Full Press Release Details
INGREZZA ® (valbenazine) Fourth Quarter Net Product Sales of $399 Million
INGREZZA ® (valbenazine) 2023 Net Product Sales Guidance of $1.67 - $1.77 Billion
Enrollment Complete in Adult and Pediatric Registrational Studies of Crinecerfont for the Treatment of Congenital Adrenal Hyperplasia
Top-Line Data for Clinical Programs in Congenital Adrenal Hyperplasia, Focal Onset Seizure and Anhedonia in Major Depressive Disorder Expected in the Second Half of 2023
SAN DIEGO , Feb. 6, 2023 /PRNewswire/ -- Neurocrine Biosciences, Inc. (Nasdaq: NBIX ) today announced its financial results for the fourth quarter and fiscal year ended December 31, 2022 and provided financial guidance for 2023.
"We enter this year with tremendous momentum aiming to help the 7 out of 10 patients living with tardive dyskinesia in the U.S. who have not received a proper diagnosis for their uncontrollable movement disorder," said Kevin Gorman , Ph.D., Chief Executive Officer of Neurocrine Biosciences. "Our capital allocation priorities remain: Invest in INGREZZA and in our pipeline. Enrollment is now complete in both the adult and pediatric registrational studies of crinecerfont for the treatment of congenital adrenal hyperplasia and we look forward to sharing the top-line data this year. With INGREZZA growing and our pipeline advancing, the fundamentals of our business are strong as we advance on our mission to be a leading neuroscience company."
| Three Months Ended December 31, | Twelve Months Ended December 31, | ||||||
| (unaudited, in millions, except per share data) | 2022 | 2021 | 2022 | 2021 | |||
| Revenues: | |||||||
| Product sales, net | $ 404.6 | $ 303.5 | $ 1,440.9 | $ 1,090.1 | |||
| Collaboration revenue | 7.4 | 8.5 | 47.8 | 43.4 | |||
| Total revenues | $ 412.0 | $ 312.0 | $ 1,488.7 | $ 1,133.5 | |||
| GAAP Research and Development (R&D) | $ 118.0 | $ 87.4 | $ 463.8 | $ 328.1 | |||
| Non-GAAP R&D | $ 103.9 | $ 75.2 | $ 406.1 | $ 279.7 | |||
| GAAP Selling, General and Administrative (SG&A) | $ 182.9 | $ 156.5 | $ 752.7 | $ 583.3 | |||
| Non-GAAP SG&A | $ 151.8 | $ 133.1 | $ 635.6 | $ 497.5 | |||
| GAAP net income (loss) | $ 89.0 | $ (7.3) | $ 154.5 | $ 89.6 | |||
| GAAP earnings (loss) per share – diluted | $ 0.88 | $ (0.08) | $ 1.56 | $ 0.92 | |||
| Non-GAAP net income | $ 124.7 | $ 4.3 | $ 343.2 | $ 185.8 | |||
| Non-GAAP earnings per share – diluted | $ 1.24 | $ 0.04 | $ 3.47 | $ 1.90 | |||
| (unaudited, in millions) | December 31, 2022 | December 31, 2021 | |||||
| Total cash, cash equivalents and marketable securities | $ 1,288.7 | $ 1,272.0 |
Fourth Quarter and Fiscal 2022 INGREZZA Net Product Sales and Commercial Highlights:
Fourth Quarter 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 earnings release.
Fiscal 2023 INGREZZA Sales and Operating Expense Guidance:
| Range | |||
| (in millions) | Low | High | |
| INGREZZA (Tardive Dyskinesia Only) Net Product Sales 1 | $ 1,670 | $ 1,770 | |
| GAAP R&D expense 2 | $ 550 | $ 580 | |
| Non-GAAP R&D expense 3 | $ 495 | $ 525 | |
| GAAP SG&A expense | $ 850 | $ 870 | |
| Non-GAAP SG&A expense 3 | $ 730 | $ 750 |
2023 Expected Pipeline Milestones and Key Activities
| Program | Indication | 2023 Milestones / Key Activities |
| Valbenazine * (Selective VMAT2 Inhibitor) | Chorea in Huntington Disease | PDUFA Aug. 20, 2023 |
| Crinecerfont (CRF1 Receptor Antagonist) | Congenital Adrenal Hyperplasia (Adult) | Top-Line Registrational Data in Second Half of 2023 |
| Congenital Adrenal Hyperplasia (Pediatric) | Top-Line Registrational Data in Second Half of 2023 | |
| NBI-921352 ** (Selective Na V 1.6 Channel Blocker) | Focal Onset Seizure in Adults | Top-Line Phase 2 Data in Second Half of 2023 |
| NBI-1065846 † (GPR-139 Agonist) | Anhedonia in Major Depressive Disorder | Top-Line Phase 2 Data in Second Half of 2023 |
| NBI-1117570 ‡ (Dual M1/ M4 Agonist) | Treatment of Schizophrenia | Initiate Phase 1 Study |
| New Chemical Entity or Entities | Indication(s) TBD | Initiate at Least One Phase 1 Study |
Key: VMAT2 = Vesicular Monoamine Transporter 2; CFR1 = Corticotropin-Releasing Factor Type 1; Na V 1.6 = Sodium Channel, Voltage-Gated; M1 / M4 = M1 / M4 Muscarinic Receptor; GPR = Orphan G Protein Coupled Receptor
Neurocrine Biosciences Partners: * Mitsubishi Tanabe Pharma Corporation has commercialization rights in East Asia ; ** In-Licensed from Xenon Pharmaceuticals; † 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 866-952-8559 (US) or 785-424-1743 (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, Parkinson's disease, endometriosis* and uterine fibroids*, and 12 mid-to-late-stage clinical programs in multiple 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. (*in collaboration with AbbVie)
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-related transaction 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.
