"We are very pleased with the positive impact INGREZZA is having on patients suffering from tardive dyskinesia and the strength of our initial product launch. Prescriber use of INGREZZA for treating tardive dyskinesia is continuing to rapidly expand across both psychiatrists and neurologists as disease state and brand awareness broadens," said
Financial Results
Neurocrine reported net product sales of
For the third quarter of 2017, the Company reported a net loss of
Research and development (R&D) expenses were
Sales, general and administrative (SG&A) expenses increased to
The Company's balance sheet at
Pipeline Highlights
INGREZZA (valbenazine) Update
INGREZZA received
In
INGREZZA is being investigated in Tourette syndrome and was recently granted Orphan Drug Designation by the
In addition, the Company has advanced the INGREZZA Tourette's program into Phase IIb by initiating the T-Force GOLD study in pediatric patients with Tourette syndrome. This study is a multicenter, randomized, double-blind, placebo-controlled, parallel group, Phase IIb study to evaluate the safety, tolerability, efficacy and optimal dose of once-daily INGREZZA in up to 120 pediatric patients with moderate to severe Tourette syndrome over 12 weeks of treatment. The primary endpoint of this study is the change from baseline of the Yale Global Tic Severity Scale between placebo and active treatment groups at the end of week 12 with top-line data expected in late 2018.
The Company is also conducting an open-label, fixed-dose study of INGREZZA in up to 180 subjects with Tourette syndrome who have completed either of the two placebo-controlled Tourette clinical trials, T-Force GREEN or T-Forward. This Phase II study will assess the long-term safety and tolerability of INGREZZA in children and adults with Tourette syndrome.
Elagolix Update
On
Recently,
Opicapone Update
In
Congenital Adrenal Hyperplasia (CAH) Program (NBI-74788) Update
In the second quarter of 2017, the Company successfully completed the Phase I, IND-opening study of NBI-74788 in healthy volunteer subjects. The study was a randomized, open-label, two-period crossover study to evaluate the pharmacokinetics (PK), the effect of food on PK, and the safety of NBI-74788 in a total of 16 healthy adults.
The Company will initiate a Phase II, proof-of-concept study examining the PK, pharmacodynamics, and safety of NBI-74788 in adult males and females with classic, 21-hydroxylase deficiency CAH in November of 2017. The study will evaluate the relationship between NBI-74788 exposures and specific steroid hormone levels in these subjects.
Conference Call and Webcast Today at
Neurocrine will hold a live conference call and webcast today at
About INGREZZA® (valbenazine) Capsules
INGREZZA, a selective VMAT2 inhibitor, is the first
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'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. INGREZZA is currently in clinical development for the treatment of Tourette syndrome.
Important Safety Information
Warnings & Precautions
Somnolence
INGREZZA can cause somnolence. Patients should not perform activities requiring mental alertness such as operating a motor vehicle or operating hazardous machinery until they know how they will be affected by INGREZZA.
QT Prolongation
INGREZZA may prolong the QT interval, although the degree of QT prolongation is not clinically significant at concentrations expected with recommended dosing. INGREZZA should be avoided in patients with congenital long QT syndrome or with arrhythmias associated with a prolonged QT interval. For patients at increased risk of a prolonged QT interval, assess the QT interval before increasing the dosage.
Adverse Reactions
The most common adverse reaction (≥5% and twice the rate of placebo) is somnolence. Other adverse reactions (≥2% and >placebo) include: anticholinergic effects, balance disorders/falls, headache, akathisia, vomiting, nausea, and arthralgia.
