinical candidates for further development; and  risk that the Company's other product candidates will not be found to be safe and effective.  With respect to its business overall, the Company faces risk that it will be unable to raise additional funding required to complete development of all of its product candidates; risk relating to the Company's dependence on contractors for clinical drug supply, commercial manufacturing and marketing and sales activities; uncertainties relating to patent protection and intellectual property rights of third parties; risks and uncertainties relating to competitive products and technological changes that may limit demand for the Company's products if approved.  The Company also faces the other risks described in the Company's annual report on Form 10-K for the year ended December 31, 2013 and quarterly report on Form 10-Q for the quarter ended March 31, 2014.  Neurocrine undertakes no obligation to update the statements contained in this press release after the date hereof.

 

NEUROCRINE BIOSCIENCES, INC.

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

(in thousands, except per share data)

(unaudited)










Three Months Ended
June 30,


Six Months Ended
June 30,


2014


2013


2014


2013

Revenues:            








License fees              

$            -


$        730


$            -


$     1,460









Total revenues               

-


730


-


1,460

Operating expenses:           








Research and development    

10,161


10,527


18,733


20,840

General and administrative     

4,200


3,370


8,353


6,762









Total operating expenses             

14,361


13,897


27,086


27,602









Loss from operations         

(14,361)


(13,167)


(27,086)


(26,142)

Other income:      








Gain (loss) on sale/disposal of assets  

5


19


(5)


32

Deferred gain on real estate    

805


781


1,609


1,563

Investment income, net           

167


121


256


224

Other income, net     

3


4


3


6









Total other income        

980


925


1,863


1,825









Net loss

$ (13,381)


$ (12,242)


$ (25,223)


$ (24,317)









Net loss per common share:








Basic and diluted      

$    (0.18)


$    (0.18)


$    (0.35)


$    (0.36)









Shares used in the calculation of net loss per common share:








Basic and diluted      

75,879


66,799


73,085


66,700






























 

NEUROCRINE BIOSCIENCES, INC

CONDENSED CONSOLIDATED BALANCE SHEETS

(in thousands)

(unaudited)






June 30,
2014


December 31,
2013

Cash, cash equivalents and short-term marketable securities

$          194,656


$          145,739

Other current assets

2,919


2,723





Total current assets

197,575


148,462

Property and equipment, net

2,239


1,771

Long-term investments, available for sale

65,282


-

Restricted cash

4,443


4,443





Total assets

$          269,539


$          154,676









Current liabilities

$            12,053


$            11,699

Long-term liabilities

20,641


22,567

Stockholders' equity

236,845


120,410





Total liabilities and stockholders' equity

$          269,539


$          154,676





SOURCE Neurocrine Biosciences, Inc.

More Stories By PR Newswire

Copyright © 2007 PR Newswire. All rights reserved. Republication or redistribution of PRNewswire content is expressly prohibited without the prior written consent of PRNewswire. PRNewswire shall not be liable for any errors or delays in the content, or for any actions taken in reliance thereon.

