On July 31, 2018 Neurocrine Biosciences, Inc. (NASDAQ: NBIX) reported its financial results for the quarter ended June 30, 2018, and provided an update on the launch of INGREZZA (valbenazine), the U.S. Food and Drug Administration (FDA) approval for ORILISSA (elagolix), and its clinical development programs (Press release, Neurocrine Biosciences, July 31, 2018, View Source [SID1234528000]).
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"Neurocrine is making great progress with the continued adoption of INGREZZA by physicians and patients, the recent FDA approval of ORILISSA for endometriosis, and the advancement of our clinical development programs," said Kevin Gorman, Ph.D., Chief Executive Officer of Neurocrine Biosciences. "AbbVie’s approval of ORILISSA marks the second FDA-approved drug discovered by scientists at Neurocrine and is a testament to our discovery and development capabilities. We remain committed toward our goal of having four commercial products with six indications, four years from now, to help patients with significant unmet medical needs."
Financial Results
Neurocrine reported net product sales for INGREZZA of $96.9 million for the three months ended June 30, 2018 compared to $6.3 million for the three months ended June 30, 2017. For the six months ended June 30, 2018 and 2017, Neurocrine reported net product sales for INGREZZA of $168.0 million and $6.3 million, respectively. INGREZZA was made available for commercial distribution on May 1, 2017.
For the second quarter of 2018, the Company reported a net loss of $5.9 million, or $0.07 loss per share, compared to a net loss of $60.0 million, or $0.68 loss per share, for the same period in 2017. For the six months ended June 30, 2018, the Company reported a net loss of $47.7 million, or $0.53 loss per share, compared to a net loss of $138.3 million, or $1.58 loss per share, for the same period in 2017.
Research and development (R&D) expenses were $37.0 million during the second quarter of 2018 compared to $21.9 million for the second quarter of 2017. The increase in R&D expense is principally due to the advancement of our Tourette clinical program and activity preparing for our intended opicapone New Drug Application (NDA) submission in the first half of 2019. For the six months ended June 30, 2018, R&D expenses were $85.9 million, compared to $73.8 million for the same period last year. The increase from the prior year is primarily due to the ongoing progression of our clinical pipeline, an approximately $8 million non-recurring share-based compensation charge, and a $10 million event-based payment to BIAL – Portela & CA, S.A. (BIAL) resulting from the ability to submit the opicapone NDA based on the existing clinical dataset, partially offset by a $30 million payment in 2017 to BIAL for the exclusive licensing of opicapone.
Sales, general and administrative (SG&A) expenses increased to $60.9 million for the second quarter of 2018 from $41.7 million for the second quarter of 2017. For the six months ended June 30, 2018, SG&A expenses were $119.6 million, compared to $69.7 million for the same period last year. The increase in SG&A expense for both periods is primarily due to the hiring of our sales force and commercialization activities for INGREZZA, which launched in the second quarter of 2017.
The Company’s balance sheet at June 30, 2018 reflected assets of $841.3 million, including cash, investments and receivables of $806.3 million, compared with total assets balances at March 31, 2018 and December 31, 2017 of $806.4 million and $817.6 million, respectively.
Pipeline Highlights
INGREZZA (valbenazine) Update
INGREZZA received U.S. Food and Drug Administration (FDA) approval on April 11, 2017, becoming the first medicine approved in the United States for the treatment of adults with tardive dyskinesia.
Valbenazine is being investigated in Tourette syndrome and has been granted Orphan Drug Designation by the FDA for the treatment of pediatric patients with Tourette syndrome. Orphan Drug Designation is granted by the FDA to drugs that are intended to treat rare diseases or conditions in the United States.
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 late 2018.
The Company also recently 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 respond 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 March 2015, the Company announced that it had entered into an exclusive collaboration and licensing agreement for the development and commercialization of INGREZZA in Japan and other select Asian markets with Mitsubishi Tanabe Pharma Corporation (MTPC). In 2017, MTPC initiated a pivotal trial of INGREZZA in Japan for the treatment of tardive dyskinesia.
ORILISSA (elagolix) Update
On July 24, 2018, AbbVie, in collaboration with Neurocrine, announced FDA approval for ORILISSA for the management of endometriosis with associated moderate to severe pain. The FDA granted priority review to ORILISSA. The FDA grants priority review designation to medicines that, if approved, would provide a significant improvement in the safety or effectiveness of treatment of a serious condition. AbbVie intends to commercialize ORILISSA in August 2018. With this FDA approval, a $40 million event-based payment will be made by AbbVie under our collaboration agreement and recognized as revenue in the third quarter of 2018.
During the first quarter of 2018, AbbVie provided positive top-line efficacy data from two Phase III studies in women with uterine fibroids. The ELARIS UF-I and UF-II studies of elagolix met all primary and ranked secondary endpoints at month six. These replicate Phase III studies were randomized, parallel, double-blind, placebo-controlled clinical trials evaluating elagolix alone or in combination with low-dose hormone (add-back) therapy in women with heavy uterine bleeding associated with uterine fibroids. The studies enrolled approximately 400 patients each for an initial six-month placebo-controlled dosing period. At the end of the six months of placebo-controlled evaluation, patients were eligible to enter an additional six-month safety extension study. The primary efficacy endpoint of the study was an assessment of the change in menstrual blood loss utilizing the alkaline hematin method comparing baseline to month six. Additional secondary efficacy endpoints were evaluated including the change in fibroid volume and hemoglobin. Bone mineral density was assessed via dual-energy x-ray absorptiometry (DEXA) scan at baseline, at the conclusion of dosing, and at six months post-dosing. Results from these studies will form the basis for an anticipated 2019 supplemental NDA submission to the FDA for the approval of elagolix in the treatment of uterine fibroids.
Opicapone Update
In February 2017, the Company entered into an exclusive licensing agreement with BIAL for the development and commercialization of opicapone in the United States and Canada. Opicapone is a once-daily, peripherally-acting, highly-selective catechol-O-methyltransferase inhibitor, being developed as an adjunct therapy to preparations of levodopa/DOPA decarboxylase inhibitors for adult patients with Parkinson’s disease and motor fluctuations. The Company met with the FDA in January and based upon the BIPARK-I and BIPARK-II pivotal Phase III studies conducted by BIAL, the FDA did not require additional Phase III trials to form an NDA submission. The Company is in the process of preparing for an NDA submission which it anticipates will occur during the first half of 2019.
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 (PK), the effect of food on PK, 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 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 patients. Data are expected to be available later in 2018.
Conference Call and Webcast Today at 4:30 PM Eastern Time
Neurocrine will hold a live conference call and webcast today at 4:30 p.m. Eastern Time (1:30 p.m. Pacific Time). Participants can access the live conference call by dialing 877-876-9177 (US) or 785-424-1669 (International) using the conference ID: NBIX. The call can also be accessed via the webcast through the Company’s website at View Source
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 trunk, extremities and/or face.
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.
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 FDA. Visit MedWatch at www.fda.gov/medwatch or call 1-800-FDA-1088.