On November 1, 2022 Neurocrine Biosciences, Inc. (Nasdaq: NBIX) reported its financial results for the third quarter ended September 30, 2022 and raised net sales guidance for INGREZZA in 2022 (Press release, Neurocrine Biosciences, NOV 1, 2022, View Source [SID1234622713]).

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"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."

Third Quarter INGREZZA Net Product Sales and Commercial Highlights:
Net product sales were $376 million with total prescriptions (TRx) of approximately 68,600
Net product sales and TRx grew 31% and 32%, respectively, vs. third quarter of 2021
Sequential growth driven by record new patients and continued strength in existing patients’ refill rates
Financial Highlights:
Third quarter 2022 GAAP net income and diluted earnings per share of $69 million and $0.69, respectively, compared with $23 million and $0.23, respectively, for third quarter 2021.
Third quarter 2022 non-GAAP net income and diluted earnings per share of $107 million and $1.08, respectively, compared with $63 million and $0.64, respectively, for third quarter 2021.
Differences in third quarter 2022 GAAP and non-GAAP operating expenses compared with third quarter 2021 driven by:
Increased R&D expense in support of an expanded and advancing clinical portfolio
Increased SG&A expense primarily due to ongoing commercial initiatives, including the deployment of the expanded salesforce in April 2022
At September 30, 2022, the Company had cash, cash equivalents and marketable securities of approximately $1.2 billion.
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.

Recent Events:
On November 1, 2022, we acquired Diurnal Group plc, or Diurnal, in an all-cash transaction, for an aggregate value of approximately £48.3 million GBP, or approximately $56 million USD. We believe the transaction presents an opportunity to accelerate the establishment of our clinical development and commercial capabilities in the United Kingdom to the benefit of patient communities and other stakeholders.

INGREZZA sales guidance for fiscal 2022 is based on recent trends and the anticipated benefit from our recently completed salesforce expansion. If new COVID-19 related disruptions emerge, the Company’s ability to meet these expectations could be negatively impacted.
GAAP R&D guidance includes (i) amounts for milestones that are probable of achievement or have been achieved and (ii) amounts for in-process research and development once significant collaboration and licensing arrangements have been completed. GAAP R&D guidance includes approximately $40 million of milestone expenses in connection with collaborations.
Non-GAAP guidance adjusted to exclude estimated non-cash stock-based compensation expense of $60 million in R&D and $110 million in SG&A.
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.

Conference Call and Webcast Today at 8:00 AM Eastern Time
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.