SAN DIEGO, Aug. 1, 2024 /PRNewswire/ -- Neurocrine Biosciences, Inc. (Nasdaq: NBIX) today announced its financial results for the second quarter ended June 30, 2024 and provided an update on its 2024 financial guidance.
"At Neurocrine, we are energized by the tremendous opportunity we see to help many more patients, and we are encouraged by our recent progress, including INGREZZA's continued success in treating tardive dyskinesia and Huntington's disease chorea and the FDA's decision to grant Priority Review for crinecerfont to treat congenital adrenal hyperplasia," said Kevin Gorman, Ph.D., Chief Executive Officer of Neurocrine Biosciences. "We are in the process of building our endocrinology team and expanding the INGREZZA salesforce, positioning our company for continued strong growth in the years ahead."
Kevin Gorman added, "As I look ahead to my planned retirement in October, I have never been more confident in Neurocrine's future. I am incredibly proud of all that we have achieved together and excited to see what this team will continue to accomplish for patients under Kyle Gano's leadership."
Financial Highlights
Three Months Ended June 30, | Six Months Ended June 30, | ||||||
(unaudited, in millions, except per share data) | 2024 | 2023 | 2024 | 2023 | |||
Revenues: | |||||||
Net Product Sales | $ 583.8 | $ 446.3 | $ 1,092.8 | $ 861.6 | |||
Collaboration Revenue | 6.4 | 6.4 | 12.7 | 11.5 | |||
Total Revenues | $ 590.2 | $ 452.7 | $ 1,105.5 | $ 873.1 | |||
GAAP Research and Development (R&D) | $ 191.1 | $ 145.8 | $ 350.5 | $ 285.3 | |||
Non-GAAP R&D | $ 175.3 | $ 122.0 | $ 317.7 | $ 247.7 | |||
GAAP Selling, General and Administrative (SG&A) | $ 242.0 | $ 221.8 | $ 485.1 | $ 464.5 | |||
Non-GAAP SG&A | $ 200.7 | $ 177.1 | $ 416.3 | $ 393.7 | |||
GAAP Net Income | $ 65.0 | $ 95.5 | $ 108.4 | $ 18.9 | |||
GAAP Earnings Per Share – Diluted | $ 0.63 | $ 0.95 | $ 1.04 | $ 0.19 | |||
Non-GAAP Net Income | $ 168.9 | $ 125.7 | $ 293.7 | $ 76.2 | |||
Non-GAAP Earnings Per Share – Diluted | $ 1.63 | $ 1.25 | $ 2.83 | $ 0.76 | |||
(unaudited, in millions) | June 30, 2024 | December 31, 2023 | |||||
Total Cash, Cash Equivalents and Marketable Securities | $ 1,676.7 | $ 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
Raised 2024 Net Sales Guidance and Updated Expense Guidance
Range | |||
(in millions) | Low | High | |
INGREZZA Net Product Sales 1 | $ 2,250 | $ 2,300 | |
GAAP R&D Expense 2 | $ 665 | $ 695 | |
Non-GAAP R&D Expense 3 | $ 600 | $ 630 | |
GAAP and Non-GAAP IPR&D 4 | $ 9 | $ 9 | |
GAAP SG&A Expense 5 | $ 955 | $ 975 | |
Non-GAAP SG&A Expense 3, 5 | $ 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 $33 million of expense for development milestones in connection with our collaborations (Nxera, Voyager and Takeda) achieved or deemed probable to achieve. These milestone expenses are associated with our advancing pre-clinical and clinical pipeline. |
3. | Non-GAAP guidance adjusted to exclude estimated non-cash stock-based compensation expense of approximately $65 million in R&D and $110 million in SG&A and $14 million leased office space impairment charge 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 announced planned expansion of the psychiatry and long-term care sales teams and pre-launch commercial activities for crinecerfont. |
2024 Pipeline Milestones and Key Activities
Program | Indication | Milestones / Key Activities |
NBI-1065845* (AMPA Potentiator) | Inadequate Response in Major Depressive Disorder | Reported Positive Top-Line Phase 2 Data; Conducting End of Phase 2 Meeting with FDA; Initiating Phase 3 Studies in 2025 |
Crinecerfont (CRF1 Receptor Antagonist) | Congenital Adrenal Hyperplasia (Pediatric and Adult) | Priority Review with PDUFA Dates Set for December 29 and 30, 2024 |
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 | Phase 2 Study Ongoing; Top-Line Data in 2025 |
NBI-1065890 (Selective VMAT2 Inhibitor) | CNS Indications | Phase 1 Study Ongoing |
