Neurocrine Biosciences Reports Third Quarter 2022 Financial Results and Raises 2022 INGREZZA Sales Guidance Neurocrine Biosciences, Inc. (Nasdaq: NBIX) today announced its financial results for the third quarter ended September 30, 2022 and raised net sales ...

INGREZZA ® (valbenazine) Third Quarter Net Product Sales of $376 Million

INGREZZA ® (valbenazine) 2022 Net Product Sales Guidance Raised to $1.4 - $1.425 Billion

Supplemental New Drug Application (sNDA) of Valbenazine For the Treatment of Chorea in Patients with Huntington Disease Submitted to the U.S. Food and Drug Administration

SAN DIEGO , Nov. 1, 2022 /PRNewswire/ -- Neurocrine Biosciences, Inc. (Nasdaq: NBIX ) today announced its financial results for the third quarter ended September 30, 2022 and raised net sales guidance for INGREZZA in 2022.

"INGREZZA continues to help more and more patients who suffer from tardive dyskinesia. With the submission of the sNDA of valbenazine for the treatment of chorea associated with Huntington Disease, we have the potential to help even more patients with our valbenazine franchise," said Kevin Gorman , Ph.D., Chief Executive Officer of Neurocrine Biosciences. "Our clinical programs continue to progress with multiple data readouts in 2023 including for crinecerfont in congenital adrenal hyperplasia and for NBI-'352 in adult focal onset seizures. Additionally, we recently dosed our first patient in our lead muscarinic program for the treatment of schizophrenia. With a strong commercial and R&D presence, and an attractive financial profile, Neurocrine Biosciences is well positioned to be a leading neuroscience-focused company."

A reconciliation of GAAP to non-GAAP financial results can be found in Table 3 and Table 4 at the end of this earnings release.

Based upon available Federal net operating losses and tax credits, the Company expects to begin making cash payments for Federal income tax beginning in the fourth quarter of 2022.

Neurocrine Biosciences will hold a live conference call and webcast today at 8:00 a.m. Eastern Time ( 5:00 a.m. Pacific Time ). Participants can access the live conference call by dialing 866-952-8559 (US) or 785-424-1881 (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.

Neurocrine Biosciences is a neuroscience-focused, biopharmaceutical company with a simple purpose: to relieve suffering for people with great needs, but few options. We are dedicated to discovering and developing life-changing treatments for patients with under-addressed neurological, neuroendocrine and neuropsychiatric disorders. The company's diverse portfolio includes FDA-approved treatments for tardive dyskinesia, Parkinson's disease, endometriosis* and uterine fibroids*, as well as over a dozen mid-to-late-stage clinical programs in multiple therapeutic areas. For three decades, we have applied our unique insight into neuroscience and the interconnections between brain and body systems to treat complex conditions. We relentlessly pursue medicines to ease the burden of debilitating diseases and disorders, because you deserve brave science. For more information, visit neurocrine.com, and follow the company on LinkedIn. (*in collaboration with AbbVie)

In addition to the financial results and financial guidance that are provided in accordance with accounting principles generally accepted in the United States (GAAP), this press release also contains the following non-GAAP financial measures: non-GAAP R&D expense, non-GAAP SG&A expense, and non-GAAP net income and net income per share. When preparing the non-GAAP financial results and guidance, the Company excludes certain GAAP items that management does not consider to be normal, including recurring cash operating expenses that might not meet the definition of unusual or non-recurring items. In particular, these non-GAAP financial measures exclude: non-cash stock-based compensation expense, non-cash interest expense related to convertible debt, loss on extinguishment of convertible senior notes, changes in fair value of equity security investments, changes in foreign currency exchange rates and certain adjustments to income tax expense. These non-GAAP financial measures are provided as a complement to results provided in accordance with GAAP as management believes these non-GAAP financial measures help indicate underlying trends in the Company's business, are important in comparing current results with prior period results and provide additional information regarding the Company's financial position. Management also uses these non-GAAP financial measures to establish budgets and operational goals that are communicated internally and externally and to manage the Company's business and evaluate its performance. The Company provides guidance regarding combined R&D and SG&A expenses on both a GAAP and a non-GAAP basis. A reconciliation of these GAAP financial results to non-GAAP financial results is included in the attached financial information.

Note: Beginning in the third quarter of 2021, milestone payments received from licenses and collaborations, milestones paid related to licenses and collaborations, non-cash collaboration revenue, and acquired in-process research and development are no longer excluded from non-GAAP financial results. 2021 non-GAAP financial results have been updated for comparability to current year periods.

SOURCE Neurocrine Biosciences, Inc.