You are encouraged to report negative side effects of prescription drugs to the
Please see INGREZZA full Prescribing Information at www.INGREZZA.com/HCP
About
Neurocrine Biosciences is a San Diego based biotechnology company focused on neurologic, psychiatric and endocrine related disorders. The Company markets INGREZZA® (valbenazine) capsules in the United States for the treatment of adults with tardive dyskinesia. INGREZZA is a novel, selective vesicular monoamine transporter 2 (VMAT2) inhibitor, and is the first
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, including INGREZZA; the value INGREZZA and our product candidates may bring to patients; the timing of completion of clinical and other development activities; and whether results from INGREZZA's clinical trials can be replicated or are indicative of real-world results. Among the factors that could cause actual results to differ materially from those indicated in the forward-looking statements are: risks and uncertainties associated with Neurocrine's future financial and operating performance; risks and uncertainties associated with the commercialization of INGREZZA, including the likelihood of continued revenue growth of INGREZZA; risks or uncertainties related to the development of the Company's product candidates; risks and uncertainties relating to competitive products and technological changes that may limit demand for INGREZZA or a product candidate; risks associated with the Company's dependence on third parties for development and manufacturing activities related to INGREZZA and the Company's product candidates, and the ability of the Company to manage these third parties; risks that the
NEUROCRINE BIOSCIENCES, INC. |
||||||||||||||
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS |
||||||||||||||
(in thousands, except per share data) |
||||||||||||||
(unaudited) |
||||||||||||||
Three Months Ended |
Nine Months Ended |
|||||||||||||
2017 |
2016 |
2017 |
2016 |
|||||||||||
Revenues: |
||||||||||||||
Product sales, net |
$ 45,774 |
$ - |
$ 52,109 |
$ - |
||||||||||
License fees and milestones |
15,000 |
- |
15,000 |
15,000 |
||||||||||
Total revenues |
60,774 |
- |
67,109 |
15,000 |
||||||||||
Operating expenses: |
||||||||||||||
Cost of product sales |
433 |
- |
494 |
- |
||||||||||
Research and development |
22,463 |
20,942 |
96,213 |
71,708 |
||||||||||
Sales, general and administrative |
43,873 |
17,494 |
113,597 |
44,413 |
||||||||||
Total operating expenses |
66,769 |
38,436 |
210,304 |
116,121 |
||||||||||
Loss from operations |
(5,995) |
(38,436) |
(143,195) |
(101,121) |
||||||||||
Other (expense) income: |
||||||||||||||
Gain (loss) on sale/disposal of assets |
5 |
(9) |
7 |
8 |
||||||||||
Deferred gain on real estate |
183 |
853 |
1,941 |
2,560 |
||||||||||
Interest expense |
(7,337) |
- |
(12,104) |
- |
||||||||||
Investment income, net |
2,019 |
705 |
3,915 |
2,122 |
||||||||||
Total other (expense) income |
(5,130) |
1,549 |
(6,241) |
4,690 |
||||||||||
Net Loss |
$ (11,125) |
$ (36,887) |
$(149,436) |
$(96,431) |
||||||||||
Net loss per common share: |
||||||||||||||
Basic and diluted |
$ (0.13) |
$ (0.43) |
$ (1.70) |
$ (1.11) |
||||||||||
Shares used in the calculation of net loss per common share: |
||||||||||||||
Basic and diluted |
88,325 |
86,784 |
87,894 |
86,659 |
||||||||||
NEUROCRINE BIOSCIENCES, INC. |
||||||||||
Condensed Consolidated Balance Sheets |
||||||||||
(in thousands) |
||||||||||
September 30, |
December 31, |
|||||||||
2017 |
2016 |
|||||||||
(unaudited) |
||||||||||
Cash, cash equivalents and short-term investments |
$ 511,018 |
$ 307,350 |
||||||||
Other current assets |
37,467 |
3,092 |
||||||||
Total current assets |
548,485 |
310,442 |
||||||||
Property and equipment, net |
9,140 |
6,271 |
||||||||
Long-term investments |
210,258 |
43,490 |
||||||||
Restricted cash |
4,613 |
4,883 |
||||||||
Total assets |
$ 772,496 |
$365,086 |
||||||||
Current liabilities |
$ 38,141 |
$ 30,414 |
||||||||
Convertible senior notes |
365,110 |
- |
||||||||
Other long-term liabilities |
21,733 |
19,795 |
||||||||
Stockholders' equity |
347,512 |
314,877 |
||||||||
Total liabilities and stockholders' equity |
$ 772,496 |
$365,086 |
View original content:http://www.prnewswire.com/news-releases/neurocrine-biosciences-reports-third-quarter-2017-results-300547630.html
SOURCE
Neurocrine Biosciences, Investor Relations, IR@neurocrine.com