On May 6, 2020 Neurocrine Biosciences, Inc. (Nasdaq: NBIX) reported its financial results for the first quarter ended March 31, 2020 and provided revised full-year 2020 financial expense guidance (Press release, Neurocrine Biosciences, MAY 6, 2020, View Source [SID1234557136]).
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"First and foremost, I would like to thank our employees, healthcare providers and suppliers for their commitment and dedication in managing these tough times. Together, we remain focused on ensuring that patients with tardive dyskinesia, many of whom are managing their involuntary movements with a mental health condition, are well supported and have uninterrupted access to INGREZZA," said Kevin Gorman, Ph.D., Chief Executive Officer of Neurocrine Biosciences. "Even during these challenging times, we continue to see strong persistency and compliance with INGREZZA."
"With the recent FDA approval of ONGENTYS for patients with Parkinson’s disease, we’re excited to add another treatment for movement disorders to our portfolio and look forward to making it available to patients later this year. In addition, we are well positioned to launch clinical studies of several compounds in our pipeline and plan to have on-going studies in three registrational programs and four mid-stage programs by the end of this year," Gorman added. "The company is in a strong financial position, enabling us to navigate through this pandemic while continuing to execute on our mission to discover, develop and deliver important medicines to treat patients with neurological, endocrine, and psychiatric disorders."
First Quarter Net Product Sales Highlights:
INGREZZA net product sales for the first quarter 2020 were $231 million, representing a year-over-year increase of 69%.
Successfully navigated through the annual seasonal payor dynamics driving steady persistency and strong momentum in the second half of the first quarter.
End of first quarter 2020 days-on-hand channel inventory slightly increased relative to the fourth quarter 2019 resulting in an approximate $4 million benefit to net product sales.
Financial Highlights:
Research and Development (R&D) investment increased in the first quarter of 2020 versus the first quarter of 2019 primarily due to the Company’s increased investment in its gene therapy programs in collaboration with Voyager Therapeutics and increased activity to support advancing its expanded clinical portfolio.
Selling, General and Administrative (SG&A) investment increased in the first quarter of 2020 versus the first quarter of 2019, primarily due to increased headcount costs and continued investment in the patient-focused disease state awareness campaign, "Talk About TD".
First quarter of 2020 GAAP net income and diluted earnings per share were $37 million and $0.39, respectively, compared to a net loss and net loss per share of $102 million and $1.12, respectively, in the first quarter of 2019, largely attributable to IPR&D expense of $113.1 million.
First quarter of 2020 non-GAAP net income and diluted earnings per share were $79 million and $0.82, respectively, compared to $28 million and $0.29, respectively, in the first quarter of 2019.
At March 31, 2020, the Company had cash, cash equivalents and debt securities available-for-sale over $1 billion.
A reconciliation of GAAP to non-GAAP quarterly financial results can be found in Table 3 at the end of this earnings release.
Recent Events
On April 3, 2020, the Company provided an update on its business operations as a result of the COVID-19 pandemic as part of its commitment to prioritize the safety, health and well-being of patients, their caregivers, healthcare providers and employees. Please refer to the press release for additional information pertaining to the status of our programs and ongoing company initiatives through the COVID-19 crisis. Key updates included:
Employees, including customer-facing teams, have been working from home since March and have been utilizing remote technologies to ensure continued support for patients and healthcare professionals.
Patients taking INGREZZA have assurance of continued supply, and specialty and mental health pharmacies remain engaged with patients to ensure they receive continuity of care and support their overall health and well-being.
Enrollment has been paused for clinical studies and will be reinstated when it is safe and appropriate to do so. In parallel, the Company continues preparations to launch new clinical studies in the second half of the year. By the end of 2020, Neurocrine Biosciences plans to have studies ongoing in three registrational and four mid-stage programs.
On April 24, 2020, the FDA approved ONGENTYS (opicapone), the first and only once-daily COMT inhibitor, as an adjunctive treatment to levodopa/carbidopa in patients with Parkinson’s disease experiencing "off" episodes – periods of time when motor symptoms such as tremor, slowed movement and difficulty walking occur. ONGENTYS also increases "on" time without troublesome dyskinesia, the time when the motor symptoms of a patient with Parkinson’s disease are better controlled. The FDA approval of ONGENTYS for Parkinson’s disease triggered a $20 million milestone under the terms of the collaboration agreement with BIAL. The commercial launch of ONGENTYS is expected to occur later in 2020.
Previously, the Company expected combined GAAP R&D and SG&A expenses in the range of $740 million to $770 million and combined non-GAAP R&D and SG&A expenses in the range of $620 million to $650 million.