NBI-1117569** (M4-Prefering Agonist) | CNS Indications | Phase 1 Study Ongoing |
NBI-1117570** (M1/M4 Dual Agonist) | CNS Indications | Phase 1 Study Ongoing |
NBI-1117567** (M1 Agonist) | CNS Indications | Phase 1 Study Ongoing |
NBI-1076986 (M4 Antagonist) | Movement Disorders | Phase 1 Study Ongoing |
Key: AMPA = alpha-amino-3-hydroxy-5-methyl-4-isoxazole propionic acid; CFR1 = Corticotropin-Releasing Factor Type 1; M4 = M4 Muscarinic Receptor; DAAO = d-amino acid oxidase; NMDA NR2B NAM = n-methyl-d-aspartate Receptor Subtype 2B Negative Allosteric Modulator; VMAT2 = Vesicular Monoamine Transporter 2; M1 = M1 Muscarinic Receptor
Neurocrine Biosciences Partners: * 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 800-445-7795 (US) or 785-424-1699 (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, charges associated with convertible senior notes, impairment charges associated with leased properties, 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.
Forward-Looking Statements
In addition to historical facts, this press release contains forward-looking statements that involve a number of risks and uncertainties. These statements include, but are not limited to, statements related to: the benefits to be derived from our products and product candidates; the value our products and/or our product candidates may bring to patients; the continued success of INGREZZA; our financial and operating performance, including our future revenues, expenses, or profits; our collaborative partnerships; expected future clinical and regulatory milestones; and the timing of the initiation and/or completion of our clinical, regulatory, and other development activities and those of our collaboration partners. Among the factors that could cause actual results to differ materially from those indicated in the forward-looking statements are: our future financial and operating performance; risks and uncertainties associated with the commercialization of INGREZZA; risks that the crinecerfont New Drug Applications (NDAs) may not obtain regulatory approval, such approval may be delayed, or may not receive the benefits associated with priority review; risks related to the development of our product candidates; risks associated with our dependence on third parties for development, manufacturing, and commercialization activities for our products and product candidates, and our ability to manage these third parties; risks that the FDA or other regulatory authorities may make adverse decisions regarding our products or product candidates; risks that clinical development activities may not be initiated or completed on time or at all, or may be delayed for regulatory, manufacturing, or other reasons, may not be successful or replicate previous clinical trial results, may fail to demonstrate that our product candidates are safe and effective, or may not be predictive of real-world results or of results in subsequent clinical trials; risks that the potential benefits of the agreements with our collaboration partners may never be realized; risks that our products, and/or our product candidates may be precluded from commercialization by the proprietary or regulatory rights of third parties, or have unintended side effects, adverse reactions or incidents of misuse; risks associated with government and third-party regulatory and/or policy efforts which may, among other things, impose sales and pharmaceutical pricing controls on our products or limit coverage and/or reimbursement for our products; risks associated with competition from other therapies or products, including potential generic entrants for our products; and other risks described in our periodic reports filed with the SEC, including our Quarterly Report on Form 10-Q for the quarter ended June 30, 2024. Neurocrine Biosciences disclaims any obligation to update the statements contained in this press release after the date hereof other than as required by law.
