1. SAN DIEGO, Sept. 10, 2021 /PRNewswire/ -- Neurocrine Biosciences, Inc. (NASDAQ:NBIX) today announced that it will present new data from its movement disorder treatments for tardive dyskinesia (TD) and Parkinson's disease at the International Parkinson and Movement Disorder Society's (MDS) Virtual Congress 2021 being held September 17–22, 2021.

    Data include a post hoc analysis from KINECT 4, a long-term Phase 3 study, demonstrating robust clinically meaningful reductions in TD symptoms at 48 weeks with once-daily INGREZZA® (valbenazine) capsules. Data show some patients met the criteria for TD remission within one year of once-daily INGREZZA treatment. Additionally, an oral presentation will introduce a new pooled data analysis from the BIPARK-1 and BIPARK-2 Phase 3 studies evaluating effects on sleep of ONGENTYS® (opicapone) compared to placebo in people with Parkinson's disease and motor fluctuations. Further, a poster presentation will feature new data from a Phase 1 open-label study assessing the effect of ONGENTYS on levodopa levels when administered as a once-daily add-on therapy to oral levodopa/carbidopa extended-release capsules, the first study to evaluate both formulations together.

    "We look forward to sharing data that helps further characterize the real-world experience of patients treated with INGREZZA and ONGENTYS with the movement disorder neurology community," said Eiry W. Roberts, M.D., Chief Medical Officer at Neurocrine Biosciences. "The analyses presented reflect our commitment to better understanding the unmet needs of individuals living with the complex and debilitating disorders of tardive dyskinesia and Parkinson's disease." 

    Presentations include:

    INGREZZA – Tardive Dyskinesia

    • Impacts of Tardive Dyskinesia (TD) Symptoms on Patients: Analysis of a TD-Specific Patient-Reported Outcome (Poster # 89)
    • Patterns of Improvement with Valbenazine in Patients with Tardive Dyskinesia (Poster # 346)
    • Reanalysis of a Patient-Reported Outcome (Tardive Dyskinesia Impact Scale) Shows Positive Results (Poster # 88)

    ONGENTYS – Parkinson's Disease (in collaboration with BIAL)

    • Effects of Opicapone on Sleep Patterns in Patients with Parkinson's Disease and Motor Fluctuations (Poster # 396)
    • Effects of Once-Daily Opicapone 50 mg on the Pharmacokinetics of Levodopa Administered as Carbidopa/Levodopa Extended-Release Capsules: An Open-Label Phase 1 Study (Poster # 507)
    • Evaluating Patients' Preferences for Parkinson's Disease Treatments (Poster # 337)
    • A Longitudinal Real-World Study of Opicapone in Patients with Parkinson's Disease and Motor Fluctuations (Poster # 410)

    A full list of all abstracts being presented by Neurocrine Biosciences at the MDS Virtual Congress 2021 are available here.

    About Tardive Dyskinesia (TD)

    Tardive dyskinesia (TD) is a movement disorder that is characterized by uncontrollable, abnormal and repetitive movements of the face, torso and/or other body parts, which may be disruptive and negatively impact patients. The condition is associated with taking certain kinds of mental health medicines (like antipsychotics) that help control dopamine receptors in the brain. Antipsychotics commonly prescribed to treat mental illnesses such as depression, bipolar disorder, schizophrenia and schizoaffective disorder, and certain medications to treat upset stomach, nausea and vomiting may also cause TD. In patients with TD, these treatments are thought to result in irregular dopamine signaling in a region of the brain that controls movement. The symptoms of TD can be severe and are often persistent and irreversible. TD is estimated to affect approximately 600,000 people in the U.S.

    About INGREZZA® (valbenazine) Capsules 

    INGREZZA, a selective vesicular monoamine transporter 2 (VMAT2) inhibitor, is an FDA-approved product indicated for the treatment of adults with tardive dyskinesia, a condition associated with uncontrollable, abnormal and repetitive movements of the face, torso and/or other body parts. 

    INGREZZA is thought to work by reducing the amount of dopamine released in a region of the brain that controls movement and motor function, helping to regulate nerve signaling in adults with tardive dyskinesia. VMAT2 is a protein in the brain that packages neurotransmitters, such as dopamine, for transport and release in presynaptic neurons. INGREZZA, developed by Neurocrine Biosciences, is novel in that it selectively inhibits VMAT2 with no appreciable binding affinity for VMAT1, dopaminergic (including D2), serotonergic, adrenergic, histaminergic or muscarinic receptors. Additionally, INGREZZA can be taken for the treatment of tardive dyskinesia as one capsule, once-daily, together with most psychiatric medications such as antipsychotics or antidepressants. 

    Important Information

    Approved Use 

    INGREZZA® (valbenazine) capsules is a prescription medicine used to treat adults with movements in the face, tongue, or other body parts that cannot be controlled (tardive dyskinesia). 

    It is not known if INGREZZA is safe and effective in children. 

    IMPORTANT SAFETY INFORMATION 

    Do not take INGREZZA if you:

    • are allergic to valbenazine, or any of the ingredients in INGREZZA. 

    INGREZZA may cause serious side effects, including

    • Sleepiness (somnolence). Do not drive, operate heavy machinery, or do other dangerous activities until you know how INGREZZA affects you. 
    • Heart rhythm problems (QT prolongation). INGREZZA may cause a heart problem known as QT prolongation. 

      Symptoms of QT prolongation may include:
      • fast, slow, or irregular heartbeat
      • shortness of breath
      • dizziness or fainting
    • Tell your healthcare provider right away if you have a change in your heartbeat (a fast or irregular heartbeat), or if you faint.
    • Abnormal movements (Parkinson-like). Symptoms include: shaking, body stiffness, trouble moving or walking, or keeping your balance.

    Before taking INGREZZA, tell your healthcare provider about all of your medical conditions including if you: have liver or heart problems, are pregnant or plan to become pregnant, or are breastfeeding or plan to breastfeed. 

    Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins and herbal supplements. 

    The most common side effect of INGREZZA is sleepiness (somnolence). Other side effects include changes in balance (balance problems, dizziness) or an increased risk of falls, headache, feelings of restlessness, dry mouth, constipation, and blurred vision. 

    These are not all of the possible side effects of INGREZZA. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. 

    Please see accompanying INGREZZA full Product Information.  

    About Parkinson's Disease

    Parkinson's disease is a chronic, progressive and debilitating neurodegenerative disorder that affects approximately 1 million people in the U.S. and 6 million people worldwide. Parkinson's disease is associated with low dopamine levels produced in the brain. Dopamine helps transmit signals between the areas of the brain that control all purposeful movements, including talking, walking and writing. As Parkinson's disease progresses, dopamine production steadily decreases, resulting in increased problems with motor symptoms including slowed movement (bradykinesia), tremor, rigidity, impaired posture and balance, and difficulty with speech and writing.

    There is presently no cure for Parkinson's disease and management of the disease consists of the use of treatments that attempt to control motor symptoms primarily through dopaminergic mechanisms. The current gold standard for treatment of motor symptoms is levodopa/carbidopa. While levodopa/carbidopa improves patients' motor symptoms, as the disease progresses, the beneficial effects of levodopa begin to wear off more quickly. Patients then experience motor fluctuations throughout the day between "on" time, periods when the medication is working and Parkinson's disease symptoms are controlled, and "off" time, when the medication is not working and motor symptoms return.

    About ONGENTYS® (opicapone) Capsules 

    ONGENTYS is a once-daily, oral, peripheral, selective and reversible catechol-O-methyltransferase (COMT) inhibitor approved by the U.S. Food and Drug Administration (FDA) as an add-on treatment to levodopa/carbidopa in patients with Parkinson's disease experiencing "off" episodes. ONGENTYS inhibits the COMT enzyme, which breaks down levodopa, making more levodopa available to reach the brain.

    In June 2016, BIAL – Portela & CA, S.A. (BIAL) received approval from the European Commission for ONGENTYS as an adjunct therapy to preparations of levodopa/DOPA decarboxylase inhibitors in adult patients with Parkinson's disease and end-of-dose motor fluctuations who cannot be stabilized on those combinations. BIAL currently markets ONGENTYS in several European countries. Neurocrine Biosciences in-licensed opicapone from BIAL in 2017 and has exclusive development and commercialization rights in the U.S. and Canada.

    Important Information

    Approved Use

    ONGENTYS® (opicapone) capsules is a prescription medicine used with levodopa and carbidopa in people with Parkinson's disease (PD) who are having "OFF" episodes.

    It is not known if ONGENTYS is safe and effective in children.

    Important Safety Information

    Do not take ONGENTYS if you:

    • take a type of medicine called a non-selective monoamine-oxidase (MAO) inhibitor.
    • have a tumor that secretes hormones known as catecholamines.

    Before taking ONGENTYS, tell your healthcare provider about all of your medical conditions, including if you:

    • have daytime sleepiness from a sleep disorder, have unexpected periods of sleep or sleepiness, or take a medicine to help you sleep or that makes you feel sleepy.
    • have had intense urges or unusual behaviors, including gambling, increased sex drive, binge eating, or compulsive shopping.
    • have a history of uncontrolled sudden movements (dyskinesia).
    • have had hallucinations or psychosis.
    • have liver or kidney problems.
    • are pregnant or plan to become pregnant, or are breastfeeding or plan to breastfeed.

    Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Especially tell your healthcare provider if you take nonselective MAO inhibitors (such as phenelzine, tranylcypromine, and isocarboxazid) or catecholamine medicines (such as isoproterenol, epinephrine, norepinephrine, dopamine, and dobutamine), regardless of how you take the medicine (by mouth, inhaled, or by injection).

    ONGENTYS and other medicines may affect each other causing side effects. ONGENTYS may affect the way other medicines work, and other medicines may affect how ONGENTYS works.

    What should I avoid while taking ONGENTYS?

    Do not drive, operate machinery, or do other dangerous activities until you know how ONGENTYS affects you.

    What are the possible side effects of ONGENTYS?

    ONGENTYS may cause serious side effects, including:

    • Falling asleep during normal activities such as driving a car, talking or eating while taking ONGENTYS or other medicines used to treat Parkinson's disease, without being drowsy or without warning. This may result in having accidents. Your chances of falling asleep while taking ONGENTYS are higher if you take other medicines that cause drowsiness.
    • Low blood pressure or dizziness, light headedness, or fainting.
    • Uncontrolled sudden movements (dyskinesia). ONGENTYS may cause uncontrolled sudden movements or make such movements worse or happen more often.
    • Seeing, hearing, or feeling things that are not real (hallucinations), believing things that are not real (delusions), or aggressive behavior.
    • Unusual urges (impulse control and compulsive disorders) such as urges to gamble, increased sexual urges, strong urges to spend money, binge eating, and the inability to control these urges.

    Tell your healthcare provider if you experience any of these side effects or notice changes in your behavior.

    The most common side effects of ONGENTYS include uncontrolled sudden movements (dyskinesia), constipation, increase in an enzyme called blood creatine kinase, low blood pressure, and weight loss.

    These are not all of the possible side effects of ONGENTYS. Call your healthcare provider for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

    Please see ONGENTYS full Product Information.

    About Neurocrine Biosciences

    Neurocrine Biosciences is a neuroscience-focused, biopharmaceutical company dedicated to discovering, developing and delivering life-changing treatments for people with serious, challenging and under-addressed neurological, endocrine and psychiatric disorders. The company's diverse portfolio includes FDA-approved treatments for tardive dyskinesia, Parkinson's disease, endometriosis*, uterine fibroids* and clinical programs in multiple therapeutic areas. For nearly three decades, Neurocrine Biosciences has specialized in targeting and interrupting disease-causing mechanisms involving the interconnected pathways of the nervous and endocrine systems. For more information, visit neurocrine.com, and follow the company on LinkedIn(*in collaboration with AbbVie)

    Forward-Looking Statements

    In addition to historical facts, this press release contains forward-looking statements that involve a number of risks and uncertainties. These statements include, but are not limited to, statements related to the benefits to be derived from Neurocrine's products and product candidates. Among the factors that could cause actual results to differ materially from those indicated in the forward-looking statements are: our future financial and operating performance; risks associated with the commercialization of INGREZZA and ONGENTYS; the impact of the COVID-19 pandemic and efforts to mitigate its spread on our business; risks and uncertainties associated with the scale and duration of the COVID-19 pandemic and resulting global, national, and local economic and financial disruptions; risks related to the development of our product candidates; risks associated with our dependence on third parties for development and manufacturing activities related to INGREZZA and our product candidates, and our ability to manage these third parties; risks that the FDA or other regulatory authorities may make adverse decisions regarding our products or product candidates; risks associated with our dependence on BIAL for manufacturing activities for ONGENTYS, and our ability to manage BIAL; risks that clinical development activities may not be completed on time or at all, or may be delayed for regulatory, manufacturing, COVID-19 or other reasons, may not be successful or replicate previous clinical trial results, may fail to demonstrate that our product candidates are safe and effective, or may not be predictive of real-world results or of results in subsequent clinical trials; risks that the potential benefits of the agreements with our collaboration partners may never be realized; risks that our products, and/or our product candidates may be precluded from commercialization by the proprietary or regulatory rights of third parties, or have unintended side effects, adverse reactions or incidents of misuse; and other risks described in our periodic reports filed with the SEC, including without limitation our quarterly report on Form 10-Q for the quarter ended June 30, 2021. Neurocrine disclaims any obligation to update the statements contained in this press release after the date hereof.

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  2. BURNABY, British Columbia, Sept. 08, 2021 (GLOBE NEWSWIRE) -- Xenon Pharmaceuticals Inc. (NASDAQ:XENE), a neurology-focused biopharmaceutical company, today announced that its collaboration to develop treatments for epilepsy with Neurocrine Biosciences, Inc. (NASDAQ:NBIX) achieved a regulatory milestone with the approval of a clinical trial application (CTA) in Europe, triggering an aggregate payment of $10.0 million to Xenon.

    Mr. Ian Mortimer, Xenon's President and Chief Executive Officer stated, "This $10 million regulatory milestone from our collaboration with Neurocrine Biosciences marks a significant achievement. We look forward to Neurocrine Biosciences initiating a Phase 2 clinical trial for NBI-921352 for the treatment of focal-onset…

    BURNABY, British Columbia, Sept. 08, 2021 (GLOBE NEWSWIRE) -- Xenon Pharmaceuticals Inc. (NASDAQ:XENE), a neurology-focused biopharmaceutical company, today announced that its collaboration to develop treatments for epilepsy with Neurocrine Biosciences, Inc. (NASDAQ:NBIX) achieved a regulatory milestone with the approval of a clinical trial application (CTA) in Europe, triggering an aggregate payment of $10.0 million to Xenon.

    Mr. Ian Mortimer, Xenon's President and Chief Executive Officer stated, "This $10 million regulatory milestone from our collaboration with Neurocrine Biosciences marks a significant achievement. We look forward to Neurocrine Biosciences initiating a Phase 2 clinical trial for NBI-921352 for the treatment of focal-onset seizures in adults later this year. In addition, Neurocrine Biosciences also expects to initiate a Phase 2 clinical trial in adolescent patients with SCN8A developmental and epileptic encephalopathy in the second half of 2021. Ultimately, our hope is that this partnership will result in new treatments to benefit the lives of people with epilepsy."

    Based on the regulatory approval of a CTA in Europe for NBI-921352 for focal-onset seizures in adults, Xenon will receive an aggregate of $10.0 million from Neurocrine Biosciences in the form of a $4.5 million payment in cash and a $5.5 million equity investment at a Xenon per share price of $19.9755, calculated as a 15% premium to Xenon's 30-day trailing volume weighted average price.

    About the Collaboration Between Xenon and Neurocrine Biosciences

    Xenon has an ongoing collaboration with Neurocrine Biosciences to develop treatments for epilepsy. Neurocrine Biosciences has an exclusive license to XEN901, now known as NBI-921352, a clinical stage selective Nav1.6 sodium channel inhibitor with potential in SCN8A developmental and epileptic encephalopathy (SCN8A-DEE) and other forms of epilepsy. The FDA has provided feedback on an Investigational New Drug (IND) application submitted by Neurocrine Biosciences in support of a Phase 2 clinical trial in SCN8A-DEE patients. Based on this feedback, Neurocrine Biosciences anticipates initiating a Phase 2 clinical trial in adolescent patients (aged 12 years and older) with SCN8A-DEE in the second half of 2021, and the trial protocol will be amended to include younger pediatric patients (aged 2-11 years) with SCN8A-DEE as soon as the FDA has reviewed and approved additional non-clinical information. Upon FDA acceptance of a protocol amendment for NBI-921352 in pediatric patients (aged 2-11 years) with SCN8A-DEE, Xenon is eligible to receive an aggregate payment of $15.0 million in the form of 45% cash and a 55% equity investment in Xenon at a 15% premium to Xenon's 30-day trailing volume weighted average price at that time. In parallel, Neurocrine Biosciences is advancing clinical plans to develop NBI-921352 for the treatment of focal-onset seizures in adults and expects to initiate a Phase 2 clinical trial in 2021.

    About Xenon Pharmaceuticals Inc.

    We are a clinical stage biopharmaceutical company committed to developing innovative therapeutics to improve the lives of patients with neurological disorders. We are advancing a novel product pipeline of neurology therapies to address areas of high unmet medical need, with a focus on epilepsy. For more information, please visit www.xenon-pharma.com.

    Safe Harbor Statement

    This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, and the Private Securities Litigation Reform Act of 1995 and Canadian securities laws. These forward-looking statements are not based on historical fact, and include statements regarding the timing of and results from clinical trials and pre-clinical development activities, including those related to NBI-921352 and other partnered and proprietary product candidates; the potential efficacy, safety profile, future development plans, addressable market, regulatory success and commercial potential of NBI-921352 and other partnered and proprietary product candidates; the anticipated timing of IND, or IND-equivalent, submissions and the initiation of future clinical trials for NBI-921352 and other partnered and proprietary product candidates; the efficacy of our clinical trial designs; the timing and results of our and our collaborators' interactions with regulators; our ability to successfully develop and achieve milestones in our NBI-921352 program with Neurocrine Biosciences and other partnered and proprietary programs; the progress and potential of our other ongoing development programs; the potential receipt of milestone payments and royalties from Neurocrine Biosciences and our other collaborators; and the timing of potential publication or presentation of future clinical data. These forward-looking statements are based on current assumptions that involve risks, uncertainties and other factors that may cause the actual results, events or developments to be materially different from those expressed or implied by such forward-looking statements. These risks and uncertainties, many of which are beyond our control, include, but are not limited to: the impact of the COVID-19 pandemic on our business, research and clinical development plans and timelines and results of operations, including impact on our clinical trial sites, collaborators, and contractors who act for or on our behalf, may be more severe and more prolonged than currently anticipated; clinical trials may not demonstrate safety and efficacy of any of our or our collaborators' product candidates; our assumptions regarding our planned expenditures and sufficiency of our cash to fund operations may be incorrect; our ongoing discovery and pre-clinical efforts may not yield additional product candidates; any of our or our collaborators' product candidates may fail in development, may not receive required regulatory approvals, or may be delayed to a point where they are not commercially viable; we may not achieve additional milestones in our proprietary or partnered programs; regulatory agencies may impose additional requirements or delay the initiation of clinical trials; regulatory agencies may be delayed in reviewing, commenting on or approving any of our or our collaborators' clinical development plans as a result of the COVID-19 pandemic, which could further delay development timelines; the impact of competition; the impact of expanded product development and clinical activities on operating expenses; impact of new or changing laws and regulations; adverse conditions in the general domestic and global economic markets; as well as the other risks identified in our filings with the Securities and Exchange Commission and the securities commissions in British Columbia, Alberta and Ontario. These forward-looking statements speak only as of the date hereof and we assume no obligation to update these forward-looking statements, and readers are cautioned not to place undue reliance on such forward-looking statements.

    "Xenon" and the Xenon logo are registered trademarks or trademarks of Xenon Pharmaceuticals Inc. in various jurisdictions. All other trademarks belong to their respective owner.

    Investor/Media Contact:

    Maria McClean

    Xenon Pharmaceuticals Inc.

    Phone: 604.484.3353

    Email: investors@xenon-pharma.com



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  3. SAN DIEGO, Sept. 2, 2021 /PRNewswire/ -- Neurocrine Biosciences, Inc. (NASDAQ:NBIX) today announced that members of the management team will participate at the following virtual investor conferences:

    • Kevin Gorman, Chief Executive Officer, will present at the Morgan Stanley 19th Annual Healthcare Conference at 10:15 a.m. ET on Monday, Sept. 13, 2021.
    • Matt Abernethy, Chief Financial Officer, and Eiry Roberts, Chief Medical Officer, will present at the Baird 2021 Global Healthcare Conference at 10:50 a.m. ET on Wednesday, Sept. 15, 2021.

    The live presentation will be webcast and may be accessed on the Company's website under Investors at www.neurocrine.com. A replay of the presentation will be available on the website approximately one hour after the conclusion of the events and will be archived for approximately one month.