Forward-Looking Statements
| 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) | 2022 | 2021 | 2022 | 2021 | |||
| Revenues: | |||||||
| Product sales, net | $ 404.6 | $ 303.5 | $ 1,440.9 | $ 1,090.1 | |||
| Collaboration revenue | 7.4 | 8.5 | 47.8 | 43.4 | |||
| Total revenues | 412.0 | 312.0 | 1,488.7 | 1,133.5 | |||
| Operating expenses: | |||||||
| Cost of revenues | 7.7 | 4.1 | 23.2 | 14.3 | |||
| Research and development | 118.0 | 87.4 | 463.8 | 328.1 | |||
| Acquired in-process research and development | — | 100.3 | — | 105.3 | |||
| Selling, general and administrative | 182.9 | 156.5 | 752.7 | 583.3 | |||
| Total operating expenses | 308.6 | 348.3 | 1,239.7 | 1,031.0 | |||
| Operating income (loss) | 103.4 | (36.3) | 249.0 | 102.5 | |||
| Other income (expense): | |||||||
| Interest expense | (1.1) | (6.6) | (7.1) | (25.8) | |||
| Unrealized gain on equity securities | 7.2 | 28.4 | 30.8 | 20.9 | |||
| Loss on extinguishment of convertible senior notes | — | — | (70.0) | — | |||
| Investment income and other, net | 8.4 | 0.7 | 11.2 | 3.8 | |||
| Total other income (expense), net | 14.5 | 22.5 | (35.1) | (1.1) | |||
| Income (loss) before provision for income taxes | 117.9 | (13.8) | 213.9 | 101.4 | |||
| Provision for (benefit from) income taxes | 28.9 | (6.5) | 59.4 | 11.8 | |||
| Net income (loss) | $ 89.0 | $ (7.3) | $ 154.5 | $ 89.6 | |||
| Earnings (loss) per share, basic | $ 0.92 | $ (0.08) | $ 1.61 | $ 0.95 | |||
| Earnings (loss) per share, diluted | $ 0.88 | $ (0.08) | $ 1.56 | $ 0.92 | |||
| Weighted average common shares outstanding, basic | 96.3 | 94.9 | 95.8 | 94.6 | |||
| Weighted average common shares outstanding, diluted | 100.8 | 94.9 | 98.9 | 97.9 |
| TABLE 2 | |||
| NEUROCRINE BIOSCIENCES, INC. | |||
| CONDENSED CONSOLIDATED BALANCE SHEETS | |||
| (unaudited) | |||
| (in millions) | December 31, 2022 | December 31, 2021 | |
| Cash, cash equivalents and debt securities available-for-sale | $ 989.3 | $ 711.3 | |
| Other current assets | 464.2 | 261.5 | |
| Total current assets | 1,453.5 | 972.8 | |
| Deferred tax assets | 305.9 | 315.1 | |
| Debt securities available-for-sale | 299.4 | 560.7 | |
| Right-of-use assets | 87.0 | 97.2 | |
| Equity securities | 102.1 | 63.7 | |
| Property and equipment, net | 58.6 | 58.6 | |
| Intangible assets, net | 37.2 | — | |
| Other assets | 25.0 | 4.4 | |
| Total assets | $ 2,368.7 | $ 2,072.5 | |
| Convertible senior notes | $ 169.4 | $ — | |
| Other current liabilities | 368.3 | 245.8 | |
| Total current liabilities | 537.7 | 245.8 | |
| Convertible senior notes | — | 335.1 | |
| Operating lease liabilities | 93.5 | 105.3 | |
| Other long-term liabilities | 29.7 | 12.3 | |
| Stockholders' equity | 1,707.8 | 1,374.0 | |
| Total liabilities and stockholders' equity | $ 2,368.7 | $ 2,072.5 |
| 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) | 2022 | 2021 | 2022 | 2021 | |||
| GAAP net income (loss) | $ 89.0 | $ (7.3) | $ 154.5 | $ 89.6 | |||
| Adjustments: | |||||||
| Stock-based compensation expense - R&D | 14.1 | 12.2 | 57.7 | 48.4 | |||
| Stock-based compensation expense - SG&A | 29.4 | 23.4 | 115.4 | 85.8 | |||
| Loss on extinguishment of convertible senior notes 1 | — | — | 70.0 | — | |||
| Non-cash interest related to convertible senior notes | 0.2 | 4.4 | 1.2 | 17.3 | |||
