Full Press Release Details
INGREZZA ® (valbenazine) Second Quarter Net Product Sales of $440 Million Representing 26% Year-Over-Year Growth
INGREZZA ® (valbenazine) 2023 Net Product Sales Guidance Raised to $1.77 - $1.82 Billion
SAN DIEGO , Aug. 1, 2023 /PRNewswire/ -- Neurocrine Biosciences, Inc. (Nasdaq: NBIX ) today announced its financial results for the second quarter ended June 30, 2023 and raised net sales guidance for INGREZZA in 2023.
"INGREZZA's performance reflects the significant benefit the medicine is providing to patients with tardive dyskinesia enabling us to raise guidance once again," said Kevin Gorman , Ph.D., Chief Executive Officer of Neurocrine Biosciences. "Operationally, we are set up well in the second half of 2023 with growing INGREZZA sales, a PDUFA for valbenazine to treat chorea associated with Huntington's disease, and meaningful progress with our muscarinic programs. Importantly, we remain on-track for four pipeline read-outs in the fourth quarter, including the Phase 3 studies of crinecerfont for the treatment of pediatric and adult congenital adrenal hyperplasia."
| Three Months Ended June 30, | Six Months Ended June 30, | ||||||
| (unaudited, in millions, except per share data) | 2023 | 2022 | 2023 | 2022 | |||
| Revenues: | |||||||
| Net Product Sales | $ 446.3 | $ 352.0 | $ 861.6 | $ 657.0 | |||
| Collaboration Revenue | 6.4 | 26.2 | 11.5 | 31.8 | |||
| Total Revenues | $ 452.7 | $ 378.2 | $ 873.1 | $ 688.8 | |||
| GAAP Research and Development (R&D) | $ 145.8 | $ 135.9 | $ 285.3 | $ 238.1 | |||
| Non-GAAP R&D | $ 122.0 | $ 119.7 | $ 247.7 | $ 209.4 | |||
| GAAP Selling, General and Administrative (SG&A) | $ 221.8 | $ 182.8 | $ 464.5 | $ 383.5 | |||
| Non-GAAP SG&A | $ 177.1 | $ 149.5 | $ 393.7 | $ 325.7 | |||
| GAAP Net Income (Loss) | $ 95.5 | $ (16.9) | $ 18.9 | $ (3.0) | |||
| GAAP Earnings (Loss) Per Share – Diluted | $ 0.95 | $ (0.18) | $ 0.19 | $ (0.03) | |||
| Non-GAAP Net Income | $ 125.7 | $ 82.1 | $ 76.2 | $ 111.8 | |||
| Non-GAAP Earnings Per Share – Diluted | $ 1.25 | $ 0.84 | $ 0.76 | $ 1.14 | |||
| (unaudited, in millions) | June 30, 2023 | December 31, 2022 | |||||
| Total Cash, Cash Equivalents and Marketable Securities | $ 1,319.3 | $ 1,288.7 |
Second Quarter INGREZZA Net Product Sales Highlights:
Second 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.
