Neurocrine Biosciences Reports Fourth Quarter And Year End 2013 Results - 21 News Now, More Local News for Youngstown, Ohio -

Neurocrine Biosciences Reports Fourth Quarter And Year End 2013 Results

  • More NewsMore>>

  • Themes for WaterFire Sharon announced

    Themes for WaterFire Sharon announced

    SHARON, Pa. - WaterFire Sharon will return this summer to the Shenango River. The three big events will have several themes.  The theme on July 19th will be "Elements", August 23rd's theme will be "Origins"More >>
    SHARON, Pa. - WaterFire Sharon will return this summer to the Shenango River. The three big events will have several themes.  The theme on July 19th will be "Elements", August 23rd's theme will be "Origins"More >>
  • Hundreds expected to help with clean up of Dave Grohl Alley

    Hundreds expected to help with clean up of Dave Grohl Alley

    WARREN, Ohio - Hundreds are expected to show up in Warren on Saturday to take part in clean-up effort, after a vandal was caught on camera damaging a tribute to a Warren-born musician.From noon until 4More >>
    WARREN, Ohio - Hundreds are expected to show up in Warren on Saturday to take part in a clean-up effort, after a vandal was caught on camera damaging a tribute to a Warren-born musician.More >>
  • Motorists reminded of more Amish buggies on the roads

    Motorists reminded of more Amish buggies on the roads

    LISBON, Ohio - Orange barrels won't be the only thing motorists will have to watch for while traveling throughout Columbiana County.  Vehicles are often using the same lanes as Amish buggies and localMore >>
    LISBON, Ohio - Orange barrels won't be the only thing motorists will have to watch for while traveling throughout Columbiana County.More >>

Information contained on this page is provided by an independent third-party content provider. WorldNow and this Station make no warranties or representations in connection therewith. If you have any questions or comments about this page please contact pressreleases@worldnow.com.

SOURCE Neurocrine Biosciences, Inc.

PROVIDES UPDATE ON RAPIDLY ADVANCING PIPELINE AND FINANCIAL GUIDANCE FOR 2014

SAN DIEGO, Feb. 6, 2014 /PRNewswire/ -- Neurocrine Biosciences, Inc. (NASDAQ: NBIX) today announced its financial results for the quarter and year ended December 31, 2013.

For the fourth quarter of 2013, the Company reported a net loss of $10.6 million, or $0.16 loss per share, compared to net income of $9.5 million, or income of $0.14 per fully diluted share, for the same period in 2012. For the year ended December 31, 2013, the Company reported a net loss of $46.1 million, or $0.69 loss per share, as compared to net income of $5.0 million, or income of $0.08 per fully diluted share, for 2012. The change in operating results from 2012 to 2013 is due to the successful completion of the sponsored research and development phases of the Company's license agreements with both AbbVie and Boehringer Ingelheim during 2012, as scheduled.

The Company's balance sheet at December 31, 2013 reflected total assets of $154.7 million, including cash, investments and receivables of $146.8 million compared with balances at December 31, 2012 of $196.0 million and $188.3 million, respectively.

"During the last twelve months we have made great progress across our clinical pipeline. Our VMAT2 program has recently successfully completed Phase II and we are now looking forward to an End-of-Phase II meeting with the FDA, while our partner AbbVie initiated the second of two Phase III trials of elagolix in endometriosis as well as a Phase IIb uterine fibroids study," said Kevin C. Gorman, President and CEO of Neurocrine Biosciences. "Looking forward to 2014 we see another year of significant growth with important data points for our two lead clinical programs as well as several promising compounds that have the potential to further strengthen our clinical pipeline."

Revenues for the fourth quarter of 2013 were $0.7 million, compared to $21.9 million for the same period in 2012. Revenues for the year ended December 31, 2013 were $2.9 million, compared with $53.1 million for the year ended December 31, 2012. The decrease in revenue is due to the successful and timely completion of the sponsored research and development phases of the Company's license agreements during 2012.

Research and development expenses decreased to $8.9 million during the fourth quarter of 2013, compared with $9.1 million for the same period in 2012. For the year ended December 31, 2013, research and development expenses were $39.2 million, compared to $37.2 million for 2012. The year-over-year increase in research and development expenses was primarily driven by Phase IIb development expenses for the VMAT2 program, coupled with increased compensation related costs, primarily due to share-based compensation.