| Non-cash amortization related to acquired intangible assets | 0.5 | — | 0.5 | — | |||
| Acquisition-related transaction costs - SG&A 2 | 1.7 | — | 1.7 | — | |||
| Changes in fair value of equity security investments 3 | (7.2) | (28.4) | (30.8) | (20.9) | |||
| Changes in foreign currency exchange rates | (1.5) | — | 1.9 | — | |||
| Income tax effect related to reconciling items 4 | (1.5) | — | (28.9) | (34.4) | |||
| Non-GAAP net income | $ 124.7 | $ 4.3 | $ 343.2 | $ 185.8 | |||
| Diluted earnings (loss) per share: | |||||||
| GAAP | $ 0.88 | $ (0.08) | $ 1.56 | $ 0.92 | |||
| Non-GAAP 5 | $ 1.24 | $ 0.04 | $ 3.47 | $ 1.90 |
| 1. | The Company recognized a loss on extinguishment of $70.0 million in connection with the partial repurchase of its convertible senior notes in the second quarter of 2022. |
| 2. | The Company recognized transaction costs of $1.7 million in connection with its acquisition of Diurnal Group plc in November 2022. |
| 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 and premium paid on repurchase of its convertible senior notes. |
| 5. | Fourth quarter 2021 non-GAAP net income per diluted common share reflects diluted shares of 97.8 million, which were calculated in accordance with the guidance on earnings per share in ASC 260. |
| Note: Beginning in the third quarter of 2021, milestone payments received from licenses and collaborations, milestones paid related to licenses and collaborations, non-cash collaboration revenue, and acquired in-process research and development are no longer excluded from non-GAAP financial results. |
| 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) | 2022 | 2021 | 2022 | 2021 | |||
| GAAP cost of revenues | $ 7.7 | $ 4.1 | $ 23.2 | $ 14.3 | |||
| Adjustments: | |||||||
| Non-cash amortization related to acquired intangible assets | 0.5 | — | 0.5 | — | |||
| Non-GAAP cost of revenues | $ 7.2 | $ 4.1 | $ 22.7 | $ 14.3 | |||
| Three Months Ended December 31, | Twelve Months Ended December 31, | ||||||
| (in millions) | 2022 | 2021 | 2022 | 2021 | |||
| GAAP R&D | $ 118.0 | $ 87.4 | $ 463.8 | $ 328.1 | |||
| Adjustments: | |||||||
| Stock-based compensation expense | 14.1 | 12.2 | 57.7 | 48.4 | |||
| Non-GAAP R&D | $ 103.9 | $ 75.2 | $ 406.1 | $ 279.7 | |||
| Three Months Ended December 31, | Twelve Months Ended December 31, | ||||||
| (in millions) | 2022 | 2021 | 2022 | 2021 | |||
| GAAP SG&A | $ 182.9 | $ 156.5 | $ 752.7 | $ 583.3 | |||
| Adjustments: | |||||||
| Stock-based compensation expense | 29.4 | 23.4 | 115.4 | 85.8 | |||
| Acquisition-related transaction costs | 1.7 | — | 1.7 | — | |||
| Non-GAAP SG&A | $ 151.8 | $ 133.1 | $ 635.6 | $ 497.5 | |||
| Three Months Ended December 31, | Twelve Months Ended December 31, | ||||||
| (in millions) | 2022 | 2021 | 2022 | 2021 | |||
| GAAP other income (expense), net | $ 14.5 | $ 22.5 | $ (35.1) | $ (1.1) | |||
| Adjustments: | |||||||
| Loss on extinguishment of convertible senior notes | — | — | 70.0 | — | |||
| Non-cash interest related to convertible senior notes | 0.2 | 4.4 | 1.2 | 17.3 | |||
| Changes in fair value of equity security investments | (7.2) | (28.4) | (30.8) | (20.9) | |||
| Changes in foreign currency exchange rates | (1.5) | — | 1.9 | — | |||
| Non-GAAP other income (expense), net | $ 6.0 | $ (1.5) | $ 7.2 | $ (4.7) |
SOURCE Neurocrine Biosciences, Inc.