Full Press Release Details
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
Other Key Financial Highlights
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
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 Disease | Approved by FDA on April 30, 2024 |
| Crinecerfont ( CRF1 Receptor Antagonist ) | Congenital Adrenal Hyperplasia (Pediatric and Adult) | Submitted New Drug Applications to the FDA |
| NBI-1065845 ** (AMPA Potentiator) | Inadequate Response in Major Depressive Disorder | Reported Positive Top-Line Phase 2 Data; Engaging with FDA on Path Forward |
| Efmody (Hydrocortisone Modified Release Hard Capsules) | Adrenal Insufficiency | Reported Positive Top-Line Phase 2 Data |
| Efmody (Hydrocortisone Modified Release Hard Capsules) | Congenital Adrenal Hyperplasia | Reported Positive Top-Line Phase 2 Data |
| NBI-1117568 † (M4 Agonist) | Schizophrenia | Top-Line Phase 2 Data in Q3'24 |
| Luvadaxistat ** (DAAO Inhibitor) | Cognitive Impairment Associated with Schizophrenia | Top-Line Phase 2 Data in Q3'24 |
| NBI-1070770 ** (NMDA NR2B NAM) | Major Depressive Disorder | Initiated Phase 2 Study |
| NBI-1065890 (Selective VMAT2 Inhibitor) | CNS Indications | Initiated Phase 1 Study |
| NBI-1117569 † (M4-Prefering Agonist) | CNS Indications | Initiated Phase 1 Study |
| NBI-1117570 † (M1/M4 Dual Agonist) | CNS Indications | Initiated Phase 1 Study |
| NBI-1117567 † (M1 Agonist) | CNS Indications | Initiating Phase 1 Study |
| NBI-1076986 (M4 Antagonist) | Movement Disorders | Initiating Phase 1 Study |
| Key: VMAT2 = Vesicular Monoamine Transporter 2; CFR1 = Corticotropin-Releasing Factor Type 1; AMPA = alpha-amino-3-hydroxy-5-methyl-4-isoxazole propionic acid; M4 = M4 Muscarinic Receptor; DAAO = d-amino acid oxidase; NMDA NR2B NAM = n-methyl-d-aspartate Receptor Subtype 2B Negative Allosteric Modulator; M1 = M1 Muscarinic Receptor |
| Neurocrine Biosciences Partners: * Mitsubishi Tanabe Pharma Corporation has commercialization rights in East Asia; ** Partnered with Takeda Pharmaceutical Company Limited; † In-Licensed from Nxera Pharma UK Limited (formerly Sosei Heptares) |
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 800-343-4136 (US) or 203-518-9814 (International) using the conference ID: NBIX. The webcast and accompanying slides can also be accessed at approximately 8:00 a.m. Eastern Time 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.
About Neurocrine Biosciences Neurocrine Biosciences is a neuroscience-focused, biopharmaceutical company with a simple purpose: to relieve suffering for people with great needs, but few options. We are dedicated to discovering and developing life-changing treatments for patients with under-addressed neurological, neuroendocrine, and neuropsychiatric disorders. The company's diverse portfolio includes FDA-approved treatments for tardive dyskinesia, chorea associated with Huntington's disease, endometriosis* and uterine fibroids*, as well as a robust pipeline including multiple compounds in mid- to late-phase clinical development across our core therapeutic areas. For three decades, we have applied our unique insight into neuroscience and the interconnections between brain and body systems to treat complex conditions. We relentlessly pursue medicines to ease the burden of debilitating diseases and disorders, because you deserve brave science. For more information, visit neurocrine.com, and follow the company on LinkedIn, X (Formerly Twitter) and Facebook. (* in collaboration with AbbVie )
NEUROCRINE BIOSCIENCES, NEUROCRINE and YOU DESERVE BRAVE SCIENCE are registered trademarks of Neurocrine Biosciences, Inc. The Neurocrine logo is a trademark of Neurocrine Biosciences, Inc.
