Neurocrine Biosciences Reports First Quarter 2024 Financial Results
Neurocrine Biosciences reported first-quarter 2024 financial results, with INGREZZA net product sales of $506 million, representing 23% growth year-over-year. They also announced FDA approval for INGREZZA SPRINKLE capsules and submitted New Drug Applications for crinecerfont. Positive Phase 2 data for NBI-1065845 in major depressive disorder was highlighted, along with strong financial performance and a robust pipeline, positioning the company as a neuroscience leader.
Strong first-quarter 2024 financial results with INGREZZA net product sales of $506 million, a 23% increase year-over-year.
FDA approval for INGREZZA SPRINKLE capsules and New Drug Applications submitted for crinecerfont demonstrate positive regulatory progress.
Positive Phase 2 data for NBI-1065845 in major depressive disorder indicates potential success in new medication development.
Robust pipeline and financial performance position Neurocrine Biosciences as a formidable player in the neuroscience industry.
Significant charge associated with convertible senior notes election impacted first-quarter 2024 financial results negatively.
Increased R&D expenses driven by expanding clinical portfolio may lead to higher operational costs in the future.
Flat SG&A expenses indicate cost-saving measures despite business growth and potential risks of overspending.
INGREZZA® (valbenazine) First Quarter Net Product Sales of
INGREZZA® SPRINKLE (valbenazine) Capsules Approved by the
Crinecerfont New Drug Applications for the Treatment of Congenital Adrenal Hyperplasia Submitted to the
Positive Phase 2 Top-Line Data for NBI-1065845, a Potential First-In-Class AMPA Positive Allosteric Modulator, in Adults with Major Depressive Disorder
"Significant unmet need still exists for the many patients living with tardive dyskinesia as exemplified with INGREZZA's first quarter year-over-year growth of
Financial Highlights
Three Months Ended March 31, | |||
(unaudited, in millions, except per share data) | 2024 | 2023 | |
Revenues: | |||
Net Product Sales | $ 509.0 | $ 415.3 | |
Collaboration Revenue | 6.3 | 5.1 | |
Total Revenues | $ 515.3 | $ 420.4 | |
GAAP Research and Development (R&D) | $ 159.4 | $ 139.5 | |
Non-GAAP R&D | $ 142.4 | $ 125.7 | |
GAAP Selling, General and Administrative (SG&A) | $ 243.1 | $ 242.7 | |
Non-GAAP SG&A | $ 215.6 | $ 216.6 | |
GAAP Net Income (Loss) | $ 43.4 | $ (76.6) | |
GAAP Earnings (Loss) Per Share – Diluted | $ 0.42 | $ (0.79) | |
Non-GAAP Net Income (Loss) | $ 124.8 | $ (49.5) | |
Non-GAAP Earnings (Loss) Per Share – Diluted | $ 1.20 | $ (0.51) | |
(unaudited, in millions) | March 31, 2024 | December 31, 2023 | |
Total Cash, Cash Equivalents and Marketable Securities | $ 1,911.0 | $ 1,719.1 | |
INGREZZA Net Product Sales Highlights
- INGREZZA first quarter 2024 net product sales were
$506 million 23% compared to the first quarter 2023 - Year-over-year growth driven by strong underlying patient demand and improvement in gross-to-net dynamics
Other Key Financial Highlights
- Differences in first quarter 2024 GAAP and non-GAAP operating expenses compared with first quarter 2023 were driven by:
- Increased R&D expense in support of an expanded and advancing clinical portfolio including preclinical investments in muscarinic compounds, gene therapy programs and second generation VMAT2 inhibitors
- Flat SG&A expense includes continued investment in INGREZZA and incremental investment in crinecerfont-related headcount and pre-launch activities
- First quarter 2024 GAAP net income and earnings per share were
$43 million $0.42 $77 million $0.79 - First quarter 2024 non-GAAP net income and earnings per share were
$125 million $1.20 $50 million $0.51 - Differences in first quarter 2024 GAAP and non-GAAP net income compared with first quarter 2023 driven by:
- Higher INGREZZA net sales and improved operating margin
- First quarter 2024 includes
$89 million - First quarter 2023 includes Acquired In-Process R&D (IPR&D) expense of
$144 million
- At March 31, 2024, the Company had cash, cash equivalents and marketable securities totaling approximately
$1
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
- In January, the Company elected to settle the convertible senior notes due May 2024 in cash.
