Neurocrine Biosciences Reports First Quarter 2001 Results; Company Updates Progress in Clinical & Research Pipeline

Apr 30, 2001, 01:00 ET from Neurocrine Biosciences, Inc.

    SAN DIEGO, April 30 /PRNewswire/ --
 Neurocrine Biosciences, Inc. (Nasdaq:   NBIX) today announced its financial
 results for the first quarter ended March 31, 2001.  The Company reported a
 net loss of $11.5 million, or $0.45 per share, for the three months ended
 March 31, 2001 compared with $6.0 million, or $0.28 per share, for the
 respective period in 2000.
     Revenues rose 25% to $3.5 million for the first quarter 2001 as compared
 with $2.8 million for the respective period last year.  The increase in
 revenues from last year to this year resulted primarily from revenues received
 under the Taisho Pharmaceuticals agreement.
     Research and development expenses increased to $15.2 million for the first
 quarter 2001 compared with $7.8 million for the respective period in 2000.
 General and administration expenses increased slightly to $2.4 million for the
 first quarter 2001 compared with $2.2 million during the same period last
 year.  Increased expenses primarily reflect higher costs associated with
 expanding development activities and the addition of scientific personnel.
 Currently, the company has 15 ongoing programs in its research and development
 pipeline as compared to 12 programs at this time last year.  Five of these
 programs are in clinical development, three programs are in advanced
 pre-clinical development expected to enter human clinical trials in 2001 and
 seven programs in various stages of research.
     The Company's balance sheet on March 31, 2001 reflected total assets of
 $172.8 million, including cash, cash equivalents, marketable securities and
 accounts receivable of $156.9 million compared with balances at December 31,
 2000 of $186.0 million and $170.6 million, respectively.  The decline in cash,
 cash equivalents, marketable securities and accounts receivable represents
 funding of current period clinical development projects and the addition of
 scientific personnel.
     "We are especially pleased with both the first quarter financial results,
 which were better than expected, and with the continued progress of our
 clinical development programs.  We are currently poised to initiate Phase III
 studies, the final clinical phase of development, for two of our products
 later this year.  During the first quarter Neurocrine announced positive
 clinical trial results in sedative activity of NBI-34060 for insomnia.
 Neurocrine's development team also selected a modified release (MR)
 formulation of NBI-34060 for sleep maintenance.  The two formulations of
 NBI-34060 (immediate release and modified release) are designed to address the
 needs of the entire insomnia population: for sleep initiation, night
 awakenings and sleep maintenance," stated Paul Hawran, Executive Vice
 President and Chief Financial Officer of Neurocrine Biosciences.
     "Results of a Phase II clinical trial comparing NBI-34060, Ambien(TM) and
 zopiclone relative to placebo during Middle of the Night (MOTN) dosing
 demonstrated that NBI-34060 does not lead to next-day hangover effects while
 both Ambien(TM) and zopiclone exhibited statistically significant measures of
 next-day adverse side effects of residual sedation.  Results of Phase I
 pharmacokinetic studies demonstrated that NBI-34060 works as a sedative-
 hypnotic with no major differences in the pharmacokinetics between young
 adults and elderly subjects in a randomized, double-blind, placebo-controlled
 clinical study with multiple doses of NBI-34060 nor are there differences in
 the pharmacokinetics in males and females.  We have successfully completed
 enrolling 14 clinical studies involving over 830 subjects to date and based on
 preliminary data are preparing for pivotal Phase III trials for NBI-34060
 starting in Q3 2001.  We expect to announce the results of the ongoing Phase
 II clinical trials in patient populations with transient and chronic insomnia
 at the end of the second quarter of this year," added Hawran.
 
     Additional Clinical Development Progress:
 
     -- Neurocrine continued enrollment in its Phase I/II clinical trial for
        Glioblastoma and is on track to complete this study and initiate Phase
        III studies later this year.
     -- Neurocrine announced the expansion of its clinical program for NBI-6024
        in Type I diabetes to the United States and that the Company will
        initiate Phase IIB trials in early second half of 2001.
     -- Neurocrine announced positive Phase I clinical trial results with its
        proprietary CRF1 receptor antagonist compound for depression and
        anxiety.  This Phase I randomized, double-blind, placebo-controlled,
        single-dose trial was conducted in 48 normal healthy volunteers and was
        designed to evaluate the safety, tolerability, pharmacokinetics and
        pharmacodynamics, including endocrine profiles over a wide range of six
        escalating doses.  Initial pharmacokinetic evaluation indicated rapid
        absorption, linear dose-proportionality with no safety issues.
     -- Neurocrine scientists presented data on its GnRH small molecule
        antagonist program at a peer review scientific meeting in Switzerland.
        In this presentation, it was reported that they have developed potent
        orally active compounds for the modulation for the reduction of hormone
        levels in the treatment of endometriosis, fibroids and prostate cancer.
        A development candidate has been selected and the Company expects to
        initiate Phase I clinical studies later this year.
 