Non-GAAP Financial Measures In addition to the financial results and financial guidance that are provided in accordance with accounting principles generally accepted in the United States (GAAP), this press release also contains the following non-GAAP financial measures: non-GAAP R&D expense, non-GAAP SG&A expense, and non-GAAP net income and net income per share. When preparing the non-GAAP financial results and guidance, the Company excludes certain GAAP items that management does not consider to be normal, including recurring cash operating expenses that might not meet the definition of unusual or non-recurring items. In particular, these non-GAAP financial measures exclude: non-cash stock-based compensation expense, loss on extinguishment of convertible senior notes, charges associated with convertible senior notes, non-cash interest expense related to convertible debt, non-cash amortization expense related to acquired intangible assets, acquisition and integration costs, changes in fair value of equity security investments, changes in foreign currency exchange rates and certain adjustments to income tax expense. These non-GAAP financial measures are provided as a complement to results provided in accordance with GAAP as management believes these non-GAAP financial measures help indicate underlying trends in the Company's business, are important in comparing current results with prior period results and provide additional information regarding the Company's financial position. Management also uses these non-GAAP financial measures to establish budgets and operational goals that are communicated internally and externally and to manage the Company's business and evaluate its performance. The Company provides guidance regarding combined R&D and SG&A expenses on both a GAAP and a non-GAAP basis. A reconciliation of these GAAP financial results to non-GAAP financial results is included in the attached financial information.
| TABLE 1 | |||
| NEUROCRINE BIOSCIENCES, INC. CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (unaudited) | |||
| Three Months Ended March 31, | |||
| (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 | |
| Operating expenses: | |||
| Cost of revenues | 7.5 | 8.5 | |
| Research and development | 159.4 | 139.5 | |
| Acquired in-process research and development | 6.0 | 143.9 | |
| Selling, general and administrative | 243.1 | 242.7 | |
| Total operating expenses | 416.0 | 534.6 | |
| Operating income (loss) | 99.3 | (114.2) | |
| Other (expense) income: | |||
| Interest expense | (1.1) | (1.1) | |
| Unrealized gain on equity security investments | 1.6 | 2.2 | |
| Charges associated with convertible senior notes | (88.7) | — | |
| Investment income and other, net | 23.4 | 9.8 | |
| Total other (expense) income, net | (64.8) | 10.9 | |
| Income (loss) before benefit from income taxes | 34.5 | (103.3) | |
| Benefit from income taxes | (8.9) | (26.7) | |
| Net income (loss) | $ 43.4 | $ (76.6) | |
| Earnings (loss) per share, basic | $ 0.43 | $ (0.79) | |
| Earnings (loss) per share, diluted | $ 0.42 | $ (0.79) | |
| Weighted average common shares outstanding, basic | 99.8 | 97.1 | |
| Weighted average common shares outstanding, diluted | 103.6 | 97.1 |
| TABLE 2 | |||
| NEUROCRINE BIOSCIENCES, INC. CONDENSED CONSOLIDATED BALANCE SHEETS (unaudited) | |||
| (in millions) | March 31, 2024 | December 31, 2023 | |
| Cash, cash equivalents and marketable securities | $ 1,210.6 | $ 1,031.6 | |
| Other current assets | 588.4 | 575.4 | |
| Total current assets | 1,799.0 | 1,607.0 | |
| Deferred tax assets | 378.2 | 362.6 | |