    About Neurocrine Biosciences

    Neurocrine Biosciences is a neuroscience-focused, biopharmaceutical company dedicated to discovering, developing and delivering life-changing treatments for people with serious, challenging and under-addressed neurological, endocrine and psychiatric disorders. The company's diverse portfolio includes FDA-approved treatments for tardive dyskinesia, Parkinson's disease, endometriosis*, uterine fibroids* and clinical programs in multiple therapeutic areas. For nearly three decades, Neurocrine Biosciences has specialized in targeting and interrupting disease-causing mechanisms involving the interconnected pathways of the nervous and endocrine systems. For more information, visit neurocrine.com, and follow the company on LinkedIn(*in collaboration with AbbVie)

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    SOURCE Neurocrine Biosciences, Inc.

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  4. SAN DIEGO, Aug. 3, 2021 /PRNewswire/ -- Neurocrine Biosciences, Inc. (NASDAQ:NBIX) today announced its financial results for the second quarter ended June 30, 2021.

    "We helped more tardive dyskinesia patients than ever before as our second quarter results reflect sustained growth for INGREZZA. While 8 out of 10 patients still remain undiagnosed, the underlying opportunity to improve the lives of patients with TD remains strong. Therefore, we continue to invest in healthcare provider and patient-focused awareness campaigns to help improve TD diagnosis and treatment rates," said Kevin Gorman, Ph.D., Chief Executive Officer of Neurocrine Biosciences. "We remain committed to advancing our R&D pipeline and are making steady progress towards initiating 9 mid-to-late-stage clinical trials this year. With significant long-term commercial growth opportunities and a diverse and growing pipeline, we are well positioned to become a leading neuroscience-focused biopharmaceutical company."

    Financial Highlights





    Three Months Ended

    June 30,



    Six Months Ended

    June 30,

    (unaudited, in millions, except per share data)

    2021



    2020



    2021



    2020

    Revenues:















    Product sales, net

    $

    266.8





    $

    267.6





    $

    497.8





    $

    498.7





    Collaboration revenue

    22.1





    34.8





    27.7





    40.8



    Total revenues

    $

    288.9





    $

    302.4





    $

    525.5





    $

    539.5





















    GAAP Research and Development (R&D)

    $

    74.8





    $

    80.9





    $

    148.0





    $

    139.2





    Non-GAAP R&D

    $

    65.6





    $

    51.0





    $

    123.8





    $

    101.6





















    GAAP Selling, General and Administrative (SG&A)

    $

    143.2





    $

    96.5





    $

    272.2





    $

    214.3





    Non-GAAP SG&A

    $

    123.8





    $

    76.9





    $

    234.9





    $

    179.6





















    GAAP net income

    $

    42.3





    $

    79.6





    $

    74.4





    $

    117.0





    GAAP net income per share – diluted

    $

    0.43





    $

    0.81





    $

    0.76





    $

    1.20





















    Non-GAAP net income

    $

    61.3





    $

    139.1





    $

    109.2





    $

    218.2





    Non-GAAP net income per share – diluted

    $

    0.63





    $

    1.42





    $

    1.11





    $

    2.24





















    (unaudited, in millions)









    June 30,

    2021



    December 31,

    2020

    Total cash, cash equivalents and debt securities available-for-sale

    $

    1,222.7





    $

    1,028.1





    Second Quarter Net Product Sales and Commercial Highlights:

    • INGREZZA net product sales for the second quarter of 2021 were $265 million and $269 million on an inventory adjusted basis
    • Record total prescriptions achieved during the second quarter 2021 reflecting increased commercial activities
    • New prescriptions increased throughout the second quarter, reaching their highest levels since March 2020 despite continued significant use of telemedicine within psychiatry
    • Second quarter refill rates per patient returned to historical normal range versus seasonally low first quarter levels

    Financial Highlights:

    • Second quarter 2021 GAAP net income and diluted earnings per share were approximately $42 million and $0.43, respectively, compared with approximately $80 million and $0.81, respectively, in the second quarter of 2020
    • Second quarter 2021 non-GAAP net income and diluted earnings per share were approximately $61 million and $0.63, respectively, compared with approximately $139 million and $1.42, respectively, in the second quarter of 2020
    • Difference between second quarter 2021 GAAP and non-GAAP net income and diluted earnings per share compared with the second quarter of 2020 were driven by:
      • Increased research and development expense primarily due to increased investment and headcount to support our expanded pipeline programs
      • Increased selling, general and administrative expense primarily due to increased investment in commercial initiatives including the launch of "TD Spotlight", our INGREZZA direct-to-consumer advertising campaign
    • Second quarter 2021 provision for income taxes was $15 million, compared with $4 million in the second quarter of 2020. In the first quarter of 2021, the Company began recording a provision for income taxes using an effective tax rate approximating federal and state statutory rates. Due to the Company's ability to offset its pre-tax income against previously benefited federal net operating losses, no federal cash tax is expected in 2021.
    • At June 30, 2021, the Company had cash, cash equivalents and debt securities available-for-sale of $1.2 billion

    A reconciliation of GAAP to non-GAAP financial results can be found in Table 3 and Table 4 at the end of this earnings release.

    Recent Events

    • In April 2021, Mitsubishi Tanabe Pharma Corporation (MTPC) submitted a Marketing Authorization Application, or MAA, with the Ministry of Health and Welfare in Japan for valbenazine for the treatment of tardive dyskinesia. The MTPC submission of valbenazine triggered a milestone payment of $15 million, which the Company recognized as collaboration revenue in the second quarter of 2021.
    • In August 2021, the Company announced plans to initiate registrational studies in the second half of 2021 with valbenazine for adjunctive treatment in schizophrenia and for dyskinesia due to cerebral palsy.

    Full-Year 2021 Expense Guidance Reaffirmed





    Range

    (in millions)

    Low



    High

    Combined GAAP R&D and SG&A expenses

    $

    855





    $

    905



    Combined Non-GAAP R&D and SG&A expenses

    $

    720





    $

    770



    • GAAP-only guidance includes approximately $130 million of share-based compensation and $5 million of In-Process Research and Development (IPR&D). GAAP-only guidance does not include any potential milestones or IPR&D costs associated with current collaborations or future business development activities.

    2021 Expected Milestones and Key Activities



    Program

    Indication

    2021 Milestones / Key Activities

    Valbenazine

    Chorea in Huntington Disease

    Study Fully Enrolled with Registrational Top-Line Data Expected by Year-End

    Tardive Dyskinesia

    MTPC Submitted Marketing Authorization with Ministry of Health and Welfare in Japan

    Dyskinesia Due to Cerebral Palsy

    (Neurological Indication)

    Initiating Registrational Study in 2H 2021

    Adjunctive Treatment in Schizophrenia

    (Psychiatric Indication)

    Initiating Registrational Study in 2H 2021

    Crinecerfont

    Congenital Adrenal Hyperplasia (Adult)

    Enrolling Registrational Study

    Congenital Adrenal Hyperplasia (Pediatric)

    Enrolling Registrational Study

    Luvadaxistat (NBI-1065844)

    Cognitive Impairment Associated with Schizophrenia (CIAS)

    Initiating Phase 2 Study in 2H 2021

    NBI-1065845

    Inadequate Response to Treatment in Major Depressive Disorder (MDD)

    Initiating Phase 2 Study in 2H 2021

    NBI-1065846

    Anhedonia in Depression

    Initiating Phase 2 Study in 2H 2021

    NBI-827104

    Rare Pediatric Epilepsy: Epileptic Encephalopathy with Continuous Spike and Wave During Sleep (CSWS)

    Enrolling Phase 2 Study

    Essential Tremor

    Enrolling Phase 2 Study

    NBI-921352

    Focal-Onset Seizure in Adults

    Initiating Phase 2 Study in 2H 2021

    Rare Pediatric Epilepsy: SCN8A Developmental Epileptic Encephalopathy (SCN8A-DEE)

    Initiating Phase 2 Study in 2H 2021

    Conference Call and Webcast Today at 4:30 PM Eastern Time

    Neurocrine Biosciences will hold a live conference call and webcast today at 4:30 p.m. Eastern Time (1:30 p.m. Pacific Time). Participants can access the live conference call by dialing 866-952-8559 (US) or 785-424-1743 (International) using the conference ID: NBIX. The webcast can also be accessed on Neurocrine Biosciences' website under Investors at www.neurocrine.com. A replay of the webcast will be available on the website approximately one hour after the conclusion of the event and will be archived for approximately one month.

    About Neurocrine Biosciences

    Neurocrine Biosciences is a neuroscience-focused, biopharmaceutical company dedicated to discovering, developing and delivering life-changing treatments for people with serious, challenging and under-addressed neurological, endocrine and psychiatric disorders. The company's diverse portfolio includes FDA-approved treatments for tardive dyskinesia, Parkinson's disease, endometriosis*, uterine fibroids* and clinical programs in multiple therapeutic areas. For nearly three decades, Neurocrine Biosciences has specialized in targeting and interrupting disease-causing mechanisms involving the interconnected pathways of the nervous and endocrine systems. For more information, visit neurocrine.com, and follow the company on LinkedIn. (*in collaboration with AbbVie)

    Non-GAAP Financial Measures

    In addition to the financial results and financial guidance that are provided in accordance with accounting principles generally accepted in the United States (GAAP), this press release also contains the following non-GAAP financial measures: non-GAAP R&D expense, non-GAAP SG&A expense, and non-GAAP net income and net income per share. When preparing the non-GAAP financial results and guidance, the Company excludes certain GAAP items that management does not consider to be normal, including recurring cash operating expenses that might not meet the definition of unusual or non-recurring items. In particular, these non-GAAP financial measures exclude: milestone payments received from licenses and collaborations, milestones paid related to licenses and collaborations, non-cash collaboration revenue, acquired in-process research and development, share-based compensation expense, non-cash interest expense related to convertible debt, changes in fair value of equity security investments and certain adjustments to income tax expense. These non-GAAP financial measures are provided as a complement to results provided in accordance with GAAP as management believes these non-GAAP financial measures help indicate underlying trends in the Company's business, are important in comparing current results with prior period results and provide additional information regarding the Company's financial position. Management also uses these non-GAAP financial measures to establish budgets and operational goals that are communicated internally and externally and to manage the Company's business and evaluate its performance. The Company provides guidance regarding combined research and development and sales, general, and administrative expenses on both a GAAP and a non-GAAP basis. The guidance regarding GAAP research and development expenses and sales, general and administrative expenses does not include estimates for expenses associated with any potential future business development activities. A reconciliation of these GAAP financial results to non-GAAP financial results is included in the attached financial information. In addition, INGREZZA net sales are presented in accordance with GAAP and as inventory-adjusted net sales, which is a non-GAAP financial measure. The difference between INGREZZA net sales and inventory-adjusted net sales reflects changes in channel inventory that are not representative of the underlying prescription demand. Management uses inventory-adjusted net sales to manage the Company's business and evaluate its performance.

    Forward-Looking Statements

    In addition to historical facts, this press release contains forward-looking statements that involve a number of risks and uncertainties. These statements include, but are not limited to, statements related to: the benefits to be derived from our products and product candidates; the value our products and/or our product candidates may bring to patients; the continued success of INGREZZA; our financial and operating performance, including our future revenues, expenses, or profits; our collaborative partnerships; expectations regarding the impact of COVID-19 on our business; expectations regarding our ability to adapt our business to the evolving COVID-19 pandemic, mitigate its impact on our business, including our ability to continue conducting our ongoing clinical trials and other development activities, to protect the safety and well-being of our employees, to continue to support uninterrupted supply of INGREZZA, and to otherwise advance our business objectives; and the timing of the initiation and/or completion of our clinical, regulatory, and other development activities and those of our collaboration partners. Among the factors that could cause actual results to differ materially from those indicated in the forward-looking statements are: our future financial and operating performance; risks associated with the commercialization of INGREZZA and ONGENTYS; the impact of the evolving COVID-19 pandemic on our business and the business operations of our customers; risks and uncertainties associated with the scale and duration of the COVID-19 pandemic and resulting global, national, and local economic and financial disruptions; risk and uncertainties related to any COVID-19 quarantine, social distancing and other requirements put in place by governments, customers, or clinical trial sites, including the impact of such requirements on the ability of patients to have in-person visits with their health care provider; risks related to the development of our product candidates; risks associated with our dependence on third parties for development and manufacturing activities for our products and product candidates, and our ability to manage these third parties; risks that the FDA or other regulatory authorities may make adverse decisions regarding our products or product candidates; risks associated with our dependence on AbbVie for the commercialization of ORILISSA and ORIAHNN, as well as the continued development of elagolix; risks that clinical development activities may not be initiated or completed on time or at all, or may be delayed for regulatory, manufacturing, COVID-19 or other reasons, may not be successful or replicate previous clinical trial results, may fail to demonstrate that our product candidates are safe and effective, or may not be predictive of real-world results or of results in subsequent clinical trials; risks that the potential benefits of the agreements with our collaboration partners may never be realized; risks that our products, and/or our product candidates may be precluded from commercialization by the proprietary or regulatory rights of third parties, or have unintended side effects, adverse reactions or incidents of misuse; and other risks described in our periodic reports filed with the SEC, including without limitation our quarterly report on Form 10-Q for the quarter ended June 30, 2021. Neurocrine Biosciences disclaims any obligation to update the statements contained in this press release after the date hereof.

    TABLE 1

     

    NEUROCRINE BIOSCIENCES, INC.

    CONDENSED CONSOLIDATED STATEMENTS OF INCOME

    (unaudited)





    Three Months Ended

    June 30,



    Six Months Ended

    June 30,

    (in millions, except per share data)

    2021



    2020



    2021



    2020

    Revenues:















    Product sales, net

    $

    266.8





    $

    267.6





    $

    497.8





    $

    498.7



    Collaboration revenue

    22.1





    34.8





    27.7





    40.8



    Total revenues

    288.9





    302.4





    525.5





    539.5



    Operating expenses:















    Cost of sales

    3.1





    2.4





    6.0





    4.5



    Research and development

    74.8





    80.9





    148.0





    139.2



    Acquired in-process research and development

    5.0





    46.0





    5.0





    46.0



    Selling, general and administrative

    143.2





    96.5





    272.2





    214.3



    Total operating expenses

    226.1





    225.8





    431.2





    404.0



    Operating income

    62.8





    76.6





    94.3





    135.5



    Other (expense) income:















    Interest expense

    (6.2)





    (8.3)





    (12.6)





    (16.5)



    Unrealized gain (loss) on equity securities





    11.3





    0.7





    (5.2)



    Investment income and other, net

    0.9





    3.6





    2.3





    8.3



    Total other (expense) income, net

    (5.3)





    6.6





    (9.6)





    (13.4)



    Income before provision for income taxes

    57.5





    83.2





    84.7





    122.1



    Provision for income taxes

    15.2





    3.6





    10.3





    5.1



    Net income

    $

    42.3





    $

    79.6





    $

    74.4





    $

    117.0



















    Net income per share, basic

    $

    0.45





    $

    0.86





    $

    0.79





    $

    1.26



    Net income per share, diluted

    $

    0.43





    $

    0.81





    $

    0.76





    $

    1.20



















    Weighted average common shares outstanding, basic

    94.6





    93.0





    94.4





    92.8



    Weighted average common shares outstanding, diluted

    97.7





    98.2





    98.0





    97.6



     

    TABLE 2

     

    NEUROCRINE BIOSCIENCES, INC.

    CONDENSED CONSOLIDATED BALANCE SHEETS

    (unaudited)



    (in millions)

    June 30,

    2021



    December 31,

    2020

    Cash, cash equivalents and debt securities available-for-sale

    $

    884.9





    $

    801.0



    Other current assets

    225.2





    215.2



    Total current assets

    1,110.1





    1,016.2



    Deferred tax assets

    316.1





    319.4



    Debt securities available-for-sale

    337.8





    227.1



    Right-of-use assets

    100.3





    82.8



    Equity securities

    38.9





    38.2



    Property and equipment, net

    50.0





    44.6



    Other assets

    3.2





    6.4



    Total assets

    $

    1,956.4





    $

    1,734.7











    Total current liabilities

    $

    212.9





    $

    186.5



    Convertible senior notes

    326.3





    317.9



    Operating lease liabilities

    109.0





    94.4



    Other long-term liabilities

    29.0





    9.7



    Stockholders' equity

    1,279.2





    1,126.2



    Total liabilities and stockholders' equity

    $

    1,956.4





    $

    1,734.7



     

    TABLE 3

     

    NEUROCRINE BIOSCIENCES, INC.

    RECONCILIATION OF GAAP TO NON-GAAP FINANCIAL RESULTS

    (unaudited)





    Three Months Ended

    June 30,



    Six Months Ended

    June 30,

    (in millions, except per share data)

    2021



    2020



    2021



    2020

    GAAP net income

    $

    42.3





    $

    79.6





    $

    74.4





    $

    117.0



    Adjustments:















    Milestones received from licenses and collaborations A

    (15.0)





    (30.0)





    (15.0)





    (30.0)



    Non-cash collaboration revenue B

    (1.3)









    (2.4)





    (1.3)



    Acquired in-process research and development (IPR&D) C

    5.0





    46.0





    5.0





    46.0



    Milestones paid related to licenses and collaborations - R&D





    20.0









    20.0



    Share-based compensation expense - R&D

    9.2





    9.9





    24.2





    17.6



    Share-based compensation expense - SG&A

    19.4





    19.6





    37.3





    34.7



    Non-cash interest related to convertible senior notes

    4.3





    5.4





    8.5





    10.7



    Changes in fair value of equity security investments D





    (11.3)





    (0.7)





    5.2



    Income tax effect related to reconciling items E

    (2.6)





    (0.1)





    (22.1)





    (1.7)



    Non-GAAP net income

    $

    61.3





    $

    139.1





    $

    109.2





    $

    218.2



















    Net income per diluted common share:















    GAAP

    $

    0.43





    $

    0.81





    $

    0.76





    $

    1.20



    Non-GAAP

    $

    0.63





    $

    1.42





    $

    1.11





    $

    2.24





    A In the second quarter of 2021, the Company recognized a $15.0 million event-based milestone as revenue upon the Mitsubishi Tanabe Pharma Corporation (MTPC) MAA submission for valbenazine for the treatment of tardive dyskinesia in Japan. In the second quarter of 2020, the Company recognized a $30.0 million event-based milestone as revenue upon AbbVie's receipt of FDA approval for ORIAHNN for uterine fibroids.

    B The Company recognized non-cash collaboration revenue under the collaboration and license agreement entered into with MTPC in 2015.

    C In the second quarter of 2021, the Company recognized IPR&D expenses of $5.0 million associated with upfront fees paid. In the second quarter of 2020, the Company recognized IPR&D expenses of $46.0 million associated with collaboration and license agreement entered into with Idorsia Pharmaceuticals.

    D The Company recognized an unrealized (gain) loss to adjust its equity security investments to fair value.

    E Estimated income tax effect of non-GAAP reconciling items are calculated using applicable statutory tax rates, taking into consideration any valuation allowance and adjustments to exclude excess tax benefits associated with share-based compensation. On December 31, 2020, the Company released substantially all of its valuation allowance against its net operating losses and other deferred tax assets.

     

    TABLE 4

     

    NEUROCRINE BIOSCIENCES, INC.

    RECONCILIATION OF GAAP TO NON-GAAP EXPENSES

    (unaudited)





    Three Months Ended

    June 30,



    Six Months Ended

    June 30,

    (in millions)

    2021



    2020



    2021



    2020

    GAAP R&D

    $

    74.8





    $

    80.9





    $

    148.0





    $

    139.2





    Adjustments:















    Milestones paid related to licenses and collaborations





    20.0









    20.0





    Share-based compensation expense

    9.2





    9.9





    24.2





    17.6





    Non-GAAP R&D

    $

    65.6





    $

    51.0





    $

    123.8





    $

    101.6





















    GAAP SG&A

    $

    143.2





    $

    96.5





    $

    272.2





    $

    214.3





    Adjustments:















    Share-based compensation expense

    19.4





    19.6





    37.3





    34.7





    Non-GAAP SG&A

    $

    123.8





    $

    76.9





    $

    234.9





    $

    179.6





















     

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  5. SAN DIEGO, July 19, 2021 /PRNewswire/ -- Neurocrine Biosciences, Inc. (NASDAQ:NBIX) announced today that it will report second quarter 2021 financial results after the Nasdaq market closes on Tuesday, August 3, 2021. Neurocrine will then host a conference call and webcast to discuss its financial results and provide a company update that day at 1:30 p.m. Pacific Time (4:30 p.m. Eastern Time).

    Participants can access the live conference call by dialing 866-952-8559 (US) or 785-424-1743 (International) using the conference ID: NBIX. The webcast can also be accessed on Neurocrine's website under Investors at www.neurocrine.com. A replay of the webcast will be available on the website approximately one hour after the conclusion of the event and will be archived for approximately one month.

    About Neurocrine Biosciences

    Neurocrine Biosciences is a neuroscience-focused, biopharmaceutical company dedicated to discovering, developing and delivering life-changing treatments for people with serious, challenging and under-addressed neurological, endocrine and psychiatric disorders. The company's diverse portfolio includes FDA-approved treatments for tardive dyskinesia, Parkinson's disease, endometriosis*, uterine fibroids* and clinical programs in multiple therapeutic areas. For nearly three decades, Neurocrine Biosciences has specialized in targeting and interrupting disease-causing mechanisms involving the interconnected pathways of the nervous and endocrine systems. For more information, visit neurocrine.com, and follow the company on LinkedIn(*in collaboration with AbbVie)

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  6. SAN DIEGO, July 8, 2021 /PRNewswire/ -- Neurocrine Biosciences, Inc. (NASDAQ:NBIX) today announced that Kyle Gano, Chief Business Development and Strategy Officer, will participate in a neuropsychology-focused panel discussion at the William Blair Biotech Focus Conference at 12:00 p.m. Eastern Time on Thursday July 15, 2021.

