Full Press Release Details
INGREZZA ® (valbenazine) Fourth Quarter and Full Year 2023 Net Product Sales of $500 Million and $1.84 Billion , Representing Year-over-Year Growth of 25% and 29% Respectively
INGREZZA ® (valbenazine) Full Year 2024 Net Product Sales Guidance of $2.1 - $2.2 Billion
Crinecerfont FDA Regulatory Submission Anticipated in the Second Quarter for the Treatment of Congenital Adrenal Hyperplasia in Adults and Pediatrics
SAN DIEGO , Feb. 7, 2024 /PRNewswire/ -- Neurocrine Biosciences, Inc. (Nasdaq: NBIX ) today announced its financial results for the fourth quarter and full year ended December 31, 2023 and provided financial guidance for 2024.
"I'm exceptionally proud of the progress we made with INGREZZA last year, helping more patients than ever before treat their tardive dyskinesia. In addition, the positive Phase 3 crinecerfont results for the treatment of congenital adrenal hyperplasia opens the door for us to help patients living with a disabling neuroendocrine disorder," said Kevin Gorman , Ph.D., Chief Executive Officer of Neurocrine Biosciences. "With a strong foundation in INGREZZA, a potential second important growth driver in crinecerfont, and an advancing pipeline, Neurocrine Biosciences is making significant progress towards becoming a leading neuroscience focused company."
Financial Highlights
| Three Months Ended December 31, | Twelve Months Ended December 31, | ||||||
| (unaudited, in millions, except per share data) | 2023 | 2022 | 2023 | 2022 | |||
| Revenues: | |||||||
| Net Product Sales | $ 507.2 | $ 404.6 | $ 1,860.6 | $ 1,440.9 | |||
| Collaboration Revenue | 8.0 | 7.4 | 26.5 | 47.8 | |||
| Total Revenues | $ 515.2 | $ 412.0 | $ 1,887.1 | $ 1,488.7 | |||
| GAAP Research and Development (R&D) | $ 137.5 | $ 118.0 | $ 565.0 | $ 463.8 | |||
| Non-GAAP R&D | $ 124.3 | $ 103.9 | $ 497.0 | $ 406.1 | |||
| GAAP Selling, General and Administrative (SG&A) | $ 218.9 | $ 182.9 | $ 887.6 | $ 752.7 | |||
| Non-GAAP SG&A | $ 194.0 | $ 151.8 | $ 757.4 | $ 635.6 | |||
| GAAP Net Income | $ 147.7 | $ 89.0 | $ 249.7 | $ 154.5 | |||
| GAAP Earnings Per Share – Diluted | $ 1.44 | $ 0.88 | $ 2.47 | $ 1.56 | |||
| Non-GAAP Net Income | $ 157.7 | $ 124.7 | $ 390.0 | $ 343.2 | |||
| Non-GAAP Earnings Per Share – Diluted | $ 1.54 | $ 1.24 | $ 3.86 | $ 3.47 | |||
| (unaudited, in millions) | December 31, 2023 | December 31, 2022 | |||||
| Total Cash, Cash Equivalents and Marketable Securities | $ 1,719.1 | $ 1,288.7 |
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
Full Year 2024 Financial Guidance
| Range | |||
| (in millions) | Low | High | |
| INGREZZA Net Product Sales 1 | $ 2,100 | $ 2,200 | |
| GAAP R&D Expense 2 | $ 645 | $ 675 | |
| Non-GAAP R&D Expense 3 | $ 570 | $ 600 | |
| GAAP SG&A Expense 4 | $ 930 | $ 950 | |
| Non-GAAP SG&A Expense 3, 4 | $ 830 | $ 850 |
| 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 expense for development milestones once determined achievement is deemed probable. Acquired in-process research and development expense is included in guidance once significant collaboration and licensing arrangements have been completed. |
| 3. | Non-GAAP guidance adjusted primarily to exclude estimated non-cash stock-based compensation expense of $75 million in R&D and $100 million in SG&A. |
| 4. | 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 |
| Valbenazine * (Selective VMAT2 Inhibitor) | Sprinkle Formulation for Tardive Dyskinesia / Chorea in Huntington's Disease | PDUFA April 30, 2024 |
| Crinecerfont (CRF1 Receptor Antagonist) | Congenital Adrenal Hyperplasia (Pediatric and Adult) | Submitting New Drug Application to the FDA in Q2'24 |
| Efmody (Hydrocortisone Modified Release Hard Capsules) | Adrenal Insufficiency | Top-Line Phase 2 Data in 1H'24 |
| Efmody (Hydrocortisone Modified Release Hard Capsules) | Congenital Adrenal Hyperplasia | Top-Line Phase 2 Data in 1H'24 |
| NBI-1065845 ** (AMPA Potentiator) | Inadequate Response in Major Depressive Disorder | Top-Line Phase 2 Data in 1H'24 |
| NBI-1117568 † (M4 Agonist) | Schizophrenia | Top-Line Phase 2 Data in 2H'24 |
| Luvadaxistat ** (DAAO Inhibitor) | Cognitive Impairment Associated with Schizophrenia | Top-Line Phase 2 Data in 2H'24 |
| NBI-1070770 ** (NMDA NR2B NAM) | Major Depressive Disorder | Initiating Phase 2 Study |
| NBI-1117567 † (M1 Agonist) | CNS Indications | Initiating Phase 1 Study |
| NBI-1076986 (M4 Antagonist) | Movement Disorders | Initiating Phase 1 Study |
| NBI-1065890 (Selective VMAT2 Inhibitor) | CNS Indications | 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 Sosei Group Corporation |
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 800-225-9448 (US) or 203-518-9708 (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.