Latest Stories
In his session at 21st Cloud Expo, Raju Shreewastava, founder of Big Data Trunk, will provide a fun and simple way to introduce Machine Leaning to anyone and everyone. Together we will solve a machine learning problem and find an easy way to be able to do machine learning without even coding. Raju Shreewastava is the founder of Big Data Trunk (www.BigDataTrunk.com), a Big Data Training and consulting firm with offices in the United States. He previously led the data warehouse/business intellige...
SYS-CON Events announced today that IBM has been named “Diamond Sponsor” of SYS-CON's 21st Cloud Expo, which will take place on October 31 through November 2nd 2017 at the Santa Clara Convention Center in Santa Clara, California.
SYS-CON Events announced today that TidalScale, a leading provider of systems and services, will exhibit at SYS-CON's 21st International Cloud Expo®, which will take place on Oct 31 - Nov 2, 2017, at the Santa Clara Convention Center in Santa Clara, CA. TidalScale has been involved in shaping the computing landscape. They've designed, developed and deployed some of the most important and successful systems and services in the history of the computing industry - internet, Ethernet, operating s...
Infoblox delivers Actionable Network Intelligence to enterprise, government, and service provider customers around the world. They are the industry leader in DNS, DHCP, and IP address management, the category known as DDI. We empower thousands of organizations to control and secure their networks from the core-enabling them to increase efficiency and visibility, improve customer service, and meet compliance requirements.
In his session at 21st Cloud Expo, Michael Burley, a Senior Business Development Executive in IT Services at NetApp, will describe how NetApp designed a three-year program of work to migrate 25PB of a major telco's enterprise data to a new STaaS platform, and then secured a long-term contract to manage and operate the platform. This significant program blended the best of NetApp’s solutions and services capabilities to enable this telco’s successful adoption of private cloud storage and launchi...
SYS-CON Events announced today that IBM has been named “Diamond Sponsor” of SYS-CON's 21st Cloud Expo, which will take place on October 31 through November 2nd 2017 at the Santa Clara Convention Center in Santa Clara, California.
Data scientists must access high-performance computing resources across a wide-area network. To achieve cloud-based HPC visualization, researchers must transfer datasets and visualization results efficiently. HPC clusters now compute GPU-accelerated visualization in the cloud cluster. To efficiently display results remotely, a high-performance, low-latency protocol transfers the display from the cluster to a remote desktop. Further, tools to easily mount remote datasets and efficiently transfer...
Cloud Expo, Inc. has announced today that Andi Mann and Aruna Ravichandran have been named Co-Chairs of @DevOpsSummit at Cloud Expo Silicon Valley which will take place Oct. 31-Nov. 2, 2017, at the Santa Clara Convention Center in Santa Clara, CA. "DevOps is at the intersection of technology and business-optimizing tools, organizations and processes to bring measurable improvements in productivity and profitability," said Aruna Ravichandran, vice president, DevOps product and solutions marketing...
Join IBM November 1 at 21st Cloud Expo at the Santa Clara Convention Center in Santa Clara, CA, and learn how IBM Watson can bring cognitive services and AI to intelligent, unmanned systems. Cognitive analysis impacts today’s systems with unparalleled ability that were previously available only to manned, back-end operations. Thanks to cloud processing, IBM Watson can bring cognitive services and AI to intelligent, unmanned systems. Imagine a robot vacuum that becomes your personal assistant tha...
In his Opening Keynote at 21st Cloud Expo, John Considine, General Manager of IBM Cloud Infrastructure, will lead you through the exciting evolution of the cloud. He'll look at this major disruption from the perspective of technology, business models, and what this means for enterprises of all sizes. John Considine is General Manager of Cloud Infrastructure Services at IBM. In that role he is responsible for leading IBM’s public cloud infrastructure including strategy, development, and offering ...
In a recent survey, Sumo Logic surveyed 1,500 customers who employ cloud services such as Amazon Web Services (AWS), Microsoft Azure, and Google Cloud Platform (GCP). According to the survey, a quarter of the respondents have already deployed Docker containers and nearly as many (23 percent) are employing the AWS Lambda serverless computing framework. It’s clear: serverless is here to stay. The adoption does come with some needed changes, within both application development and operations. Tha...
SYS-CON Events announced today that Avere Systems, a leading provider of enterprise storage for the hybrid cloud, will exhibit at SYS-CON's 21st International Cloud Expo®, which will take place on Oct 31 - Nov 2, 2017, at the Santa Clara Convention Center in Santa Clara, CA. Avere delivers a more modern architectural approach to storage that doesn't require the overprovisioning of storage capacity to achieve performance, overspending on expensive storage media for inactive data or the overbui...
In his general session at 21st Cloud Expo, Greg Dumas, Calligo’s Vice President and G.M. of US operations, will go over the new Global Data Protection Regulation and how Calligo can help business stay compliant in digitally globalized world. Greg Dumas is Calligo's Vice President and G.M. of US operations. Calligo is an established service provider that provides an innovative platform for trusted cloud solutions. Calligo’s customers are typically most concerned about GDPR compliance, applicatio...
Widespread fragmentation is stalling the growth of the IIoT and making it difficult for partners to work together. The number of software platforms, apps, hardware and connectivity standards is creating paralysis among businesses that are afraid of being locked into a solution. EdgeX Foundry is unifying the community around a common IoT edge framework and an ecosystem of interoperable components.
SYS-CON Events announced today that N3N will exhibit at SYS-CON's @ThingsExpo, which will take place on Oct 31 – Nov 2, 2017, at the Santa Clara Convention Center in Santa Clara, CA. N3N’s solutions increase the effectiveness of operations and control centers, increase the value of IoT investments, and facilitate real-time operational decision making. N3N enables operations teams with a four dimensional digital “big board” that consolidates real-time live video feeds alongside IoT sensor data a...