    The live presentation will be webcast and may be accessed on the Company's website under Investors at www.neurocrine.com. A replay of the presentation will be available on the website approximately one hour after the conclusion of the events and will be archived for approximately one month.

    About Neurocrine Biosciences

    Neurocrine Biosciences is a neuroscience-focused, biopharmaceutical company dedicated to discovering, developing and delivering life-changing treatments for people with serious, challenging and under-addressed neurological, endocrine and psychiatric disorders. The company's diverse portfolio includes FDA-approved treatments for tardive dyskinesia, Parkinson's disease, endometriosis*, uterine fibroids* and clinical programs in multiple therapeutic areas. For nearly three decades, Neurocrine Biosciences has specialized in targeting and interrupting disease-causing mechanisms involving the interconnected pathways of the nervous and endocrine systems. For more information, visit neurocrine.com, and follow the company on LinkedIn(*in collaboration with AbbVie)

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  7. SAN DIEGO, June 1, 2021 /PRNewswire/ -- Neurocrine Biosciences, Inc. (NASDAQ:NBIX) will present at the Goldman Sachs 42nd Annual Global Healthcare Conference at 1:20 p.m. Eastern Time on Tuesday, June 8, 2021. Kevin Gorman, Chief Executive Officer, will present at the conference.

    The live presentation will be webcast and may be accessed on the Company's website under Investors at www.neurocrine.com. A replay of the presentation will be available on the website approximately one hour after the conclusion of the events and will be archived for approximately one month.

    About Neurocrine Biosciences

    Neurocrine Biosciences is a neuroscience-focused, biopharmaceutical company dedicated to discovering, developing and delivering life-changing treatments for people with serious, challenging and under-addressed neurological, endocrine and psychiatric disorders. The company's diverse portfolio includes FDA-approved treatments for tardive dyskinesia, Parkinson's disease, endometriosis*, uterine fibroids* and clinical programs in multiple therapeutic areas. For nearly three decades, Neurocrine Biosciences has specialized in targeting and interrupting disease-causing mechanisms involving the interconnected pathways of the nervous and endocrine systems. For more information, visit neurocrine.com, and follow the company on LinkedIn(*in collaboration with AbbVie)

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/neurocrine-biosciences-to-present-at-the-goldman-sachs-42nd-annual-global-healthcare-conference-301303189.html

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  8. SAN DIEGO, May 11, 2021 /PRNewswire/ -- Neurocrine Biosciences, Inc. (NASDAQ:NBIX) will present at the 2021 RBC Capital Markets Healthcare Conference at 10:55 a.m. Eastern Time on Tuesday May 18, 2021. Matt Abernethy, Chief Financial Officer, and Eiry Roberts, Chief Medical Officer, will present at the conference.

    The live presentation will be webcast and may be accessed on the Company's website under Investors at www.neurocrine.com. A replay of the presentation will be available on the website approximately one hour after the conclusion of the events and will be archived for approximately one month.

    About Neurocrine Biosciences

    Neurocrine Biosciences is a neuroscience-focused, biopharmaceutical company dedicated to discovering, developing and delivering life-changing treatments for people with serious, challenging and under-addressed neurological, endocrine and psychiatric disorders. The company's diverse portfolio includes FDA-approved treatments for tardive dyskinesia, Parkinson's disease, endometriosis*, uterine fibroids* and clinical programs in multiple therapeutic areas. For nearly three decades, Neurocrine Biosciences has specialized in targeting and interrupting disease-causing mechanisms involving the interconnected pathways of the nervous and endocrine systems. For more information, visit neurocrine.com, and follow the company on LinkedIn(*in collaboration with AbbVie)

     

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  9. SAN DIEGO, May 5, 2021 /PRNewswire/ -- Neurocrine Biosciences, Inc. (NASDAQ:NBIX) today announced its financial results for the first quarter ended March 31, 2021 and provided revised full-year 2021 financial expense guidance.

    "Our first quarter results reflect a lower than normal refill rate per patient due to the typical seasonal payor dynamics for INGREZZA that were exacerbated by COVID. Importantly, we did not see an increase in discontinuations and exited the quarter with more patients on INGREZZA versus the prior quarter. New patient starts did pick up late in the quarter and we are focused on restoring INGREZZA growth as the impact of the pandemic wanes," said Kevin Gorman, Ph.D., Chief Executive Officer of Neurocrine Biosciences. "We made meaningful progress advancing our large, growing and diverse pipeline, including initiating a registrational study for the treatment of pediatric patients with congenital adrenal hyperplasia and a Phase II study in essential tremor. With important commercial products addressing patient needs and on track to initiate nine mid-to-late stage clinical studies this year, we are executing our plan to build a leading neuroscience-based company."

    Financial Highlights





    Three Months Ended

    March 31,

    (unaudited, in millions, except per share data)

    2021



    2020

    Revenues:







    Product sales, net

    $

    231.0





    $

    231.1



    Collaboration revenue

    5.6





    6.0



    Total revenues

    $

    236.6





    $

    237.1











    GAAP Research and Development (R&D)

    $

    73.2





    $

    58.3



    Non-GAAP R&D

    $

    58.2





    $

    50.6











    GAAP Selling, General and Administrative (SG&A)

    $

    129.0





    $

    117.8



    Non-GAAP SG&A

    $

    111.1





    $

    102.7











    GAAP net income

    $

    32.1





    $

    37.4



    GAAP net income per share – diluted

    $

    0.33





    $

    0.39











    Non-GAAP net income

    $

    47.9





    $

    79.1



    Non-GAAP net income per share – diluted

    $

    0.49





    $

    0.82











    (unaudited, in millions)

    March 31,

    2021



    December 31,

    2020

    Total cash, cash equivalents and debt securities available-for-sale

    $

    1,123.3





    $

    1,028.1



    First Quarter Net Product Sales and Commercial Highlights:

    • INGREZZA net product sales for the first quarter of 2021 were $230 million and $227 million on an inventory adjusted basis
    • Annual seasonal payor dynamics resulted in lower refill rates per existing patient as compared to historical norms due to the COVID-19 pandemic and related disruption on timing of patient insurance reauthorizations
    • Exiting the first quarter, commercial activity and weekly new prescriptions both achieved their highest levels since the start of the pandemic reflecting an improved environment for diagnosis of tardive dyskinesia (TD). We expect second quarter inventory adjusted sales sequential dollar growth to be similar to 2020.
    • INGREZZA direct-to-consumer advertising campaign, "TD Spotlight", to be launched in May to educate patients about tardive dyskinesia and the benefits of INGREZZA

    Financial Highlights:

    • First quarter 2021 GAAP net income and diluted earnings per share were approximately $32 million and $0.33, respectively, compared with approximately $37 million and $0.39, respectively, in the first quarter of 2020
    • First quarter 2021 non-GAAP net income and diluted earnings per share were approximately $48 million and $0.49, respectively, compared with approximately $79 million and $0.82, respectively, in the first quarter of 2020
    • Difference between first quarter 2021 GAAP and non-GAAP net income and diluted earnings per share vs. the first quarter of 2020 were driven by:
      • Increased Research and Development (R&D) expense primarily due to increased investment across our expanded pipeline programs and higher headcount costs
      • Increased Selling, General and Administrative (SG&A) expense primarily due to increased investment in commercial initiatives
    • At March 31, 2021, the Company had cash, cash equivalents and debt securities available-for-sale of $1.1 billion

    A reconciliation of GAAP to non-GAAP financial results can be found in Table 3 and Table 4 at the end of this earnings release.

    Provision for Income Taxes:

    First quarter 2021 benefit from income taxes was $4.9 million, compared with a provision for income taxes of $1.5 million in the first quarter of 2020. Our effective tax rate for the first quarter of 2021 was lower than federal and state statutory rates primarily due to excess tax benefits related to stock compensation. On December 31, 2020, the Company released substantially all of its valuation allowance against its net operating losses and other deferred tax assets. Beginning in the first quarter of 2021, the Company began recording a provision for income taxes using an effective tax rate approximating federal and state statutory rates. Due to our ability to offset our pre-tax income against previously benefited federal net operating losses, no federal cash tax is expected in 2021.

    Recent Events

    • In February 2021, the Mitsubishi Tanabe Pharma Corporation (MTPC) reported positive top-line results from the J-KINECT Phase III Study, designed to evaluate the efficacy and safety of valbenazine in tardive dyskinesia. Detailed results from this trial will be presented at a future medical conference. In April 2021, MTPC submitted a Marketing Authorization Application (MAA) with the Ministry of Health and Welfare in Japan for valbenazine for the treatment of tardive dyskinesia. MTPC submission of valbenazine triggered a milestone payment of $15 million, to be paid by MTPC to Neurocrine Biosciences and recognized as collaboration revenue in the second quarter of 2021.
    • In February 2021, the Company notified Voyager Therapeutics, Inc. (Voyager) of the Company's termination of the NBIb-1817 (VY-AADC) development program in Parkinson's disease (the Program). The Company will work to transfer the rights to the Program to Voyager by August 2, 2021.
    • On March 2, 2021, the Company announced that investigational drug luvadaxistat (NBI-1065844/TAK-831) did not meet its primary endpoint in the Phase II INTERACT study in adults with negative symptoms of schizophrenia. Luvadaxistat met both secondary endpoints of cognitive assessment. The Company plans to initiate a Phase II study for the treatment of cognitive impairment associated with schizophrenia (CIAS) by the end of 2021.
    • In April 2021, the U.S. Food and Drug Administration (FDA) approved a 60 mg INGREZZA capsule for the treatment of adults with tardive dyskinesia. The 60 mg capsule of INGREZZA is expected to be available to patients by late second quarter 2021.

    Full-Year 2021 Revised Expense Guidance





    Range

    (in millions)

    Low



    High

    Combined GAAP R&D and SG&A expenses

    $

    855





    $

    905



    Combined Non-GAAP R&D and SG&A expenses

    $

    720





    $

    770



    • Previously, the Company expected combined GAAP R&D and SG&A expenses in the range of $800 million to $850 million and combined non-GAAP R&D and SG&A expenses in the range of $675 million to $725 million
    • Increase to GAAP and Non-GAAP expense guidance range primarily driven by investment in INGREZZA direct-to-consumer marketing campaign, "TD Spotlight"
    • GAAP-only guidance includes approximately $130 million of share-based compensation. GAAP-only guidance does not include any potential milestones or in-process research and development costs associated with current collaborations or future business development activities.

    2021 Expected Milestones and Key Activities



    Program

    Indication

    2021 Milestones / Key Activities

    Valbenazine

    Chorea in Huntington Disease

    Registrational Top-Line Data Expected by Year-End

    Tardive Dyskinesia

    MTPC Submitted Marketing Authorization with Ministry of Health and Welfare in Japan

    Neurological Indication

    Initiate Registrational Study

    Psychiatric Indication

    Initiate Registrational Study

    Crinecerfont

    Congenital Adrenal Hyperplasia (Adult)

    Enrolling Registrational Study

    Congenital Adrenal Hyperplasia (Pediatric)

    Enrolling Registrational Study

    Luvadaxistat (NBI-1065844)

    Cognitive Impairment Associated with Schizophrenia (CIAS)

    Initiate Phase II Study

    NBI-1065845

    Inadequate Response to Treatment in Major Depressive Disorder (MDD)

    Initiate Phase II Study

    NBI-1065846

    Anhedonia in Depression

    Initiate Phase II Study

    NBI-827104

    Rare Pediatric Epilepsy: Epileptic Encephalopathy with Continuous Spike and Wave During Sleep (CSWS)

    Enrolling Phase II Study

    Essential Tremor

    Enrolling Phase II Study

    NBI-921352

    Focal-Onset Seizure in Adults

    Initiate Phase II

    Rare Pediatric Epilepsy: SCN8A Developmental Epileptic Encephalopathy (SCN8A-DEE)

    Initiate Phase II

    Conference Call and Webcast Today at 4:30 PM Eastern Time

    Neurocrine Biosciences will hold a live conference call and webcast today at 4:30 p.m. Eastern Time (1:30 p.m. Pacific Time). Participants can access the live conference call by dialing 800-895-3361 (US) or 785-424-1062 (International) using the conference ID: NBIX. The webcast can also be accessed on Neurocrine Biosciences' website under Investors at www.neurocrine.com. A replay of the webcast will be available on the website approximately one hour after the conclusion of the event and will be archived for approximately one month.

    About Neurocrine Biosciences

    Neurocrine Biosciences is a neuroscience-focused, biopharmaceutical company dedicated to discovering, developing and delivering life-changing treatments for people with serious, challenging and under-addressed neurological, endocrine and psychiatric disorders. The company's diverse portfolio includes FDA-approved treatments for tardive dyskinesia, Parkinson's disease, endometriosis*, uterine fibroids* and clinical programs in multiple therapeutic areas. For nearly three decades, Neurocrine Biosciences has specialized in targeting and interrupting disease-causing mechanisms involving the interconnected pathways of the nervous and endocrine systems. For more information, visit neurocrine.com, and follow the company on LinkedIn. (*in collaboration with AbbVie)

    Non-GAAP Financial Measures

    In addition to the financial results and financial guidance that are provided in accordance with accounting principles generally accepted in the United States (GAAP), this press release also contains the following non-GAAP financial measures: non-GAAP R&D expense, non-GAAP SG&A expense, and non-GAAP net income and net income per share. When preparing the non-GAAP financial results and guidance, the Company excludes certain GAAP items that management does not consider to be normal, including recurring cash operating expenses that might not meet the definition of unusual or non-recurring items. In particular, these non-GAAP financial measures exclude: milestone payments received from licenses and collaborations, milestones paid related to licenses and collaborations, non-cash collaboration revenue, acquired in-process research and development, share-based compensation expense, non-cash interest expense related to convertible debt, changes in fair value of equity security investments and certain adjustments to income tax expense. These non-GAAP financial measures are provided as a complement to results provided in accordance with GAAP as management believes these non-GAAP financial measures help indicate underlying trends in the Company's business, are important in comparing current results with prior period results and provide additional information regarding the Company's financial position. Management also uses these non-GAAP financial measures to establish budgets and operational goals that are communicated internally and externally and to manage the Company's business and evaluate its performance. The Company provides guidance regarding combined research and development and sales, general, and administrative expenses on both a GAAP and a non-GAAP basis. The guidance regarding GAAP research and development expenses and sales, general and administrative expenses does not include estimates for expenses associated with any potential future business development activities. A reconciliation of these GAAP financial results to non-GAAP financial results is included in the attached financial information. In addition, INGREZZA net sales are presented in accordance with GAAP and as inventory-adjusted net sales, which is a non-GAAP financial measure. The difference between INGREZZA net sales and inventory-adjusted net sales reflects changes in channel inventory that are not representative of the underlying prescription demand. Management uses inventory-adjusted net sales to manage the Company's business and evaluate its performance.

    Forward-Looking Statements

    In addition to historical facts, this press release contains forward-looking statements that involve a number of risks and uncertainties. These statements include, but are not limited to, statements related to: the benefits to be derived from our products and product candidates; the value our products and/or our product candidates may bring to patients; the continued success of INGREZZA; our launch of ONGENTYS; our financial and operating performance, including our future expenses; our collaborative partnerships; expectations regarding the impact of COVID-19 on our business; expectations regarding our ability to adapt our business to the evolving COVID-19 pandemic, mitigate its impact on our business and maintain business continuity, including our ability to protect the safety and well-being of our employees, to continue to support uninterrupted supply of INGREZZA, patient in-person access to their healthcare provider, to continue our ongoing clinical trials and other development activities, and to otherwise advance our business objectives; and the timing of the initiation and/or completion of our clinical, regulatory, and other development activities and those of our collaboration partners. Among the factors that could cause actual results to differ materially from those indicated in the forward-looking statements are: our future financial and operating performance; risks associated with the commercialization of INGREZZA and ONGENTYS; the impact of the COVID-19 pandemic on our business and the business operations of our customers; risks and uncertainties associated with the scale and duration of the COVID-19 pandemic and resulting global, national, and local economic and financial disruptions; risk and uncertainties related to any COVID-19 quarantines, shelter-in-place, social distancing and other government orders that are currently in place or that may be put in place in the future, including the impact of such orders on our and our customers' business operations and the business operations of the third parties on which we rely; risks related to the development of our product candidates; risks associated with our dependence on third parties for development and manufacturing activities for our products and product candidates, and our ability to manage these third parties; risks that the FDA or other regulatory authorities may make adverse decisions regarding our products or product candidates; risks associated with our dependence on AbbVie for the commercialization of ORILISSA and ORIAHNN, as well as the continued development of elagolix; risks that clinical development activities may not be initiated or completed on time or at all, or may be delayed for regulatory, manufacturing, COVID-19 or other reasons, may not be successful or replicate previous clinical trial results, may fail to demonstrate that our product candidates are safe and effective, or may not be predictive of real-world results or of results in subsequent clinical trials; risks that the potential benefits of the agreements with our collaboration partners may never be realized; risks that our products, and/or our product candidates may be precluded from commercialization by the proprietary or regulatory rights of third parties, or have unintended side effects, adverse reactions or incidents of misuse; and other risks described in our periodic reports filed with the SEC, including without limitation our quarterly report on Form 10-Q for the quarter ended March 31, 2021. Neurocrine Biosciences disclaims any obligation to update the statements contained in this press release after the date hereof.

     

    TABLE 1

     

    NEUROCRINE BIOSCIENCES, INC.

    CONDENSED CONSOLIDATED STATEMENTS OF INCOME

    (unaudited)





    Three Months Ended

    March 31,

    (in millions, except per share data)

    2021



    2020

    Revenues:







    Product sales, net

    $

    231.0





    $

    231.1



    Collaboration revenue

    5.6





    6.0



    Total revenues

    236.6





    237.1



    Operating expenses:







    Cost of sales

    2.9





    2.1



    Research and development

    73.2





    58.3



    Selling, general and administrative

    129.0





    117.8



    Total operating expenses

    205.1





    178.2



    Operating income

    31.5





    58.9



    Other (expense) income:







    Interest expense

    (6.4)





    (8.2)



    Unrealized gain (loss) on equity securities

    0.7





    (16.5)



    Investment income and other, net

    1.4





    4.7



    Total other expense, net

    (4.3)





    (20.0)



    Income before (benefit from) provision for income taxes

    27.2





    38.9



    (Benefit from) provision for income taxes

    (4.9)





    1.5



    Net income

    $

    32.1





    $

    37.4











    Net income per share, basic

    $

    0.34





    $

    0.40



    Net income per share, diluted

    $

    0.33





    $

    0.39











    Weighted average common shares outstanding, basic

    94.2





    92.6



    Weighted average common shares outstanding, diluted

    98.2





    97.0



     

    TABLE 2

     

    NEUROCRINE BIOSCIENCES, INC.

    CONDENSED CONSOLIDATED BALANCE SHEETS

    (unaudited)



    (in millions)

    March 31,

    2021



    December 31,

    2020

    Cash, cash equivalents and debt securities available-for-sale

    $

    873.7





    $

    801.0



    Other current assets

    211.7





    215.2



    Total current assets

    1,085.4





    1,016.2



    Deferred tax assets

    325.6





    319.4



    Debt securities available-for-sale

    249.6





    227.1



    Right-of-use assets

    97.0





    82.8



    Equity securities

    38.9





    38.2



    Property and equipment, net

    45.3





    44.6



    Restricted cash and other long-term assets

    4.6





    6.4



    Total assets

    $

    1,846.4





    $

    1,734.7











    Total current liabilities

    $

    190.0





    $

    186.5



    Convertible senior notes

    322.0





    317.9



    Operating lease liabilities

    107.5





    94.4



    Other long-term liabilities

    21.3





    9.7



    Stockholders' equity

    1,205.6





    1,126.2



    Total liabilities and stockholders' equity

    $

    1,846.4





    $

    1,734.7



     

    TABLE 3

     

    NEUROCRINE BIOSCIENCES, INC.

    RECONCILIATION OF GAAP TO NON-GAAP FINANCIAL RESULTS

    (unaudited)





    Three Months Ended

    March 31,

    (in millions, except per share data)

    2021



    2020

    GAAP net income

    $

    32.1





    $

    37.4



    Adjustments:







    Non-cash collaboration revenue A

    (1.1)





    (1.3)



    Share-based compensation expense - R&D

    15.0





    7.7



    Share-based compensation expense - SG&A

    17.9





    15.1



    Non-cash interest related to convertible senior notes

    4.2





    5.3



    Changes in fair value of equity security investments B

    (0.7)





    16.5



    Income tax effect related to reconciling items C

    (19.5)





    (1.6)



    Non-GAAP net income

    $

    47.9





    $

    79.1











    Net income per diluted common share:







    GAAP

    $

    0.33





    $

    0.39



    Non-GAAP

    $

    0.49





    $

    0.82





    A The Company recognized non-cash collaboration revenue under the collaboration and license agreement entered into with Mitsubishi Tanabe Pharma Corporation in 2015.

    B The Company recognized an unrealized (gain) loss to adjust its equity security investments to fair value.