GAAP and non-GAAP expense guidance range reflects increased investment in R&D programs including three registrational programs, meaningful investments across early stage programs including Voyager and Xenon collaborations, continued investment in INGREZZA and marketing costs associated with the anticipated launch of ONGENTYS.
GAAP-only guidance includes approximately $105 million of share-based compensation and a $20 million milestone to BIAL connected with the approval of ONGENTYS by the FDA. GAAP-only guidance does not include any other potential milestones or in-process research and development costs associated with current collaborations or future business development activities.
Conference Call and Webcast Today at 4:30 PM Eastern Time
Neurocrine Biosciences 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 800-894-5910 (US) or 785-424-1052 (International) using the conference ID: NBIX. The webcast can also be accessed on Neurocrine Biosciences’ website under Investors at www.neurocrine.com. A replay of the webcast will be available on the website approximately one hour after the conclusion of the event and will be archived for approximately one month.
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 face, torso, and/or other body parts.
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.
Please see INGREZZA full Prescribing Information at www.INGREZZA.com/PI.
About ONGENTYS (opicapone) Capsules
ONGENTYS is a novel, once-daily, oral, peripheral, selective and reversible catechol-O-methyltransferase (COMT) inhibitor approved by the U.S. Food and Drug Administration (FDA) as an add-on treatment to levodopa/carbidopa in patients with Parkinson’s disease experiencing "off" episodes. ONGENTYS inhibits the COMT enzyme, which breaks down levodopa, making more levodopa available to reach the brain.
Important Safety Information
Contraindications
ONGENTYS is contraindicated in patients with:
Concomitant use of non-selective monoamine oxidase (MAO) inhibitors.
Pheochromocytoma, paraganglioma, or other catecholamine secreting neoplasms.
Warnings & Precautions
Cardiovascular Effects with Concomitant Use of Drugs Metabolized by Catechol-O-Methyltransferase (COMT)
Possible arrhythmias, increased heart rate, and excessive changes in blood pressure may occur with concomitant use of ONGENTYS and drugs metabolized by COMT, regardless of the route of administration (including inhalation). Monitor patients treated concomitantly with ONGENTYS and drugs metabolized by COMT.
Falling Asleep During Activities of Daily Living and Somnolence
Patients treated with dopaminergic medications and medications that increase levodopa exposure, including ONGENTYS, have reported falling asleep while engaged in activities of daily living, including the operation of motor vehicles, which sometimes has resulted in accidents. If a patient develops daytime sleepiness or somnolence, consider discontinuing ONGENTYS or adjusting other dopaminergic or sedating medications and advise patients to avoid driving and other potentially dangerous activities.
Hypotension/Syncope
Monitor patients for hypotension and advise patients about the risk for syncope. If these adverse reactions occur, consider discontinuing ONGENTYS or adjusting the dosage of other medications that can lower blood pressure.
Dyskinesia
ONGENTYS potentiates the effects of levodopa which may result in dyskinesia or exacerbate pre-existing dyskinesia. Reducing the patient’s levodopa dosage or the dosage of another dopaminergic drug may reduce dyskinesia that occurs during treatment with ONGENTYS.
Hallucinations and Psychosis
Consider stopping ONGENTYS if hallucinations or psychotic-like behaviors occur. Patients with a major psychotic disorder should ordinarily not be treated with ONGENTYS.
Impulse Control/Compulsive Disorders
Patients may experience intense urges (e.g., gambling, sexual, spending money, binge eating) and the inability to control them. It is important for prescribers to specifically ask patients or their caregivers about the development of new or increased urges. Re-evaluate the patient’s current therapies for Parkinson’s disease and consider stopping ONGENTYS if a patient develops such urges while taking ONGENTYS.
Withdrawal-Emergent Hyperpyrexia and Confusion
A symptom complex resembling neuroleptic malignant syndrome (elevated temperature, muscular rigidity, altered consciousness, and autonomic instability), has been reported in association with rapid dose reduction or withdrawal of drugs that increase central dopaminergic tone. There were no reports of neuroleptic malignant syndrome in ONGENTYS controlled clinical studies. When discontinuing ONGENTYS, monitor patients and consider adjustment of other dopaminergic therapies as needed.
Adverse Reactions
The most common adverse reactions (incidence at least 4% and greater than placebo) were dyskinesia, constipation, blood creatine kinase increase, hypotension/syncope, and weight decrease.
Please see ONGENTYS full Prescribing Information at www.neurocrine.com/ongentyspi.
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.