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 is a registered trademark 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, 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 December 31, | Twelve Months Ended December 31, | ||||||
| (in millions, except per share data) | 2023 | 2022 | 2023 | 2022 | |||
| Revenues: | |||||||
| Net product sales | $ 507.2 | $ 404.6 | $ 1,860.6 | $ 1,440.9 | |||
| Collaboration revenue | 8.0 | 7.4 | 26.5 | 47.8 | |||
| Total revenues | 515.2 | 412.0 | 1,887.1 | 1,488.7 | |||
| Operating expenses: | |||||||
| Cost of revenues | 8.5 | 7.7 | 39.7 | 23.2 | |||
| Research and development | 137.5 | 118.0 | 565.0 | 463.8 | |||
| Acquired in-process research and development | — | — | 143.9 | — | |||
| Selling, general and administrative | 218.9 | 182.9 | 887.6 | 752.7 | |||
| Total operating expenses | 364.9 | 308.6 | 1,636.2 | 1,239.7 | |||
| Operating income | 150.3 | 103.4 | 250.9 | 249.0 | |||
| Other income (expense): | |||||||
| Interest expense | (1.1) | (1.1) | (4.6) | (7.1) | |||
| Unrealized gain on equity security investments | 29.0 | 7.2 | 28.4 | 30.8 | |||
| Loss on extinguishment of convertible senior notes | — | — | — | (70.0) | |||
| Investment income and other, net | 20.0 | 8.4 | 57.4 | 11.2 | |||
| Total other income (expense), net | 47.9 | 14.5 | 81.2 | (35.1) | |||
| Income before provision for income taxes | 198.2 | 117.9 | 332.1 | 213.9 | |||
| Provision for income taxes | 50.5 | 28.9 | 82.4 | 59.4 | |||
| Net income | $ 147.7 | $ 89.0 | $ 249.7 | $ 154.5 | |||
| Earnings per share, basic | $ 1.50 | $ 0.92 | $ 2.56 | $ 1.61 | |||
| Earnings per share, diluted | $ 1.44 | $ 0.88 | $ 2.47 | $ 1.56 | |||
| Weighted average common shares outstanding, basic | 98.4 | 96.3 | 97.7 | 95.8 | |||
| Weighted average common shares outstanding, diluted | 102.3 | 100.8 | 101.0 | 98.9 |
| TABLE 2 NEUROCRINE BIOSCIENCES, INC. CONDENSED CONSOLIDATED BALANCE SHEETS (unaudited) | |||
| (in millions) | December 31, 2023 | December 31, 2022 | |
| Cash, cash equivalents and marketable securities | $ 1,031.6 | $ 989.3 | |
| Other current assets | 575.4 | 464.2 | |
| Total current assets | 1,607.0 | 1,453.5 | |
| Deferred tax assets | 362.6 | 305.9 | |
| Debt securities available-for-sale | 687.5 | 299.4 | |
| Right-of-use assets | 276.5 | 87.0 | |
| Equity security investments | 161.9 | 102.1 | |
| Property and equipment, net | 70.8 | 58.6 | |
| Intangible assets, net | 35.5 | 37.2 | |
| Other assets | 49.6 | 25.0 | |
| Total assets | $ 3,251.4 | $ 2,368.7 | |
| Convertible senior notes | $ 170.1 | $ 169.4 | |
| Other current liabilities | 484.7 | 368.3 | |
| Total current liabilities | 654.8 | 537.7 | |
| Operating lease liabilities | 258.3 | 93.5 | |
| Other long-term liabilities | 106.3 | 29.7 | |
| Stockholders' equity | 2,232.0 | 1,707.8 | |
| Total liabilities and stockholders' equity | $ 3,251.4 | $ 2,368.7 |
| TABLE 3 NEUROCRINE BIOSCIENCES, INC. RECONCILIATION OF GAAP TO NON-GAAP FINANCIAL RESULTS (unaudited) | |||||||
| Three Months Ended December 31, | Twelve Months Ended December 31, | ||||||
| (in millions, except per share data) | 2023 | 2022 | 2023 | 2022 | |||
| GAAP net income | $ 147.7 | $ 89.0 | $ 249.7 | $ 154.5 | |||
| Adjustments: | |||||||
| Stock-based compensation expense - R&D | 13.2 | 14.1 | 68.0 | 57.7 | |||
