Neurocrine Biosciences Reports Fourth Quarter and Fiscal 2023 Financial Results and Provides Financial Expectations for 2024
- Year-over-year growth of 25% and 29% in net product sales for the fourth quarter and full year of 2023, respectively
- Full-year 2024 net product sales guidance of $2.1 - $2.2 billion
- Crinecerfont FDA regulatory submission anticipated in the second quarter for the treatment of Congenital Adrenal Hyperplasia
- Increased GAAP and non-GAAP net income and earnings per share
- Resolution of patent litigation and Breakthrough Therapy designation for crinecerfont
- Provided financial guidance for 2024 and expected pipeline milestones and key activities
- None.
Insights
The reported year-over-year growth in net product sales for INGREZZA is a significant indicator of Neurocrine Biosciences' financial health and market performance. A 25% increase in Q4 and a 29% increase for the full year suggest robust demand and effective market penetration for INGREZZA, which is used to treat tardive dyskinesia. The growth trajectory is also promising for investors, as it reflects the company's ability to scale its sales efforts successfully.
Furthermore, the company's guidance for 2024, projecting net product sales between $2.1 and $2.2 billion, provides a clear expectation of continued growth. This forward-looking statement can influence investor sentiment and stock valuation, as it suggests confidence in the company's pipeline and commercial strategy. However, it's important to note that such projections are subject to market conditions and regulatory developments, which can impact actual future performance.
From a financial perspective, the increase in both GAAP and non-GAAP R&D and SG&A expenses reflect the company's strategic reinvestment into its product pipeline and commercial capabilities. While increased expenses can pressure short-term earnings, they are often necessary for long-term growth and competitiveness in the biopharmaceutical industry.
The Breakthrough Therapy designation for crinecerfont, aimed at treating Congenital Adrenal Hyperplasia (CAH), is a critical milestone. This designation can expedite the development and review process, potentially leading to faster market access. For stakeholders, this suggests a strategic expansion of Neurocrine Biosciences' portfolio into endocrinology, diversifying its neurological focus.
The anticipated FDA regulatory submission in Q2 for crinecerfont represents an upcoming inflection point. If approved, crinecerfont would address a significant unmet medical need for CAH patients, potentially leading to a new revenue stream for the company. Stakeholders should monitor the FDA's response, as any delays or issues in the approval process could impact the company's projected growth.
Neurocrine Biosciences' cash, cash equivalents and marketable securities total approximately $1.7 billion as of December 31, 2023. This strong cash position provides the company with the financial flexibility to invest in R&D, support commercial initiatives and navigate market uncertainties. For investors, a robust balance sheet is often seen as a buffer against operational risks and a facilitator for strategic opportunities, such as mergers and acquisitions or licensing deals.
The resolution of patent litigation and the allowance for generic versions of INGREZZA to be sold starting March 2038 provides long-term clarity on the product's exclusivity period. While this does not have immediate financial impact, it ensures that investors can assess the value of INGREZZA's revenue stream without near-term generic competition concerns.
INGREZZA® (valbenazine) Fourth Quarter and Full Year 2023 Net Product Sales of
INGREZZA® (valbenazine) Full Year 2024 Net Product Sales Guidance of
Crinecerfont FDA Regulatory Submission Anticipated in the Second Quarter for the Treatment of Congenital Adrenal Hyperplasia in Adults and Pediatrics
"I'm exceptionally proud of the progress we made with INGREZZA last year, helping more patients than ever before treat their tardive dyskinesia. In addition, the positive Phase 3 crinecerfont results for the treatment of congenital adrenal hyperplasia opens the door for us to help patients living with a disabling neuroendocrine disorder," said Kevin Gorman, Ph.D., Chief Executive Officer of Neurocrine Biosciences. "With a strong foundation in INGREZZA, a potential second important growth driver in crinecerfont, and an advancing pipeline, Neurocrine Biosciences is making significant progress towards becoming a leading neuroscience focused company."
