"We are extremely proud of what we have accomplished since INGREZZA was approved in 2017 and the impact INGREZZA is having on the lives of many patients with tardive dyskinesia. Our field sales team expansion and educational efforts position us to further help patients struggling with tardive dyskinesia," said
Financial Results
Total revenue was
Total revenues were comprised of the following (unaudited, in thousands):
Three Months Ended
December 31, |
Year Ended
December 31, |
|||||||
2018 |
2017 |
2018 |
2017 |
|||||
Revenues: |
||||||||
INGREZZA product sales, net |
$ 130,326 |
$ 64,517 |
$ 409,608 |
$ 116,626 |
||||
Collaboration revenue |
1,166 |
30,000 |
41,632 |
45,000 |
||||
Total revenue |
$ 131,492 |
$ 94,517 |
$ 451,240 |
$ 161,626 |
INGREZZA was made available for commercial distribution on
The Company reported net income of
Research and development (R&D) expenses increased to
Sales, general and administrative (SG&A) expenses increased to
The Company's balance sheet at
2019 Financial Guidance
Revenue milestones under the AbbVie agreement for 2019 are expected to be $20 million contingent on
Pipeline Highlights
INGREZZA (valbenazine) Update
INGREZZA received
In
ORILISSA (elagolix) Update
On
Opicapone Update
In
CAH Program (NBI-74788) Update
In the second quarter of 2017, the Company successfully completed the Phase I investigational new drug (IND)-opening study of NBI-74788 in healthy volunteer participants. The study was a randomized, open-label, two-period crossover study to evaluate the pharmacokinetics, the effect of food on pharmacokinetics, and the safety of NBI-74788 in a total of 16 healthy adults.
The Company began a Phase II proof-of-concept study examining the pharmacokinetics, pharmacodynamics, and safety of NBI-74788 in adult males and females with classic 21-hydroxylase deficiency CAH in November of 2017. This study will evaluate the safety and tolerability of NBI-74788 in patients with CAH together with the relationship between exposure and specific steroid hormone levels in these patients. Initial results from this trial are expected during the first quarter of 2019.
New VMAT2 Inhibitor
The Company has filed an IND and completed dosing in the single ascending dose portion of a Phase I study designed to assess initial safety, tolerability and pharmacokinetics of a novel, internally discovered VMAT2 inhibitor. This compound has the potential to be used in the treatment of several neurology and/or psychiatry disorders. The multiple dosing portion of this Phase I study is ongoing and is expected to be completed during the first half of 2019.
New CNS Compound
The Company has filed an IND and completed dosing in a Phase I single ascending dose study for an internally discovered first-in-class CNS compound with potential use in the treatment of several neurology and/or psychiatry disorders. The study is a randomized, double-blind, single ascending dose study to evaluate the safety, tolerability, and pharmacokinetic profile of the compound in healthy participants. The Company is currently analyzing the data from this study to inform the design of future clinical studies for the program.
Voyager Collaboration
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 from 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.
Important Safety Information
Contraindications
INGREZZA is contraindicated in patients with a history of hypersensitivity to valbenazine or any components of INGREZZA. Rash, urticaria, and reactions consistent with angioedema (e.g., swelling of the face, lips, and mouth) have been reported.
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 FDA. Visit MedWatch at www.fda.gov/medwatch or call 1-800-
Please see INGREZZA full Prescribing Information at www.INGREZZA.com/PI.
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 the benefits to be derived from Neurocrine's products and product candidates, including INGREZZA and our partnered product, ORILISSA; the value INGREZZA, ORILISSA, and/or our product candidates may bring to patients; the continued success of the launch of INGREZZA;
NEUROCRINE BIOSCIENCES, INC. |
||||||||||||||||
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS |
||||||||||||||||
(in thousands, except per share data) |
||||||||||||||||
(unaudited) |
||||||||||||||||
Three Months Ended December 31, |
Year Ended December 31, |
|||||||||||||||
2018 |
2017 |
2018 |
2017 |
|||||||||||||
Revenues: |
||||||||||||||||
Product sales, net |
$ |
130,326 |
$ |
64,517 |
$ |
409,608 |
$ |
116,626 |
||||||||
Collaboration revenue |
1,166 |
30,000 |
41,632 |
45,000 |
||||||||||||
Total revenues |
131,492 |
94,517 |
451,240 |
161,626 |
||||||||||||
Operating expenses: |
||||||||||||||||
Cost of sales |
1,534 |
760 |
4,889 |
1,254 |
||||||||||||
Research and development |
39,107 |
25,614 |
160,524 |
121,827 |
||||||||||||
Sales, general and administrative |
68,980 |
56,309 |
248,932 |
169,906 |
||||||||||||
Total operating expenses |
109,621 |
82,683 |
414,345 |
292,987 |
||||||||||||
Income (loss) from operations |
21,871 |
11,834 |
36,895 |
(131,361) |
||||||||||||
Other (expense) income: |
||||||||||||||||
Interest expense |
(7,763) |
(7,419) |
(30,530) |
(19,523) |
||||||||||||
Investment income and other, net |
4,700 |
2,479 |
15,476 |
8,342 |
||||||||||||
Total other expense, net |
(3,063) |
(4,940) |
(15,054) |
(11,181) |
||||||||||||
Income (loss) before provision for income taxes |
18,808 |
6,894 |
21,841 |
(142,542) |
||||||||||||
Provision for income taxes |
730 |
- |
730 |
- |
||||||||||||
Net income (loss) |
$ |
18,078 |
$ |
6,894 |
$ |
21,111 |
$ |
(142,542) |
||||||||
Net income (loss) per common share: |
||||||||||||||||
Basic |
$ |
0.20 |
$ |
0.08 |
$ |
0.23 |
$ |
(1.62) |
||||||||
Diluted |
$ |
0.19 |
$ |
0.07 |
$ |
0.22 |
$ |
(1.62) |
||||||||
Shares used in the calculation of net income (loss) per common share: |
||||||||||||||||
Basic |
90,742 |
88,665 |
90,235 |
88,089 |
||||||||||||
Diluted |
95,724 |
92,659 |
95,386 |
88,089 |
NEUROCRINE BIOSCIENCES, INC. |
|||||||||||
CONDENSED CONSOLIDATED BALANCE SHEETS |
|||||||||||
(in thousands)
(unaudited) |
|||||||||||
December 31,
2018 |
December 31,
2017 |
||||||||||
Cash, cash equivalents and short-term investments |
$ 650,913 |
$ 515,929 |
|||||||||
Other current assets |
86,864 |
38,990 |
|||||||||
Total current assets |
737,777 |
554,919 |
|||||||||
Property and equipment, net |
33,869 |
10,811 |
|||||||||
Long-term investments |
216,028 |
247,361 |
|||||||||
Restricted cash |
5,477 |
4,500 |
|||||||||
Total assets |
$ 993,151 |
$ 817,591 |
|||||||||
Current liabilities |
$ 88,233 |
$ 54,426 |
|||||||||
Convertible senior notes |
388,496 |
369,618 |
|||||||||
Other long-term liabilities |
35,657 |
21,409 |
|||||||||
Stockholders' equity |
480,765 |
372,138 |
|||||||||
Total liabilities and stockholders' equity |
$ 993,151 |
$ 817,591 |
|||||||||
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SOURCE
Neurocrine Biosciences, Inc., Navjot Rai (Media & Investors), 858-617-7623, IR@neurocrine.com