Neurocrine Biosciences Q4 2022 Earnings Report
Key Takeaways
Neurocrine Biosciences reported Q4 2022 net product sales of $404.6 million and GAAP net income of $89 million, with diluted earnings per share of $0.88. INGREZZA net product sales were $399 million, reflecting a 33% growth compared to Q4 2021. The company completed enrollment in adult and pediatric registrational studies of crinecerfont for congenital adrenal hyperplasia and anticipates top-line data in the second half of 2023.
INGREZZA fourth quarter net product sales were $399 million and fiscal 2022 net product sales were $1.43 billion.
INGREZZA fourth quarter net product sales and total prescriptions grew 33% and 29%, respectively, vs. fourth quarter of 2021.
Fourth quarter 2022 GAAP net income was $89 million and diluted earnings per share was $0.88, compared to a GAAP net loss of $7 million and earnings per share of $0.08 for fourth quarter 2021.
Fourth quarter 2022 non-GAAP net income was $125 million and diluted earnings per share was $1.24, compared with $4 million and $0.04, respectively, for fourth quarter 2021.
Neurocrine Biosciences
Neurocrine Biosciences
Neurocrine Biosciences Revenue by Segment
Forward Guidance
Neurocrine Biosciences provided financial guidance for fiscal year 2023, including INGREZZA net product sales expectations between $1.67 billion and $1.77 billion, GAAP R&D expense between $550 million and $580 million, non-GAAP R&D expense between $495 million and $525 million, GAAP SG&A expense between $850 million and $870 million, and non-GAAP SG&A expense between $730 million and $750 million.
Positive Outlook
- INGREZZA sales guidance for fiscal 2023 reflects expected sales of INGREZZA in tardive dyskinesia only.
- The guidance range is based upon recent trends and underlying business initiatives underway to help advance the development of the tardive dyskinesia market.
- GAAP R&D guidance reflects the progression of the Company’s pipeline including 12 mid-to-late-stage clinical studies, meaningful investments in the muscarinic portfolio and expanded pre-clinical research efforts.
- GAAP R&D guidance includes amounts for milestones that are probable of achievement or have been achieved and amounts for in-process research and development once significant collaboration and licensing arrangements have been completed.
- GAAP SG&A guidance reflects the continued investment in the expanded commercial organization to support INGREZZA as well as the Company’s direct-to-consumer advertising campaign.
Challenges Ahead
- Guidance includes an investment to support the anticipated approval for valbenazine to treat patients with chorea associated with Huntington disease.
- Non-GAAP guidance adjusted to exclude estimated non-cash stock-based compensation expense of $55 million in R&D
- Non-GAAP guidance adjusted to exclude estimated non-cash stock-based compensation expense of $120 million in SG&A.
- Risks associated with the commercialization of INGREZZA and ONGENTYS
- Impact of the evolving COVID-19 pandemic globally on our business and the business operations of our customers, collaborators, vendors, and clinical trial sites including the impact on the ability of patients to have in-person visits with their health care provider