Financial Highlights
Three Months Ended December 31, | Twelve Months Ended December 31, | ||||||
(unaudited, in millions, except per share data) | 2023 | 2022 | 2023 | 2022 | |||
Revenues: | |||||||
Net Product Sales | $ 507.2 | $ 404.6 | $ 1,860.6 | $ 1,440.9 | |||
Collaboration Revenue | 8.0 | 7.4 | 26.5 | 47.8 | |||
Total Revenues | $ 515.2 | $ 412.0 | $ 1,887.1 | $ 1,488.7 | |||
GAAP Research and Development (R&D) | $ 137.5 | $ 118.0 | $ 565.0 | $ 463.8 | |||
Non-GAAP R&D | $ 124.3 | $ 103.9 | $ 497.0 | $ 406.1 | |||
GAAP Selling, General and Administrative (SG&A) | $ 218.9 | $ 182.9 | $ 887.6 | $ 752.7 | |||
Non-GAAP SG&A | $ 194.0 | $ 151.8 | $ 757.4 | $ 635.6 | |||
GAAP Net Income | $ 147.7 | $ 89.0 | $ 249.7 | $ 154.5 | |||
GAAP Earnings Per Share – Diluted | $ 1.44 | $ 0.88 | $ 2.47 | $ 1.56 | |||
Non-GAAP Net Income | $ 157.7 | $ 124.7 | $ 390.0 | $ 343.2 | |||
Non-GAAP Earnings Per Share – Diluted | $ 1.54 | $ 1.24 | $ 3.86 | $ 3.47 | |||
(unaudited, in millions) | December 31, 2023 | December 31, 2022 | |||||
Total Cash, Cash Equivalents and Marketable Securities | $ 1,719.1 | $ 1,288.7 | |||||
INGREZZA Net Product Sales Highlights
- INGREZZA fourth quarter and fiscal 2023 net product sales were
$500 million $1.84 billion - INGREZZA fourth quarter net product sales grew
25% compared with fourth quarter 2022, driven by strong underlying patient demand offset slightly by seasonal gross-to-net dynamics
Other Key Financial Highlights
- Differences in fourth quarter 2023 GAAP and non-GAAP operating expenses compared with fourth quarter 2022 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
- Increased SG&A expense primarily due to ongoing commercial initiatives supporting INGREZZA growth including the expanded indication to treat chorea associated with Huntington's disease
- Fourth quarter 2023 GAAP net income and earnings per share were
$148 million $1.44 $89 million $0.88 - Fourth quarter 2023 non-GAAP net income and earnings per share were
$158 million $1.54 $125 million $1.24 - At December 31, 2023, the Company had cash, cash equivalents and marketable securities totaling approximately
$1.7 billion
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 November 2023, the Company announced that all patent litigation brought by Neurocrine Biosciences against the companies that filed Abbreviated New Drug Applications (ANDA) to the FDA seeking approval to market generic versions of INGREZZA prior to the expiration of the Orange Book listed patents have been resolved. Accordingly, such companies have the right to sell generic versions of INGREZZA in the
U.S. beginning March 2038, or earlier under certain circumstances. - In December 2023, the Company announced crinecerfont received Breakthrough Therapy designation from the FDA for the treatment of Congenital Adrenal Hyperplasia in adults and pediatrics.
Full Year 2024 Financial Guidance
Range | |||
(in millions) | Low | High | |
INGREZZA Net Product Sales 1 | $ 2,100 | $ 2,200 | |
GAAP R&D Expense 2 | $ 645 | $ 675 | |
Non-GAAP R&D Expense 3 | $ 570 | $ 600 | |
GAAP SG&A Expense 4 | $ 930 | $ 950 | |
Non-GAAP SG&A Expense 3, 4 | $ 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 expense for development milestones once determined achievement is deemed probable. Acquired in-process research and development expense is included in guidance once significant collaboration and licensing arrangements have been completed. |
3. | Non-GAAP guidance adjusted primarily to exclude estimated non-cash stock-based compensation expense of |
4. | 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 |
Valbenazine* (Selective VMAT2 Inhibitor) | Sprinkle Formulation for Tardive Dyskinesia | PDUFA April 30, 2024 |