TABLE 1 | |||||||
NEUROCRINE BIOSCIENCES, INC. | |||||||
Three Months Ended | Six Months Ended | ||||||
(in millions, except per share data) | 2024 | 2023 | 2024 | 2023 | |||
Revenues: | |||||||
Net product sales | $ 583.8 | $ 446.3 | $ 1,092.8 | $ 861.6 | |||
Collaboration revenue | 6.4 | 6.4 | 12.7 | 11.5 | |||
Total revenues | 590.2 | 452.7 | 1,105.5 | 873.1 | |||
Operating expenses: | |||||||
Cost of revenues | 9.2 | 11.5 | 16.7 | 20.0 | |||
Research and development | 191.1 | 145.8 | 350.5 | 285.3 | |||
Acquired in-process research and development | 2.5 | — | 8.5 | 143.9 | |||
Selling, general and administrative | 242.0 | 221.8 | 485.1 | 464.5 | |||
Total operating expenses | 444.8 | 379.1 | 860.8 | 913.7 | |||
Operating income (loss) | 145.4 | 73.6 | 244.7 | (40.6) | |||
Other (expense) income: | |||||||
Unrealized (loss) gain on equity securities | (19.9) | 37.3 | (18.3) | 39.5 | |||
Charges associated with convertible senior notes | (49.7) | — | (138.4) | — | |||
Investment income and other, net | 22.8 | 10.7 | 45.1 | 19.4 | |||
Total other (expense) income, net | (46.8) | 48.0 | (111.6) | 58.9 | |||
Income before provision for income taxes | 98.6 | 121.6 | 133.1 | 18.3 | |||
Provision for (benefit from) income taxes | 33.6 | 26.1 | 24.7 | (0.6) | |||
Net income | $ 65.0 | $ 95.5 | $ 108.4 | $ 18.9 | |||
Earnings per share, basic | $ 0.64 | $ 0.98 | $ 1.08 | $ 0.19 | |||
Earnings per share, diluted | $ 0.63 | $ 0.95 | $ 1.04 | $ 0.19 | |||
Weighted average common shares outstanding, basic | 100.8 | 97.6 | 100.3 | 97.4 | |||
Weighted average common shares outstanding, diluted | 103.9 | 100.2 | 103.8 | 100.3 | |||
TABLE 2 | |||
NEUROCRINE BIOSCIENCES, INC. | |||
(in millions) | June 30, 2024 | December 31, 2023 | |
Cash, cash equivalents and marketable securities | $ 1,038.9 | $ 1,031.6 | |
Other current assets | 630.9 | 575.4 | |
Total current assets | 1,669.8 | 1,607.0 | |
Deferred tax assets | 419.5 | 362.6 | |
Debt securities available-for-sale | 637.8 | 687.5 | |
Right-of-use assets | 262.9 | 276.5 | |
Equity security investments | 143.6 | 161.9 | |
Property and equipment, net | 80.1 | 70.8 | |
Intangible assets, net | 33.5 | 35.5 | |
Other noncurrent assets | 57.8 | 49.6 | |
Total assets | $ 3,305.0 | $ 3,251.4 | |
Convertible senior notes | $ — | $ 170.1 | |
Other current liabilities | 398.5 | 484.7 | |
Total current liabilities | 398.5 | 654.8 | |
Noncurrent operating lease liabilities | 256.2 | 258.3 | |
Other noncurrent long-term liabilities | 141.1 | 106.3 | |
Stockholders' equity | 2,509.2 | 2,232.0 | |
Total liabilities and stockholders' equity | $ 3,305.0 | $ 3,251.4 | |
TABLE 3 | |||||||
NEUROCRINE BIOSCIENCES, INC. | |||||||
Three Months Ended | Six Months Ended | ||||||
(in millions, except per share data) | 2024 | 2023 | 2024 | 2023 | |||
GAAP net income 1 | $ 65.0 | $ 95.5 | $ 108.4 | $ 18.9 | |||
Adjustments: | |||||||
Stock-based compensation expense - R&D | 15.8 | 23.8 | 32.8 | 37.6 | |||
Stock-based compensation expense - SG&A | 27.3 | 44.7 | 54.8 | 70.8 | |||