    C Estimated income tax effect of non-GAAP reconciling items are calculated using applicable statutory tax rates, taking into consideration any valuation allowance. On December 31, 2020, the Company released substantially all of its valuation allowance against its net operating losses and other deferred tax assets. First quarter of 2021, also includes adjustment to exclude the excess tax benefits related to stock compensation.

     

    TABLE 4

     

    NEUROCRINE BIOSCIENCES, INC.

    RECONCILIATION OF GAAP TO NON-GAAP EXPENSES

    (unaudited)





    Three Months Ended

    March 31,

    (in millions)

    2021



    2020

    GAAP R&D

    $

    73.2





    $

    58.3



    Adjustments:







    Share-based compensation expense

    15.0





    7.7



    Non-GAAP R&D

    $

    58.2





    $

    50.6











    GAAP SG&A

    $

    129.0





    $

    117.8



    Adjustments:







    Share-based compensation expense

    17.9





    15.1



    Non-GAAP SG&A

    $

    111.1





    $

    102.7











     

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  10. SAN DIEGO, May 4, 2021 /PRNewswire/ -- Neurocrine Biosciences, Inc. (NASDAQ:NBIX) will present at the Bank of America 2021 Healthcare Conference at 11:00 a.m. Eastern Time on Tuesday May 11, 2021. Kevin Gorman, Chief Executive Officer, will present at the conference.

    The live presentation will be webcast and may be accessed on the Company's website under Investors at www.neurocrine.com. A replay of the presentation will be available on the website approximately one hour after the conclusion of the events and will be archived for approximately one month.

    About Neurocrine Biosciences

    Neurocrine Biosciences is a neuroscience-focused, biopharmaceutical company dedicated to discovering, developing and delivering life-changing treatments for people with serious, challenging and under-addressed neurological, endocrine and psychiatric disorders. The company's diverse portfolio includes FDA-approved treatments for tardive dyskinesia, Parkinson's disease, endometriosis*, uterine fibroids* and clinical programs in multiple therapeutic areas. For nearly three decades, Neurocrine Biosciences has specialized in targeting and interrupting disease-causing mechanisms involving the interconnected pathways of the nervous and endocrine systems. For more information, visit neurocrine.com, and follow the company on LinkedIn(*in collaboration with AbbVie)

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  11. SAN DIEGO, May 3, 2021 /PRNewswire/ -- Neurocrine Biosciences, Inc. (NASDAQ:NBIX) today announced its support of Mental Health Month and commitment to raising awareness of and supporting people living with tardive dyskinesia (TD). Some people living with a mental health condition may also experience TD, an involuntary movement disorder that may develop after a few months of taking certain medications to treat bipolar disorder, depression and schizophrenia.1-3 The uncontrollable movements of TD, which can affect the face, torso and/or other body parts, may be disruptive to people's lives due to the symptoms and impact on their physical, emotional and social well-being.1,2,4 To help raise awareness of TD, the mental health advocacy community and…

    SAN DIEGO, May 3, 2021 /PRNewswire/ -- Neurocrine Biosciences, Inc. (NASDAQ:NBIX) today announced its support of Mental Health Month and commitment to raising awareness of and supporting people living with tardive dyskinesia (TD). Some people living with a mental health condition may also experience TD, an involuntary movement disorder that may develop after a few months of taking certain medications to treat bipolar disorder, depression and schizophrenia.1-3 The uncontrollable movements of TD, which can affect the face, torso and/or other body parts, may be disruptive to people's lives due to the symptoms and impact on their physical, emotional and social well-being.1,2,4 To help raise awareness of TD, the mental health advocacy community and states across the country are recognizing the first full week of May (2-8) as Tardive Dyskinesia Awareness Week for the fourth year in a row.  

    "Most people living with tardive dyskinesia are already living with an underlying mental health condition, and their involuntary movements present additional physical, emotional and social challenges," said Josie Cooper, Executive Director of the Movement Disorders Policy Coalition (MDPC). "The pandemic has significantly affected the mental health of many, especially those living with a mental health condition, making this year's Mental Health Month such an important time to elevate this national conversation. MDPC is proud to recognize Tardive Dyskinesia Awareness Week during Mental Health Month and help support those impacted by this isolating condition."

    Impact of Tardive Dyskinesia

    A recent survey of patients with diagnosed or suspected TD (n=350) indicated that their movements impacted both their overall mental health and daily activities.More than half of the patients surveyed felt that their mental health has been impacted by their involuntary movements (60%) and over two-thirds of patients reported that they were frustrated by their involuntary movements (69%).† According to the survey, patients with diagnosed or suspected TD reported the condition moderately, very or extremely affected them in the following areas:5‡ more than half said it affected their ability to sleep (51%) and nearly one-third said it impacted their ability to eat and drink (33%) and their ability to speak (30%).

    "Tardive dyskinesia may impact people's overall mental health and cause a significant disruption to their daily lives, yet awareness of the condition remains low," said Eiry W. Roberts, M.D., Chief Medical Officer at Neurocrine Biosciences. "Tardive Dyskinesia Awareness Week is an important time, especially during this already challenging and isolating year, to support those impacted by this burdensome condition by broadening the conversation, sharing resources, and highlighting the importance of seeking a diagnosis and treatment."

    About Tardive Dyskinesia Awareness Week

    Over the past four years, more than 40 states, Washington, D.C., and various mental health advocacy organizations have recognized the first full week of May as Tardive Dyskinesia Awareness Week. This year, states are continuing to declare Tardive Dyskinesia Awareness Week to recognize the approximately 600,000 Americans living with this involuntary movement disorder.3,6 Some states and local advocacy groups are also hosting virtual educational briefings to raise awareness. Tardive Dyskinesia Awareness Week encourages the mental health and broader communities to learn about ways to recognize TD symptoms, understand the burden of the condition and talk to their healthcare provider if they think they or someone they know may have the condition.

    As part of Neurocrine Biosciences' commitment to TD education, resources are available at www.TalkAboutTD.com. These resources can help patients and care partners understand TD and recognize its symptoms, request support and have a conversation with their healthcare provider about ways to manage their TD, including treatment options. For more information, follow and join the conservation online by sharing #TDAwarenessWeek.

    About Tardive Dyskinesia (TD)

    Tardive dyskinesia (TD) is a movement disorder that is characterized by uncontrollable, abnormal and repetitive movements of the face, torso and/or other body parts, which may be disruptive and negatively impact patients. The condition is associated with taking certain kinds of mental health medicines (like antipsychotics) that help control dopamine receptors in the brain. Antipsychotics commonly prescribed to treat mental illnesses such as depression, bipolar disorder, schizophrenia and schizoaffective disorder, and certain medications to treat upset stomach, nausea and vomiting may also cause TD. In patients with TD, these treatments are thought to result in irregular dopamine signaling in a region of the brain that controls movement. The symptoms of TD can be severe and are often persistent and irreversible. TD is estimated to affect approximately 600,000 people in the U.S. For more information, visit www.TalkAboutTD.com.

    About Neurocrine Biosciences

    Neurocrine Biosciences is a neuroscience-focused, biopharmaceutical company dedicated to discovering, developing and delivering life-changing treatments for people with serious, challenging and under-addressed neurological, endocrine and psychiatric disorders. The company's diverse portfolio includes FDA-approved treatments for tardive dyskinesia, Parkinson's disease, endometriosis*, uterine fibroids* and clinical programs in multiple therapeutic areas. For nearly three decades, Neurocrine Biosciences has specialized in targeting and interrupting disease-causing mechanisms involving the interconnected pathways of the nervous and endocrine systems. For more information, visit neurocrine.com, and follow the company on LinkedIn(*in collaboration with AbbVie) 

    References

    1. American Psychiatric Association. Diagnostic and Statistical Manual of Mental Disorders. 5th ed. American Psychiatric Association; 2013:712.
    2. Kenney C, Hunter C, Davidson A. Metaclopramide, an increasingly recognized cause of tardive dyskinesia. J Clin Pharmacol. 2008;48(3):379-384.
    3. Cloud LJ, Zutshi D, Factor SA. Tardive dyskinesia: therapeutic options for an increasingly common disorder. Neurotherapeutics. 2014;11(1):166-176.
    4. Ascher-Svanum H, Zhu B, Faries D, Peng X, Kinon BJ, Tohen M. Tardive dyskinesia and the 3-year course of schizophrenia: results from a large, prospective, naturalistic study. J Clin Psych. 2008;69(10):1580-1588
    5. Data on file. Neurocrine Biosciences.
    6. Data on file. Neurocrine Biosciences.

    § Base: Patient ATU 2021. Target patients (diagnosed TD or suspected TD) n=350

    Responses based on survey question: To what extent is the physical impact of your involuntary movements frustrating? Rating scale: 1 to 5 where 1 means "not at all frustrating," and 5 means "extremely frustrating."

    Responses based on survey question: Since first experiencing involuntary movements, how has your ability to perform the following daily activities been affected, if at all? Rating scale: 1 to 5 when 1 means "not affected at all," and 5 means "extremely negatively affected."

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  12. SAN DIEGO, April 26, 2021 (GLOBE NEWSWIRE) -- Sentia Medical Sciences Inc. today announced that they have entered into a research collaboration with Neurocrine Biosciences, Inc. (NASDAQ:NBIX) aimed at discovering novel, long-acting corticotropin-releasing factor (CRF) receptor antagonist peptide therapeutics. The collaboration will leverage Sentia's proprietary peptide-based platform and Neurocrine's drug development expertise in CRF biology to develop and commercialize medicines with the potential to treat a variety of hypothalamic-pituitary-adrenal (HPA) axis modulated diseases.

    Under the terms of the agreement, Sentia will provide to Neurocrine an exclusive license to existing preclinical CRF receptor antagonist peptide compounds. Additionally…

    SAN DIEGO, April 26, 2021 (GLOBE NEWSWIRE) -- Sentia Medical Sciences Inc. today announced that they have entered into a research collaboration with Neurocrine Biosciences, Inc. (NASDAQ:NBIX) aimed at discovering novel, long-acting corticotropin-releasing factor (CRF) receptor antagonist peptide therapeutics. The collaboration will leverage Sentia's proprietary peptide-based platform and Neurocrine's drug development expertise in CRF biology to develop and commercialize medicines with the potential to treat a variety of hypothalamic-pituitary-adrenal (HPA) axis modulated diseases.

    Under the terms of the agreement, Sentia will provide to Neurocrine an exclusive license to existing preclinical CRF receptor antagonist peptide compounds. Additionally, Sentia and Neurocrine will work together to discover novel peptide antagonists targeting CRF and advance them to development candidate stage, after which Neurocrine would be solely responsible for all further development, manufacturing, regulatory and commercial activities. As part of the collaboration, Sentia will receive an up-front payment and committed research funding from Neurocrine to support discovery efforts. Sentia is eligible to receive milestone and royalty payments based on products developed from this collaboration.

    "Neurocrine Biosciences is the perfect company to partner with on our proprietary peptide CRF platform given their long-standing leadership in endocrinology and the CRF field," said Dominic P. Behan, Ph.D., D.Sc., Chief Executive Officer of Sentia Medical Sciences. "This important collaboration advances Sentia's mission of becoming a world leader in the development of novel peptide therapeutics to manage HPA axis driven diseases."

    "We are eager to partner with Sentia Medical Sciences on their proprietary peptide CRF platform which is highly complementary with our long-standing interest and expertise in understanding CRF biology and the role it plays in a variety of disease states," said Dimitri E. Grigoriadis, Ph.D., Chief Research Officer of Neurocrine Biosciences.

    About Sentia Medical Sciences

    Sentia Medical Sciences Inc. is a privately held company with a vision to be a world leader in the development of novel peptide therapeutics to manage and cure stress-related diseases (www.sentiamedical.com).



    Contact:
    Sentia Medical Sciences Inc.
    info@sentiamedical.com
    www.sentiamedical.com 
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  13. SAN DIEGO, April 16, 2021 /PRNewswire/ -- Neurocrine Biosciences, Inc. (NASDAQ:NBIX) today announced the appointment of Johanna Mercier to its Board of Directors. Ms. Mercier is the Chief Commercial Officer of Gilead Sciences, with responsibility for the global commercialization of Gilead's medicines.

    "We are pleased to add Johanna Mercier to the Board of Directors at Neurocrine Biosciences," said William H. Rastetter, Chairman of the Board of Neurocrine Biosciences. "Johanna is an accomplished commercial leader and her extensive global experience within the biopharmaceutical industry will be invaluable to Neurocrine and our Board of Directors."

    Johanna joined Gilead Sciences in 2019 as Chief Commercial Officer after 25 years at Bristol Myers Squibb, where she served in a number of executive leadership positions, gaining broad experience across geographies and in all aspects of the commercial business. In her time at Bristol Myers Squibb, she drove strong commercial strategy and performance with multiple launches that changed the standard of care in melanoma and renal cancers.

    Johanna holds a bachelor's degree in biology from the University of Montreal and an MBA from Concordia University. She is a member of the board of the University of Southern California's Leonard D. Schaeffer Center for Health Policy and Economics. Johanna is also a member of World 50.

    About Neurocrine Biosciences

    Neurocrine Biosciences is a neuroscience-focused, biopharmaceutical company dedicated to discovering, developing and delivering life-changing treatments for people with serious, challenging and under-addressed neurological, endocrine and psychiatric disorders. The company's diverse portfolio includes FDA-approved treatments for tardive dyskinesia, Parkinson's disease, endometriosis*, uterine fibroids* and clinical programs in multiple therapeutic areas. For nearly three decades, Neurocrine Biosciences has specialized in targeting and interrupting disease-causing mechanisms involving the interconnected pathways of the nervous and endocrine systems. For more information, visit neurocrine.com, and follow the company on LinkedIn(*in collaboration with AbbVie)

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  14. SAN DIEGO, April 14, 2021 /PRNewswire/ -- Neurocrine Biosciences, Inc. (NASDAQ:NBIX) announced today that it will report first quarter 2021 financial results after the Nasdaq market closes on Wednesday, May 5, 2021. Neurocrine will then host a conference call and webcast to discuss its financial results and provide a company update that day at 1:30 p.m. Pacific Time (4:30 p.m. Eastern Time).

    Participants can access the live conference call by dialing 800-895-3361 (US) or 785-424-1062 (International) using the conference ID: NBIX. The webcast can also be accessed on Neurocrine's website under Investors at www.neurocrine.com. A replay of the webcast will be available on the website approximately one hour after the conclusion of the event and will be archived for approximately one month.

    About Neurocrine Biosciences

    Neurocrine Biosciences is a neuroscience-focused, biopharmaceutical company dedicated to discovering, developing and delivering life-changing treatments for people with serious, challenging and under-addressed neurological, endocrine and psychiatric disorders. The company's diverse portfolio includes FDA-approved treatments for tardive dyskinesia, Parkinson's disease, endometriosis*, uterine fibroids* and clinical programs in multiple therapeutic areas. For nearly three decades, Neurocrine Biosciences has specialized in targeting and interrupting disease-causing mechanisms involving the interconnected pathways of the nervous and endocrine systems. For more information, visit neurocrine.com, and follow the company on LinkedIn(*in collaboration with AbbVie)

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  15. SAN DIEGO, April 8, 2021 /PRNewswire/ -- Neurocrine Biosciences, Inc. (NASDAQ:NBIX) today announced that it will present data from its movement disorders and epilepsy programs at the American Academy of Neurology's (AAN) 73rd Annual Meeting being held virtually from April 17–22, 2021.

    Key highlights include:

    • Analysis from the KINECT 4 Phase III open-label study that demonstrated the effect of INGREZZA® (valbenazine) capsules on the overall severity of abnormal movements in adult patients living with tardive dyskinesia based on item 8 of the abnormal involuntary movement scale (AIMS)
    • Phase III post-hoc sub-group data analysis that showed long-term use (one-year duration) of ONGENTYS® (opicapone) capsules in patients with Parkinson's disease with motor fluctuations reduced "on" time with troublesome dyskinesia and increased "on" time without troublesome dyskinesia
    • New real-world data from EMPATHY, a retrospective medical chart review, highlight the need to simplify treatment regimens for patients with Parkinson's disease to manage motor fluctuations
    • Results of an online caregiver survey include data on the relationship between genetic variants and disease characteristics in patients with SCN8A developmental epileptic encephalopathy (SCN8A-DEE) and SCN8A-related epilepsy
    • Data from the Enroll-HD registry, a worldwide observational study, showed that the majority of patients with manifest Huntington disease have chorea, yet the majority of those with chorea were not prescribed medication to treat the condition.

    "We are pleased to share important clinical and real-world data that builds on our understanding of neurological conditions with great unmet medical need," said Eiry W. Roberts, M.D., Chief Medical Officer at Neurocrine Biosciences. "These data further demonstrate the strength of our broad neurology portfolio and reinforce our commitment to delivering treatments and innovative solutions that have the potential to improve the lives of those living with neurological conditions, including tardive dyskinesia, Parkinson's disease, epilepsy and chorea in Huntington disease." 

    Presentations include:

    INGREZZA – Tardive Dyskinesia

    • Using Item 8 of the Abnormal Involuntary Movement Scale (AIMS) to Assess Improvement in Patients with Tardive Dyskinesia (Poster # P14.030)

    ONGENTYS – Parkinson's Disease (in collaboration with BIAL)

    • Long-term Efficacy of Opicapone in the Reduction of ON-time with Troublesome Dyskinesia in Parkinson's Disease Patients with Motor Fluctuations and Reporting Troublesome Dyskinesia (Poster # P14.127)
    • Treatment Patterns in a Real-World Sample of Patients with Parkinson's Disease and Motor Fluctuations (Poster # P14.179)
    • Medical Education Improves Knowledge Among Neurologists of Newly Approved Pharmacotherapies for the Management of Wearing-Off in Parkinson's Disease (Poster # P14.077)

    Investigational NBI-921352/XEN901 – Epilepsy

    • Relationship Between Genetic Variants and Disease Characteristics in Patients with SCN8A Developmental and Epileptic Encephalopathy (SCN8A-DEE) or SCN8A-Related Epilepsy (Poster # P7.067)

    Chorea in Huntington Disease

    • Chorea Characteristics and Medication Use in Patients with Huntington Disease: Current Data from Enroll HD (Poster # P14.145)

    A full list of all abstracts being presented by Neurocrine Biosciences at the 2021 AAN Annual Meeting are available here.

    About Tardive Dyskinesia (TD)

    Tardive dyskinesia (TD) is a movement disorder that is characterized by uncontrollable, abnormal and repetitive movements of the face, torso and/or other body parts, which may be disruptive and negatively impact patients. The condition is caused by prolonged use of treatments that block dopamine receptors in the brain, such as antipsychotics commonly prescribed to treat mental illnesses such as schizophrenia, bipolar disorder and depression, and certain anti-nausea medications. In patients with TD, these treatments are thought to result in irregular dopamine signaling in a region of the brain that controls movement. The symptoms of TD can be severe and are often persistent and irreversible. TD is estimated to affect approximately 600,000 people in the U.S.

    About INGREZZA® (valbenazine) Capsules 

    INGREZZA, a selective vesicular monoamine transporter 2 (VMAT2) inhibitor, is the first FDA-approved product indicated for the treatment of adults with tardive dyskinesia, a condition associated with uncontrollable, abnormal and repetitive movements of the face, torso and/or other body parts. 

    INGREZZA is thought to work by reducing the amount of dopamine released in a region of the brain that controls movement and motor function, helping to regulate nerve signaling in adults with tardive dyskinesia. VMAT2 is a protein in the brain that packages neurotransmitters, such as dopamine, for transport and release in presynaptic neurons. INGREZZA, developed by Neurocrine Biosciences, is novel in that it selectively inhibits VMAT2 with no appreciable binding affinity for VMAT1, dopaminergic (including D2), serotonergic, adrenergic, histaminergic or muscarinic receptors. Additionally, INGREZZA can be taken for the treatment of tardive dyskinesia as one capsule, once-daily, together with most psychiatric medications such as antipsychotics or antidepressants. 

    Important Safety Information 

    Approved Use 

    INGREZZA® (valbenazine) capsules is a prescription medicine used to treat adults with movements in the face, tongue, or other body parts that cannot be controlled (tardive dyskinesia). 

    It is not known if INGREZZA is safe and effective in children. 

    Important Safety Information 

    Do not take INGREZZA if you are allergic to valbenazine, or any of the ingredients in INGREZZA. 

    INGREZZA may cause serious side effects, including

    • Sleepiness (somnolence). Do not drive, operate heavy machinery, or do other dangerous activities until you know how INGREZZA affects you.
    • Heart rhythm problems (QT prolongation). INGREZZA may cause a heart problem known as QT prolongation.
    • Symptoms of QT prolongation may include: fast, slow, or irregular heartbeat, shortness of breath, dizziness or fainting.
    • Parkinson-like symptoms. Symptoms include: shaking, body stiffness, trouble moving or walking, or keeping your balance.

    Tell your healthcare provider right away if you have a change in your heartbeat (a fast or irregular heartbeat), or if you faint. 

    Before taking INGREZZA, tell your healthcare provider about all of your medical conditions including if you: have liver or heart problems, are pregnant or plan to become pregnant, or are breastfeeding or plan to breastfeed. 

    Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins and herbal supplements. 

    The most common side effect of INGREZZA is sleepiness (somnolence). Other side effects include changes in balance (balance problems, dizziness) or an increased risk of falls, headache, feelings of restlessness, dry mouth, constipation, and blurred vision. 