     Hawran continued, "In our research pipeline we have developed accelerated
 processes to identify and develop high potential, high value compounds to
 deliver three new drug candidates over the next five years.  While Neurocrine
 uses all of the traditional technologies of drug discovery, we have taken
 science to the next step, with a new technology we call Multi-Channel
 Discovery or MCD(TM).  MCD(TM) is a system applied to drug design, which is
 driven by the power of traditional medicinal chemistry and accelerated by
 computational methodologies to guide the synthesis of highly active small
 molecules for a specific molecular target, importantly, derived from multiple
 series."
     "We have made important scientific advances in our seven research programs
 focusing on CNS, psychiatric and metabolic therapeutic areas.  Neurocrine
 scientists continue to develop new targets and are also exploiting new
 indications for our existing technologies such as CRF receptor antagonists for
 additional stress related diseases such as irritable bowel syndrome and IL-4
 fusion toxin (NBI-3001) for peripheral cancers," added Hawran.
 
     Neurocrine Biosciences, Inc. is a product-based biopharmaceutical company
 focused on neurologic and endocrine diseases and disorders.  Our product
 candidates address some of the largest pharmaceutical markets in the world
 including insomnia, anxiety, depression, cancer and diabetes.
     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 contains 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 research and development programs and business
 and finances including, but not limited to, risks and uncertainties associated
 with, or arising out of, drug discovery, pre-clinical and clinical development
 of products including risk that research may not generate development
 candidates, development candidates will not successfully proceed through early
 clinical trials or that in later stage clinical trials will not show that they
 are effective in treating humans; determinations by regulatory and
 governmental authorities; changes in relationships with strategic partners and
 dependence upon strategic partners for performance of clinical and
 commercialization activities under collaborative agreements including
 potential for any collaboration agreement to be terminated without any product
 success; uncertainties relating to patent protection and intellectual property
 rights of third parties; impact of competitive products and technological
 changes; availability of capital and cost of capital; and other material
 risks.  A more complete description of these risks can be found in the
 Company's Form 10K for the year ended December 31, 2000 and the current form
 10Q each of which should be read before making any investment in Neurocrine
 common stock.  Neurocrine undertakes no obligation to update the statements
 contained in this press release after the date hereof.
 
 
                          NEUROCRINE BIOSCIENCES, INC.
                            Statement of Operations
            (unaudited; in thousands except for loss per share data)
 
                                                    Three Months Ended
                                                         March 31,
                                                    2001           2000
     Revenues:
       Sponsored research and development         $2,965         $1,522
       License and option fees                       229          1,000
       Grant income and other revenues               294            256
         Total revenues                            3,488          2,778
 
     Operating expenses:
       Research and development                   15,190          7,771
       General and administrative                  2,377          2,233
         Total operating expenses                 17,567         10,004
 
     Loss from operations                        (14,079)        (7,226)
 
     Other income and (expenses):
       Interest and other income, net              2,533          1,514
       Other income and expenses, net                 83           (135)
 
     Loss before taxes                           (11,463)        (5,847)
     Income taxes                                    $--            200
 
     Net loss                                   $(11,463)       $(6,047)
     Loss per common share:
       Basic and diluted                          $(0.45)        $(0.28)
 
     Shares used in the calculation of
      loss per common share:
       Basic and diluted                          25,407         21,771
 
 
                                   Balance Sheet
                                   (in thousands)
 
                                                March 31,    December 31,
                                                  2001           2000
                                               (unaudited)
     Cash, cash equivalents
      and marketable securities                 $155,689       $164,670
     Other current assets                          3,195          7,735
         Total current assets                    158,884        172,405
 
     Property and equipment, net                  11,510         11,300
     Other assets                                  2,443          2,257
         Total assets                           $172,837       $185,962
 
     Current liabilities                         $12,093        $14,959
     Long-term liabilities                         7,452          7,795
     Stockholders' equity                        153,292        163,208
         Total liabilities and
          stockholders' equity                  $172,837       $185,962
 
                     MAKE YOUR OPINION COUNT -  Click Here
                http://tbutton.prnewswire.com/prn/11690X64381654
 
