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
- INGREZZA inventory adjusted net product sales for the fourth quarter were approximately
- 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
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
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
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
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
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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SOURCE
Neurocrine Biosciences, Inc., Navjot Rai (Media), 858-617-7623, media@neurocrine.com; Todd Tushla (Investors), 858-617-7143, ir@neurocrine.com