    These are not all of the possible side effects of INGREZZA. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. 

    Please see INGREZZA full Product Information.  

    About Parkinson's Disease

    Parkinson's disease is a chronic, progressive and debilitating neurodegenerative disorder that affects approximately 1 million people in the U.S. and 6 million people worldwide. Parkinson's disease is caused by low dopamine levels produced in the brain. Dopamine helps transmit signals between the areas of the brain that control all purposeful movements, including talking, walking and writing. As Parkinson's disease progresses, dopamine production steadily decreases, resulting in increased problems with motor symptoms including slowed movement (bradykinesia), tremor, rigidity, impaired posture and balance, and difficulty with speech and writing.

    There is presently no cure for Parkinson's disease and management of the disease consists of the use of treatments that attempt to control motor symptoms primarily through dopaminergic mechanisms. The current gold standard for treatment of motor symptoms is levodopa/carbidopa. While levodopa/carbidopa improves patients' motor symptoms, as the disease progresses, the beneficial effects of levodopa begin to wear off more quickly. Patients then experience motor fluctuations throughout the day between "on" time, periods when the medication is working and Parkinson's disease symptoms are controlled, and "off" time, when the medication is not working and motor symptoms return.

    About ONGENTYS® (opicapone) Capsules 

    ONGENTYS is a once-daily, oral, peripheral, selective and reversible catechol-O-methyltransferase (COMT) inhibitor approved by the U.S. Food and Drug Administration (FDA) as an add-on treatment to levodopa/carbidopa in patients with Parkinson's disease experiencing "off" episodes. ONGENTYS inhibits the COMT enzyme, which breaks down levodopa, making more levodopa available to reach the brain.

    In June 2016, BIAL – Portela & CA, S.A. (BIAL) received approval from the European Commission for ONGENTYS as an adjunct therapy to preparations of levodopa/DOPA decarboxylase inhibitors in adult patients with Parkinson's disease and end-of-dose motor fluctuations who cannot be stabilized on those combinations. BIAL currently markets ONGENTYS in several European countries. Neurocrine Biosciences in-licensed opicapone from BIAL in 2017 and has exclusive development and commercialization rights in the U.S. and Canada.

    Important Information

    Approved Use

    ONGENTYS® (opicapone) capsules is a prescription medicine used with levodopa and carbidopa in people with Parkinson's disease (PD) who are having "OFF" episodes.

    It is not known if ONGENTYS is safe and effective in children.

    Important Safety Information

    Do not take ONGENTYS if you:

    • take a type of medicine called a non-selective monoamine-oxidase (MAO) inhibitor.
    • have a tumor that secretes hormones known as catecholamines.

    Before taking ONGENTYS, tell your healthcare provider about all of your medical conditions, including if you:

    • have daytime sleepiness from a sleep disorder, have unexpected periods of sleep or sleepiness, or take a medicine to help you sleep or that makes you feel sleepy.
    • have had intense urges or unusual behaviors, including gambling, increased sex drive, binge eating, or compulsive shopping.
    • have a history of uncontrolled sudden movements (dyskinesia).
    • have had hallucinations or psychosis.
    • have liver or kidney problems.
    • are pregnant or plan to become pregnant, or are breastfeeding or plan to breastfeed.

    Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Especially tell your healthcare provider if you take nonselective MAO inhibitors (such as phenelzine, tranylcypromine, and isocarboxazid) or catecholamine medicines (such as isoproterenol, epinephrine, norepinephrine, dopamine, and dobutamine), regardless of how you take the medicine (by mouth, inhaled, or by injection).

    ONGENTYS and other medicines may affect each other causing side effects. ONGENTYS may affect the way other medicines work, and other medicines may affect how ONGENTYS works.

    What should I avoid while taking ONGENTYS?

    Do not drive, operate machinery, or do other dangerous activities until you know how ONGENTYS affects you.

    What are the possible side effects of ONGENTYS?

    ONGENTYS may cause serious side effects, including:

    • Falling asleep during normal activities such as driving a car, talking or eating while taking ONGENTYS or other medicines used to treat Parkinson's disease, without being drowsy or without warning. This may result in having accidents. Your chances of falling asleep while taking ONGENTYS are higher if you take other medicines that cause drowsiness.
    • Low blood pressure or dizziness, light headedness, or fainting.
    • Uncontrolled sudden movements (dyskinesia). ONGENTYS may cause uncontrolled sudden movements or make such movements worse or happen more often.
    • Seeing, hearing, or feeling things that are not real (hallucinations), believing things that are not real (delusions), or aggressive behavior.
    • Unusual urges (impulse control and compulsive disorders) such as urges to gamble, increased sexual urges, strong urges to spend money, binge eating, and the inability to control these urges.

    Tell your healthcare provider if you experience any of these side effects or notice changes in your behavior.

    The most common side effects of ONGENTYS include uncontrolled sudden movements (dyskinesia), constipation, increase in an enzyme called blood creatine kinase, low blood pressure, and weight loss.

    These are not all of the possible side effects of ONGENTYS. Call your healthcare provider for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

    Please see ONGENTYS full Product Information.

    About NBI-921352/XEN901

    NBI-921352 is an investigational, potent, highly selective Nav1.6 sodium channel inhibitor being developed to treat pediatric patients with SCN8A developmental and epileptic encephalopathy (SCN8A-DEE), adult focal epilepsy and other potential indications. Neurocrine Biosciences has received a rare pediatric disease designation from the U.S. FDA for NBI-921352. The company acquired the exclusive rights to NBI-921352 from Xenon Pharmaceuticals.

    About SCN8A-DEE

    SCN8A developmental and epileptic encephalopathy (SCN8A-DEE), is a rare, severe syndrome linked to gain-of-function mutations in the SCN8A gene that codes for the Nav1.6 sodium channel and affects how brain cells conduct electrical impulses in the brain. It is characterized by severe epilepsy, early onset developmental delay, cognitive impairment and other medical challenges. Seizures associated with this syndrome are highly refractory to currently available antiseizure medication. The seizures, which begin occurring at a median age of four months, can vary in frequency, with some patients experiencing up to several per day. Over 90% of children with SCN8A-DEE are non-verbal, and half are not ambulatory. About 10% of children living with the syndrome die from Sudden Unexpected Death in Epilepsy (SUDEP). There are currently no approved therapies for this form of pediatric epilepsy.

    About Chorea in Huntington Disease

    Huntington disease (HD) is a hereditary progressive neurodegenerative disorder in which neurons within the brain break down, resulting in motor, cognitive and psychiatric symptoms. Symptoms generally appear between the ages of 30 to 50 and worsen over a 10 to 25-year period. Many patients with HD experience chorea, a troublesome involuntary movement disorder, in which patients develop abnormal, abrupt or irregular movements. Chorea can affect various body parts and interfere with speech, swallowing, posture and gait. HD is estimated to affect approximately 30,000 adults in the U.S., with more than 200,000 at risk of inheriting the disease.

    About Neurocrine Biosciences

    Neurocrine Biosciences is a neuroscience-focused, biopharmaceutical company dedicated to discovering, developing and delivering life-changing treatments for people with serious, challenging and under-addressed neurological, endocrine and psychiatric disorders. The company's diverse portfolio includes FDA-approved treatments for tardive dyskinesia, Parkinson's disease, endometriosis*, uterine fibroids* and clinical programs in multiple therapeutic areas. For nearly three decades, Neurocrine Biosciences has specialized in targeting and interrupting disease-causing mechanisms involving the interconnected pathways of the nervous and endocrine systems. For more information, visit neurocrine.com, and follow the company on LinkedIn(*in collaboration with AbbVie)

    Forward-Looking Statements

    In addition to historical facts, this press release contains forward-looking statements that involve a number of risks and uncertainties. These statements include, but are not limited to, statements regarding the potential benefits to be derived from the Company's products and product candidates. Among the factors that could cause actual results to differ materially from those indicated in the forward-looking statements include: the Company's future financial and operating performance; the impact of the COVID-19 pandemic and efforts to mitigate its spread on the Company's business; risks and uncertainties associated with the scale and duration of the COVID-19 pandemic and resulting global, national, and local disruptions, the risk that the Company's products or product candidates will not be found to be safe and/or effective or may not prove to be beneficial to patients; that development activities for the Company's product candidates may not be completed on time or at all; risks that clinical development activities may be delayed for regulatory or other reasons, may not be successful or replicate previous and/or interim clinical trial results, or may not be predictive of real-world results or of results in subsequent clinical trials; risks that regulatory submissions for the Company's product candidates may not occur or be submitted in a timely manner; risks that the Company's product candidates may not obtain regulatory approvals; risks that the potential benefits of the agreements with the Company's collaboration partners may never be realized; risks that the Company's products and/or product candidates may be precluded from commercialization by the proprietary or regulatory rights of third parties, or have unintended side effects, adverse reactions or incidents of misuse; and other risks described in the Company's periodic reports filed with the Securities and Exchange Commission, including without limitation the Company's quarterly report on Form 10-K for the year ended December 31, 2020. Neurocrine Biosciences disclaims any obligation to update the statements contained in this press release after the date hereof.

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    SOURCE Neurocrine Biosciences, Inc.

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  16. SAN DIEGO, March 25, 2021 /PRNewswire/ -- Neurocrine Biosciences, Inc. (NASDAQ:NBIX) will present at the Stifel 3rd Annual CNS Day at 12:30 p.m. Eastern Time on Thursday Apr. 1, 2021. Eiry Roberts, Chief Medical Officer, and Kyle Gano, Chief Business Development and Strategy Officer, will present at the conference.

    The live presentation will be webcast and may be accessed on the Company's website under Investors at www.neurocrine.com. A replay of the presentation will be available on the website approximately one hour after the conclusion of the events and will be archived for approximately one month.

    About Neurocrine Biosciences

    Neurocrine Biosciences is a neuroscience-focused, biopharmaceutical company dedicated to discovering, developing and delivering life-changing treatments for people with serious, challenging and under-addressed neurological, endocrine and psychiatric disorders. The company's diverse portfolio includes FDA-approved treatments for tardive dyskinesia, Parkinson's disease, endometriosis*, uterine fibroids* and clinical programs in multiple therapeutic areas. For nearly three decades, Neurocrine Biosciences has specialized in targeting and interrupting disease-causing mechanisms involving the interconnected pathways of the nervous and endocrine systems. For more information, visit neurocrine.com, and follow the company on LinkedIn(*in collaboration with AbbVie)

     

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  17. NEW YORK, March 24, 2021 /PRNewswire/ -- Neurocrine Biosciences Inc. (NASD:NBIX) will replace O-I Glass Inc. (NYSE:OI) in the S&P MidCap 400, and O-I Glass will replace HMS Holdings Corp (NASD:HMSY) in the S&P SmallCap 600 effective prior to the opening of trading on Tuesday, March 30. Veritas Capital is acquiring HMS Holding in a deal expected to be completed soon pending final conditions. O-I Glass is more representative of the small-cap market space.

    Following is a summary of the changes that will take place prior to the open of trading on the effective date:

    Effective Date

    Index Name      

    Action

    Company Name

    Ticker

    GICS Sector

    March 30, 2021

    S&P MidCap 400

    Addition

    Neurocrine Biosciences

    NBIX

    Health Care


    S&P MidCap 400

    Deletion

    O-I Glass

    NEW YORK, March 24, 2021 /PRNewswire/ -- Neurocrine Biosciences Inc. (NASD:NBIX) will replace O-I Glass Inc. (NYSE:OI) in the S&P MidCap 400, and O-I Glass will replace HMS Holdings Corp (NASD:HMSY) in the S&P SmallCap 600 effective prior to the opening of trading on Tuesday, March 30. Veritas Capital is acquiring HMS Holding in a deal expected to be completed soon pending final conditions. O-I Glass is more representative of the small-cap market space.

    Following is a summary of the changes that will take place prior to the open of trading on the effective date:

    Effective Date

    Index Name      

    Action

    Company Name

    Ticker

    GICS Sector

    March 30, 2021

    S&P MidCap 400

    Addition

    Neurocrine Biosciences

    NBIX

    Health Care



    S&P MidCap 400

    Deletion

    O-I Glass

    OI

    Materials



    S&P SmallCap 600

    Addition

    O-I Glass

    OI

    Materials



    S&P SmallCap 600

    Deletion

    HMS Holdings

    HMSY

    Health Care

    For more information about S&P Dow Jones Indices, please visit www.spdji.com

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    S&P Dow Jones Indices is a division of S&P Global (NYSE:SPGI), which provides essential intelligence for individuals, companies, and governments to make decisions with confidence. For more information, visit www.spdji.com.

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  18. SAN DIEGO, March 20, 2021 /PRNewswire/ -- Neurocrine Biosciences, Inc. (NASDAQ:NBIX) today announced that it will present additional positive data from its Phase II CAHlibrate study of crinecerfont, an investigational, oral, non-steroidal corticotropin-releasing factor type 1 (CRF1) receptor antagonist for the potential treatment of classic congenital adrenal hyperplasia (CAH) due to 21-hydroxylase deficiency (21-OHD), at ENDO 2021, the Endocrine Society's annual meeting, on March 20–23, 2021. These new analyses, based on data from seven male subjects with classic CAH receiving crinecerfont, demonstrate dose-dependent decreases in androstenedione (A4), a key marker of CAH control and precursor to testosterone, with similar dose-dependent decreases…

    SAN DIEGO, March 20, 2021 /PRNewswire/ -- Neurocrine Biosciences, Inc. (NASDAQ:NBIX) today announced that it will present additional positive data from its Phase II CAHlibrate study of crinecerfont, an investigational, oral, non-steroidal corticotropin-releasing factor type 1 (CRF1) receptor antagonist for the potential treatment of classic congenital adrenal hyperplasia (CAH) due to 21-hydroxylase deficiency (21-OHD), at ENDO 2021, the Endocrine Society's annual meeting, on March 20–23, 2021. These new analyses, based on data from seven male subjects with classic CAH receiving crinecerfont, demonstrate dose-dependent decreases in androstenedione (A4), a key marker of CAH control and precursor to testosterone, with similar dose-dependent decreases in the A4 to testosterone ratio. Testosterone levels were preserved despite the marked reductions in A4, suggesting a positive effect on reproductive hormones and providing early indications of improved testicular function. During the ENDO 2021 Virtual Poster Hall, Neurocrine Biosciences will present the Phase II CAHlibrate data, along with two additional abstracts that highlight real-world data evaluating the impact of CAH in adult and pediatric patients.

    "As we continue to evaluate crinecerfont, we find the additional Phase II analyses that we are presenting at ENDO 2021 very encouraging," said Richard Auchus, M.D., Ph.D., the study's lead investigator and Professor of Internal Medicine, Division of Metabolism, Endocrinology & Diabetes at Michigan Medicine. "These data are consistent with preserved and possibly even improved testicular function in men with classic CAH during 14 days of crinecerfont treatment. These results are an important addition to growing clinical evidence that demonstrates the potential benefit of this investigational compound."

    Of the two additional abstracts, one presents analyses from the International CAH (I-CAH) Registry, a research database that includes patients from 29 countries with longitudinal data dating back to 1989, evaluating the impact of CAH on bone age advancement and growth patterns in pediatric patients. In the other abstract, the company will present analyses from a real-world evidence repository of medical and prescription claims and electronic health records demonstrating the impact of possible glucocorticoid-related and disease-related co-morbidities in over 1,100 adult and pediatric patients with assumed classic CAH.

    "These real-world data demonstrate the significant clinical impact that both CAH and its long-term treatment with high doses of glucocorticoids have on patients," said Eiry W. Roberts, M.D., Chief Medical Officer at Neurocrine Biosciences. "Through the Phase III CAHtalyst studies in adults and pediatric patients with classic CAH, we hope to demonstrate the potential value of crinecerfont in controlling disease-related symptoms while also creating the opportunity for a reduction in the adverse effects created by current outdated treatment options."

    Presentations at ENDO 2021 include:

    All posters will be on display in the virtual poster hall throughout ENDO 2021 starting at 11:00 a.m. ET on March 20, 2021. ENDO 2021 abstracts will also be included in a supplemental issue of the Journal of the Endocrine Society following the meeting.

    Neurocrine Biosciences is developing crinecerfont, an investigational, oral, non-steroidal corticotropin-releasing factor type 1 (CRF1) receptor antagonist as a novel therapy for the treatment of classic CAH. Crinecerfont is currently being evaluated in global registrational Phase III studies in adults (CAHtalyst Study, clinicaltrials.gov) and pediatric patients (CAHtalyst Pediatric Study, clinicaltrials.gov) with classic CAH.

    Crinecerfont Phase II Study Design

    The Phase II open-label, multiple-dose, dose-finding study assessed the safety, tolerability, pharmacokinetics and pharmacodynamics of crinecerfont in 18 adults with classic congenital adrenal hyperplasia (CAH) due to 21-hydroxylase deficiency (21-OHD). The study's sequential-cohort design evaluated four crinecerfont oral dosing regimens: 50 mg at bedtime (Cohort 1; n=8); 100 mg at bedtime (Cohort 2; n=7); 100 mg once-daily with an evening meal (Cohort 3; n=8); and 100 mg twice-daily with meals (Cohort 4; n=8). Participants in Cohorts 1 and 2 could enroll in Cohorts 3 and/or 4. Each regimen was administered for 14 consecutive days. ACTH, 17-OHP, androstenedione (A4) and testosterone, key disease hormone markers in CAH patients, were measured over a 24-hour period at baseline and after 14 consecutive days of dosing.

    About Classic Congenital Adrenal Hyperplasia (CAH)

    Classic CAH is a genetic disorder in which an enzyme deficiency alters the production of adrenal hormones. Because of this deficiency, the adrenal glands fail to produce enough cortisol and, in approximately 75% of cases, aldosterone, resulting in a potentially life-threatening condition. The lack of cortisol stimulates the release of high levels of adrenocorticotropic hormone (ACTH) from the pituitary gland, leading to excessive production of adrenal androgens. Elevated androgens can lead to virilization, menstrual irregularities, hirsutism and acne in females, and accelerated growth and precocious puberty in childhood (resulting in short stature and fertility problems) in both males and females.

    Corticosteroids, the current standard of care for more than 60 years, are prescribed to treat cortisol deficiency and reduce the high ACTH levels in order to attempt to control androgen excess. However, the dose and duration of glucocorticoids required to suppress ACTH and control androgen levels are often well above what is needed for replacement dosing to treat cortisol deficiency. Long-term, chronic exposure to greater than physiologic dosing of glucocorticoids can cause metabolic issues, bone loss, growth impairment and infection risk typical of iatrogenic Cushing's syndrome. Classic CAH is a disease that affects approximately 30,000 people in the U.S. and roughly 50,000 people in Europe.

    To learn more about CAH, click here.

    About Crinecerfont

    Crinecerfont is an investigational, oral, non-steroidal corticotropin-releasing factor type 1 (CRF1) receptor antagonist under evaluation for the treatment of classic congenital adrenal hyperplasia (CAH) due to 21-hydroxylase deficiency (21-OHD). The blockade of CRF receptors in the pituitary has been shown to decrease the release of adrenocorticotropic hormone (ACTH), which in turn decreases the production of adrenal androgens, and potentially the symptoms associated with classic CAH. Adding crinecerfont treatment to glucocorticoid therapy has the potential to reduce the adverse consequences of androgen excess and of long-term exposure to greater than replacement doses of glucocorticoids, enabling patients to better manage the symptoms of classic CAH.

    To learn more about crinecerfont, click here.

    About Neurocrine Biosciences

    Neurocrine Biosciences is a neuroscience-focused, biopharmaceutical company dedicated to discovering, developing and delivering life-changing treatments for people with serious, challenging and under-addressed neurological, endocrine and psychiatric disorders. The company's diverse portfolio includes FDA-approved treatments for tardive dyskinesia, Parkinson's disease, endometriosis*, uterine fibroids* and clinical programs in multiple therapeutic areas. For nearly three decades, Neurocrine Biosciences has specialized in targeting and interrupting disease-causing mechanisms involving the interconnected pathways of the nervous and endocrine systems. For more information, visit neurocrine.com, and follow the company on LinkedIn. (*in collaboration with AbbVie)

    Neurocrine Biosciences Forward-Looking Statements

    In addition to historical facts, this press release contains forward-looking statements that involve a number of risks and uncertainties. These statements include, but are not limited to, statements regarding the potential benefits of crinecerfont to patients and future clinical development plans. Among the factors that could cause actual results to differ materially from those indicated in the forward-looking statements include: our future financial and operating performance; the impact of the COVID-19 pandemic and efforts to mitigate its spread on our business; risks and uncertainties associated with the scale and duration of the COVID-19 pandemic and resulting global, national, and local disruptions, the risk that crinecerfont will not be found to be safe and/or effective or may not prove to be beneficial to patients; that development activities for crinecerfont may not be completed on time or at all; risks that clinical development activities may be delayed for regulatory or other reasons, may not be successful or replicate previous and/or interim clinical trial results, or may not be predictive of real-world results or of results in subsequent clinical trials; risks that regulatory submissions for crinecerfont may not occur or be submitted in a timely manner; risks that crinecerfont may not obtain regulatory approvals; or that the U.S. Food and Drug Administration or regulatory authorities outside the U.S. may make adverse decisions regarding crinecerfont; and other risks described in the Company's periodic reports filed with the Securities and Exchange Commission, including without limitation the Company's quarterly report on Form 10-K for the year ended December 31, 2020. Neurocrine Biosciences disclaims any obligation to update the statements contained in this press release after the date hereof.