2014 Financial Guidance

The Company expects to have a net cash burn of approximately $43 million to $47 million in 2014. Expenses for 2014 should approximate $60 million to $64 million. The anticipated increase in expenses over 2013 levels is primarily due to an increase in research and development efforts as well as higher share-based compensation expense. Net loss for 2014 is expected to be $56 million to $61 million, or $0.82 to $0.90 loss per share based on 68 million basic shares outstanding. The Company expects to end 2014 with approximately $100 million in cash, investments and receivables.

Pipeline Highlights

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.

AbbVie has also initiated the second Phase III study of elagolix for endometriosis. 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.

AbbVie is also currently conducting a Phase IIb study of elagolix in uterine fibroids. This study is assessing uterine blood loss in 520 women with heavy uterine bleeding due to uterine fibroids.

VMAT2 Update

The Company is utilizing the Kinect and Kinect 2 datasets to compile the End-of-Phase II briefing package along with a proposed Phase III protocol for submission to the FDA in the second quarter of 2014.

The Company also anticipates the End-of-Phase-II meeting for NBI-98854 in tardive dyskinesia to be held with the FDA in the second quarter of 2014. Upon completion of this meeting, the Company anticipates initiating the pivotal Phase III program of NBI-98854 during the second half of 2014.

Additionally, the Company is conducting appropriate preclinical studies to support the advancement of NBI-98854 into clinical trials for individuals suffering from Tourette syndrome, and expects to open the investigational new drug application for Tourette syndrome in 2014.

Conference Call and Webcast Today at 5:00 PM Eastern Time
Neurocrine will hold a live conference call and webcast today at 5:00 p.m. Eastern Time (2:00 p.m. Pacific Time). Participants can access the live conference call by dialing 800-862-9098 (US) or 785-424-1051 (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 (858) 617-7600. A replay of the conference call will be available approximately one hour after the conclusion of the call by dialing 800-723-8184 (US) or 402-220-2668 (International) using the conference ID: NBIX. The call will be archived for two weeks.

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 business and finances in general, as well as risks and uncertainties associated with the Company's R & D pipeline and the Company overall. Specifically, the risks and uncertainties the Company faces with respect to the Company's R & D pipeline include risk that elagolix, the company's lead clinical program, will fail to demonstrate that elagolix is safe and effective; risk that elagolix Phase III clinical trials will be delayed for regulatory or other reasons; and risks associated with the Company's dependence on corporate collaborators for Phase III development, commercial manufacturing and marketing and sales activities. Similarly, the Company faces risk that the clinical studies for NBI-98854, the company's VMAT2 inhibitor candidate, will fail to demonstrate that NBI-98854 is safe and effective and risk that NBI-98854 will not proceed to later stage clinical trials. 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 clinical candidates will not be found to be safe and effective; and risk that the Company's research programs will not identify pre-clinical candidates for further development. With respect to the Company 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 contract manufacturers for clinical drug supply; risk associated with the Company's dependence on corporate collaborators for commercial manufacturing and marketing and sales activities; uncertainties relating to patent protection and intellectual property rights of third parties; risk and uncertainties relating to competitive products and technological changes that may limit demand for the Company's products; and the other risks described in the Company's annual report on Form 10-K for the year ended December 31, 2012 and quarterly reports on Form 10-Q for the quarters ended March 31, 2013, June 30, 2013 and September 30, 2013. 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

December 31,

Year Ended

December 31,


2013

2012

2013

2012

Revenues:





Sponsored research and development

$               -

$      13,959

$                 -

$       18,897

Milestones and license fees

730

7,988

2,919

34,243






Total revenues

730

21,947

2,919

53,140

Operating expenses:





Research and development

8,918

9,097

39,248

37,163

General and administrative

3,342

3,311

13,349

13,437

Cease-use expense

-

957

-

1,092






Total operating expenses

12,260

13,365

52,597

51,692






(Loss) income from operations

(11,530)

8,582

(49,678)

1,448

Other income:





(Loss) gain on sale/disposal of assets

(1)

7

37

32

Deferred gain on real estate

789

766

3,133

3,042

Investment income, net

85

130

402

489

Other income, net

15

5

16

14






Total other income

888

908

3,588

3,577






Net (loss) income

$   (10,642)

$        9,490

$    (46,090)

$         5,025






Net (loss) income per common share:





Basic

$       (0.16)

$          0.14

$        (0.69)

$           0.08






Diluted

$       (0.16)

