INGREZZA® (valbenazine) First Quarter Net Product Sales of $506 Million Representing 23% Year-Over-Year Growth INGREZZA® SPRINKLE (valbenazine) Capsules Approved by the U.S. FDA Crinecerfont New Drug Applications for the Treatment of Congenital Adrenal Hyperplasia Submitted to the U.S. FDA Positive Phase 2 Top-Line Data for NBI-1065845, a Potential First-In-Class AMPA Positive Allosteric Modulator, in Adults with Major Depressive Disorder SAN DIEGO, May 1, 2024 /PRNewswire/ -- Neurocrine Biosciences, Inc. (NASDAQ:NBIX) today announced its financial results for the first quarter ended March 31, 2024 and provided an update on its 2024 financial guidance. "Significant unmet need still exists for the many patients living with tardive dyskinesia as exemplified with INGREZZA's first quarter year-over-year growth of 23%," said Kevin Gorman, Ph.D., Chief Executive Officer of Neurocrine Biosciences. "With the recent New Drug Application submissions for crinecerfont, positive Phase 2 results for a potential first-in-class medication in NBI-'845 for major depressive disorder, and the deepest pipeline in our company's history, Neurocrine Biosciences is well positioned to become a leader in neuroscience." Financial Highlights Three Months Ended March 31, (unaudited, in millions, except per share data) 2024 2023 Revenues: Net Product Sales $       509.0 $       415.3 Collaboration Revenue 6.3 5.1 Total Revenues $       515.3 $       420.4 GAAP Research and Development (R&D) $       159.4 $       139.5 Non-GAAP R&D $       142.4 $       125.7 GAAP Selling, General and Administrative (SG&A) $       243.1 $       242.7 Non-GAAP SG&A $       215.6 $       216.6 GAAP Net Income (Loss) $         43.4 $        (76.6) GAAP Earnings (Loss) Per Share – Diluted $         0.42 $        (0.79) Non-GAAP Net Income (Loss) $       124.8 $        (49.5) Non-GAAP Earnings (Loss) Per Share – Diluted $         1.20 $        (0.51) (unaudited, in millions) March 31, 2024 December 31, 2023 Total Cash, Cash Equivalents and Marketable Securities $     1,911.0 $     1,719.1 INGREZZA Net Product Sales Highlights INGREZZA first quarter 2024 net product sales were $506 million and grew 23% compared to the first quarter 2023 Year-over-year growth driven by strong underlying patient demand and improvement in gross-to-net dynamics Other Key Financial Highlights Differences in first quarter 2024 GAAP and non-GAAP operating expenses compared with first quarter 2023 were driven by: Increased R&D expense in support of an expanded and advancing clinical portfolio including preclinical investments in muscarinic compounds, gene therapy programs and second generation VMAT2 inhibitors Flat SG&A expense includes continued investment in INGREZZA and incremental investment in crinecerfont-related headcount and pre-launch activities First quarter 2024 GAAP net income and earnings per share were $43 million and $0.42, respectively, compared with GAAP net loss and loss per share of $77 million and $0.79, respectively, for first quarter 2023 First quarter 2024 non-GAAP net income and earnings per share were $125 million and $1.20, respectively, compared with non-GAAP net loss and loss per share of $50 million and $0.51, respectively, for first quarter 2023 Differences in first quarter 2024 GAAP and non-GAAP net income compared with first quarter 2023 driven by: Higher INGREZZA net sales and improved operating margin First quarter 2024 includes $89 million charge associated with convertible senior notes election to settle outstanding principal and conversion premium in cash (non-GAAP adjustment) First quarter 2023 includes Acquired In-Process R&D (IPR&D) expense of $144 million associated with expansion of strategic partnership with Voyager Therapeutics, Inc. (Voyager) At March 31, 2024, the Company had cash, cash equivalents and marketable securities totaling approximately $1.9 billion A reconciliation of GAAP to non-GAAP financial results can be found in Table 3 and Table 4 at the end of this news release. Recent Developments In January, the Company elected to settle the convertible senior notes due May 2024 in cash. In April, the Company reported positive Phase 2 data for its completed Phase 2 study of NBI-1065845 in adult subjects with major depressive disorder. The study met its primary and key secondary endpoints, demonstrating that once-daily, oral administration of NBI-1065845 produced a statistically significant change from baseline in Montgomery Åsberg Depression Rating Scale (MADRS) total score at both Day 28 (primary endpoint) and Day 56 (key secondary endpoint). In April, the Company submitted two New Drug Applications to the FDA for crinecerfont as a treatment for adult and pediatric patients with classic congenital adrenal hyperplasia. In April, the Company received approval from the U.S. Food and Drug Administration for INGREZZA SPRINKLE (valbenazine) capsules, a new oral granules formulation of INGREZZA (valbenazine) capsules. Reaffirmed 2024 Net Sales Guidance and Updated Expense Guidance Range (in millions) Low High INGREZZA Net Product Sales 1 $        2,100 $        2,200 GAAP R&D Expense 2 $           665 $           695 Non-GAAP R&D Expense 3 $           600 $           630 GAAP and Non-GAAP IPR&D 4 $               6 $               6 GAAP SG&A Expense 5 $           920 $           940 Non-GAAP SG&A Expense 3, 5 $           810 $           830 1. INGREZZA sales guidance reflects expected net product sales of INGREZZA in tardive dyskinesia and chorea associated with Huntington's disease. 2. GAAP R&D guidance includes approximately $34 million expense for development milestones in connection with our collaborations (Nxera, Voyager and Takeda) achieved in first quarter 2024 or achievement is deemed probable in second quarter 2024. These milestone expenses are associated with our advancing pre-clinical and clinical pipeline. 3. Non-GAAP guidance adjusted primarily to exclude estimated non-cash stock-based compensation expense of $65 million in R&D and $110 million in SG&A. 4. Acquired in-process R&D (IPR&D) is included in guidance once significant collaboration and licensing arrangements have been completed. 5. SG&A guidance range reflects expense for ongoing commercial initiatives supporting INGREZZA growth including the expanded indication to treat chorea associated with Huntington's disease and pre-launch commercial activities for crinecerfont.   •   2024 Expected Pipeline Milestones and Key Activities Program Indication Expected Milestones / Key Activities INGREZZA* (Selective VMAT2 Inhibitor) Sprinkle Formulation for Tardive Dyskinesia / Chorea in Huntington's ...