 

SOURCE Neurocrine Biosciences, Inc.
    SAN DIEGO, April 30 /PRNewswire/ --
 Neurocrine Biosciences, Inc. (Nasdaq:   NBIX) today announced its financial
 results for the first quarter ended March 31, 2001.  The Company reported a
 net loss of $11.5 million, or $0.45 per share, for the three months ended
 March 31, 2001 compared with $6.0 million, or $0.28 per share, for the
 respective period in 2000.
     Revenues rose 25% to $3.5 million for the first quarter 2001 as compared
 with $2.8 million for the respective period last year.  The increase in
 revenues from last year to this year resulted primarily from revenues received
 under the Taisho Pharmaceuticals agreement.
     Research and development expenses increased to $15.2 million for the first
 quarter 2001 compared with $7.8 million for the respective period in 2000.
 General and administration expenses increased slightly to $2.4 million for the
 first quarter 2001 compared with $2.2 million during the same period last
 year.  Increased expenses primarily reflect higher costs associated with
 expanding development activities and the addition of scientific personnel.
 Currently, the company has 15 ongoing programs in its research and development
 pipeline as compared to 12 programs at this time last year.  Five of these
 programs are in clinical development, three programs are in advanced
 pre-clinical development expected to enter human clinical trials in 2001 and
 seven programs in various stages of research.
     The Company's balance sheet on March 31, 2001 reflected total assets of
 $172.8 million, including cash, cash equivalents, marketable securities and
 accounts receivable of $156.9 million compared with balances at December 31,
 2000 of $186.0 million and $170.6 million, respectively.  The decline in cash,
 cash equivalents, marketable securities and accounts receivable represents
 funding of current period clinical development projects and the addition of
 scientific personnel.
     "We are especially pleased with both the first quarter financial results,
 which were better than expected, and with the continued progress of our
 clinical development programs.  We are currently poised to initiate Phase III
 studies, the final clinical phase of development, for two of our products
 later this year.  During the first quarter Neurocrine announced positive
 clinical trial results in sedative activity of NBI-34060 for insomnia.
 Neurocrine's development team also selected a modified release (MR)
 formulation of NBI-34060 for sleep maintenance.  The two formulations of
 NBI-34060 (immediate release and modified release) are designed to address the
 needs of the entire insomnia population: for sleep initiation, night
 awakenings and sleep maintenance," stated Paul Hawran, Executive Vice
 President and Chief Financial Officer of Neurocrine Biosciences.
     "Results of a Phase II clinical trial comparing NBI-34060, Ambien(TM) and
 zopiclone relative to placebo during Middle of the Night (MOTN) dosing
 demonstrated that NBI-34060 does not lead to next-day hangover effects while
 both Ambien(TM) and zopiclone exhibited statistically significant measures of
 next-day adverse side effects of residual sedation.  Results of Phase I
 pharmacokinetic studies demonstrated that NBI-34060 works as a sedative-
 hypnotic with no major differences in the pharmacokinetics between young
 adults and elderly subjects in a randomized, double-blind, placebo-controlled
 clinical study with multiple doses of NBI-34060 nor are there differences in
 the pharmacokinetics in males and females.  We have successfully completed
 enrolling 14 clinical studies involving over 830 subjects to date and based on
 preliminary data are preparing for pivotal Phase III trials for NBI-34060
 starting in Q3 2001.  We expect to announce the results of the ongoing Phase
 II clinical trials in patient populations with transient and chronic insomnia
 at the end of the second quarter of this year," added Hawran.
 
     Additional Clinical Development Progress:
 
     -- Neurocrine continued enrollment in its Phase I/II clinical trial for
        Glioblastoma and is on track to complete this study and initiate Phase
        III studies later this year.
     -- Neurocrine announced the expansion of its clinical program for NBI-6024
        in Type I diabetes to the United States and that the Company will
        initiate Phase IIB trials in early second half of 2001.
     -- Neurocrine announced positive Phase I clinical trial results with its
        proprietary CRF1 receptor antagonist compound for depression and
        anxiety.  This Phase I randomized, double-blind, placebo-controlled,
        single-dose trial was conducted in 48 normal healthy volunteers and was
        designed to evaluate the safety, tolerability, pharmacokinetics and
        pharmacodynamics, including endocrine profiles over a wide range of six
        escalating doses.  Initial pharmacokinetic evaluation indicated rapid
        absorption, linear dose-proportionality with no safety issues.
     -- Neurocrine scientists presented data on its GnRH small molecule
        antagonist program at a peer review scientific meeting in Switzerland.
        In this presentation, it was reported that they have developed potent
        orally active compounds for the modulation for the reduction of hormone
        levels in the treatment of endometriosis, fibroids and prostate cancer.
        A development candidate has been selected and the Company expects to
        initiate Phase I clinical studies later this year.
 