Updated 2023 INGREZZA Sales Guidance and Reaffirmed Operating Expense Guidance:
| Range | |||
| (in millions) | Low | High | |
| INGREZZA Net Product Sales 1 | $ 1,770 | $ 1,820 | |
| GAAP R&D Expense 2 | $ 550 | $ 580 | |
| Non-GAAP R&D Expense 3 | $ 495 | $ 525 | |
| GAAP and Non-GAAP IPR&D 4 | $ 144 | $ 144 | |
| GAAP SG&A Expense | $ 850 | $ 870 | |
| Non-GAAP SG&A Expense 3 | $ 730 | $ 750 |
| 1. INGREZZA sales guidance for fiscal 2023 reflects expected sales of INGREZZA in tardive dyskinesia only. |
| 2. GAAP R&D guidance includes amounts for milestones that are probable of achievement or have been achieved. |
| 3. Non-GAAP guidance adjusted to exclude estimated non-cash stock-based compensation expense of $65 million in R&D and $135 million in SG &A. |
| 4. 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. |
| 2023 Expected Pipeline Milestones and Key Activities | ||
| Program | Indication | 2023 Milestones / Key Activities |
| Valbenazine * (Selective VMAT2 Inhibitor) | Chorea in Huntington's Disease | PDUFA Date = August 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 | Clinical Trial Application Accepted; Initiating Phase 1 Study in Q3 |
| 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 Corporation65 |
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 June 30, | Six Months Ended June 30, | |||||||
| (in millions, except per share data) | 2023 | 2022 | 2023 | 2022 | ||||
| Revenues: | ||||||||
| Net product sales | $ 446.3 | $ 352.0 | $ 861.6 | $ 657.0 | ||||
| Collaboration revenue | 6.4 | 26.2 | 11.5 | 31.8 | ||||
| Total revenues | 452.7 | 378.2 | 873.1 | 688.8 | ||||
| Operating expenses: | ||||||||
| Cost of revenues | 11.5 | 4.8 | 20.0 | 9.4 | ||||
| Research and development | 145.8 | 135.9 | 285.3 | 238.1 | ||||
| Acquired in-process research and development | — | — | 143.9 | — | ||||
| Selling, general and administrative | 221.8 | 182.8 | 464.5 | 383.5 | ||||
| Total operating expenses | 379.1 | 323.5 | 913.7 | 631.0 | ||||
| Operating income (loss) | 73.6 | 54.7 | (40.6) | 57.8 | ||||
| Other income (expense): | ||||||||
| Interest expense | (1.3) | (2.2) | (2.4) | (4.8) | ||||
| Unrealized gain (loss) on equity security investments | 37.3 | (7.4) | 39.5 | 12.5 | ||||
| Loss on extinguishment of convertible senior notes | — | (70.0) | — | (70.0) | ||||
| Investment income and other, net | 12.0 | 1.6 | 21.8 | 2.6 | ||||
| Total other income (expense), net | 48.0 | (78.0) | 58.9 | (59.7) | ||||
| Income (loss) before provision for (benefit from) income taxes | 121.6 | (23.3) | 18.3 | (1.9) | ||||
| Provision for (benefit from) income taxes | 26.1 | (6.4) | (0.6) | 1.1 | ||||
| Net income (loss) | $ 95.5 | $ (16.9) | $ 18.9 | $ (3.0) | ||||
| Earnings (loss) per share, basic | $ 0.98 | $ (0.18) | $ 0.19 | $ (0.03) | ||||
| Earnings (loss) per share, diluted | $ 0.95 | $ (0.18) | $ 0.19 | $ (0.03) | ||||
| Weighted average common shares outstanding, basic | 97.6 | 95.6 | 97.4 | 95.4 | ||||
| Weighted average common shares outstanding, diluted | 100.2 | 95.6 | 100.3 | 95.4 |
| TABLE 2 | |||
| NEUROCRINE BIOSCIENCES, INC. | |||
| CONDENSED CONSOLIDATED BALANCE SHEETS | |||
| (unaudited) | |||
| (in millions) | June 30, 2023 | December 31, 2022 | |
| Cash, cash equivalents and marketable securities | $ 976.7 | $ 989.3 | |
| Other current assets | 519.9 | 464.2 | |
| Total current assets | 1,496.6 | 1,453.5 | |
| Deferred tax assets | 379.0 | 305.9 | |
| Debt securities available-for-sale | 342.6 | 299.4 | |
| Right-of-use assets | 83.5 | 87.0 | |
| Equity security investments | 173.0 | 102.1 | |
| Property and equipment, net | 65.6 | 58.6 | |
| Intangible assets, net | 36.9 | 37.2 | |
| Other assets | 35.9 | 25.0 | |
