On August 4, 2022 Neurocrine Biosciences, Inc. (Nasdaq: NBIX) reported its financial results for the second quarter ended June 30, 2022 and raised net sales guidance for INGREZZA in 2022 (Press release, Neurocrine Biosciences, AUG 4, 2022, View Source [SID1234617525]).
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"Following INGREZZA’s strong performance in the first half of this year, we raised full year net sales guidance. Growth continues to be driven by improving diagnosis and treatment rates for patients with tardive dyskinesia," said Kevin Gorman, Ph.D., Chief Executive Officer of Neurocrine Biosciences. "Although disappointed that our essential tremor data was not what we hoped to see, we look forward to the continued advancement of our pipeline with the recent FDA approval to initiate a Phase 2 proof-of-concept study for the treatment of schizophrenia with our selective M4 agonist."
Second Quarter INGREZZA Net Product Sales and Commercial Highlights:
Net product sales were $350 million with total prescriptions (TRx) of approximately 64,200
Net product sales and TRx grew 32% and 31%, respectively, vs. second quarter of 2021
Sequential growth driven by record new patients and continued strength in existing patients’ refill rates
Financial Highlights:
Second quarter 2022 GAAP net loss and loss per share of $17 million and $0.18, respectively, compared with second quarter 2021 GAAP net income and diluted earnings per share of $42 million and $0.43, respectively, primarily driven by $70 million loss on extinguishment of debt in the second quarter of 2022.
Second quarter 2022 non-GAAP net income and diluted earnings per share of $82 million and $0.84, respectively, compared with $70 million and $0.72, respectively, for second quarter 2021.
Differences in second quarter 2022 GAAP and non-GAAP operating expenses compared with second quarter 2021 driven by:
Increased R&D expense in support of an expanded and advancing clinical portfolio, including $30 million milestone expense incurred for our Sosei Heptares muscarinic collaboration
Increased SG&A expense primarily due to ongoing commercial initiatives, including the INGREZZA direct-to-consumer advertising campaign which launched in May 2021 and deployment of the expanded salesforce in March 2022
Total debt outstanding decreased by $211 million to $170 million following our repurchase of approximately 55% of total debt outstanding in the second quarter of 2022. The total aggregate repurchase price of $279 million was paid in cash and resulted in the recognition of a $70 million loss on extinguishment in the second quarter of 2022.
At June 30, 2022, the Company had cash, cash equivalents and marketable securities of approximately $1.1 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 June 2022, the Mitsubishi Tanabe Pharma Corporation (MTPC) launched DYSVAL (valbenazine) in Japan for the treatment of tardive dyskinesia. In connection with MTPC’s first commercial sale of DYSVAL in Japan, we received a milestone payment of $20.0 million, which was recognized as revenue in the second quarter of 2022.
In the second quarter of 2022, the FDA accepted our submission of an investigational new drug application (IND) for NBI-1117568 for the treatment of schizophrenia, for which we anticipate initiating a Phase 2 study during the second half of 2022. Based upon this progress, a milestone of $30.0 million was expensed as R&D in the second quarter of 2022, which we expect to pay to Sosei Heptares in the third quarter of 2022.
In August, the Phase 2a study of NBI-827104 in essential tremor did not meet specified endpoints. Based on the totality of data from the Phase 2a study, at this time, we do not plan to proceed further with the clinical development of NBI-827104 in essential tremor.
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 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.