- In April, the Company reported positive Phase 2 data for its completed Phase 2 study of NBI-1065845 in adult subjects with major depressive disorder. The study met its primary and key secondary endpoints, demonstrating that once-daily, oral administration of NBI-1065845 produced a statistically significant change from baseline in Montgomery Åsberg Depression Rating Scale (MADRS) total score at both Day 28 (primary endpoint) and Day 56 (key secondary endpoint).
- In April, the Company submitted two New Drug Applications to the FDA for crinecerfont as a treatment for adult and pediatric patients with classic congenital adrenal hyperplasia.
- In April, the Company received approval from the
U.S. Food and Drug Administration for INGREZZA SPRINKLE (valbenazine) capsules, a new oral granules formulation of INGREZZA (valbenazine) capsules.
Reaffirmed 2024 Net Sales Guidance and Updated Expense Guidance
Range | |||
(in millions) | Low | High | |
INGREZZA Net Product Sales 1 | $ 2,100 | $ 2,200 | |
GAAP R&D Expense 2 | $ 665 | $ 695 | |
Non-GAAP R&D Expense 3 | $ 600 | $ 630 | |
GAAP and Non-GAAP IPR&D 4 | $ 6 | $ 6 | |
GAAP SG&A Expense 5 | $ 920 | $ 940 | |
Non-GAAP SG&A Expense 3, 5 | $ 810 | $ 830 | |
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 approximately |
3. | Non-GAAP guidance adjusted primarily to exclude estimated non-cash stock-based compensation expense of |
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 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 |
INGREZZA* (Selective VMAT2 Inhibitor) | Sprinkle Formulation for Tardive Dyskinesia | Approved by FDA on April 30, 2024 |
Crinecerfont (CRF1 Receptor Antagonist) | Congenital Adrenal Hyperplasia (Pediatric and Adult) | Submitted New Drug Applications to the FDA |
NBI-1065845** (AMPA Potentiator) | Inadequate Response in Major Depressive Disorder | Reported Positive Top-Line Phase 2 Data; Engaging with FDA on Path Forward |
Efmody (Hydrocortisone Modified Release Hard Capsules) | Adrenal Insufficiency | Reported Positive Top-Line Phase 2 Data |
Efmody (Hydrocortisone Modified Release Hard Capsules) | Congenital Adrenal Hyperplasia | Reported Positive Top-Line Phase 2 Data |
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 | Initiated Phase 2 Study |
NBI-1065890 (Selective VMAT2 Inhibitor) | CNS Indications | Initiated Phase 1 Study |
NBI-1117569† (M4-Prefering Agonist) | CNS Indications | Initiated Phase 1 Study |
NBI-1117570† (M1/M4 Dual Agonist) | CNS Indications | Initiated Phase 1 Study |
NBI-1117567† (M1 Agonist) | CNS Indications | Initiating Phase 1 Study |
NBI-1076986 (M4 Antagonist) | Movement Disorders | 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 |
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 800-343-4136 (US) or 203-518-9814 (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
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 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 March 31, 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. CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (unaudited) | |||
Three Months Ended | |||
(in millions, except per share data) | 2024 | 2023 | |
Revenues: | |||
Net product sales | $ 509.0 | $ 415.3 | |
Collaboration revenue | 6.3 | 5.1 | |
Total revenues | 515.3 | 420.4 | |
Operating expenses: | |||
Cost of revenues | 7.5 | 8.5 | |
Research and development | 159.4 | 139.5 | |
Acquired in-process research and development | 6.0 | 143.9 | |
Selling, general and administrative | 243.1 | 242.7 | |
Total operating expenses | 416.0 | 534.6 | |
Operating income (loss) | 99.3 | (114.2) | |
Other (expense) income: | |||
Interest expense | (1.1) | (1.1) | |
Unrealized gain on equity security investments | 1.6 | 2.2 | |
Charges associated with convertible senior notes | (88.7) | — | |
Investment income and other, net | 23.4 | 9.8 | |
Total other (expense) income, net | (64.8) | 10.9 | |
Income (loss) before benefit from income taxes | 34.5 | (103.3) | |
Benefit from income taxes | (8.9) | (26.7) | |
Net income (loss) | $ 43.4 | $ (76.6) | |
Earnings (loss) per share, basic | $ 0.43 | $ (0.79) | |
Earnings (loss) per share, diluted | $ 0.42 | $ (0.79) | |