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    SOURCE Neurocrine Biosciences, Inc.

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  19. SAN DIEGO, March 9, 2021 /PRNewswire/ -- Neurocrine Biosciences, Inc. (NASDAQ:NBIX) will present at the Oppenheimer 31st Annual Healthcare Conference at 4:30 p.m. Eastern Time on Tuesday Mar. 16, 2021. Matt Abernethy, Chief Financial Officer, will present at the conference.

    The live presentation will be webcast and may be accessed on the Company's website under Investors at www.neurocrine.com. A replay of the presentation will be available on the website approximately one hour after the conclusion of the events and will be archived for approximately one month.

    About Neurocrine Biosciences

    Neurocrine Biosciences is a neuroscience-focused, biopharmaceutical company dedicated to discovering, developing and delivering life-changing treatments for people with serious, challenging and under-addressed neurological, endocrine and psychiatric disorders. The company's diverse portfolio includes FDA-approved treatments for tardive dyskinesia, Parkinson's disease, endometriosis*, uterine fibroids* and clinical programs in multiple therapeutic areas. For nearly three decades, Neurocrine Biosciences has specialized in targeting and interrupting disease-causing mechanisms involving the interconnected pathways of the nervous and endocrine systems. For more information, visit neurocrine.com, and follow the company on LinkedIn(*in collaboration with AbbVie)

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  20. SAN DIEGO, March 2, 2021 /PRNewswire/ -- Neurocrine Biosciences (NASDAQ:NBIX) today announced that investigational drug luvadaxistat (NBI-1065844/TAK-831) did not meet its primary endpoint in the Phase II INTERACT study in adults with negative symptoms of schizophrenia, as measured by the change from baseline on the PANSS NSFS at Day 84. Luvadaxistat met secondary endpoints of cognitive assessment, which merit further clinical evaluation. The adverse event profiles for luvadaxistat were consistent with previous trials. Takeda Pharmaceutical Company Limited ("Takeda") granted an exclusive license to Neurocrine Biosciences for seven pipeline programs, including luvadaxistat, in June 2020. The results from the Phase II INTERACT study are being…

    SAN DIEGO, March 2, 2021 /PRNewswire/ -- Neurocrine Biosciences (NASDAQ:NBIX) today announced that investigational drug luvadaxistat (NBI-1065844/TAK-831) did not meet its primary endpoint in the Phase II INTERACT study in adults with negative symptoms of schizophrenia, as measured by the change from baseline on the PANSS NSFS at Day 84. Luvadaxistat met secondary endpoints of cognitive assessment, which merit further clinical evaluation. The adverse event profiles for luvadaxistat were consistent with previous trials. Takeda Pharmaceutical Company Limited ("Takeda") granted an exclusive license to Neurocrine Biosciences for seven pipeline programs, including luvadaxistat, in June 2020. The results from the Phase II INTERACT study are being evaluated to determine next steps for development activities.

    "The Phase II INTERACT study was a well-designed and executed clinical study that resulted in a negative outcome for luvadaxistat on the primary endpoint assessing the change from baseline in negative symptoms of schizophrenia. We are, however, encouraged that secondary endpoints assessing cognitive performance within the trial were met and that treatment emergent adverse events reported were consistent with previous luvadaxistat studies," said Eiry W. Roberts, M.D., Chief Medical Officer of Neurocrine Biosciences. "The totality of the top-line data from this study therefore support further clinical evaluation of luvadaxistat. We plan to work with our partner Takeda as we move forward."

    About the INTERACT Study

    INTERACT is a Phase II, twelve-week, multi-center, randomized, double-blind, placebo-controlled, parallel-group study that evaluated the efficacy, safety, tolerability and pharmacokinetics of three dosing levels of investigational drug luvadaxistat (NBI-1065844/TAK-831) as an adjunctive treatment of adult patients with negative symptoms of schizophrenia. Study enrollment began in January 2018 and included a total of 256 randomized patients.

    About Luvadaxistat (NBI-1065844/TAK-831)

    Luvadaxistat is a potential first-in-class, investigational, oral, selective inhibitor with a high binding affinity to d-amino acid oxidase (DAAO). It targets glutamate, an abundant neurotransmitter in the brain. In schizophrenia, N-methyl D-aspartate (NMDA) receptor hypofunction on PV+ gamma-aminobutyric acid (GABA) interneurons results in disinhibition of cortical or hippocampal glutamate neurons projecting to the pyramidal neurons. The cortical disturbances account for the negative/cognitive symptoms of schizophrenia, while the downstream subcortical dopamine release manifests as the positive symptoms of the disorder.

    About Schizophrenia

    Schizophrenia is a serious and complex syndrome with heterogeneous symptoms that impacts more than 20 million people worldwide. This chronic and disabling disorder is thought to result from a complex interplay of genetic and environmental risk factors. Schizophrenia is characterized by positive symptoms (e.g. hallucinations, delusions and disorganized thinking), negative symptoms [e.g., blunted affect, alogia (reduction in quantity of words spoken), avolition (reduced goal-directed activity due to decreased motivation), asociality, and anhedonia (reduced experience of pleasure)] and cognitive deficits. Annual associated costs for schizophrenia are estimated to be more than $150 billion in the United States.

    Current schizophrenia medications include antipsychotics, which work primarily through antagonism of the dopamine D2 receptor. These approaches do not impact the negative symptoms of schizophrenia or cognitive impairment associated with schizophrenia (CIAS), suggesting that dysfunction of the dopamine system might not fully explain the negative and cognitive symptoms associated with schizophrenia. Animal, brain imaging, genetic, and postmortem brain studies have advanced our understanding of the underlying neurobiology of schizophrenia, with converging lines of evidence from these studies implicating NMDA receptor hypofunction in the pathophysiology of schizophrenia.

    About Neurocrine-Takeda Collaboration

    On June 16, 2020, Neurocrine and Takeda announced a strategic collaboration to develop and commercialize compounds in Takeda's early-to-mid-stage psychiatry pipeline. Specifically, Takeda granted an exclusive license to Neurocrine Biosciences for seven pipeline programs, including three clinical stage assets for schizophrenia, treatment-resistant depression and anhedonia.

    About Neurocrine Biosciences

    Neurocrine Biosciences is a neuroscience-focused, biopharmaceutical company dedicated to discovering, developing and delivering life-changing treatments for people with serious, challenging and under-addressed neurological, endocrine and psychiatric disorders. The company's diverse portfolio includes FDA-approved treatments for tardive dyskinesia, Parkinson's disease, endometriosis*, uterine fibroids* and clinical programs in multiple therapeutic areas. For nearly three decades, Neurocrine Biosciences has specialized in targeting and interrupting disease-causing mechanisms involving the interconnected pathways of the nervous and endocrine systems. For more information, visit neurocrine.com, and follow the company on LinkedIn. (*in collaboration with AbbVie)

    Neurocrine Biosciences Forward-Looking Statements

    In addition to historical facts, this press release contains forward-looking statements that involve a number of risks and uncertainties. These statements include, but are not limited to, statements related to: the benefits to be derived from our collaboration with Takeda, the future development of luvadaxistat, and the timing of the commencement or completion of our clinical, regulatory, and other development activities. Among the factors that could cause actual results to differ materially from those indicated in the forward-looking statements are: our future financial and operating performance; the impact of the COVID-19 pandemic and efforts to mitigate its spread on our business; risks and uncertainties associated with the scale and duration of the COVID-19 pandemic and resulting global, national, and local disruptions; risks related to the development of luvadaxistat; risks associated with our dependence on third parties for development and manufacturing activities related to luvadaxistat, and our ability to manage these third parties; risks that the FDA or other regulatory authorities may make adverse decisions regarding our product candidates; risks that clinical development activities may not be completed on time or at all, or may be delayed for regulatory, manufacturing, COVID-19 or other reasons, may not be successful or replicate previous clinical trial results, may fail to demonstrate that our product candidates are safe and effective, or may not be predictive of real-world results or of results in subsequent clinical trials; risks that the potential benefits of our collaboration with Takeda may never be realized; risks that luvadaxistat may be precluded from commercialization by the proprietary or regulatory rights of third parties, or have unintended side effects, adverse reactions or incidents of misuse; and other risks described in our periodic reports filed with the SEC, including without limitation our annual report on Form 10-K for the year ended December 31, 2020. Neurocrine disclaims any obligation to update the statements contained in this press release after the date hereof.

     

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    SOURCE Neurocrine Biosciences, Inc.

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  21. SAN DIEGO, Feb. 23, 2021 /PRNewswire/ -- Neurocrine Biosciences, Inc. (NASDAQ:NBIX) will present at the Cowen 41st Annual Health Care Conference at 1:30 p.m. Eastern Time on Tuesday Mar. 2, 2021. Kevin Gorman, Chief Executive Officer, will present at the conference.

    The live presentation will be webcast and may be accessed on the Company's website under Investors at www.neurocrine.com. A replay of the presentation will be available on the website approximately one hour after the conclusion of the events and will be archived for approximately one month.

    About Neurocrine Biosciences

    Neurocrine Biosciences is a neuroscience-focused, biopharmaceutical company dedicated to discovering, developing and delivering life-changing treatments for people with serious, challenging and under-addressed neurological, endocrine and psychiatric disorders. The company's diverse portfolio includes FDA-approved treatments for tardive dyskinesia, Parkinson's disease, endometriosis*, uterine fibroids* and clinical programs in multiple therapeutic areas. For nearly three decades, Neurocrine Biosciences has specialized in targeting and interrupting disease-causing mechanisms involving the interconnected pathways of the nervous and endocrine systems. For more information, visit neurocrine.com, and follow the company on LinkedIn(*in collaboration with AbbVie)

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/neurocrine-biosciences-to-present-at-the-cowen-41st-annual-health-care-conference-301233900.html

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  22. SAN DIEGO, Feb. 4, 2021 /PRNewswire/ -- Neurocrine Biosciences, Inc. (NASDAQ:NBIX) today announced its financial results for the fourth quarter and full-year ended December 31, 2020 and provided full-year 2021 financial expense guidance.

    "In 2020, we served more patients with tardive dyskinesia than ever before despite the pandemic weighing on the development of the overall market. We are pleased with the recently updated guidelines from the American Psychiatric Association that now recommend first-line treatment for tardive dyskinesia with a VMAT2 inhibitor, which we hope will benefit even more patients as the vast majority of patients living with tardive dyskinesia remain undiagnosed," said Kevin Gorman, Ph.D., Chief Executive Officer of Neurocrine Biosciences. "In 2021, we plan to initiate eight mid-to-late stage clinical studies and look forward to important data read-outs for NBI-1065844 in the negative symptoms of schizophrenia and valbenazine for the treatment of chorea associated with Huntington's Disease."

    Financial Highlights



    Three Months Ended

    December 31,



    Twelve Months Ended

    December 31,

    (unaudited, in millions, except per share data)

    2020



    2019



    2020



    2019

    Revenues:















    Product sales, net

    $

    241.3





    $

    237.9





    $

    994.1





    $

    752.9



    Collaboration revenue

    6.6





    6.2





    51.8





    35.2



    Total revenues

    $

    247.9





    $

    244.1





    $

    1,045.9





    $

    788.1



















    GAAP Research and Development (R&D)

    $

    66.7





    $

    55.3





    $

    275.0





    $

    200.0



    Non-GAAP R&D

    $

    59.4





    $

    47.9





    $

    221.3





    $

    164.2



















    GAAP Selling, General and Administrative (SG&A)

    $

    106.5





    $

    101.3





    $

    433.3





    $

    354.1



    Non-GAAP SG&A

    $

    92.8





    $

    87.4





    $

    367.0





    $

    304.6



















    GAAP net income

    $

    347.9





    $

    34.0





    $

    407.3





    $

    37.0



    GAAP net income per share – diluted

    $

    3.58





    $

    0.35





    $

    4.16





    $

    0.39



















    Non-GAAP net income

    $

    88.1





    $

    102.2





    $

    402.3





    $

    283.8



    Non-GAAP net income per share – diluted

    $

    0.91





    $

    1.05





    $

    4.11





    $

    2.96



















    (unaudited, in millions)



    December 31,

    2020



    December 31,

    2019

    Total cash, cash equivalents and debt securities available-for-sale

    $

    1,028.1





    $

    970.2



    Fourth Quarter and Full-Year Net Product Sales and Revenues Highlights:

    • INGREZZA net product sales for the fourth quarter and full-year 2020 were $240 million and $993 million, respectively, representing an increase of 1% and 32% versus respective 2019 comparable periods
    • INGREZZA inventory adjusted net product sales for the fourth quarter of 2020 were $258 million representing 4% sequential growth vs. the third quarter of 2020
    • INGREZZA end of fourth quarter 2020 days-on-hand channel inventory decreased by $18 million relative to the third quarter
    • INGREZZA new prescriptions increased in the fourth quarter of 2020 vs. the third quarter of 2020
    • Refill and persistency rates continued to be strong for existing INGREZZA patients
    • ONGENTYS launched in the United States in late September 2020 and net product sales for the fourth quarter of 2020 were approximately $1 million reflecting growing uptake throughout the quarter
    • Elagolix royalties received from AbbVie on combined fourth quarter 2020 net sales of ORILISSA® (elagolix tablets) and ORIAHNNTM (elagolix, estradiol and norethindrone acetate capsules and elagolix capsules) totaled $6 million

    Financial Highlights:

    • Fourth quarter 2020 GAAP net income and diluted earnings per share were approximately $348 million and $3.58, respectively, compared with approximately $34 million and $0.35, respectively, in the fourth quarter of 2019, primarily driven by a non-cash tax benefit of $296 million related to the release of substantially all of the Company's valuation allowance against its deferred tax assets on December 31, 2020
    • Fourth quarter 2020 non-GAAP net income and diluted earnings per share were approximately $88 million and $0.91, respectively, compared with approximately $102 million and $1.05, respectively, in the fourth quarter of 2019 driven by:
      • Increased Research and Development (R&D) expense primarily due to increased investment across our expanded pipeline programs and higher headcount costs
      • Increased Selling, General and Administrative (SG&A) expense primarily due to increased investment in marketing initiatives and higher headcount costs
    • 2020 full-year GAAP and non-GAAP net income of $407 million and $402 million, respectively, represents year-over-year growth of approximately 10 times and 41%, respectively
    • Total debt outstanding decreased by $136 million to $381 million after repurchase of approximately 26% of debt outstanding during the fourth quarter of 2020. The total aggregate repurchase price of $187 million was paid in cash and the transaction resulted in an $18 million loss recognized during the fourth quarter of 2020.
    • At December 31, 2020, the Company had cash, cash equivalents and debt securities available-for-sale of $1.0 billion

    A reconciliation of GAAP to non-GAAP financial results can be found in Table 3 and Table 4 at the end of this earnings release.

    Income Tax Benefit:

    The Company's fourth quarter financial results include the reversal of substantially all of the valuation allowance recorded against the deferred tax assets of the Company. This reversal resulted in the recognition of a non-cash income tax benefit in the fourth quarter 2020 of $296 million, or $3.05 earnings per diluted share. The Company has performed a continuing evaluation of its deferred tax asset valuation allowance on a quarterly basis. The Company has now concluded that, as of December 31, 2020, it is more likely than not that the Company will generate sufficient taxable income within the applicable net operating loss and R&D carryforward periods to realize substantially all of its deferred tax assets. This conclusion, and the resulting reversal of the deferred tax asset valuation allowance, is based upon consideration of a number of factors, including the Company's strong financial performance over the past few years and its forecast of future profitability.

    After recognizing the valuation allowance reversal, the Company's net deferred tax assets totaled $319 million at December 31, 2020, net of a valuation allowance of $50 million. The ability to recognize the remaining deferred tax assets that continue to be subject to a valuation allowance will be evaluated on a quarterly basis to determine if there are significant events that would affect the Company's ability to utilize these deferred tax assets. As a result of this reversal, the Company will begin recording federal and state tax expense on its earnings beginning in the first quarter of 2021. No federal cash tax is expected in 2021 based upon a net operating loss position of approximately $500 million entering 2021.

    Recent Events

    • In October 2020, the U.S. Food and Drug Administration (FDA) requested additional non-clinical data to support the Investigational New Drug Application (IND) we submitted in August 2020 in support of a Phase II clinical study for NBI-921352 in patients with SCN8A Developmental Epileptic Encephalopathy (SCN8A-DEE). Based on feedback received in January 2021, we plan to initiate a Phase II clinical study in adolescent patients (aged 12 years and older) with SCN8A-DEE in the third quarter of 2021, and the study protocol will be amended to include younger pediatric patients (aged 2-11 years) with SCN8A-DEE as soon as the FDA has reviewed and approved additional non-clinical information. We are also advancing clinical plans to initiate a Phase II clinical study of NBI-921352 for the treatment of adult focal epilepsy in 2021. In addition, in October 2020, we announced the FDA granted us Rare Pediatric Disease Designation for NBI-921352 for the treatment of SCN8A-DEE.
    • In November 2020, the Company announced the initiation of a Phase II study of NBI-827104 (formerly ACT-709478) in Epileptic Encephalopathy with Continuous Spike and Wave during Sleep (CSWS), a rare pediatric epilepsy. NBI-827104 was licensed from Idorsia and is a potent, selective, orally active and brain penetrating T-type calcium channel blocker.
    • In February 2021, the Mitsubishi Tanabe Pharma Corporation (MTPC) reported positive top-line results from the J-KINECT Phase III Study, designed to evaluate the efficacy and safety of valbenazine in tardive dyskinesia. Detailed results from this trial will be presented at a future medical conference. With positive data in hand, a marketing authorization with the Ministry of Health and Welfare is planned for 2021 in Japan. In addition, MTPC submitted filings for marketing authorization in South Korea, Thailand, Singapore, Indonesia, and Malaysia in 2020.
    • In February 2021, the Company notified Voyager Therapeutics, Inc. (Voyager) of the Company's termination of the NBIb-1817 (VY-AADC) development program in Parkinson's disease (the Program). The Company will work to transfer the rights to the Program to Voyager by August 2, 2021.

    Full-Year 2021 Expense Guidance



    Range

    (in millions)

    Low



    High

    Combined GAAP R&D and SG&A expenses

    $

    800





    $

    850



    Combined Non-GAAP R&D and SG&A expenses

    $

    675





    $

    725



     

    • GAAP and Non-GAAP expense guidance range reflects increased investment in:
      • R&D expense including meaningful investments in collaboration programs (specifically with Idorsia, Xenon and Takeda) and the planned initiation of eight mid-to-late-stage clinical studies
      • INGREZZA and ONGENTYS marketing costs
    • GAAP-only guidance includes approximately $125 million of share-based compensation. GAAP-only guidance does not include any potential milestones or in-process research and development costs associated with current collaborations or future business development activities.

    2021 Expected Milestones and Key Activities

    Program

    Indication

    2021 Milestones / Key Activities

    Valbenazine

    Chorea in Huntington's Disease

    Phase III Top-Line Data Expected in Q4 2021

    Tardive Dyskinesia

    Marketing Authorization with Ministry of Health and Welfare in Japan

    Neurological Indication

    Initiate Phase III Registrational Study

    Psychiatric Indication

    Initiate Registrational Study

    Crinecerfont

    Congenital Adrenal Hyperplasia (Adult)

    Continue Phase III Registrational Study Enrollment

    Congenital Adrenal Hyperplasia (Pediatric)

    Initiate Phase III Registrational Study

    NBI-1065844

    Negative Symptoms of Schizophrenia

    Phase II Top-Line Data Expected in Q1 2021

    NBI-1065845

    Treatment Resistant Depression

    Initiate Phase II

    NBI-1065846

    Anhedonia in Depression

    Initiate Phase II

    NBI-827104

    Rare Pediatric Epilepsy: CSWS

    Continue Phase II Enrollment

    Neurological Indication

    Initiate Phase II

    NBI-921352

    Focal Onset Seizure in Adults

    Initiate Phase II

    Rare Pediatric Epilepsy: SCN8A-DEE

    Initiate Phase II

    Conference Call and Webcast Today at 4:30 PM Eastern Time

    Neurocrine Biosciences will hold a live conference call and webcast today at 4:30 p.m. Eastern Time (1:30 p.m. Pacific Time). Participants can access the live conference call by dialing 800-895-3361 (US) or 785-424-1062 (International) using the conference ID: NBIX. The webcast can also be accessed on Neurocrine Biosciences' website under Investors at www.neurocrine.com. A replay of the webcast will be available on the website approximately one hour after the conclusion of the event and will be archived for approximately one month.