| Stock-based compensation expense - SG&A | 24.9 | 29.4 | 126.3 | 115.4 | |||
| Loss on extinguishment of convertible senior notes 1 | — | — | — | 70.0 | |||
| Non-cash interest related to convertible senior notes | 0.1 | 0.2 | 0.7 | 1.2 | |||
| Non-cash amortization related to acquired intangible assets | 0.8 | 0.5 | 3.5 | 0.5 | |||
| Acquisition and integration costs - SG&A 2 | — | 1.7 | 3.9 | 1.7 | |||
| Changes in fair value of equity security investments 3 | (29.0) | (7.2) | (28.4) | (30.8) | |||
| Changes in foreign currency exchange rates | — | (1.5) | — | 1.9 | |||
| Income tax effect related to reconciling items 4 | — | (1.5) | (33.7) | (28.9) | |||
| Non-GAAP net income | $ 157.7 | $ 124.7 | $ 390.0 | $ 343.2 | |||
| Diluted earnings per share: | |||||||
| GAAP | $ 1.44 | $ 0.88 | $ 2.47 | $ 1.56 | |||
| Non-GAAP | $ 1.54 | $ 1.24 | $ 3.86 | $ 3.47 |
| 1. | The Company recognized a loss on extinguishment of $70.0 million related to the partial repurchase of its convertible senior notes in the second quarter of 2022. |
| 2. | Reflects transaction and integration costs for contract terminations related to the Diurnal Group plc acquisition. |
| 3. | Reflects periodic fluctuations in the fair values of the Company's equity security investments. |
| 4. | 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 non-cash stock-based compensation. |
| TABLE 4 NEUROCRINE BIOSCIENCES, INC. RECONCILIATION OF GAAP TO NON-GAAP EXPENSES (unaudited) | |||||||
| Three Months Ended December 31, | Twelve Months Ended December 31, | ||||||
| (in millions) | 2023 | 2022 | 2023 | 2022 | |||
| GAAP cost of revenues | $ 8.5 | $ 7.7 | $ 39.7 | $ 23.2 | |||
| Adjustments: | |||||||
| Non-cash amortization related to acquired intangible assets | 0.8 | 0.5 | 3.5 | 0.5 | |||
| Non-GAAP cost of revenues | $ 7.7 | $ 7.2 | $ 36.2 | $ 22.7 | |||
| Three Months Ended December 31, | Twelve Months Ended December 31, | ||||||
| (in millions) | 2023 | 2022 | 2023 | 2022 | |||
| GAAP R&D | $ 137.5 | $ 118.0 | $ 565.0 | $ 463.8 | |||
| Adjustments: | |||||||
| Stock-based compensation expense | 13.2 | 14.1 | 68.0 | 57.7 | |||
| Non-GAAP R&D | $ 124.3 | $ 103.9 | $ 497.0 | $ 406.1 | |||
| Three Months Ended December 31, | Twelve Months Ended December 31, | ||||||
| (in millions) | 2023 | 2022 | 2023 | 2022 | |||
| GAAP SG&A | $ 218.9 | $ 182.9 | $ 887.6 | $ 752.7 | |||
| Adjustments: | |||||||
| Stock-based compensation expense | 24.9 | 29.4 | 126.3 | 115.4 | |||
| Acquisition and integration costs | — | 1.7 | 3.9 | 1.7 | |||
| Non-GAAP SG&A | $ 194.0 | $ 151.8 | $ 757.4 | $ 635.6 | |||
| Three Months Ended December 31, | Twelve Months Ended December 31, | ||||||
| (in millions) | 2023 | 2022 | 2023 | 2022 | |||
| GAAP other income (expense), net | $ 47.9 | $ 14.5 | $ 81.2 | $ (35.1) | |||
| Adjustments: | |||||||
| Loss on extinguishment of convertible senior notes | — | — | — | 70.0 | |||
| Non-cash interest related to convertible senior notes | 0.1 | 0.2 | 0.7 | 1.2 | |||
| Changes in fair value of equity security investments | (29.0) | (7.2) | (28.4) | (30.8) | |||
| Changes in foreign currency exchange rates | — | (1.5) | — | 1.9 | |||
| Non-GAAP other income, net | $ 19.0 | $ 6.0 | $ 53.5 | $ 7.2 |
SOURCE Neurocrine Biosciences, Inc.