     Hawran continued, "In our research pipeline we have developed accelerated
 processes to identify and develop high potential, high value compounds to
 deliver three new drug candidates over the next five years.  While Neurocrine
 uses all of the traditional technologies of drug discovery, we have taken
 science to the next step, with a new technology we call Multi-Channel
 Discovery or MCD(TM).  MCD(TM) is a system applied to drug design, which is
 driven by the power of traditional medicinal chemistry and accelerated by
 computational methodologies to guide the synthesis of highly active small
 molecules for a specific molecular target, importantly, derived from multiple
 series."
     "We have made important scientific advances in our seven research programs
 focusing on CNS, psychiatric and metabolic therapeutic areas.  Neurocrine
 scientists continue to develop new targets and are also exploiting new
 indications for our existing technologies such as CRF receptor antagonists for
 additional stress related diseases such as irritable bowel syndrome and IL-4
 fusion toxin (NBI-3001) for peripheral cancers," added Hawran.
 
     Neurocrine Biosciences, Inc. is a product-based biopharmaceutical company
 focused on neurologic and endocrine diseases and disorders.  Our product
 candidates address some of the largest pharmaceutical markets in the world
 including insomnia, anxiety, depression, cancer and diabetes.
     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 contains 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 research and development programs and business
 and finances including, but not limited to, risks and uncertainties associated
 with, or arising out of, drug discovery, pre-clinical and clinical development
 of products including risk that research may not generate development
 candidates, development candidates will not successfully proceed through early
 clinical trials or that in later stage clinical trials will not show that they
 are effective in treating humans; determinations by regulatory and
 governmental authorities; changes in relationships with strategic partners and
 dependence upon strategic partners for performance of clinical and
 commercialization activities under collaborative agreements including
 potential for any collaboration agreement to be terminated without any product
 success; uncertainties relating to patent protection and intellectual property
 rights of third parties; impact of competitive products and technological
 changes; availability of capital and cost of capital; and other material
 risks.  A more complete description of these risks can be found in the
 Company's Form 10K for the year ended December 31, 2000 and the current form
 10Q each of which should be read before making any investment in Neurocrine
 common stock.  Neurocrine undertakes no obligation to update the statements
 contained in this press release after the date hereof.
 
 
                          NEUROCRINE BIOSCIENCES, INC.
                            Statement of Operations
            (unaudited; in thousands except for loss per share data)
 
                                                    Three Months Ended
                                                         March 31,
                                                    2001           2000
     Revenues:
       Sponsored research and development         $2,965         $1,522
       License and option fees                       229          1,000
       Grant income and other revenues               294            256
         Total revenues                            3,488          2,778
 
     Operating expenses:
       Research and development                   15,190          7,771
       General and administrative                  2,377          2,233
         Total operating expenses                 17,567         10,004
 
     Loss from operations                        (14,079)        (7,226)
 
     Other income and (expenses):
       Interest and other income, net              2,533          1,514
       Other income and expenses, net                 83           (135)
 
     Loss before taxes                           (11,463)        (5,847)
     Income taxes                                    $--            200
 
     Net loss                                   $(11,463)       $(6,047)
     Loss per common share:
       Basic and diluted                          $(0.45)        $(0.28)
 
     Shares used in the calculation of
      loss per common share:
       Basic and diluted                          25,407         21,771
 
 
                                   Balance Sheet
                                   (in thousands)
 
                                                March 31,    December 31,
                                                  2001           2000
                                               (unaudited)
     Cash, cash equivalents
      and marketable securities                 $155,689       $164,670
     Other current assets                          3,195          7,735
         Total current assets                    158,884        172,405
 
     Property and equipment, net                  11,510         11,300
     Other assets                                  2,443          2,257
         Total assets                           $172,837       $185,962
 
     Current liabilities                         $12,093        $14,959
     Long-term liabilities                         7,452          7,795
     Stockholders' equity                        153,292        163,208
         Total liabilities and
          stockholders' equity                  $172,837       $185,962
 
                     MAKE YOUR OPINION COUNT -  Click Here
                http://tbutton.prnewswire.com/prn/11690X64381654
 
 SOURCE  Neurocrine Biosciences, Inc.

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