    About Neurocrine Biosciences

    Neurocrine Biosciences is a neuroscience-focused, biopharmaceutical company dedicated to discovering, developing and delivering life-changing treatments for people with serious, challenging and under-addressed neurological, endocrine and psychiatric disorders. The company's diverse portfolio includes FDA-approved treatments for tardive dyskinesia, Parkinson's disease, endometriosis*, uterine fibroids* and clinical programs in multiple therapeutic areas. For nearly three decades, Neurocrine Biosciences has specialized in targeting and interrupting disease-causing mechanisms involving the interconnected pathways of the nervous and endocrine systems. For more information, visit neurocrine.com, and follow the company on LinkedIn. (*in collaboration with AbbVie)

    Non-GAAP Financial Measures

    In addition to the financial results and financial guidance that are provided in accordance with accounting principles generally accepted in the United States (GAAP), this press release also contains the following non-GAAP financial measures: non-GAAP R&D expense, non-GAAP SG&A expense, and non-GAAP net income and net income per share. When preparing the non-GAAP financial results and guidance, the Company excludes certain GAAP items that management does not consider to be normal, including recurring cash operating expenses that might not meet the definition of unusual or non-recurring items. In particular, these non-GAAP financial measures exclude: milestone payments received from licenses and collaborations, milestones paid related to licenses and collaborations, non-cash collaboration revenue, acquired in-process research and development, share-based compensation expense, non-cash interest expense related to convertible debt, changes in fair value of equity security investments and certain adjustments to income tax expense. These non-GAAP financial measures are provided as a complement to results provided in accordance with GAAP as management believes these non-GAAP financial measures help indicate underlying trends in the Company's business, are important in comparing current results with prior period results and provide additional information regarding the Company's financial position. Management also uses these non-GAAP financial measures to establish budgets and operational goals that are communicated internally and externally and to manage the Company's business and evaluate its performance. The Company provides guidance regarding combined research and development and sales, general, and administrative expenses on both a GAAP and a non-GAAP basis. The guidance regarding GAAP research and development expenses and sales, general and administrative expenses does not include estimates for expenses associated with any potential future business development activities. A reconciliation of these GAAP financial results to non-GAAP financial results is included in the attached financial information. In addition, INGREZZA net sales are presented in accordance with GAAP and as inventory-adjusted net sales, which is a non-GAAP financial measure. The difference between INGREZZA net sales and inventory-adjusted net sales reflects changes in channel inventory that are not representative of the underlying prescription demand. Management uses inventory-adjusted net sales to manage the Company's business and evaluate its performance.

    Forward-Looking Statements

    In addition to historical facts, this press release contains forward-looking statements that involve a number of risks and uncertainties. These statements include, but are not limited to, statements related to: the benefits to be derived from our products and product candidates; the value our products and/or our product candidates may bring to patients; the continued success of INGREZZA; our launch of ONGENTYS; our financial and operating performance, including our future expenses; our collaborative partnerships; expectations regarding the impact of COVID-19 on our business; expectations regarding our ability to adapt our business to the evolving COVID-19 pandemic, mitigate its impact on our business and maintain business continuity, including our ability to protect the safety and well-being of our employees, to continue to support uninterrupted supply of INGREZZA, patient in-person access to their healthcare provider, to continue our ongoing clinical trials and other development activities, and to otherwise advance our business objectives; and the timing of the initiation and/or completion of our clinical, regulatory, and other development activities and those of our collaboration partners. Among the factors that could cause actual results to differ materially from those indicated in the forward-looking statements are: our future financial and operating performance; risks associated with the commercialization of INGREZZA and ONGENTYS; the impact of the COVID-19 pandemic on our business and the business operations of our customers; risks and uncertainties associated with the scale and duration of the COVID-19 pandemic and resulting global, national, and local economic and financial disruptions; risk and uncertainties related to any COVID-19 quarantines, shelter-in-place, social distancing and other government orders that are currently in place or that may be put in place in the future, including the impact of such orders on our and our customers' business operations and the business operations of the third parties on which we rely; risks related to the development of our product candidates; risks associated with our dependence on third parties for development and manufacturing activities for our products and product candidates, and our ability to manage these third parties; risks that the FDA or other regulatory authorities may make adverse decisions regarding our products or product candidates; risks associated with our dependence on AbbVie for the commercialization of ORILISSA and ORIAHNN, as well as the continued development of elagolix; risks that clinical development activities may not be initiated or completed on time or at all, or may be delayed for regulatory, manufacturing, COVID-19 or other reasons, may not be successful or replicate previous clinical trial results, may fail to demonstrate that our product candidates are safe and effective, or may not be predictive of real-world results or of results in subsequent clinical trials; risks that the potential benefits of the agreements with our collaboration partners may never be realized; risks that our products, and/or our product candidates may be precluded from commercialization by the proprietary or regulatory rights of third parties, or have unintended side effects, adverse reactions or incidents of misuse; and other risks described in our periodic reports filed with the SEC, including without limitation our quarterly report on Form 10-Q for the quarter ended September 30, 2020. Neurocrine disclaims any obligation to update the statements contained in this press release after the date hereof.

    TABLE 1



    NEUROCRINE BIOSCIENCES, INC.

    CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

    (unaudited)





    Three Months Ended

    December 31,



    Twelve Months Ended

    December 31,

    (in millions, except per share data)

    2020



    2019



    2020



    2019

    Revenues:















    Product sales, net

    $

    241.3





    $

    237.9





    $

    994.1





    $

    752.9



    Collaboration revenue

    6.6





    6.2





    51.8





    35.2



    Total revenues

    247.9





    244.1





    1,045.9





    788.1



    Operating expenses:















    Cost of sales

    2.9





    2.5





    10.1





    7.4



    Research and development

    66.7





    55.3





    275.0





    200.0



    Acquired in-process research and development





    36.2





    164.5





    154.3



    Selling, general and administrative

    106.5





    101.3





    433.3





    354.1



    Total operating expenses

    176.1





    195.3





    882.9





    715.8



    Operating income

    71.8





    48.8





    163.0





    72.3



    Other (expense) income:















    Interest expense

    (7.8)





    (8.2)





    (32.8)





    (32.0)



    Unrealized loss on equity securities

    (5.5)





    (7.2)





    (17.7)





    (13.0)



    Loss on extinguishment of convertible senior notes

    (18.4)









    (18.4)







    Investment income and other, net

    1.6





    5.2





    12.6





    19.2



    Total other expense, net

    (30.1)





    (10.2)





    (56.3)





    (25.8)



    Income before (benefit from) provision for income taxes

    41.7





    38.6





    106.7





    46.5



    (Benefit from) provision for income taxes

    (306.2)





    4.6





    (300.6)





    9.5



    Net income

    $

    347.9





    $

    34.0





    $

    407.3





    $

    37.0



















    Net income per share, basic

    $

    3.72





    $

    0.37





    $

    4.38





    $

    0.40



    Net income per share, diluted

    $

    3.58





    $

    0.35





    $

    4.16





    $

    0.39



















    Weighted average common shares outstanding, basic

    93.5





    92.2





    93.1





    91.6



    Weighted average common shares outstanding, diluted

    97.2





    97.2





    97.8





    95.7



     

    TABLE 2



    NEUROCRINE BIOSCIENCES, INC.

    CONDENSED CONSOLIDATED BALANCE SHEETS

    (unaudited)



    (in millions)

    December 31,

    2020



    December 31,

    2019

    Cash, cash equivalents and debt securities available-for-sale

    $

    801.0





    $

    670.5



    Other current assets

    215.2





    160.5



    Total current assets

    1,016.2





    831.0



    Debt securities available-for-sale

    227.1





    299.7



    Right-of-use assets

    82.8





    74.3



    Equity securities

    38.2





    55.9



    Property and equipment, net

    44.6





    41.9



    Deferred tax assets

    319.4







    Restricted cash and other long-term assets

    6.4





    3.2



    Total assets

    $

    1,734.7





    $

    1,306.0











    Convertible senior notes

    $





    $

    408.8



    Other current liabilities

    186.5





    156.5



    Total current liabilities

    186.5





    565.3



    Convertible senior notes

    317.9







    Operating lease liabilities

    94.4





    86.7



    Other long-term liabilities

    9.7





    17.1



    Stockholders' equity

    1,126.2





    636.9



    Total liabilities and stockholders' equity

    $

    1,734.7





    $

    1,306.0



     

    TABLE 3



    NEUROCRINE BIOSCIENCES, INC.

    RECONCILIATION OF GAAP TO NON-GAAP FINANCIAL RESULTS

    (unaudited)





    Three Months Ended

    December 31,



    Twelve Months Ended

    December 31,

    (in millions, except per share data)

    2020



    2019



    2020



    2019

    GAAP net income

    $

    347.9





    $

    34.0





    $

    407.3





    $

    37.0



    Adjustments:















    Milestones received from licenses and collaborations A









    (30.0)





    (20.0)



    Non-cash collaboration revenue B

    (0.9)





    (0.9)





    (2.7)





    (0.9)



    Acquired in-process research and development (IPR&D) C





    36.2





    164.5





    154.3



    Milestones paid related to licenses and collaborations - R&D









    20.0





    10.0



    Share-based compensation expense - R&D

    7.3





    7.4





    33.7





    25.8



    Share-based compensation expense - SG&A

    13.7





    13.9





    66.3





    49.5



    Loss on extinguishment of convertible senior notes D

    18.4









    18.4







    Non-cash interest related to convertible senior notes

    5.2





    5.2





    21.4





    20.3



    Changes in fair value of equity security investments E

    5.5





    7.2





    17.7





    13.0



    Income tax effect related to reconciling items F

    (309.0)





    (0.8)





    (314.3)





    (5.2)



    Non-GAAP net income

    $

    88.1





    $

    102.2





    $

    402.3





    $

    283.8



















    Net income per diluted common share:















    GAAP

    $

    3.58





    $

    0.35





    $

    4.16





    $

    0.39



    Non-GAAP

    $

    0.91





    $

    1.05





    $

    4.11





    $

    2.96





    A During 2020, the Company recognized a $30.0 million event-based milestone as revenue upon FDA approval for ORIAHNN for uterine fibroids. During 2019, the Company recognized a $20.0 million event-based milestone as revenue upon FDA acceptance of the New Drug Application for elagolix for uterine fibroids.



    B The Company recognized non-cash collaboration revenue under the collaboration and license agreement entered into with Mitsubishi Tanabe Pharma Corporation in 2015.



    C The Company incurred IPR&D expenses of $164.5 million during 2020 in association with the exclusive license agreement entered into with Takeda Pharmaceutical and the collaboration and license agreement entered into with Idorsia Pharmaceuticals. During 2019, the Company incurred IPR&D expenses of $154.3 million in association with collaboration and license agreements entered into with Voyager Therapeutics and Xenon Pharmaceuticals.



    D The Company recognized a loss on extinguishment of $18.4 million related to the partial repurchase of its convertible debt in the fourth quarter of 2020.



    E The Company recognized an unrealized loss to adjust its equity security investments to fair value.



    F Estimated income tax effect of non-GAAP reconciling items are calculated using applicable statutory tax rates, taking into consideration any valuation allowance. In the fourth quarter of 2020, the Company recognized a non-cash tax benefit of approximately $296 million related to the release of substantially all of its valuation allowance against its deferred tax assets on December 31, 2020. The fourth quarter 2020 benefit associated with the valuation allowance release has been excluded from non-GAAP net income.

     

    TABLE 4



    NEUROCRINE BIOSCIENCES, INC.

    RECONCILIATION OF GAAP TO NON-GAAP EXPENSES

    (unaudited)





    Three Months Ended

    December 31,



    Twelve Months Ended

    December 31,

    (in millions)

    2020



    2019



    2020



    2019

    GAAP R&D

    $

    66.7





    $

    55.3





    $

    275.0





    $

    200.0



    Adjustments:















    Milestones paid related to licenses and collaborations









    20.0





    10.0



    Share-based compensation expense

    7.3





    7.4





    33.7





    25.8



    Non-GAAP R&D

    $

    59.4





    $

    47.9





    $

    221.3





    $

    164.2



















    GAAP SG&A

    $

    106.5





    $

    101.3





    $

    433.3





    $

    354.1



    Adjustments:















    Share-based compensation expense

    13.7





    13.9





    66.3





    49.5



    Non-GAAP SG&A

    $

    92.8





    $

    87.4





    $

    367.0





    $

    304.6



     

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  23. CAMBRIDGE, Mass., Feb. 02, 2021 (GLOBE NEWSWIRE) -- Voyager Therapeutics, Inc. (NASDAQ:VYGR) today announced that Neurocrine Biosciences, Inc. (NASDAQ:NBIX) provided notice of termination of the Parkinson's disease portion of the collaboration agreement, effective August 2, 2021. The Friedreich's ataxia program and two discovery programs that are also part of the agreement are not impacted and remain under active collaboration.

    Voyager's understanding is that Neurocrine's decision to terminate the NBIb-1817 (VY-AADC) program was based on a portfolio review and prioritization of its current pipeline assets.   Voyager plans to support Neurocrine, the IND holder and sponsor of the RESTORE-1 Phase 2 clinical trial, on any ongoing matters related…

    CAMBRIDGE, Mass., Feb. 02, 2021 (GLOBE NEWSWIRE) -- Voyager Therapeutics, Inc. (NASDAQ:VYGR) today announced that Neurocrine Biosciences, Inc. (NASDAQ:NBIX) provided notice of termination of the Parkinson's disease portion of the collaboration agreement, effective August 2, 2021. The Friedreich's ataxia program and two discovery programs that are also part of the agreement are not impacted and remain under active collaboration.

    Voyager's understanding is that Neurocrine's decision to terminate the NBIb-1817 (VY-AADC) program was based on a portfolio review and prioritization of its current pipeline assets.   Voyager plans to support Neurocrine, the IND holder and sponsor of the RESTORE-1 Phase 2 clinical trial, on any ongoing matters related to additional imaging and clinical assessments requested by the Data Safety & Monitoring Board (DSMB) and other information that may be requested by the U.S. Food and Drug Administration (FDA).  

    In December 2020, Voyager announced that the FDA had notified Neurocrine that it had placed a clinical hold on the RESTORE-1 clinical trial of NBIb-1817 (VY-AADC). The FDA notification followed a request by the study's independent DSMB for a pause in dosing pending the receipt of information about magnetic resonance imaging (MRI) abnormalities observed in trial participants. In January 2021, the FDA informed Neurocrine of the information required to provide a complete response to the FDA in connection with the clinical hold. Information required by the FDA includes an assessment of how the investigational product may have given rise to the adverse findings, a mitigation plan to manage the adverse findings, and supportive data to justify that a favorable benefit/risk profile remains for the product.

    Voyager is evaluating the complete financial impact of the termination and the future of the Parkinson's program and expects to provide a subsequent update.

    About Parkinson's Disease and NBIb-1817 (VY-AADC)

    Parkinson's disease is a chronic, progressive, and debilitating neurodegenerative disease that affects approximately one million people in the U.S. and ten million people worldwide. It is characterized by a loss of dopamine and neuronal degeneration with a concomitant loss of the aromatic L-amino acid decarboxylase (AADC) enzyme required to synthesize dopamine in the brain, leading to associated impairment in motor, neuropsychiatric, and autonomic functions. Dopamine is a chemical "messenger" that is produced in the brain and is involved in the control of movement. It is made when AADC converts the chemical levodopa to dopamine. As Parkinson's disease progresses, there is less AADC enzyme in parts of the brain where levodopa is converted to dopamine.

    NBIb-1817 (VY-AADC) is an investigational recombinant adeno-associated viral (AAV) serotype 2 vector encoding the gene for human AADC that is designed to help produce the AADC enzyme in brain cells where it can convert levodopa to dopamine. NBIb-1817 (VY-AADC) is administered into the brain using intraoperative monitoring with magnetic resonance imaging (MRI)-facilitated targeted delivery.

    About Voyager Therapeutics

    Voyager Therapeutics is a clinical-stage gene therapy company focused on developing life-changing treatments for severe neurological diseases. Voyager is committed to advancing the field of AAV gene therapy through innovation and investment in vector engineering and optimization, manufacturing, and dosing and delivery techniques. Voyager's wholly-owned and partnered pipeline focuses on severe neurological diseases for which effective new therapies are needed, including Parkinson's disease, Huntington's disease, Friedreich's ataxia, and other severe neurological diseases. For more information on Voyager Therapeutics, please visit the company's website at www.voyagertherapeutics.com or follow @VoyagerTx on Twitter and LinkedIn.

    Voyager Therapeutics® is a registered trademark of Voyager Therapeutics, Inc.

    Voyager Therapeutics Forward-Looking Statements

    This press release contains forward-looking statements for the purposes of the safe harbor provisions under The Private Securities Litigation Reform Act of 1995 and other federal securities laws. The use of words such as "may," "might," "will," "would," "should," "expect," "plan," "anticipate," "believe," "estimate," "undoubtedly," "project," "intend," "future," "potential," or "continue," and other similar expressions are intended to identify forward-looking statements. For example, all statements Voyager makes regarding the progress, activities, goals and reporting of results of its clinical trials, the potential benefits and future operation of its collaboration with Neurocrine and the activities thereunder, Voyager's ability to perform its obligations under the collaboration agreement with Neurocrine, the ability of Neurocrine and Voyager to gather additional information to further characterize the safety profile of NBIb-1817 (VY-AADC) and to work with the FDA to determine the next steps for the RESTORE-1 clinical trial, the regulatory pathway of, and the timing or likelihood of its regulatory filings and approvals for, any of Voyager's product candidates, and its anticipated financial results, including the financial impact of the termination of the NBIb-1817 (VY-AADC) program, are forward looking.  

    All forward-looking statements are based on estimates and assumptions by Voyager's management that, although Voyager believes such forward-looking statements to be reasonable, are inherently uncertain. All forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those that Voyager expected. Such risks and uncertainties include, among others, those related to the initiation and conduct of preclinical studies and clinical trials; the availability of data from clinical trials; the expectations for regulatory communications, submissions and approvals; the continued development of the gene therapy platform and its TRACER system; Voyager's scientific approach and general development progress; the sufficiency of its cash resources; the availability or commercial potential of Voyager's product candidates; and the ability of Neurocrine and Voyager to complete their evaluation and to meet the information requests of, and to resolve questions raised by, the FDA required to bring an end to the clinical hold on the RESTORE-1 clinical trial. These statements are also subject to a number of material risks and uncertainties that are described in Voyager's Annual Report on Form 10-K filed with the Securities and Exchange Commission, as updated by its subsequent filings with the Securities and Exchange Commission. All information in the press release is as of the date of this press release, and any forward-looking statement speaks only as of the date on which it was made. Voyager undertakes no obligation to publicly update or revise this information or any forward-looking statement, whether as a result of new information, future events or otherwise, except as required by law.

    Contact Information

    Voyager Therapeutics

    Investors:        

    Investors@voyagertherapeutics.com

    Media:        

    Sheryl Seapy

    W2Opure

    949-903-4750

    sseapy@purecommunications.com



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  24. SAN DIEGO, Jan. 20, 2021 /PRNewswire/ -- Neurocrine Biosciences, Inc. (NASDAQ:NBIX) announced today that it will report fourth quarter and year-end 2020 financial results after the Nasdaq market closes on Thursday, Feb. 4, 2021. Neurocrine will then host a conference call and webcast to discuss its financial results and provide a company update that day at 1:30 p.m. Pacific Time (4:30 p.m. Eastern Time).

    Participants can access the live conference call by dialing 800-895-3361 (US) or 785-424-1062 (International) using the conference ID: NBIX. The webcast can also be accessed on Neurocrine's website under Investors at www.neurocrine.com. A replay of the webcast will be available on the website approximately one hour after the conclusion of the event and will be archived for approximately one month.

    About Neurocrine Biosciences

    Neurocrine Biosciences is a neuroscience-focused, biopharmaceutical company dedicated to discovering, developing and delivering life-changing treatments for people with serious, challenging and under-addressed neurological, endocrine and psychiatric disorders. The company's diverse portfolio includes FDA-approved treatments for tardive dyskinesia, Parkinson's disease, endometriosis*, uterine fibroids* and clinical programs in multiple therapeutic areas. For nearly three decades, Neurocrine Biosciences has specialized in targeting and interrupting disease-causing mechanisms involving the interconnected pathways of the nervous and endocrine systems. For more information, visit neurocrine.com, and follow the company on LinkedIn(*in collaboration with AbbVie)

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  25. SAN DIEGO, Jan. 8, 2021 /PRNewswire/ -- Neurocrine Biosciences, Inc. (NASDAQ:NBIX) today provided an update on its business performance, including preliminary net product and inventory adjusted sales results of INGREZZA® (valbenazine) for 2020, and key commercial and clinical development milestones for 2021. Kevin Gorman, Chief Executive Officer of Neurocrine Biosciences, will discuss these updates as part of a webcast presentation at the 39th Annual J.P. Morgan Healthcare Conference to be held virtually on Monday, January 11 at 2:00 p.m. Eastern Time, followed by a Question and Answer session at approximately 2:20 p.m. Eastern Time.

    Preliminary Fourth Quarter and Full-Year 2020 INGREZZA® (valbenazine) Net Product Sales and Inventory Adjusted Net Product Sales (Unaudited)

    Based on preliminary unaudited financial information, the Company expects INGREZZA net product sales for the three months and full-year ended December 31, 2020 to be approximately $240 million and $993 million respectively. Preliminary analysis of INGREZZA net product sales suggests:

    - INGREZZA inventory adjusted net product sales for the fourth quarter were approximately $258 million reflecting an $18 million channel inventory decrease in Q4

    - New prescriptions and refills increased in the fourth quarter of 2020 vs. the third quarter of 2020

    - Full-year 2020 total INGREZZA prescriptions grew 32% to approximately 175,700 versus 2019 total prescriptions of approximately 132,700 

    "I am very proud of our team's resilience and adaptability to bring INGREZZA to patients living with tardive dyskinesia this past year and we remain encouraged by the continued strength in persistence and refill rates, which is a testament to the many benefits of INGREZZA. We also continue to focus on healthcare provider educational initiatives, patient outreach programs and investing in telemedicine capabilities to improve diagnosis and treatment rates for the estimated 80% of patients with tardive dyskinesia who have not yet been diagnosed," said Kevin Gorman, Ph.D., Chief Executive Officer of Neurocrine Biosciences. "Adding to our movement disorder portfolio, we launched our second commercial treatment, ONGENTYS, and continue to make great progress in our development programs with plans to initiate seven mid-to-late stage clinical studies in 2021 focused on neurological, endocrine and psychiatric disorders."

