On November 1, 2021 Neurocrine Biosciences, Inc. (Nasdaq: NBIX) reported its financial results for the third quarter ended September 30, 2021 (Press release, Neurocrine Biosciences, NOV 1, 2021, View Source [SID1234594006]).
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"Our third quarter results reflect INGREZZA’s continued growth. With this momentum and increased investment to expand our commercial footprint, we can better serve patients and our customers, and significantly improve diagnosis and treatment rates for people living with tardive dyskinesia," said Kevin Gorman, Ph.D., Chief Executive Officer of Neurocrine Biosciences. "We are prudently investing in our advancing and growing R&D pipeline. With important clinical data read-outs expected over the next two years, we are executing well on our strategy to become a leading neuroscience-focused company."
Third Quarter INGREZZA Net Product Sales and Commercial Highlights:
Net product sales for the third quarter of 2021 were $287 million and $285 million on an inventory adjusted basis
Record total prescriptions achieved during the third quarter 2021 reflecting higher customer demand and increased commercial activities
New prescriptions increased throughout the third quarter, reaching their highest levels since March 2020
Expanding commercial organization in 2022 to establish dedicated field teams to better meet the needs of healthcare professionals across diverse sites of care and help more patients access effective treatment more quickly
Financial Highlights:
Third quarter 2021 GAAP net income and diluted earnings per share were approximately $23 million and $0.23, respectively, compared with a net loss and net loss per share of approximately $58 million and $0.62, respectively, in the third quarter of 2020
Third quarter 2021 non-GAAP net income and diluted earnings per share were approximately $63 million and $0.64, respectively, compared with a net loss and net loss per share of approximately $17 million and $0.18, respectively, in the third quarter of 2020
Difference between third quarter 2021 GAAP and non-GAAP net income and diluted earnings per share compared with the third quarter of 2020 were driven by:
Prior year In-Process Research and Development (IPR&D) associated with $118.5 million of upfront fees paid pursuant to our exclusive license agreement with Takeda Pharmaceutical Company Limited (Takeda)
Increased R&D expense primarily due to increased investment to support advancing our pipeline programs, including our psychiatry programs in-licensed in mid-2020 and advancement of our in-licensed epilepsy programs which began at the end of 2019
Increased SG&A expense primarily due to increased investment in commercial initiatives including the launch of our INGREZZA direct-to-consumer advertising campaign, "TD Spotlight"
Third quarter 2021 provision for income taxes was approximately $8 million, compared with approximately $1 million in the third quarter of 2020. In the first quarter of 2021, the Company began recording a provision for income taxes using an effective tax rate approximating federal and state statutory rates. Due to the Company’s ability to offset its pre-tax income against previously benefited federal net operating losses, no federal cash tax is expected in 2021
At September 30, 2021, the Company had cash, cash equivalents and debt securities available-for-sale of approximately $1.3 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
In August 2021, the Company announced plans to initiate registrational studies in the second half of 2021 with valbenazine for adjunctive treatment in schizophrenia and for dyskinesia due to cerebral palsy
In September 2021, the Company received approval of a clinical trial application (CTA) submitted in the European Union for NBI-921352 for the treatment of focal-onset seizures in adults. In connection with the approval, the Company paid Xenon a $10 million milestone, of which the Company expensed $5.4 million as R&D in the third quarter of 2021, and purchased an additional $4.6 million of Xenon’s common stock
Previously, the Company expected combined GAAP R&D and SG&A expenses in the range of $855 million to $905 million and Non-GAAP R&D and SG&A expenses in the range of $720 million to $770 million.
GAAP expense guidance range includes $10 million of IPR&D and milestone expenses, and approximately $135 million of share-based compensation, including increased share-based compensation for an equity grant to full-time employees other than executive officers in September 2021.
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 800-895-3361 (US) or 785-424-1062 (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.