Crinecerfont (CRF1 Receptor Antagonist) | Congenital Adrenal Hyperplasia (Pediatric and Adult) | Submitting New Drug Application to the |
Efmody (Hydrocortisone Modified | Adrenal Insufficiency | Top-Line Phase 2 Data in 1H'24 |
Efmody (Hydrocortisone Modified | Congenital Adrenal Hyperplasia | Top-Line Phase 2 Data in 1H'24 |
NBI-1065845** (AMPA Potentiator) | Inadequate Response in Major Depressive | Top-Line Phase 2 Data in 1H'24 |
NBI-1117568† (M4 Agonist) | Schizophrenia | Top-Line Phase 2 Data in 2H'24 |
Luvadaxistat** (DAAO Inhibitor) | Cognitive Impairment Associated with | Top-Line Phase 2 Data in 2H'24 |
NBI-1070770** (NMDA NR2B NAM) | Major Depressive Disorder | Initiating Phase 2 Study |
NBI-1117567† (M1 Agonist) | CNS Indications | Initiating Phase 1 Study |
NBI-1076986 (M4 Antagonist) | Movement Disorders | Initiating Phase 1 Study |
NBI-1065890 (Selective VMAT2 Inhibitor) | CNS Indications | 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 800-225-9448 (US) or 203-518-9708 (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, 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 is a registered trademark 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 September 30, 2023. 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 | Twelve Months Ended | ||||||
(in millions, except per share data) | 2023 | 2022 | 2023 | 2022 | |||
Revenues: | |||||||
Net product sales | $ 507.2 | $ 404.6 | $ 1,860.6 | $ 1,440.9 | |||
Collaboration revenue | 8.0 | 7.4 | 26.5 | 47.8 | |||
Total revenues | 515.2 | 412.0 | 1,887.1 | 1,488.7 | |||
Operating expenses: | |||||||
Cost of revenues | 8.5 | 7.7 | 39.7 | 23.2 | |||
Research and development | 137.5 | 118.0 | 565.0 | 463.8 | |||
Acquired in-process research and development | — | — | 143.9 | — | |||
Selling, general and administrative | 218.9 | 182.9 | 887.6 | 752.7 | |||
Total operating expenses | 364.9 | 308.6 | 1,636.2 | 1,239.7 | |||
Operating income | 150.3 | 103.4 | 250.9 | 249.0 | |||
Other income (expense): | |||||||
Interest expense | (1.1) | (1.1) | (4.6) | (7.1) | |||
Unrealized gain on equity security investments | 29.0 | 7.2 | 28.4 | 30.8 | |||
Loss on extinguishment of convertible senior notes | — | — | — | (70.0) | |||
Investment income and other, net | 20.0 | 8.4 | 57.4 | 11.2 | |||
Total other income (expense), net | 47.9 | 14.5 | 81.2 | (35.1) | |||
Income before provision for income taxes | 198.2 | 117.9 | 332.1 | 213.9 | |||
Provision for income taxes | 50.5 | 28.9 | 82.4 | 59.4 | |||
Net income | $ 147.7 | $ 89.0 | $ 249.7 | $ 154.5 | |||
Earnings per share, basic | $ 1.50 | $ 0.92 | $ 2.56 | $ 1.61 | |||
Earnings per share, diluted | $ 1.44 | $ 0.88 | $ 2.47 | $ 1.56 | |||
Weighted average common shares outstanding, basic | 98.4 | 96.3 | 97.7 | 95.8 | |||
Weighted average common shares outstanding, diluted | 102.3 | 100.8 | 101.0 | 98.9 | |||
TABLE 2
NEUROCRINE BIOSCIENCES, INC. CONDENSED CONSOLIDATED BALANCE SHEETS (unaudited) | |||
(in millions) | December 31, 2023 | December 31, 2022 | |
Cash, cash equivalents and marketable securities | $ 1,031.6 | $ 989.3 | |
Other current assets | 575.4 | 464.2 | |
Total current assets | 1,607.0 | 1,453.5 | |
Deferred tax assets | 362.6 | 305.9 | |
Debt securities available-for-sale | 687.5 | 299.4 | |
Right-of-use assets | 276.5 | 87.0 | |
Equity security investments | 161.9 | 102.1 | |
Property and equipment, net | 70.8 | 58.6 | |
Intangible assets, net | 35.5 | 37.2 | |
Other assets | 49.6 | 25.0 | |
Total assets | $ 3,251.4 | $ 2,368.7 | |
Convertible senior notes | $ 170.1 | $ 169.4 | |
Other current liabilities | 484.7 | 368.3 | |
