Full Press Release Details
INGREZZA ® (valbenazine) First Quarter Net Product Sales of $410 Million
INGREZZA ® (valbenazine) 2023 Net Product Sales Guidance Reiterated at $1.67 - $1.77 Billion
SAN DIEGO , May 3, 2023 /PRNewswire/ -- Neurocrine Biosciences, Inc. (Nasdaq: NBIX ) today announced its financial results for the first quarter ended March 31, 2023 and provided an update on its 2023 financial guidance.
"INGREZZA's first quarter results highlight the steady progress we are making to help improve the lives of patients living with tardive dyskinesia, yet we still have a tremendous opportunity to help even more patients for many years to come," said Kevin Gorman , Ph.D., Chief Executive Officer of Neurocrine Biosciences. "We are executing well across our clinical portfolio and anticipate several important milestones in the months ahead including the August 20th PDUFA date for valbenazine for the treatment of chorea associated with Huntington disease. In addition, we remain on-track for top-line data in the second half of this year for several investigational programs, including crinecerfont for the treatment of pediatric and adult congenital adrenal hyperplasia."
| Three Months Ended March 31, | |||
| (unaudited, in millions, except per share data) | 2023 | 2022 | |
| Revenues: | |||
| Product sales, net | $ 415.3 | $ 305.0 | |
| Collaboration revenue | 5.1 | 5.6 | |
| Total revenues | $ 420.4 | $ 310.6 | |
| GAAP Research and Development (R&D) | $ 139.5 | $ 102.2 | |
| Non-GAAP R&D | $ 125.7 | $ 89.7 | |
| GAAP Selling, General and Administrative (SG&A) | $ 242.7 | $ 200.7 | |
| Non-GAAP SG&A | $ 216.6 | $ 176.2 | |
| GAAP net (loss) income | $ (76.6) | $ 13.9 | |
| GAAP (loss) earnings per share – diluted | $ (0.79) | $ 0.14 | |
| Non-GAAP net (loss) income | $ (49.5) | $ 29.7 | |
| Non-GAAP (loss) earnings per share – diluted | $ (0.51) | $ 0.30 | |
| (unaudited, in millions) | March 31, 2023 | December 31, 2022 | |
| Total cash, cash equivalents and marketable securities | $ 1,139.2 | $ 1,288.7 |
First Quarter INGREZZA Net Product Sales Highlights:
First 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.
Reiterated 2023 INGREZZA Sales and Updated Operating Expense Guidance:
| Range | |||
| (in millions) | Low | High | |
| INGREZZA Net Product Sales 1 | $ 1,670 | $ 1,770 | |
| GAAP R&D expense 2 | $ 550 | $ 580 | |
| Non-GAAP R&D expense 5 | $ 495 | $ 525 | |
| GAAP and Non-GAAP IPR&D 3 | $ 144 | $ 144 | |
| GAAP SG&A expense 4 | $ 850 | $ 870 | |
| Non-GAAP SG&A expense 5 | $ 730 | $ 750 |
| 1. | INGREZZA sales guidance for fiscal 2023 reflects expected sales of INGREZZA in tardive dyskinesia only. |
| 2. | GAAP R&D guidance reflects the progression of the Company's pipeline including multiple compounds in mid- to late-phase clinical development, 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. |
| 3. | IPR&D guidance reflects acquired in-process research and development once significant collaboration and licensing arrangements have been completed. IPR&D guidance includes $143.9 million associated with the new strategic collaboration with Voyager. |
| 4. | GAAP SG&A guidance reflects the continued investment in the expanded commercial organization to support INGREZZA and to support the anticipated approval for valbenazine to treat patients with chorea associated with Huntington disease. |
| 5. | Non-GAAP guidance adjusted to exclude estimated non-cash stock-based compensation expense of $55 million in R&D and $120 million in SG&A. |
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 Early Q4 2023 |
| Congenital Adrenal Hyperplasia (Pediatric) | Top-Line Registrational Data in Early Q4 2023 | |
| NBI-921352 ** (Selective Na V 1.6 Channel Blocker) | Focal Onset Seizure in Adults | Top-Line Phase 2 Data in Q4 2023 |
| NBI-1065846 † (GPR-139 Agonist) | Anhedonia in Major Depressive Disorder | Top-Line Phase 2 Data in Q4 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 800-895-3361 (US) or 785-424-1062 (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*, 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, Twitter and Facebook. (* 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.