$          0.14

$        (0.69)

$           0.08






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





Basic

67,346

66,406

66,989

65,619






Diluted

67,346

67,720

66,989

66,946






 

NEUROCRINE BIOSCIENCES, INC

CONDENSED CONSOLIDATED BALANCE SHEETS

(in thousands)

(unaudited)






December 31,

2013

December 31,

2012

Cash, cash equivalents and short-term marketable securities

$       145,739

$       173,013

Other current assets

2,723

16,251




Total current assets

148,462

189,264

Property and equipment, net

1,771

1,900

Long-term investments

-

480

Restricted cash

4,443

4,335




Total assets

$       154,676

$       195,979







Current liabilities

$         11,699

$         15,646

Long-term liabilities

22,567

25,961

Stockholders' equity

120,410

154,372




Total liabilities and stockholders' equity

$       154,676

$       195,979




 

©2012 PR Newswire. All Rights Reserved.

  • Around the WebMore>>

  • Ohio teacher fired over comment on black president

    Ohio teacher fired over comment on black president

    CINCINNATI (AP) - An Ohio teacher has been fired following allegations that he told a black student who said he wanted to become president that the nation didn't need another black president.The Cincinnati Enquirer reports (http://cin.ci/1kIkFmQ ) the Fairfield Board of Education voted 4-0 on Thursday to fire science teacher Gil Voigt.Voigt didn't immediately return a call for comment Friday but has said the student misquoted him.Voigt, who is white, says what he actually told the teen was th...More >>
    CINCINNATI (AP) - An Ohio teacher has been fired following allegations that he told a black student who said he wanted to become president that the nation didn't need another black president.The Cincinnati Enquirer reports (http://cin.ci/1kIkFmQ ) the Fairfield Board of Education voted 4-0 on Thursday to fire science teacher Gil Voigt.Voigt didn't immediately return a call for comment Friday but has said the student misquoted him.Voigt, who is white, says what he actually told the teen was th...More >>
  • 13-1/2 pound boy born at southeastern Pa. hospital

    13-1/2 pound boy born at southeastern Pa. hospital

    Saturday, April 19 2014 8:54 PM EDT2014-04-20 00:54:06 GMT
    DREXEL HILL, Pa. (AP) - A woman has given birth to a more than 13-pound baby at a southeastern Pennsylvania hospital.Officials at Delaware County Memorial Hospital say Brian and Danielle Dwyer's son born Monday is the largest baby they can recall there.Waldo James Mysterious Dwyer tipped the scales at 13 pounds, 8-1/2 ounces.The couple loved the "Where's Waldo?" books as children, so that's where they got their son's first name.Brian Dwyer said the middle name Mysterious is because Waldo was ...More >>
    DREXEL HILL, Pa. (AP) - A woman has given birth to a more than 13-pound baby at a southeastern Pennsylvania hospital.Officials at Delaware County Memorial Hospital say Brian and Danielle Dwyer's son born Monday is the largest baby they can recall there.Waldo James Mysterious Dwyer tipped the scales at 13 pounds, 8-1/2 ounces.The couple loved the "Where's Waldo?" books as children, so that's where they got their son's first name.Brian Dwyer said the middle name Mysterious is because Waldo was ...More >>
  • Teen suspended for asking Miss America to prom

    Teen suspended for asking Miss America to prom

    Saturday, April 19 2014 8:44 PM EDT2014-04-20 00:44:23 GMT
    YORK, Pa. (AP) - A Pennsylvania high school student is in hot water for asking Miss America to prom during a question and answer session at school.Eighteen-year-old Patrick Farves said he received three days of in-school suspension Thursday because he asked Nina Davuluri to prom.The senior at Central York High School stood up and popped the prom question, then walked to the stage with a plastic flower. Davuluri just laughed and the students cheered.School officials heard about Farves' plan in...More >>
    YORK, Pa. (AP) - A Pennsylvania high school student is in hot water for asking Miss America to prom during a question and answer session at school.Eighteen-year-old Patrick Farves said he received three days of in-school suspension Thursday because he asked Nina Davuluri to prom.The senior at Central York High School stood up and popped the prom question, then walked to the stage with a plastic flower. Davuluri just laughed and the students cheered.School officials heard about Farves' plan in...More >>
Powered by WorldNow
All content © Copyright 2000 - 2014 Worldnow and WFMJ. All Rights Reserved. For more information on this site, please read our Privacy Policy and Terms