Weighted average common shares outstanding, basic | 99.8 | 97.1 | |
Weighted average common shares outstanding, diluted | 103.6 | 97.1 | |
TABLE 2 | |||
NEUROCRINE BIOSCIENCES, INC. CONDENSED CONSOLIDATED BALANCE SHEETS (unaudited) | |||
(in millions) | March 31, 2024 | December 31, 2023 | |
Cash, cash equivalents and marketable securities | $ 1,210.6 | $ 1,031.6 | |
Other current assets | 588.4 | 575.4 | |
Total current assets | 1,799.0 | 1,607.0 | |
Deferred tax assets | 378.2 | 362.6 | |
Debt securities available-for-sale | 700.4 | 687.5 | |
Right-of-use assets | 270.8 | 276.5 | |
Equity security investments | 163.5 | 161.9 | |
Property and equipment, net | 75.3 | 70.8 | |
Intangible assets, net | 34.3 | 35.5 | |
Other assets | 50.9 | 49.6 | |
Total assets | $ 3,472.4 | $ 3,251.4 | |
Convertible senior notes, at carrying value ( | $ 122.8 | $ 170.1 | |
Convertible senior notes embedded derivative liability | 136.2 | — | |
Other current liabilities | 453.9 | 484.7 | |
Total current liabilities | 712.9 | 654.8 | |
Operating lease liabilities | 252.9 | 258.3 | |
Other long-term liabilities | 120.5 | 106.3 | |
Stockholders' equity | 2,386.1 | 2,232.0 | |
Total liabilities and stockholders' equity | $ 3,472.4 | $ 3,251.4 | |
TABLE 3 | |||
NEUROCRINE BIOSCIENCES, INC. RECONCILIATION OF GAAP TO NON-GAAP FINANCIAL RESULTS (unaudited) | |||
Three Months Ended | |||
(in millions, except per share data) | 2024 | 2023 | |
GAAP net income (loss) | $ 43.4 | $ (76.6) | |
Adjustments: | |||
Stock-based compensation expense - R&D | 17.0 | 13.8 | |
Stock-based compensation expense - SG&A | 27.5 | 26.1 | |
Charges associated with convertible senior notes 1 | 88.7 | — | |
Non-cash interest related to convertible senior notes | 0.2 | 0.2 | |
Non-cash amortization related to acquired intangible assets | 0.9 | 0.9 | |
Changes in fair value of equity security investments 2 | (1.6) | (2.2) | |
Income tax effect related to reconciling items 3 | (51.3) | (11.7) | |
Non-GAAP net income | $ 124.8 | $ (49.5) | |
Diluted earnings per share: | |||
GAAP | $ 0.42 | $ (0.79) | |
Non-GAAP | $ 1.20 | $ (0.51) | |
1. | Reflects charges associated with election to cash settle principal and conversion premium of convertible senior notes and the requirement to bifurcate the embedded conversion option and accrete to other expense. |
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 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 | |||
(in millions) | 2024 | 2023 | |
GAAP cost of revenues | $ 7.5 | $ 8.5 | |
Adjustments: | |||
Non-cash amortization related to acquired intangible assets | 0.9 | 0.9 | |
Non-GAAP cost of revenues | $ 6.6 | $ 7.6 | |
Three Months Ended | |||
(in millions) | 2024 | 2023 | |
GAAP R&D | $ 159.4 | $ 139.5 | |
Adjustments: | |||
Stock-based compensation expense | 17.0 | 13.8 | |
Non-GAAP R&D | $ 142.4 | $ 125.7 | |
Three Months Ended | |||
(in millions) | 2024 | 2023 | |
GAAP SG&A | $ 243.1 | $ 242.7 | |
Adjustments: | |||
Stock-based compensation expense | 27.5 | 26.1 | |
Non-GAAP SG&A | $ 215.6 | $ 216.6 | |
Three Months Ended | |||
(in millions) | 2024 | 2023 | |
GAAP other (expense) income, net | $ (64.8) | $ 10.9 | |
Adjustments: | |||
Charges associated with convertible senior notes | 88.7 | — | |
Non-cash interest related to convertible senior notes | 0.2 | 0.2 | |
Changes in fair value of equity security investments | (1.6) | (2.2) | |
Non-GAAP other income, net | $ 22.5 | $ 8.9 | |
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SOURCE Neurocrine Biosciences, Inc.
FAQ
What were Neurocrine Biosciences' INGREZZA net product sales for the first quarter of 2024?
Neurocrine Biosciences reported INGREZZA net product sales of $506 million for the first quarter of 2024.
What positive development did Neurocrine Biosciences announce regarding NBI-1065845?
Neurocrine Biosciences reported positive Phase 2 data for NBI-1065845 in major depressive disorder.
What financial guidance did Neurocrine Biosciences provide for 2024?
Neurocrine Biosciences provided a range of financial guidance, including INGREZZA net product sales and R&D and SG&A expenses for 2024.