    2021 Expected Milestones and Key Activities

    Program

    Indication

    2021 Milestones / Key Activities

    Valbenazine

    Chorea in Huntington Disease

    Phase III Top-Line Data Expected in Q4 2021

    Neurological Indication

    Initiate Phase III

    Psychiatric Indication

    Initiate Phase II

    Crinecerfont

    Congenital Adrenal Hyperplasia (Adult)

    Continue Phase III Enrollment

    Congenital Adrenal Hyperplasia (Pediatric)

    Initiate Phase III

    NBI-1065844

    Negative Symptoms of Schizophrenia

    Phase II Top-Line Data Expected in

    1st Half of 2021

    NBI-1065845

    Treatment Resistant Depression

    Initiate Phase II

    NBI-1065846

    Anhedonia in Depression

    Initiate Phase II

    NBI-827104

    Rare Pediatric Epilepsy:

    Epileptic Encephalopathy with Continuous Spike and Wave During Sleep

    Continue Phase II Enrollment

    Neurological Indication

    Initiate Phase II

    NBI-921352

    Focal Onset Seizure in Adults

    Initiate Phase II

    Rare Pediatric Epilepsy: SCN8A-DEE

    Ongoing Dialogue with FDA

    NBIb-1817

    Gene Therapy for Parkinson's Disease

    Determine Regulatory Path with FDA

    About Tardive Dyskinesia (TD)

    Tardive dyskinesia (TD) is a movement disorder that is characterized by uncontrollable, abnormal and repetitive movements of the face, torso and/or other body parts, which may be disruptive and negatively impact patients. The condition is caused by prolonged use of treatments that block dopamine receptors in the brain, such as antipsychotics commonly prescribed to treat mental illnesses such as schizophrenia, bipolar disorder and depression, and certain anti-nausea medications. In patients with TD, these treatments are thought to result in irregular dopamine signaling in a region of the brain that controls movement. The symptoms of TD can be severe and are often persistent and irreversible. TD is estimated to affect at least 500,000 people in the U.S.

    About INGREZZA® (valbenazine) Capsules

    INGREZZA, a selective vesicular monoamine transporter 2 (VMAT2) inhibitor, is the first FDA-approved product indicated for the treatment of adults with tardive dyskinesia, a condition associated with uncontrollable, abnormal and repetitive movements of the face, torso and/or other body parts.

    INGREZZA is thought to work by reducing the amount of dopamine released in a region of the brain that controls movement and motor function, helping to regulate nerve signaling in adults with tardive dyskinesia. VMAT2 is a protein in the brain that packages neurotransmitters, such as dopamine, for transport and release in presynaptic neurons. INGREZZA, developed in Neurocrine Biosciences's laboratories, is novel in that it selectively inhibits VMAT2 with no appreciable binding affinity for VMAT1, dopaminergic (including D2), serotonergic, adrenergic, histaminergic, or muscarinic receptors. Additionally, INGREZZA can be taken for the treatment of tardive dyskinesia as one capsule, once-daily, together with psychiatric medications such as antipsychotics or antidepressants.

    Important Information

    Approved Use

    INGREZZA® (valbenazine) capsules is a prescription medicine used to treat adults with movements in the face, tongue, or other body parts that cannot be controlled (tardive dyskinesia).

    It is not known if INGREZZA is safe and effective in children.

    Important Safety Information

    Do not take INGREZZA if you are allergic to valbenazine, or any of the ingredients in INGREZZA.

    INGREZZA may cause serious side effects, including:

    • Sleepiness (somnolence). Do not drive, operate heavy machinery, or do other dangerous activities until you know how INGREZZA affects you.
    • Heart rhythm problems (QT prolongation). INGREZZA may cause a heart problem known as QT prolongation.
    • Symptoms of QT prolongation may include: fast, slow, or irregular heartbeat, shortness of breath, dizziness or fainting.
    • Parkinson-like symptoms. Symptoms include: shaking, body stiffness, trouble moving or walking, or keeping your balance.

    Tell your healthcare provider right away if you have a change in your heartbeat (a fast or irregular heartbeat), or if you faint.

    Before taking INGREZZA, tell your healthcare provider about all of your medical conditions including if you: have liver or heart problems, are pregnant or plan to become pregnant, or are breastfeeding or plan to breastfeed.

    Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins and herbal supplements.

    The most common side effect of INGREZZA is sleepiness (somnolence). Other side effects include changes in balance (balance problems, dizziness) or an increased risk of falls, headache, feelings of restlessness, dry mouth, constipation, and blurred vision.

    These are not all of the possible side effects of INGREZZA. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

    Please see INGREZZA full Product Information.

    About Neurocrine Biosciences

    Neurocrine Biosciences is a neuroscience-focused, biopharmaceutical company dedicated to discovering, developing and delivering life-changing treatments for people with serious, challenging and under-addressed neurological, endocrine and psychiatric disorders. The company's diverse portfolio includes FDA-approved treatments for tardive dyskinesia, Parkinson's disease, endometriosis*, uterine fibroids* and clinical programs in multiple therapeutic areas. For nearly three decades, Neurocrine Biosciences has specialized in targeting and interrupting disease-causing mechanisms involving the interconnected pathways of the nervous and endocrine systems. For more information, visit neurocrine.com, and follow the company on LinkedIn. (*in collaboration with AbbVie)

    Forward-Looking Statements

    In addition to historical facts, this press release contains forward-looking statements that involve a number of risks and uncertainties. These statements include, but are not limited to, statements related to: our preliminary unaudited financial information; the benefits to be derived from our products and product candidates; the value our products and/or our product candidates may bring to patients; the continued success of INGREZZA; our financial and operating performance, our collaborative partnerships; expectations regarding the impact of COVID-19 on our business, including patient and healthcare provider access to INGREZZA, our ability to continue our ongoing clinical trials and other development activities, and to otherwise advance our business objectives; and the timing of completion of our clinical, regulatory, and other development activities and those of our collaboration partners. 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 items that may be identified during the financial statement closing process that cause adjustments to the estimates included in this press release; our future financial and operating performance; risks associated with the commercialization of INGREZZA and ONGENTYS; the impact of the COVID-19 pandemic on our business and the business operations of our customers; risks and uncertainties associated with the scale and duration of the COVID-19 pandemic and resulting global, national, and local economic and financial disruptions; risk and uncertainties related to any COVID-19 quarantines, shelter-in-place, social distancing and other government orders that are currently in place or that may be put in place in the future, including the impact of such orders on our business operations and the business operations of the third parties on which we rely; risks related to the development of our product candidates; risks associated with our dependence on third parties for development and manufacturing activities related to INGREZZA and our product candidates, and our ability to manage these third parties; risks that the FDA or other regulatory authorities may make adverse decisions regarding our products or product candidates; risks associated with our dependence on AbbVie for the commercialization of ORILISSA and ORIAHNN, as well as the continued development of elagolix; risks associated with our dependence on BIAL for manufacturing activities for ONGENTYS, and our ability to manage BIAL; risks that clinical development activities may not be completed on time or at all, or may be delayed for regulatory, manufacturing, COVID-19 or other reasons, may not be successful or replicate previous clinical trial results, may fail to demonstrate that our product candidates are safe and effective, or may not be predictive of real-world results or of results in subsequent clinical trials; risks that the potential benefits of the agreements with our collaboration partners may never be realized; risks that our products, and/or our product candidates may be precluded from commercialization by the proprietary or regulatory rights of third parties, or have unintended side effects, adverse reactions or incidents of misuse; and other risks described in our periodic reports filed with the SEC, including without limitation our quarterly report on Form 10-Q for the quarter ended September 30, 2020. Neurocrine disclaims any obligation to update the statements contained in this press release after the date hereof.

    This press release refers to preliminary unaudited net sales in certain non-GAAP financial measures. These non-GAAP financial measures should not be considered replacements for, and should be read together with, the comparable GAAP financial measures, which are included in this press release.

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  26. SAN DIEGO, Jan. 4, 2021 /PRNewswire/ -- Neurocrine Biosciences, Inc. (NASDAQ:NBIX) will present at the 39th Annual J.P. Morgan Healthcare Conference at 2:00 p.m. Eastern Time on Monday Jan. 11, 2021. Kevin Gorman, Chief Executive Officer, will present at the conference.

    The live presentation will be webcast and may be accessed on the Company's website under Investors at www.neurocrine.com. A replay of the presentation will be available on the website approximately one hour after the conclusion of the events and will be archived for approximately one month.

    About Neurocrine Biosciences

    Neurocrine Biosciences is a neuroscience-focused, biopharmaceutical company dedicated to discovering, developing and delivering life-changing treatments for people with serious, challenging and under-addressed neurological, endocrine and psychiatric disorders. The company's diverse portfolio includes FDA-approved treatments for tardive dyskinesia, Parkinson's disease, endometriosis*, uterine fibroids* and clinical programs in multiple therapeutic areas. For nearly three decades, Neurocrine Biosciences has specialized in targeting and interrupting disease-causing mechanisms involving the interconnected pathways of the nervous and endocrine systems. For more information, visit neurocrine.com, and follow the company on LinkedIn(*in collaboration with AbbVie)

    ###

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    SOURCE Neurocrine Biosciences, Inc.

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  27. CAMBRIDGE, Mass., Dec. 22, 2020 (GLOBE NEWSWIRE) -- Voyager Therapeutics, Inc. (NASDAQ:VYGR) today announced that the U.S. Food and Drug Administration (FDA) has notified Neurocrine Biosciences (NASDAQ:NBIX) that it has placed a clinical hold on the RESTORE-1 clinical trial of NBIb-1817 (VY-AADC). As previously announced, trial sites participating in RESTORE-1 had not been screening, enrolling or dosing patients as a result of the COVID-19 pandemic and more recently, as a result of the independent Data Safety Monitoring Board (DSMB)'s request to pause dosing pending its review of additional data. The DSMB has requested additional patient level data from the trial and now plans to review these data in early 2021. The clinical hold follows the…

    CAMBRIDGE, Mass., Dec. 22, 2020 (GLOBE NEWSWIRE) -- Voyager Therapeutics, Inc. (NASDAQ:VYGR) today announced that the U.S. Food and Drug Administration (FDA) has notified Neurocrine Biosciences (NASDAQ:NBIX) that it has placed a clinical hold on the RESTORE-1 clinical trial of NBIb-1817 (VY-AADC). As previously announced, trial sites participating in RESTORE-1 had not been screening, enrolling or dosing patients as a result of the COVID-19 pandemic and more recently, as a result of the independent Data Safety Monitoring Board (DSMB)'s request to pause dosing pending its review of additional data. The DSMB has requested additional patient level data from the trial and now plans to review these data in early 2021. The clinical hold follows the submission by Neurocrine Biosciences of an IND Safety Report related to the observation of MRI abnormalities in some RESTORE-1 study participants. The clinical implications of this observation are currently unknown and are being evaluated.

    RESTORE-1 is a Phase 2 clinical trial of NBIb-1817 (VY-AADC), an intracerebral AAV-based investigational gene therapy, in development for the treatment of Parkinson's disease. The RESTORE-1 DSMB has been informed of the clinical hold, as have the study investigators and central and local ethics committees. Neurocrine Biosciences and Voyager will work closely with the FDA and the DSMB to determine the next steps for the RESTORE-1 clinical trial.

    About Parkinson's Disease and NBIb-1817 (VY-AADC)

    Parkinson's disease is a chronic, progressive, and debilitating neurodegenerative disease that affects approximately one million people in the U.S. and ten million people worldwide. It is characterized by a loss of dopamine and neuronal degeneration with a concomitant loss of the aromatic L-amino acid decarboxylase (AADC) enzyme required to synthesize dopamine in the brain, leading to associated impairment in motor, neuropsychiatric, and autonomic functions. Dopamine is a chemical "messenger" that is produced in the brain and is involved in the control of movement. It is made when AADC converts the chemical levodopa to dopamine. As Parkinson's disease progresses, there is less AADC enzyme in parts of the brain where levodopa is converted to dopamine.

    NBIb-1817 (VY-AADC) is an investigational recombinant adeno-associated viral (AAV) serotype 2 vector encoding the gene for human AADC that is designed to help produce the AADC enzyme in brain cells where it can convert levodopa to dopamine. NBIb-1817 (VY-AADC) is administered into the brain using intraoperative monitoring with magnetic resonance imaging (MRI)-facilitated targeted delivery.

    About Voyager Therapeutics

    Voyager Therapeutics is a clinical-stage gene therapy company focused on developing life-changing treatments for severe neurological diseases. Voyager is committed to advancing the field of AAV gene therapy through innovation and investment in vector engineering and optimization, manufacturing, and dosing and delivery techniques. Voyager's wholly-owned and partnered pipeline focuses on severe neurological diseases for which effective new therapies are needed, including Parkinson's disease, Huntington's disease, Friedreich's ataxia, and other severe neurological diseases. For more information on Voyager Therapeutics, please visit the company's website at www.voyagertherapeutics.com or follow @VoyagerTx on Twitter and LinkedIn.

    Voyager Therapeutics® is a registered trademark of Voyager Therapeutics, Inc.

    Voyager Therapeutics Forward-Looking Statements

    This press release contains forward-looking statements for the purposes of the safe harbor provisions under The Private Securities Litigation Reform Act of 1995 and other federal securities laws. The use of words such as "may," "might," "will," "would," "should," "expect," "plan," "anticipate," "believe," "estimate," "undoubtedly," "project," "intend," "future," "potential," or "continue," and other similar expressions are intended to identify forward-looking statements. For example, all statements Voyager makes regarding the ability of Neurocrine and Voyager to gather additional information to further characterize the safety profile of NBIb-1817 (VY-AADC) and to work with the FDA to determine the next steps for the RESTORE-1 clinical trial.

    All forward-looking statements are based on estimates and assumptions by Voyager's management that, although Voyager believes such forward-looking statements to be reasonable, are inherently uncertain. All forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those that Voyager expected. Such risks and uncertainties include, among others, the ability of Neurocrine and Voyager to complete their evaluation and to meet the information requests of, and to resolve questions raised by, the FDA required to bring an end to the clinical hold on the RESTORE-1 clinical trial. These statements are also subject to a number of material risks and uncertainties that are described in Voyager's Annual Report on Form 10-K filed with the Securities and Exchange Commission, as updated by its subsequent filings with the Securities and Exchange Commission. All information in the press release is as of the date of this press release, and any forward-looking statement speaks only as of the date on which it was made. Voyager undertakes no obligation to publicly update or revise this information or any forward-looking statement, whether as a result of new information, future events or otherwise, except as required by law.

    Contact Information

    Voyager Therapeutics

    Investors:        

    Investors@voyagertherapeutics.com

    Media:        

    Sheryl Seapy

    W2Opure

    949-903-4750

    sseapy@purecommunications.com

     



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  28. SAN DIEGO, Nov. 19, 2020 /PRNewswire/ -- Neurocrine Biosciences, Inc. (NASDAQ:NBIX) today announced that Neurocrine Biosciences management will present at the following investor conferences:

    • Matt Abernethy, Chief Financial Officer, and Eiry Roberts, Chief Medical Officer, will present at the Piper Sandler 32nd Annual Virtual Healthcare Conference at 10:00 a.m. Eastern Time on Monday, November 23, 2020.



    • Kevin Gorman, Chief Executive Officer, and Matt Abernethy, Chief Financial Officer, will present at the Evercore ISI 3rd Annual HealthCONx Conference at 1:50 p.m. Eastern Time on Tuesday, December 1, 2020.

    The live presentations will be webcast and may be accessed on the Company's website under Investors at www.neurocrine.com. A replay of the presentations will be available on the website approximately one hour after the conclusion of the events and will be archived for approximately one month.

    About Neurocrine Biosciences

    Neurocrine Biosciences is a neuroscience-focused, biopharmaceutical company dedicated to discovering, developing and delivering life-changing treatments for people with serious, challenging and under-addressed neurological, endocrine and psychiatric disorders. The company's diverse portfolio includes FDA-approved treatments for tardive dyskinesia, Parkinson's disease, endometriosis*, uterine fibroids* and clinical programs in multiple therapeutic areas. For nearly three decades, Neurocrine Biosciences has specialized in targeting and interrupting disease-causing mechanisms involving the interconnected pathways of the nervous and endocrine systems. For more information, visit neurocrine.com, and follow the company on LinkedIn(*in collaboration with AbbVie)

     

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  29. SAN DIEGO, Nov. 19, 2020 /PRNewswire/ -- Neurocrine Biosciences, Inc. (NASDAQ:NBIX) today announced that the Company has entered into separate, privately negotiated transactions (the "Agreements") with certain holders of its existing 2.25% Convertible Senior Notes due 2024 (the "2024 Notes") to repurchase approximately $83 million aggregate principal amount of the 2024 Notes for an aggregate repurchase price of an amount of cash estimated to be the sum of (i) approximately $110 million based on the Company's November 18, 2020 closing stock price of $86.91 per share, (ii) an amount based in part on the daily volume-weighted average prices per share of the Company's common stock during a five-trading day pricing period following execution of the…

    SAN DIEGO, Nov. 19, 2020 /PRNewswire/ -- Neurocrine Biosciences, Inc. (NASDAQ:NBIX) today announced that the Company has entered into separate, privately negotiated transactions (the "Agreements") with certain holders of its existing 2.25% Convertible Senior Notes due 2024 (the "2024 Notes") to repurchase approximately $83 million aggregate principal amount of the 2024 Notes for an aggregate repurchase price of an amount of cash estimated to be the sum of (i) approximately $110 million based on the Company's November 18, 2020 closing stock price of $86.91 per share, (ii) an amount based in part on the daily volume-weighted average prices per share of the Company's common stock during a five-trading day pricing period following execution of the Agreements and (iii) accrued and unpaid interest. The 2024 Notes repurchases are expected to close on December 2, 2020, subject to customary closing conditions. Such repurchases of the 2024 Notes could affect the market price of the Company's common stock. 

    This press release does not constitute an offer to sell or a solicitation of an offer to buy these securities, nor shall there be any offer or sale of these securities in any state or jurisdiction in which the offer, solicitation, or sale would be unlawful prior to the registration or qualification thereof under the securities laws of any such state or jurisdiction.

    About Neurocrine Biosciences

    Neurocrine Biosciences is a neuroscience-focused, biopharmaceutical company dedicated to discovering, developing and delivering life-changing treatments for people with serious, challenging and under-addressed neurological, endocrine and psychiatric disorders. The Company's diverse portfolio includes FDA-approved treatments for tardive dyskinesia, Parkinson's disease, endometriosis*, uterine fibroids* and clinical programs in multiple therapeutic areas. For nearly three decades, Neurocrine Biosciences has specialized in targeting and interrupting disease-causing mechanisms involving the interconnected pathways of the nervous and endocrine systems. For more information, visit neurocrine.com, and follow the company on LinkedIn. (*in collaboration with AbbVie)

    Forward-Looking Statements

    In addition to historical facts, this press release contains forward-looking statements that involve a number of risks and uncertainties. These statements include, but are not limited to, statements related to the amount of 2024 Notes to be repurchased, the timing of completion of the repurchases, and the impact of the repurchases on the market price of the Company's common stock.  Among the factors that could cause actual results to differ materially from those indicated in the forward-looking statements are: changes in the price of the Company's common stock; changes in the convertible note and other capital markets; and other risks described in the Company's periodic reports filed with the Securities and Exchange Commission, including without limitation the Company's quarterly report on Form 10-Q for the quarter ended September 30, 2020. The Company disclaims any obligation to update the statements contained in this press release after the date hereof.

     

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  30. SAN DIEGO, Nov. 9, 2020 /PRNewswire/ -- Neurocrine Biosciences, Inc. (NASDAQ:NBIX) today announced its financial results for the third quarter ended September 30, 2020 and provided revised full-year 2020 financial expense guidance.

    "Our focus remains on helping as many patients with tardive dyskinesia as possible and we are adapting to the challenges posed by the pandemic, including the slow recovery of in-person visits with psychiatrists. We are encouraged by recent trends and remain confident in the intermediate and long-term opportunity of INGREZZA to help many more patients with tardive dyskinesia," said Kevin Gorman, Ph.D., Chief Executive Officer of Neurocrine Biosciences. "We are pleased to expand our reach with neurologists with the addition of ONGENTYS to our movement disorder portfolio and continue to advance our development programs focused on neurological, endocrine and psychiatric disorders."

    Financial Highlights



    Three Months Ended

    September 30,



    Nine Months Ended

    September 30,

    (unaudited, in millions, except per share data)

    2020



    2019



    2020



    2019

    Revenues:















    Product sales, net

    $

    254.1





    $

    198.1





    $

    752.8





    $

    515.0



    Collaboration revenue

    4.4





    24.0