"We remain committed to delivering hope for patients with serious unmet medical needs as evidenced by the growing adoption of INGREZZA and the recent commercial launch of ORILISSA - both treatments were discovered at
Financial Results
Total revenue for the three and nine months ended
For the Three Months Ended September 30, |
For the Nine Months Ended September 30, |
|||||||
2018 |
2017 |
2018 |
2017 |
|||||
Revenues: |
||||||||
INGREZZA product sales, net |
$ 111,291 |
$ 45,774 |
$ 279,282 |
$ 52,109 |
||||
Collaboration revenue |
40,466 |
15,000 |
40,466 |
15,000 |
||||
Total revenue |
$ 151,757 |
$ 60,774 |
$ 319,748 |
$ 67,109 |
INGREZZA was made available for commercial distribution on
For the third quarter of 2018, the Company reported net income of
Research and development (R&D) expenses were
Sales, general and administrative (SG&A) expenses increased to
The Company's balance sheet at
Updated 2018 Expense Guidance
Ongoing operating expenses for 2018 are now expected to approximate
Pipeline Highlights
INGREZZA (valbenazine) Update
INGREZZA received
Valbenazine is being investigated in Tourette syndrome and has been granted Orphan Drug Designation by the
In the fourth quarter of 2017, the Company initiated T-Force GOLD, a Phase IIb study of valbenazine in pediatric patients with Tourette syndrome. This study is a multicenter, randomized, double-blind, placebo-controlled, parallel-group, which will evaluate the safety, tolerability, efficacy and optimized dosing of once-daily valbenazine 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 comparison of the change from baseline of the Yale Global Tic Severity Scale between placebo and active treatment groups at the end of week 12. Top-line data are expected in
In the second quarter of 2018, the Company commenced enrollment into the open-label extension study, T-Force GOLD Plus, for pediatric patients with Tourette syndrome. Patients who complete participation in the T-Force GOLD study are eligible to roll over into participation in this open-label extension study for an additional six months of treatment with optimized doses of valbenazine. The study will collect longer-term safety and tolerability data in children and adolescents as well as providing useful information about the maintenance of efficacy in these patients over the six months period of dosing.
In the second quarter of 2018, the Company started T-Force PLATINUM, a double-blind, placebo-controlled, randomized withdrawal study of valbenazine in pediatric patients with Tourette syndrome. This study is designed to evaluate longer-term efficacy and safety in patients who initially responded to open-label therapy with optimized doses of valbenazine. Approximately 180 patients will participate in the study with top-line data expected in late 2019.
In
ORILISSA (elagolix) Update
On
Opicapone Update
In
BIAL –
Congenital Adrenal Hyperplasia (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 recruitment for 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. The study will evaluate the relationship between NBI-74788 exposures and specific steroid hormone levels in these patients. The Company recently expanded this study to include additional patients to further optimize dosing flexibility and convenience. Data are expected during the first quarter of 2019.
New VMAT2 Inhibitor
The Company has filed an IND and initiated a Phase I study for a novel, internally discovered vesicular monoamine transporter 2 (VMAT2) inhibitor with potential use in the treatment of several neurology and/or psychiatry disorders. The initial randomized, double-blind, single ascending dose study to evaluate the safety, tolerability, and pharmacokinetic profile of the compound in healthy participants is anticipated to be completed during the fourth quarter of 2018.
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 Central Nervous System (CNS) compound with potential use in the treatment of several neurology and/or psychiatry disorders. This 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.
Conference Call and Webcast Today at
Neurocrine will hold a live 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 or functional inhibition 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.INGREZZAHCP.com
About Neurocrine Biosciences, Inc.
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) |
||||||||||||||||
For the Three Months Ended September 30, |
For the Nine Months Ended September 30, |
|||||||||||||||
2018 |
2017 |
2018 |
2017 |
|||||||||||||
Revenues: |
||||||||||||||||
Product sales, net |
$ |
111,291 |
$ |
45,774 |
$ |
279,282 |
$ |
52,109 |
||||||||
Collaboration revenue |
40,466 |
15,000 |
40,466 |
15,000 |
||||||||||||
Total revenues |
151,757 |
60,774 |
319,748 |
67,109 |
||||||||||||
Operating expenses: |
||||||||||||||||
Cost of sales |
1,551 |
433 |
3,355 |
494 |
||||||||||||
Research and development |
35,482 |
22,463 |
121,417 |
96,213 |
||||||||||||
Sales, general and administrative |
60,401 |
43,873 |
179,952 |
113,597 |
||||||||||||
Total operating expenses |
97,434 |
66,769 |
304,724 |
210,304 |
||||||||||||
Income (loss) from operations |
54,323 |
(5,995) |
15,024 |
(143,195) |
||||||||||||
Other (expense) income: |
||||||||||||||||
Interest expense |
(7,672) |
(7,337) |
(22,767) |
(12,104) |
||||||||||||
Investment income and other, net |
4,113 |
2,207 |
10,776 |
5,863 |
||||||||||||
Total other expense, net |
(3,559) |
(5,130) |
(11,991) |
(6,241) |
||||||||||||
Net income (loss) |
$ |
50,764 |
$ |
(11,125) |
$ |
3,033 |
$ |
(149,436) |
||||||||
Net income (loss) per common share: |
||||||||||||||||
Basic |
$ |
0.56 |
$ |
(0.13) |
$ |
0.03 |
$ |
(1.70) |
||||||||
Diluted |
$ |
0.52 |
$ |
(0.13) |
$ |
0.03 |
$ |
(1.70) |
||||||||
Shares used in the calculation of net income (loss) per common share: |
||||||||||||||||
Basic |
90,555 |
88,325 |
90,064 |
87,894 |
||||||||||||
Diluted |
96,798 |
88,325 |
95,272 |
87,894 |
NEUROCRINE BIOSCIENCES, INC. |
|||||||||||
CONDENSED CONSOLIDATED BALANCE SHEETS |
|||||||||||
(in thousands) (unaudited) |
|||||||||||
September 30, 2018 |
December 31, 2017 |
||||||||||
Cash, cash equivalents and short-term investments |
$ 635,343 |
$ 515,929 |
|||||||||
Other current assets |
79,051 |
38,990 |
|||||||||
Total current assets |
714,394 |
554,919 |
|||||||||
Property and equipment, net |
28,618 |
10,811 |
|||||||||
Long-term investments |
185,257 |
247,361 |
|||||||||
Restricted cash |
5,477 |
4,500 |
|||||||||
Total assets |
$ 933,746 |
$ 817,591 |
|||||||||
Current portion of convertible senior notes |
$ 383,647 |
$ — |
|||||||||
Other current liabilities |
72,753 |
54,426 |
|||||||||
Convertible senior notes |
— |
369,618 |
|||||||||
Other long-term liabilities |
29,833 |
21,409 |
|||||||||
Stockholders' equity |
447,513 |
372,138 |
|||||||||
Total liabilities and stockholders' equity |
$ 933,746 |
$ 817,591 |
|||||||||
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SOURCE
Neurocrine Biosciences, Inc., Navjot Rai (Media & Investors), 858-617-7623, IR@neurocrine.com