"We are pleased that a record number of new patients initiated treatment with INGREZZA as healthcare providers continue to recognize and treat the involuntary movements associated with tardive dyskinesia," said
Financial Results
Total revenues for the three and nine months ended
Total revenues were comprised of the following (unaudited):
Three Months Ended September 30, |
Nine Months Ended September 30, |
||||||||||||||
(in thousands) |
2019 |
2018 |
2019 |
2018 |
|||||||||||
INGREZZA product sales, net |
$ |
198,094 |
$ |
111,291 |
$ |
515,069 |
$ |
279,282 |
|||||||
Collaboration revenue |
24,000 |
40,466 |
29,008 |
40,466 |
|||||||||||
Total revenues |
$ |
222,094 |
$ |
151,757 |
$ |
544,077 |
$ |
319,748 |
Collaboration revenue reflects event-based milestones and royalties earned under the Company's collaboration agreement with AbbVie. During the third quarter of 2019, the Company recognized a
For the third quarter of 2019, the Company reported net income of
Research and development (R&D) expenses for the three and nine months ended
In further connection with the Voyager collaboration, the Company recognized IPR&D of
Sales, general and administrative (SG&A) expenses for the three and nine months ended
As of
Updated 2019 SG&A and R&D Expense Guidance
SG&A, IPR&D, and R&D expenses for 2019 are expected to be
Pipeline Highlights
Valbenazine Update - Chorea Associated with Huntington's Disease
In
Opicapone Update
In
Elagolix Update
On
Congenital Adrenal Hyperplasia (CAH) Program (NBI-74788) Update
The Company began an adaptive, Phase II proof-of-concept study examining the pharmacokinetics, pharmacodynamics, and safety of NBI-74788 in adults with classic 21-hydroxylase deficiency congenital adrenal hyperplasia (CAH) in
In
Voyager Collaboration and VY-AADC Program
During the first quarter of 2019,
Based on the results from the VY-AADC Phase I programs in Parkinson's disease, RESTORE-1, a Phase II, randomized, placebo-surgery controlled, double-blinded, multi-center, clinical trial was initiated to evaluate the safety and efficacy of VY-AADC in patients who have been diagnosed with Parkinson's disease for at least four years, are not responding adequately to oral medications, and have at least three hours of OFF time during the day as measured by a validated self-reported patient diary.
Conference Call and Webcast Today at
About INGREZZA® (valbenazine) Capsules
INGREZZA, a selective vesicular monoamine transporter 2 (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.
Parkinsonism
INGREZZA may cause Parkinsonism in patients with tardive dyskinesia. Parkinsonism has also been observed with other VMAT2 inhibitors. Reduce the dose or discontinue INGREZZA treatment in patients who develop clinically significant parkinson-like signs or symptoms.
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 INCOME |
|||||||||||||||
(unaudited) |
|||||||||||||||
Three Months Ended September 30, |
Nine Months Ended September 30, |
||||||||||||||
(in thousands, except per share data) |
2019 |
2018 |
2019 |
2018 |
|||||||||||
Revenues: |
|||||||||||||||
Product sales, net |
$ |
198,094 |
$ |
111,291 |
$ |
515,069 |
$ |
279,282 |
|||||||
Collaboration revenue |
24,000 |
40,466 |
29,008 |
40,466 |
|||||||||||
Total revenues |
222,094 |
151,757 |
544,077 |
319,748 |
|||||||||||
Operating expenses: |
|||||||||||||||
Cost of sales |
2,229 |
1,551 |
4,966 |
3,355 |
|||||||||||
Research and development |
45,278 |
35,482 |
144,617 |
121,417 |
|||||||||||
Acquired in-process research and development |
— |
— |
118,081 |
— |
|||||||||||
Selling, general and administrative |
84,489 |
60,401 |
252,851 |
179,952 |
|||||||||||
Total operating expenses |
131,996 |
97,434 |
520,515 |
304,724 |
|||||||||||
Operating income |
90,098 |
54,323 |
23,562 |
15,024 |
|||||||||||
Other (expense) income: |
|||||||||||||||
Interest expense |
(8,038) |
(7,672) |
(23,833) |
(22,767) |
|||||||||||
Unrealized loss on restricted equity securities |
(28,450) |
— |
(5,805) |
— |
|||||||||||
Investment income and other, net |
4,797 |
4,113 |
13,980 |
10,776 |
|||||||||||
Total other expense, net |
(31,691) |
(3,559) |
(15,658) |
(11,991) |
|||||||||||
Income before provision for income taxes |
58,407 |
50,764 |
7,904 |
3,033 |
|||||||||||
Provision for income taxes |
4,618 |
— |
4,892 |
— |
|||||||||||
Net income |
$ |
53,789 |
$ |
50,764 |
$ |
3,012 |
$ |
3,033 |
|||||||
Net income per share, basic |
$ |
0.59 |
$ |
0.56 |
$ |
0.03 |
$ |
0.03 |
|||||||
Net income per share, diluted |
$ |
0.56 |
$ |
0.52 |
$ |
0.03 |
$ |
0.03 |
|||||||
Weighted average common shares outstanding, basic |
91,859 |
90,555 |
91,440 |
90,064 |
|||||||||||
Weighted average common shares outstanding, diluted |
96,074 |
96,798 |
95,231 |
95,272 |
NEUROCRINE BIOSCIENCES, INC. |
||||
CONDENSED CONSOLIDATED BALANCE SHEETS |
||||
(unaudited) |
||||
September 30, |
December 31, |
|||
(in thousands) |
||||
Cash, cash equivalents and short-term investments |
$ 670,162 |
$ 650,913 |
||
Other current assets |
149,070 |
86,864 |
||
Total current assets |
819,232 |
737,777 |
||
Property and equipment, net |
40,302 |
33,869 |
||
Long-term investments |
204,793 |
216,028 |
||
Investment in restricted equity securities |
48,915 |
- |
||
Operating lease assets |
61,987 |
- |
||
Restricted cash |
4,706 |
5,477 |
||
Total assets |
$ 1,179,935 |
$ 993,151 |
||
Current liabilities |
$ 115,652 |
$ 88,233 |
||
Noncurrent operating lease liabilities |
74,482 |
- |
||
Convertible senior notes |
403,589 |
388,496 |
||
Other long-term liabilities |
11,697 |
35,657 |
||
Stockholders' equity |
574,515 |
480,765 |
||
Total liabilities and stockholders' equity |
$ 1,179,935 |
$ 993,151 |
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SOURCE
Neurocrine Biosciences, Inc., Navjot Rai (Media), 858-617-7623, media@neurocrine.com or Todd Tushla (Investors), 858-617-7143, ir@neurocrine.com