Total current liabilities | 654.8 | 537.7 | |
Operating lease liabilities | 258.3 | 93.5 | |
Other long-term liabilities | 106.3 | 29.7 | |
Stockholders' equity | 2,232.0 | 1,707.8 | |
Total liabilities and stockholders' equity | $ 3,251.4 | $ 2,368.7 | |
TABLE 3
NEUROCRINE BIOSCIENCES, INC. RECONCILIATION OF GAAP TO NON-GAAP FINANCIAL RESULTS (unaudited) | |||||||
Three Months Ended | Twelve Months Ended | ||||||
(in millions, except per share data) | 2023 | 2022 | 2023 | 2022 | |||
GAAP net income | $ 147.7 | $ 89.0 | $ 249.7 | $ 154.5 | |||
Adjustments: | |||||||
Stock-based compensation expense - R&D | 13.2 | 14.1 | 68.0 | 57.7 | |||
Stock-based compensation expense - SG&A | 24.9 | 29.4 | 126.3 | 115.4 | |||
Loss on extinguishment of convertible senior notes 1 | — | — | — | 70.0 | |||
Non-cash interest related to convertible senior notes | 0.1 | 0.2 | 0.7 | 1.2 | |||
Non-cash amortization related to acquired intangible assets | 0.8 | 0.5 | 3.5 | 0.5 | |||
Acquisition and integration costs - SG&A 2 | — | 1.7 | 3.9 | 1.7 | |||
Changes in fair value of equity security investments 3 | (29.0) | (7.2) | (28.4) | (30.8) | |||
Changes in foreign currency exchange rates | — | (1.5) | — | 1.9 | |||
Income tax effect related to reconciling items 4 | — | (1.5) | (33.7) | (28.9) | |||
Non-GAAP net income | $ 157.7 | $ 124.7 | $ 390.0 | $ 343.2 | |||
Diluted earnings per share: | |||||||
GAAP | $ 1.44 | $ 0.88 | $ 2.47 | $ 1.56 | |||
Non-GAAP | $ 1.54 | $ 1.24 | $ 3.86 | $ 3.47 | |||
1. | The Company recognized a loss on extinguishment of |
2. | Reflects transaction and integration costs for contract terminations related to the Diurnal Group plc acquisition. |
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. |
TABLE 4
NEUROCRINE BIOSCIENCES, INC. RECONCILIATION OF GAAP TO NON-GAAP EXPENSES (unaudited) | |||||||
Three Months Ended | Twelve Months Ended | ||||||
(in millions) | 2023 | 2022 | 2023 | 2022 | |||
GAAP cost of revenues | $ 8.5 | $ 7.7 | $ 39.7 | $ 23.2 | |||
Adjustments: | |||||||
Non-cash amortization related to acquired intangible assets | 0.8 | 0.5 | 3.5 | 0.5 | |||
Non-GAAP cost of revenues | $ 7.7 | $ 7.2 | $ 36.2 | $ 22.7 | |||
Three Months Ended | Twelve Months Ended | ||||||
(in millions) | 2023 | 2022 | 2023 | 2022 | |||
GAAP R&D | $ 137.5 | $ 118.0 | $ 565.0 | $ 463.8 | |||
Adjustments: | |||||||
Stock-based compensation expense | 13.2 | 14.1 | 68.0 | 57.7 | |||
Non-GAAP R&D | $ 124.3 | $ 103.9 | $ 497.0 | $ 406.1 | |||
Three Months Ended | Twelve Months Ended | ||||||
(in millions) | 2023 | 2022 | 2023 | 2022 | |||
GAAP SG&A | $ 218.9 | $ 182.9 | $ 887.6 | $ 752.7 | |||
Adjustments: | |||||||
Stock-based compensation expense | 24.9 | 29.4 | 126.3 | 115.4 | |||
Acquisition and integration costs | — | 1.7 | 3.9 | 1.7 | |||
Non-GAAP SG&A | $ 194.0 | $ 151.8 | $ 757.4 | $ 635.6 | |||
Three Months Ended | Twelve Months Ended | ||||||
(in millions) | 2023 | 2022 | 2023 | 2022 | |||
GAAP other income (expense), net | $ 47.9 | $ 14.5 | $ 81.2 | $ (35.1) | |||
Adjustments: | |||||||
Loss on extinguishment of convertible senior notes | — | — | — | 70.0 | |||
Non-cash interest related to convertible senior notes | 0.1 | 0.2 | 0.7 | 1.2 | |||
Changes in fair value of equity security investments | (29.0) | (7.2) | (28.4) | (30.8) | |||
Changes in foreign currency exchange rates | — | (1.5) | — | 1.9 | |||
Non-GAAP other income, net | $ 19.0 | $ 6.0 | $ 53.5 | $ 7.2 | |||
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SOURCE Neurocrine Biosciences, Inc.
FAQ
What were Neurocrine Biosciences' net product sales for the fourth quarter and full year of 2023?
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