Charges associated with convertible senior notes 2 | 49.7 | — | 138.4 | — | |||
Impairment charges associated with leased properties 3 | 14.0 | — | 14.0 | — | |||
Non-cash amortization related to acquired intangible assets | 0.9 | 0.9 | 1.8 | 1.8 | |||
Changes in fair value of equity security investments 4 | 19.9 | (37.3) | 18.3 | (39.5) | |||
Other | 0.1 | 0.2 | 0.3 | 0.4 | |||
Income tax effect related to reconciling items 5 | (23.8) | (2.1) | (75.1) | (13.8) | |||
Non-GAAP net income | $ 168.9 | $ 125.7 | $ 293.7 | $ 76.2 | |||
Diluted earnings per share: | |||||||
GAAP | $ 0.63 | $ 0.95 | $ 1.04 | $ 0.19 | |||
Non-GAAP | $ 1.63 | $ 1.25 | $ 2.83 | $ 0.76 | |||
1. | Three and six months ended June 30, 2024 reflect $26.5 million and $32.6 million, respectively, of development milestone expense achieved under collaboration agreements. Six months ended June 30, 2023 reflects IPR&D expense of $143.9 million related to expansion of strategic partnership with Voyager Therapeutics, Inc. |
2. | Reflects charges associated with the settlement of convertible senior notes conversions. |
3. | Reflects impairment charges associated with leased office space that has been vacated as the Company continues to occupy its new campus facility. |
4. | Reflects periodic fluctuations in the fair values of the Company's equity security investments. |
5. | 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 | Six Months Ended | ||||||
(in millions) | 2024 | 2023 | 2024 | 2023 | |||
GAAP cost of revenues | $ 9.2 | $ 11.5 | $ 16.7 | $ 20.0 | |||
Adjustments: | |||||||
Non-cash amortization related to acquired intangible assets | 0.9 | 0.9 | 1.8 | 1.8 | |||
Non-GAAP cost of revenues | $ 8.3 | $ 10.6 | $ 14.9 | $ 18.2 | |||
Three Months Ended | Six Months Ended | ||||||
(in millions) | 2024 | 2023 | 2024 | 2023 | |||
GAAP R&D | $ 191.1 | $ 145.8 | $ 350.5 | $ 285.3 | |||
Adjustments: | |||||||
Stock-based compensation expense | 15.8 | 23.8 | 32.8 | 37.6 | |||
Non-GAAP R&D | $ 175.3 | $ 122.0 | $ 317.7 | $ 247.7 | |||
Three Months Ended | Six Months Ended | ||||||
(in millions) | 2024 | 2023 | 2024 | 2023 | |||
GAAP SG&A | $ 242.0 | $ 221.8 | $ 485.1 | $ 464.5 | |||
Adjustments: | |||||||
Stock-based compensation expense | 27.3 | 44.7 | 54.8 | 70.8 | |||
Impairment charges associated with leased properties | 14.0 | — | 14.0 | — | |||
Non-GAAP SG&A | $ 200.7 | $ 177.1 | $ 416.3 | $ 393.7 | |||
Three Months Ended | Six Months Ended | ||||||
(in millions) | 2024 | 2023 | 2024 | 2023 | |||
GAAP other (expense) income, net | $ (46.8) | $ 48.0 | $ (111.6) | $ 58.9 | |||
Adjustments: | |||||||
Charges associated with convertible senior notes | 49.7 | — | 138.4 | — | |||
Changes in fair value of equity security investments | 19.9 | (37.3) | 18.3 | (39.5) | |||
Other | 0.1 | 0.2 | 0.3 | 0.4 | |||
Non-GAAP other income, net | $ 22.9 | $ 10.9 | $ 45.4 | $ 19.8 | |||
| Last Trade: | US$138.37 |
| Daily Change: | -1.07 -0.77 |
| Daily Volume: | 268,054 |
| Market Cap: | US$14.010B |
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