| Total assets | $ 2,613.1 | $ 2,368.7 | |
| Convertible senior notes | $ 169.7 | $ 169.4 | |
| Other current liabilities | 412.8 | 368.3 | |
| Total current liabilities | 582.5 | 537.7 | |
| Operating lease liabilities | 89.1 | 93.5 | |
| Other long-term liabilities | 88.5 | 29.7 | |
| Stockholders' equity | 1,853.0 | 1,707.8 | |
| Total liabilities and stockholders' equity | $ 2,613.1 | $ 2,368.7 |
| TABLE 3 | |||||||
| NEUROCRINE BIOSCIENCES, INC. | |||||||
| RECONCILIATION OF GAAP TO NON-GAAP FINANCIAL RESULTS | |||||||
| (unaudited) | |||||||
| Three Months Ended June 30, | Six Months Ended June 30, | ||||||
| (in millions, except per share data) | 2023 | 2022 | 2023 | 2022 | |||
| GAAP net income (loss) | $ 95.5 | $ (16.9) | $ 18.9 | $ (3.0) | |||
| Adjustments: | |||||||
| Stock-based compensation expense - R&D | 23.8 | 16.2 | 37.6 | 28.7 | |||
| Stock-based compensation expense - SG&A | 44.7 | 33.3 | 70.8 | 57.8 | |||
| Loss on extinguishment of convertible senior notes 1 | — | 70.0 | — | 70.0 | |||
| Non-cash interest related to convertible senior notes | 0.2 | 0.4 | 0.4 | 0.8 | |||
| Non-cash amortization related to acquired intangible assets | 0.9 | — | 1.8 | — | |||
| Changes in fair value of equity security investments 2 | (37.3) | 7.4 | (39.5) | (12.5) | |||
| Income tax effect related to reconciling items 3 | (2.1) | (28.3) | (13.8) | (30.0) | |||
| Non-GAAP net income | $ 125.7 | $ 82.1 | $ 76.2 | $ 111.8 | |||
| Diluted earnings (loss) per share: | |||||||
| GAAP | $ 0.95 | $ (0.18) | $ 0.19 | $ (0.03) | |||
| Non-GAAP 4 | $ 1.25 | $ 0.84 | $ 0.76 | $ 1.14 |
| 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 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 non-cash stock- based compensation. |
| 4. Non-GAAP diluted earnings per share for the three and six months ended June 30, 2022, reflect diluted shares of 98.2 million and 97.9 million, respectively, which were calculated in accordance with the guidance on earnings per share in ASC 260. |
| TABLE 4 | |||||||
| NEUROCRINE BIOSCIENCES, INC. | |||||||
| RECONCILIATION OF GAAP TO NON-GAAP EXPENSES | |||||||
| (unaudited) | |||||||
| Three Months Ended June 30, | Six Months Ended June 30, | ||||||
| (in millions) | 2023 | 2022 | 2023 | 2022 | |||
| GAAP cost of revenues | $ 11.5 | $ 4.8 | $ 20.0 | $ 9.4 | |||
| Adjustments: | |||||||
| Non-cash amortization related to acquired intangible assets | 0.9 | — | 1.8 | — | |||
| Non-GAAP cost of revenues | $ 10.6 | $ 4.8 | $ 18.2 | $ 9.4 | |||
| Three Months Ended June 30, | Six Months Ended June 30, | ||||||
| (in millions) | 2023 | 2022 | 2023 | 2022 | |||
| GAAP R&D | $ 145.8 | $ 135.9 | $ 285.3 | $ 238.1 | |||
| Adjustments: | |||||||
| Stock-based compensation expense | 23.8 | 16.2 | 37.6 | 28.7 | |||
| Non-GAAP R&D | $ 122.0 | $ 119.7 | $ 247.7 | $ 209.4 | |||
| Three Months Ended June 30, | Six Months Ended June 30, | ||||||
| (in millions) | 2023 | 2022 | 2023 | 2022 | |||
| GAAP SG&A | $ 221.8 | $ 182.8 | $ 464.5 | $ 383.5 | |||
| Adjustments: | |||||||
| Stock-based compensation expense | 44.7 | 33.3 | 70.8 | 57.8 | |||
| Non-GAAP SG&A | $ 177.1 | $ 149.5 | $ 393.7 | $ 325.7 | |||
| Three Months Ended June 30, | Six Months Ended June 30, | ||||||
| (in millions) | 2023 | 2022 | 2023 | 2022 | |||
| GAAP other income, net | $ 48.0 | $ (78.0) | $ 58.9 | $ (59.7) | |||
| Adjustments: | |||||||
| Loss on extinguishment of convertible senior notes | — | 70.0 | — | 70.0 | |||
| Non-cash interest related to convertible senior notes | 0.2 | 0.4 | 0.4 | 0.8 | |||
| Changes in fair value of equity security investments | (37.3) | 7.4 | (39.5) | (12.5) | |||
| Non-GAAP other income (expense), net | $ 10.9 | $ (0.2) | $ 19.8 | $ (1.4) |
SOURCE Neurocrine Biosciences, Inc.