| TABLE 1 | |||
| NEUROCRINE BIOSCIENCES, INC. | |||
| CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS | |||
| (unaudited) | |||
| Three Months Ended March 31, | |||
| (in millions, except per share data) | 2023 | 2022 | |
| Revenues: | |||
| Product sales, net | $ 415.3 | $ 305.0 | |
| Collaboration revenue | 5.1 | 5.6 | |
| Total revenues | 420.4 | 310.6 | |
| Operating expenses: | |||
| Cost of revenues | 8.5 | 4.6 | |
| Research and development | 139.5 | 102.2 | |
| Acquired in-process research and development | 143.9 | — | |
| Selling, general and administrative | 242.7 | 200.7 | |
| Total operating expenses | 534.6 | 307.5 | |
| Operating (loss) income | (114.2) | 3.1 | |
| Other income (expense): | |||
| Interest expense | (1.1) | (2.6) | |
| Unrealized gain on equity security investments | 2.2 | 19.9 | |
| Investment income and other, net | 9.8 | 1.0 | |
| Total other income, net | 10.9 | 18.3 | |
| (Loss) income before (benefit from) provision for income taxes | (103.3) | 21.4 | |
| (Benefit from) provision for income taxes | (26.7) | 7.5 | |
| Net (loss) income | $ (76.6) | $ 13.9 | |
| (Loss) earnings per share, basic | $ (0.79) | $ 0.15 | |
| (Loss) earnings per share, diluted | $ (0.79) | $ 0.14 | |
| Weighted average common shares outstanding, basic | 97.1 | 95.3 | |
| Weighted average common shares outstanding, diluted | 97.1 | 97.6 |
| TABLE 2 | |||
| NEUROCRINE BIOSCIENCES, INC. | |||
| CONDENSED CONSOLIDATED BALANCE SHEETS | |||
| (unaudited) | |||
| (in millions) | March 31, 2023 | December 31, 2022 | |
| Cash, cash equivalents and debt securities available-for-sale | $ 894.6 | $ 989.3 | |
| Other current assets | 538.2 | 464.2 | |
| Total current assets | 1,432.8 | 1,453.5 | |
| Deferred tax assets | 337.4 | 305.9 | |
| Debt securities available-for-sale | 244.6 | 299.4 | |
| Right-of-use assets | 84.4 | 87.0 | |
| Equity security investments | 135.7 | 102.1 | |
| Property and equipment, net | 62.8 | 58.6 | |
| Intangible assets, net | 37.2 | 37.2 | |
| Other assets | 24.9 | 25.0 | |
| Total assets | $ 2,359.8 | $ 2,368.7 | |
| Convertible senior notes | $ — | $ 169.4 | |
| Other current liabilities | 374.1 | 368.3 | |
| Total current liabilities | 374.1 | 537.7 | |
| Convertible senior notes | 169.5 | — | |
| Operating lease liabilities | 90.4 | 93.5 | |
| Other long-term liabilities | 41.3 | 29.7 | |
| Stockholders' equity | 1,684.5 | 1,707.8 | |
| Total liabilities and stockholders' equity | $ 2,359.8 | $ 2,368.7 |
| 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) | 2023 | 2022 | |
| GAAP net (loss) income | $ (76.6) | $ 13.9 | |
| Adjustments: | |||
| Stock-based compensation expense - R&D | 13.8 | 12.5 | |
| Stock-based compensation expense - SG&A | 26.1 | 24.5 | |
| Non-cash interest related to convertible senior notes | 0.2 | 0.4 | |
| Non-cash amortization related to acquired intangible assets | 0.9 | — | |
| Changes in fair value of equity security investments 1 | (2.2) | (19.9) | |
| Income tax effect related to reconciling items 2 | (11.7) | (1.7) | |
| Non-GAAP net (loss) income | $ (49.5) | $ 29.7 | |
| Diluted (loss) earnings per share: | |||
| GAAP | $ (0.79) | $ 0.14 | |
| Non-GAAP | $ (0.51) | $ 0.30 |
| 1. | Reflects periodic fluctuations in the fair values of the Company's equity security investments. |
| 2. | 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 March 31, | |||
| (in millions) | 2023 | 2022 | |
| GAAP cost of revenues | $ 8.5 | $ 4.6 | |
| Adjustments: | |||
| Non-cash amortization related to acquired intangible assets | 0.9 | — | |
| Non-GAAP cost of revenues | $ 7.6 | $ 4.6 | |
| Three Months Ended March 31, | |||
| (in millions) | 2023 | 2022 | |
| GAAP R&D | $ 139.5 | $ 102.2 | |
| Adjustments: | |||
| Stock-based compensation expense | 13.8 | 12.5 | |
| Non-GAAP R&D | $ 125.7 | $ 89.7 | |
| Three Months Ended March 31, | |||
| (in millions) | 2023 | 2022 | |
| GAAP SG&A | $ 242.7 | $ 200.7 | |
| Adjustments: | |||
| Stock-based compensation expense | 26.1 | 24.5 | |
| Non-GAAP SG&A | $ 216.6 | $ 176.2 | |
| Three Months Ended March 31, | |||
| (in millions) | 2023 | 2022 | |
| GAAP other income, net | $ 10.9 | $ 18.3 | |
| Adjustments: | |||
| Non-cash interest related to convertible senior notes | 0.2 | 0.4 | |
| Changes in fair value of equity security investments | (2.2) | (19.9) | |
| Non-GAAP other income (expense), net | $ 8.9 | $ (1.2) |
SOURCE Neurocrine Biosciences, Inc.