| Debt securities available-for-sale | 700.4 | 687.5 | |
| Right-of-use assets | 270.8 | 276.5 | |
| Equity security investments | 163.5 | 161.9 | |
| Property and equipment, net | 75.3 | 70.8 | |
| Intangible assets, net | 34.3 | 35.5 | |
| Other assets | 50.9 | 49.6 | |
| Total assets | $ 3,472.4 | $ 3,251.4 | |
| Convertible senior notes, at carrying value ($170.4 million face value) | $ 122.8 | $ 170.1 | |
| Convertible senior notes embedded derivative liability | 136.2 | — | |
| Other current liabilities | 453.9 | 484.7 | |
| Total current liabilities | 712.9 | 654.8 | |
| Operating lease liabilities | 252.9 | 258.3 | |
| Other long-term liabilities | 120.5 | 106.3 | |
| Stockholders' equity | 2,386.1 | 2,232.0 | |
| Total liabilities and stockholders' equity | $ 3,472.4 | $ 3,251.4 |
| TABLE 3 | |||
| NEUROCRINE BIOSCIENCES, INC. RECONCILIATION OF GAAP TO NON-GAAP FINANCIAL RESULTS (unaudited) | |||
| Three Months Ended March 31, | |||
| (in millions, except per share data) | 2024 | 2023 | |
| GAAP net income (loss) | $ 43.4 | $ (76.6) | |
| Adjustments: | |||
| Stock-based compensation expense - R&D | 17.0 | 13.8 | |
| Stock-based compensation expense - SG&A | 27.5 | 26.1 | |
| Charges associated with convertible senior notes 1 | 88.7 | — | |
| Non-cash interest related to convertible senior notes | 0.2 | 0.2 | |
| Non-cash amortization related to acquired intangible assets | 0.9 | 0.9 | |
| Changes in fair value of equity security investments 2 | (1.6) | (2.2) | |
| Income tax effect related to reconciling items 3 | (51.3) | (11.7) | |
| Non-GAAP net income | $ 124.8 | $ (49.5) | |
| Diluted earnings per share: | |||
| GAAP | $ 0.42 | $ (0.79) | |
| Non-GAAP | $ 1.20 | $ (0.51) |
| 1. | Reflects charges associated with election to cash settle principal and conversion premium of convertible senior notes and the requirement to bifurcate the embedded conversion option and accrete to other expense. |
| 2. | Reflects periodic fluctuations in the fair values of the Company's equity security investments. |
| 3. | Estimated income tax effect of non-GAAP reconciling items are calculated using applicable statutory tax rates, taking into consideration any valuation allowance and adjustments to exclude tax benefits or expenses associated with charges associated with convertible senior notes and non-cash stock-based compensation. |
| TABLE 4 | |||
| NEUROCRINE BIOSCIENCES, INC. RECONCILIATION OF GAAP TO NON-GAAP EXPENSES (unaudited) | |||
| Three Months Ended March 31, | |||
| (in millions) | 2024 | 2023 | |
| GAAP cost of revenues | $ 7.5 | $ 8.5 | |
| Adjustments: | |||
| Non-cash amortization related to acquired intangible assets | 0.9 | 0.9 | |
| Non-GAAP cost of revenues | $ 6.6 | $ 7.6 | |
| Three Months Ended March 31, | |||
| (in millions) | 2024 | 2023 | |
| GAAP R&D | $ 159.4 | $ 139.5 | |
| Adjustments: | |||
| Stock-based compensation expense | 17.0 | 13.8 | |
| Non-GAAP R&D | $ 142.4 | $ 125.7 | |
| Three Months Ended March 31, | |||
| (in millions) | 2024 | 2023 | |
| GAAP SG&A | $ 243.1 | $ 242.7 | |
| Adjustments: | |||
| Stock-based compensation expense | 27.5 | 26.1 | |
| Non-GAAP SG&A | $ 215.6 | $ 216.6 | |
| Three Months Ended March 31, | |||
| (in millions) | 2024 | 2023 | |
| GAAP other (expense) income, net | $ (64.8) | $ 10.9 | |
| Adjustments: | |||
| Charges associated with convertible senior notes | 88.7 | — | |
| Non-cash interest related to convertible senior notes | 0.2 | 0.2 | |
| Changes in fair value of equity security investments | (1.6) | (2.2) | |
| Non-GAAP other income, net | $ 22.5 | $ 8.9 |
SOURCE Neurocrine Biosciences, Inc.